FIRVANQ is indicated for the treatment of Clostridium difficile‑associated diarrhea in adults and pediatric patients less than 18 years of age.

{ "type": "p", "children": [], "text": "FIRVANQ is indicated for the treatment of\n \n Clostridium difficile‑associated diarrhea in adults and pediatric patients less than 18 years of age.\n\n " }

FIRVANQ is also indicated for the treatment of enterocolitis caused by Staphylococcus aureus(including methicillin‑resistant strains) in adults and pediatric patients less than 18 years of age.

{ "type": "p", "children": [], "text": "FIRVANQ is also indicated for the treatment of enterocolitis caused by\n \n Staphylococcus aureus(including methicillin‑resistant strains) in adults and pediatric patients less than 18 years of age.\n\n " }

Important Limitations of Use

{ "type": "p", "children": [], "text": "\nImportant Limitations of Use\n" }

{ "type": "ul", "children": [ "Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin must be given orally for these infections.", "Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections." ], "text": "" }

To reduce the development of drug‑resistant bacteria and maintain the effectiveness of FIRVANQ and other antibacterial drugs, FIRVANQ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

{ "type": "p", "children": [], "text": "To reduce the development of drug‑resistant bacteria and maintain the effectiveness of FIRVANQ and other antibacterial drugs, FIRVANQ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy." }

Prior to oral administration, the supplied FIRVANQ powder must be reconstituted by the healthcare provider (i.e., a pharmacist) to produce the oral solution [ see Dosage and Administration ( 2.4) ].

For both C. difficile‑associated diarrhea and staphylococcal enterocolitis, the usual daily dosage of FIRVANQ is 40 mg/kg in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g.

Each FIRVANQ kit contains 1 bottle of vancomycin hydrochloride USP powder and 1 bottle of pre‑measured Grape‑Flavored Diluent to be added to the vancomycin bottle. A healthcare provider (i.e., a pharmacist) must reconstitute vancomycin hydrochloride USP powder with the Grape‑Flavored Diluent provided in the kit. FIRVANQ is available in various strengths and volumes in the kit as shown in Table 1.

<div class="scrollingtable"><table cellpadding="3.6pt" width="75%"> <caption> <span>Table 1: Vancomycin Concentration and Volume after Reconstitution</span> </caption> <col width="21%"/> <col width="21%"/> <col width="21%"/> <col width="21%"/> <thead> <tr class="First Last"> <th align="left" class="Botrule" valign="middle"><span class="Bold">Vancomycin Concentration after Reconstitution</span></th><th align="left" class="Botrule" valign="middle"><span class="Bold">Final Volume of FIRVANQ after Reconstitution</span></th><th align="left" class="Botrule" valign="middle"><span class="Bold">Vancomycin Strength per Bottle</span></th><th align="left" class="Botrule" valign="middle"><span class="Bold">Diluent for FIRVANQ</span></th> </tr> </thead> <tbody> <tr class="First"> <td class="Toprule" valign="top"> <p class="First">25 mg/mL</p> </td><td class="Toprule" valign="top"> <p class="First">150 mL</p> </td><td class="Toprule" valign="top"> <p class="First">3.75 g</p> </td><td class="Toprule" valign="top"> <p class="First">147 mL</p> </td> </tr> <tr> <td class="Botrule" valign="top"></td><td class="Botrule" valign="top"> <p class="First">300 mL</p> </td><td class="Botrule" valign="top"> <p class="First">7.5 g</p> </td><td class="Botrule" valign="top"> <p class="First">295 mL</p> </td> </tr> <tr> <td class="Toprule" valign="top"> <p class="First">50 mg/mL</p> </td><td class="Toprule" valign="top"> <p class="First">150 mL</p> </td><td class="Toprule" valign="top"> <p class="First">7.5 g</p> </td><td class="Toprule" valign="top"> <p class="First">145 mL</p> </td> </tr> <tr class="Last"> <td valign="top"></td><td valign="top"> <p class="First">300 mL</p> </td><td valign="top"> <p class="First">15.0 g</p> </td><td valign="top"> <p class="First">289 mL</p> </td> </tr> </tbody> </table></div>

Steps for the Preparation of Solutions of FIRVANQ

Each FIRVANQ kit contains vancomycin hydrochloride USP as white to almost white or tan to brown powder for oral solution, equivalent to 3.75 g, 7.5 g or 15.0 g vancomycin, and Grape‑Flavored Diluent for reconstitution.

{ "type": "p", "children": [], "text": "Each FIRVANQ kit contains vancomycin hydrochloride USP as white to almost white or tan to brown powder for oral solution, equivalent to 3.75 g, 7.5 g or 15.0 g vancomycin, and Grape‑Flavored Diluent for reconstitution." }

FIRVANQ is contraindicated in patients with known hypersensitivity to vancomycin.

{ "type": "p", "children": [], "text": "FIRVANQ is contraindicated in patients with known hypersensitivity to vancomycin." }

FIRVANQ must be given orally for treatment of C. difficile‑associated diarrhea and staphylococcal enterocolitis. Orally administered vancomycin is not effective for treatment of other types of infections.

Parenteral administration of vancomycin is noteffective for treatment of C. difficile‑associated diarrhea and staphylococcal enterocolitis. If parenteral vancomycin therapy is desired, use an intravenous preparation of vancomycin and consult the Full Prescribing Information accompanying that preparation.

Significant systemic absorption has been reported in some patients (e.g., patients with renal insufficiency and/or colitis) who have taken multiple oral doses of vancomycin hydrochloride for C. difficile‑associated diarrhea. In these patients, serum vancomycin concentrations reached therapeutic levels for the treatment of systemic infections. Some patients with inflammatory disorders of the intestinal mucosa also may have significant systemic absorption of vancomycin. These patients may be at risk for the development of adverse reactions associated with higher doses of FIRVANQ; therefore, monitoring of serum concentrations of vancomycin may be appropriate in some instances, e.g., in patients with renal insufficiency and/or colitis or in those receiving concomitant therapy with an aminoglycoside antibacterial drug.

Nephrotoxicity (e.g., reports of renal failure, renal impairment, blood creatinine increased) has occurred following oral vancomycin hydrochloride therapy in randomized controlled clinical trials and can occur either during or after completion of therapy. The risk of nephrotoxicity is increased in patients over 65 years of age [ see Adverse Reactions ( 6.1) and Use in Specific Populations ( 8.5) ].

In patients over 65 years of age, including those with normal renal function prior to treatment, renal function should be monitored during and following treatment with FIRVANQ to detect potential vancomycin- induced nephrotoxicity.

Ototoxicity has occurred in patients receiving vancomycin. It may be transient or permanent. It has been reported mostly in patients who have been given high intravenous doses, who have an underlying hearing loss, or who are receiving concomitant therapy with another ototoxic agent, such as an aminoglycoside. Serial tests of auditory function may be helpful in order to minimize the risk of ototoxicity [ see Adverse Reactions ( 6.2) ].

Severe dermatologic reactions such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and linear lgA bullous dermatosis (LABD) have been reported in association with the use of vancomycin. Cutaneous signs or symptoms reported include skin rashes, mucosal lesions, and blisters. Discontinue FIRVANQ at the first appearance of signs and symptoms of TEN, SJS, DRESS, AGEP, or LABD.

Use of FIRVANQ may result in the overgrowth of non‑susceptible bacteria. If superinfection occurs during therapy, appropriate measures should be taken.

Prescribing FIRVANQ in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug‑resistant bacteria.

Hemorrhagic occlusive retinal vasculitis, including permanent loss of vision, occurred in patients receiving intracameral or intravitreal administration of vancomycin during or after cataract surgery. The safety and efficacy of vancomycin administered by the intracameral or intravitreal route have not been established by adequate and well‑controlled studies. Vancomycin is not indicated for prophylaxis of endophthalmitis.

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to vancomycin hydrochloride in 260 adult subjects in two Phase 3 clinical trials for the treatment of C. difficile‑associated diarrhea. In both trials, subjects received vancomycin hydrochloride 125 mg orally four times daily. The mean duration of treatment was 9.4 days. The median age of patients was 67, ranging between 19 and 96 years of age. Patients were predominantly Caucasian (93%), and 52% were male.

Adverse reactions occurring in ≥ 5% of vancomycin hydrochloride‑treated subjects are shown in Table 2. The most common adverse reactions associated with vancomycin hydrochloride (≥ 10%) were nausea, abdominal pain, and hypokalemia.

<div class="scrollingtable"><table cellpadding="3.6pt" width="75%"> <caption> <span>Table 2: Common (≥ 5%) Adverse Reactions* for Vancomycin Hydrochloride Reported in Clinical Trials for Treatment of C. difficile Associated Diarrhea</span> </caption> <col width="28%"/> <col width="28%"/> <col width="30%"/> <tfoot> <tr class="First Last"> <td align="left" class="Botrule" colspan="3" valign="top">* Adverse reaction rates were derived from the incidence of treatment‑emergent adverse events.</td> </tr> </tfoot> <tbody class="Headless"> <tr class="First Toprule"> <td class="Botrule" valign="middle"> <p class="First"> <span class="Bold">System/Organ Class</span> </p> </td><td class="Botrule" valign="middle"> <p class="First"> <span class="Bold">Adverse Reaction</span> </p> </td><td class="Botrule" valign="middle"> <p class="First"> <span class="Bold">Vancomycin Hydrochloride <br/> (%) (N=260) </span> </p> </td> </tr> <tr> <td class="Toprule" rowspan="5" valign="top"> <p class="First">Gastrointestinal disorders</p> </td><td class="Toprule" valign="top"> <p class="First">Nausea</p> </td><td class="Toprule" valign="top"> <p class="First">17</p> </td> </tr> <tr> <td valign="top"> <p class="First">Abdominal pain</p> </td><td valign="top"> <p class="First">15</p> </td> </tr> <tr> <td valign="top"> <p class="First">Vomiting</p> </td><td valign="top"> <p class="First">9</p> </td> </tr> <tr> <td valign="top"> <p class="First">Diarrhea</p> </td><td valign="top"> <p class="First">9</p> </td> </tr> <tr> <td class="Botrule" valign="top"> <p class="First">Flatulence</p> </td><td class="Botrule" valign="top"> <p class="First">8</p> </td> </tr> <tr> <td class="Toprule" rowspan="3" valign="top"> <p class="First">General disorders and administration site conditions</p> </td><td class="Toprule" valign="top"> <p class="First">Pyrexia</p> </td><td class="Toprule" valign="top"> <p class="First">9</p> </td> </tr> <tr> <td valign="top"> <p class="First">Edema peripheral</p> </td><td valign="top"> <p class="First">6</p> </td> </tr> <tr> <td class="Botrule" valign="top"> <p class="First">Fatigue</p> </td><td class="Botrule" valign="top"> <p class="First">5</p> </td> </tr> <tr> <td class="Botrule Toprule" valign="top"> <p class="First">Infections and infestations</p> </td><td class="Botrule Toprule" valign="top"> <p class="First">Urinary tract infection</p> </td><td class="Botrule Toprule" valign="top"> <p class="First">8</p> </td> </tr> <tr> <td class="Botrule Toprule" valign="top"> <p class="First">Metabolism and nutrition disorders</p> </td><td class="Botrule Toprule" valign="top"> <p class="First">Hypokalemia</p> </td><td class="Botrule Toprule" valign="top"> <p class="First">13</p> </td> </tr> <tr> <td class="Botrule Toprule" valign="top"> <p class="First">Musculoskeletal and connective tissue disorders</p> </td><td class="Botrule Toprule" valign="top"> <p class="First">Back pain</p> </td><td class="Botrule Toprule" valign="top"> <p class="First">6</p> </td> </tr> <tr class="Botrule Last"> <td class="Toprule" valign="top"> <p class="First">Nervous system disorders</p> </td><td class="Toprule" valign="top"> <p class="First">Headache</p> </td><td class="Toprule" valign="top"> <p class="First">7</p> </td> </tr> </tbody> </table></div>

Nephrotoxicity (e.g., reports of renal failure, renal impairment, blood creatinine increased) occurred in 5% of subjects treated with vancomycin hydrochloride. Nephrotoxicity following vancomycin hydrochloride typically first occurred within one week after completion of treatment (median day of onset was Day 16). Nephrotoxicity following vancomycin hydrochloride occurred in 6% of subjects over 65 years of age and 3% of subjects 65 years of age and younger [ see Warnings and Precautions ( 5.3) ]. Nephrotoxicity can also occur during oral vancomycin administration.

The incidences of hypokalemia, urinary tract infection, peripheral edema, insomnia, constipation, anemia, depression, vomiting, and hypotension were higher among subjects over 65 years of age than in subjects 65 years of age and younger [ see Use in Specific Populations ( 8.5) ].

Discontinuation of study drug due to adverse events occurred in 7% of subjects treated with vancomycin hydrochloride. The most common adverse events leading to discontinuation of vancomycin hydrochloride were C. difficilecolitis (< 1%), nausea (< 1%), and vomiting (< 1%).

The following adverse reactions have been identified during post‑approval use of vancomycin hydrochloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Ototoxicity: Cases of hearing loss associated with intravenously administered vancomycin have been reported. Most of these patients had kidney dysfunction or a preexisting hearing loss or were receiving concomitant treatment with an ototoxic drug [ see Warnings and Precautions ( 5.4) ]. Vertigo, dizziness, and tinnitus have been reported.

Skin and Subcutaneous Tissue Disorders:Severe dermatologic reactions such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and linear lgA bullous dermatosis (LABD) [ see Warnings and Precautions ( 5.5) ], rashes (including exfoliative dermatitis).

Hematopoietic: Reversible neutropenia, usually starting 1 week or more after onset of intravenous therapy with vancomycin or after a total dose of more than 25 g, has been reported. Neutropenia appears to be promptly reversible when vancomycin is discontinued. Thrombocytopenia has been reported.

Miscellaneous: Anaphylaxis, drug fever, chills, nausea, eosinophilia, and vasculitis have been reported with the administration of vancomycin.

A condition has been reported with oral vancomycin that is similar to the IV–induced syndrome with symptoms consistent with anaphylactoid reactions, including hypotension, wheezing, dyspnea, urticaria, pruritus, flushing of the upper body (“vancomycin infusion reaction”), pain and muscle spasm of the chest and back. These reactions usually resolve within 20 minutes but may persist for several hours.

No drug interaction studies have been conducted using orally administered vancomycin hydrochloride products.

{ "type": "p", "children": [], "text": "No drug interaction studies have been conducted using orally administered vancomycin hydrochloride products." }

There are no available data on FIRVANQ use in pregnant women to inform a drug-associated risk of major birth defects or miscarriage. Available published data on vancomycin use in pregnancy during the second and third trimesters have not shown an association with adverse pregnancy-related outcomes (see Data) . Vancomycin did not show adverse developmental effects when administered intravenously to pregnant rats and rabbits during organogenesis at doses less than or equal to the recommended maximum human dose based on body surface area (see Data) .

All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Human Data

A published study evaluated hearing loss and nephrotoxicity in infants of pregnant intravenous drug users treated with vancomycin for suspected or documented methicillin‑resistant S. aureusin the second or third trimester. The comparison groups were 10 non‑intravenous drug‑dependent patients who received no treatment, and 10 untreated intravenous drug‑dependent patients served as substance abuse controls. No infant in the vancomycin-exposed group had abnormal sensorineural hearing at 3 months of age or nephrotoxicity.

A published prospective study assessed outcomes in 55 pregnant women with a positive Group B Streptococcusculture and a high‑risk penicillin allergy with resistance to clindamycin or unknown sensitivity who were administered vancomycin at the time of delivery. Vancomycin dosing ranged from the standard 1 g intravenously every 12 hours to 20 mg/kg intravenous every 8 hours (maximum individual dose 2 g). No major adverse reactions were recorded either in the mothers or their newborns. None of the newborns had sensorineural hearing loss. Neonatal renal function was not examined, but all of the newborns were discharged in good condition.

Animal Data

Vancomycin did not cause fetal malformations when administered during organogenesis to pregnant rats (gestation days 6 to 15) and rabbits (gestation days 6 to 18) at the equivalent recommended maximum human dose (based on body surface area comparisons) of 200 mg/kg/day IV to rats or 120 mg/kg/day IV to rabbits. No effects on fetal weight or development were seen in rats at the highest dose tested or in rabbits given 80 mg/kg/day (approximately 1 and 0.8 times the recommended maximum human dose based on body surface area, respectively). Maternal toxicity was observed in rats (at doses 120 mg/kg and above) and rabbits (at 80 mg/kg and above).

There are insufficient data to inform the levels of vancomycin in human milk. However, systemic absorption of vancomycin following oral administration is expected to be minimal [ see Clinical Pharmacology ( 12.3) ]. There are no data on the effects of FIRVANQ on the breastfed infant or milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for FIRVANQ and any potential adverse effects on the breastfed infant from FIRVANQ or from the underlying maternal condition.

FIRVANQ is indicated in pediatric patients less than 18 years of age for the treatment of C. difficile‑associated diarrhea and enterocolitis caused by S. aureus(including methicillin‑resistant strains) [ see Indications and Usage ( 1) and Dosage and Administration ( 2.3) ].

In clinical trials, 54% of vancomycin hydrochloride‑treated subjects were > 65 years of age. Of these, 40% were between the ages of > 65 and 75, and 60% were > 75 years of age.

Clinical studies with vancomycin hydrochloride in C. difficile‑associated diarrhea have demonstrated that geriatric subjects are at increased risk of developing nephrotoxicity following treatment with oral vancomycin hydrochloride, which may occur during or after completion of therapy. In patients over 65 years of age, including those with normal renal function prior to treatment, renal function should be monitored during and following treatment with vancomycin hydrochloride to detect potential vancomycin-induced nephrotoxicity [ see Warnings and Precautions( 5.3), Adverse Reactions ( 6.1) and Clinical Studies ( 14.1) ].

Patients over 65 years of age may take longer to respond to therapy compared to patients 65 years of age and younger [ see Clinical Studies ( 14.1) ]. Clinicians should be aware of the importance of appropriate duration of vancomycin hydrochloride treatment in patients over 65 years of age and not discontinue or switch to alternative treatment prematurely.

Supportive care is advised, with maintenance of glomerular filtration. Vancomycin is poorly removed by dialysis. Hemofiltration and hemoperfusion with polysulfone resin have been reported to result in increased vancomycin clearance.

{ "type": "p", "children": [], "text": "Supportive care is advised, with maintenance of glomerular filtration. Vancomycin is poorly removed by dialysis. Hemofiltration and hemoperfusion with polysulfone resin have been reported to result in increased vancomycin clearance." }

For current information on the management of overdosage, contact the National Poison Control Center at 1‑800‑222‑1222 or www.poison.org.

{ "type": "p", "children": [], "text": "For current information on the management of overdosage, contact the National Poison Control Center at 1‑800‑222‑1222 or\n \n www.poison.org.\n\n " }

FIRVANQ for oral administration contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis(formerly Nocardia orientalis), which has the chemical formula C 66H 75Cl 2N 9O 24•HCl. The molecular weight of vancomycin hydrochloride is 1485.71 g/mol.

{ "type": "p", "children": [], "text": "FIRVANQ for oral administration contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibiotic derived from\n \n Amycolatopsis orientalis(formerly\n \n Nocardia orientalis), which has the chemical formula C\n \n 66H\n \n 75Cl\n \n 2N\n \n 9O\n \n 24•HCl. The molecular weight of vancomycin hydrochloride is 1485.71 g/mol.\n\n " }

Vancomycin hydrochloride has the structural formula:

{ "type": "p", "children": [], "text": "Vancomycin hydrochloride has the structural formula:" }

Each FIRVANQ kit contains a bottle of vancomycin hydrochloride USP, as white to almost white or tan to brown powder for oral solution, and a bottle of pre‑measured Grape‑Flavored Diluent, in the strengths and volumes listed in Table 3.

{ "type": "p", "children": [], "text": "Each FIRVANQ kit contains a bottle of vancomycin hydrochloride USP, as white to almost white or tan to brown powder for oral solution, and a bottle of pre‑measured Grape‑Flavored Diluent, in the strengths and volumes listed in\n \n Table 3.\n\n " }

<div class="scrollingtable"><table cellpadding="3.6pt" width="75%"> <caption> <span>Table 3: Vancomycin Strength, Diluent Volume and Vancomycin Concentration after Reconstitution</span> </caption> <col width="21%"/> <col width="21%"/> <col width="21%"/> <col width="21%"/> <thead> <tr class="First Last"> <th align="left" class="Botrule" valign="middle"><span class="Bold">Vancomycin Strength per Bottle</span></th><th align="left" class="Botrule" valign="middle"><span class="Bold">Equivalent Amount of Vancomycin Hydrochloride <br/> per Bottle </span></th><th align="left" class="Botrule" valign="middle"><span class="Bold">Diluent Volume for FIRVANQ</span></th><th align="left" class="Botrule" valign="middle"><span class="Bold">Vancomycin Concentration after Reconstitution</span></th> </tr> </thead> <tbody> <tr class="First"> <td class="Toprule" valign="top"> <p class="First">3.75 g</p> </td><td class="Toprule" valign="top"> <p class="First">3.84 g</p> </td><td class="Toprule" valign="top"> <p class="First">147 mL</p> </td><td class="Toprule" valign="top"> <p class="First">25 mg/mL</p> </td> </tr> <tr> <td valign="top"> <p class="First">7.5 g</p> </td><td valign="top"> <p class="First">7.7 g</p> </td><td valign="top"> <p class="First">295 mL</p> </td><td valign="top"></td> </tr> <tr> <td valign="top"> <p class="First">7.5 g</p> </td><td valign="top"> <p class="First">7.7 g</p> </td><td valign="top"> <p class="First">145 mL</p> </td><td valign="top"> <p class="First">50 mg/mL</p> </td> </tr> <tr class="Last"> <td valign="top"> <p class="First">15.0 g</p> </td><td valign="top"> <p class="First">15.4 g</p> </td><td valign="top"> <p class="First">289 mL</p> </td><td valign="top"></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table cellpadding=\"3.6pt\" width=\"75%\">\n<caption>\n<span>Table 3: Vancomycin Strength, Diluent Volume and Vancomycin Concentration after Reconstitution</span>\n</caption>\n<col width=\"21%\"/>\n<col width=\"21%\"/>\n<col width=\"21%\"/>\n<col width=\"21%\"/>\n<thead>\n<tr class=\"First Last\">\n<th align=\"left\" class=\"Botrule\" valign=\"middle\"><span class=\"Bold\">Vancomycin Strength per Bottle</span></th><th align=\"left\" class=\"Botrule\" valign=\"middle\"><span class=\"Bold\">Equivalent Amount of Vancomycin Hydrochloride \n <br/> per Bottle\n </span></th><th align=\"left\" class=\"Botrule\" valign=\"middle\"><span class=\"Bold\">Diluent Volume for FIRVANQ</span></th><th align=\"left\" class=\"Botrule\" valign=\"middle\"><span class=\"Bold\">Vancomycin Concentration after Reconstitution</span></th>\n</tr>\n</thead>\n<tbody>\n<tr class=\"First\">\n<td class=\"Toprule\" valign=\"top\">\n<p class=\"First\">3.75 g</p>\n</td><td class=\"Toprule\" valign=\"top\">\n<p class=\"First\">3.84 g</p>\n</td><td class=\"Toprule\" valign=\"top\">\n<p class=\"First\">147 mL</p>\n</td><td class=\"Toprule\" valign=\"top\">\n<p class=\"First\">25 mg/mL</p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">7.5 g</p>\n</td><td valign=\"top\">\n<p class=\"First\">7.7 g</p>\n</td><td valign=\"top\">\n<p class=\"First\">295 mL</p>\n</td><td valign=\"top\"></td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">7.5 g</p>\n</td><td valign=\"top\">\n<p class=\"First\">7.7 g</p>\n</td><td valign=\"top\">\n<p class=\"First\">145 mL</p>\n</td><td valign=\"top\">\n<p class=\"First\">50 mg/mL</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td valign=\"top\">\n<p class=\"First\">15.0 g</p>\n</td><td valign=\"top\">\n<p class=\"First\">15.4 g</p>\n</td><td valign=\"top\">\n<p class=\"First\">289 mL</p>\n</td><td valign=\"top\"></td>\n</tr>\n</tbody>\n</table></div>" }

The Grape‑Flavored Diluent used to reconstitute the oral solution contains: artificial grape flavor, citric acid (anhydrous), D&C Yellow No. 10, FD&C Red No. 40, purified water, sodium benzoate and sucralose.

{ "type": "p", "children": [], "text": "The Grape‑Flavored Diluent used to reconstitute the oral solution contains: artificial grape flavor, citric acid (anhydrous), D&C Yellow No. 10, FD&C Red No. 40, purified water, sodium benzoate and sucralose." }

Vancomycin is an antibacterial drug [ see Microbiology ( 12.4) ].

Vancomycin is poorly absorbed after oral administration. During multiple dosing of vancomycin hydrochloride capsules at 250 mg every 8 hours for 7 doses, fecal concentrations of vancomycin in volunteers exceeded 100 mcg/g in the majority of samples. No blood concentrations were detected and urinary recovery did not exceed 0.76%. In anephric subjects with no inflammatory bowel disease who received vancomycin oral solution 2 g for 16 days, blood concentrations of vancomycin were ≤ 0.66 mcg/mL in 2 of 5 subjects. No measurable blood concentrations were attained in the other 3 subjects. Following doses of 2 g daily, concentrations of drug were > 3100 mcg/g in the feces and < 1 mcg/mL in the serum of subjects with normal renal function who had C. difficile‑associated diarrhea. After multiple‑dose oral administration of vancomycin, measurable serum concentrations may occur in patients with active C. difficile‑associated diarrhea, and, in the presence of renal impairment, the possibility of accumulation exists. It should be noted that the total systemic and renal clearances of vancomycin are reduced in the elderly [ see Use in Specific Populations ( 8.5) ].

Mechanism of Action

The bactericidal action of vancomycin against the vegetative cells of C. difficileand S. aureusresults primarily from inhibition of cell‑wall biosynthesis. In addition, vancomycin alters bacterial‑cell‑membrane permeability and RNA synthesis.

Mechanism of Resistance

C. difficile

Isolates of C. difficilegenerally have vancomycin minimal inhibitory concentrations (MICs) of < 1 mcg/mL; however, vancomycin MICs ranging from 4 mcg/mL to 16 mcg/mL have been reported. The mechanism which mediates C. difficile's decreased susceptibility to vancomycin has not been fully elucidated.

S. aureus

S. aureusisolates with vancomycin MICs as high as 1024 mcg/mL have been reported. The exact mechanism of this resistance is not clear but is believed to be due to cell wall thickening and potentially the transfer of genetic material.

Vancomycin has been shown to be active against susceptible isolates of the following bacteria in clinical infections [ see Indications and Usage ( 1) ].

Anaerobic gram‑positive bacteria C. difficileisolates associated with C. difficile‑associated diarrhea.

Gram‑positive bacteria S. aureus(including methicillin‑resistant isolates) associated with enterocolitis.

No long‑term carcinogenesis studies in animals have been conducted.

At concentrations up to 1000 mcg/mL, vancomycin had no mutagenic effect in vitroin the mouse lymphoma forward mutation assay or the primary rat hepatocyte unscheduled DNA synthesis assay. The concentrations tested in vitrowere above the peak plasma vancomycin concentrations of 20 to 40 mcg/mL usually achieved in humans after slow infusion of the maximum recommended dose of 1 g. Vancomycin had no mutagenic effect in vivoin the Chinese hamster sister chromatid exchange assay (400 mg/kg IP) or the mouse micronucleus assay (800 mg/kg IP).

No definitive fertility studies have been conducted.

In two trials, vancomycin hydrochloride 125 mg orally four times daily for 10 days was evaluated in 266 adult subjects with C. difficile‑associated diarrhea (CDAD). Enrolled subjects were 18 years of age or older and received no more than 48 hours of treatment with oral vancomycin hydrochloride or oral/intravenous metronidazole in the 5 days preceding enrollment. CDAD was defined as ≥ 3 loose or watery bowel movements within the 24 hours preceding enrollment, and the presence of either C. difficiletoxin A or B, or pseudomembranes on endoscopy within the 72 hours preceding enrollment. Subjects with fulminant C. difficiledisease, sepsis with hypotension, ileus, peritoneal signs or severe hepatic disease were excluded.

Efficacy analyses were performed on the Full Analysis Set (FAS), which included randomized subjects who received at least one dose of vancomycin hydrochloride and had any post‑dosing investigator evaluation data (N = 259; 134 in Trial 1 and 125 in Trial 2).

The demographic profile and baseline CDAD characteristics of enrolled subjects were similar in the two trials. Vancomycin hydrochloride‑treated subjects had a median age of 67 years, were mainly white (93%), and male (52%). CDAD was classified as severe (defined as 10 or more unformed bowel movements per day or white blood cell count (WBC) ≥ 15000/mm 3) in 25% of subjects, and 47% were previously treated for CDAD.

Efficacy was assessed by using clinical success, defined as diarrhea resolution and the absence of severe abdominal discomfort due to CDAD, on Day 10. An additional efficacy endpoint was the time to resolution of diarrhea, defined as the beginning of diarrhea resolution that was sustained through the end of the prescribed active treatment period.

The results for clinical success for vancomycin hydrochloride‑treated subjects in both trials are shown in Table 4.

<div class="scrollingtable"><table cellpadding="3.6pt" width="75%"> <caption> <span>Table 4: Clinical Success Rates (Full Analysis Set)</span> </caption> <col width="28%"/> <col width="28%"/> <col width="28%"/> <tbody class="Headless"> <tr class="First Toprule"> <td class="Botrule" valign="middle"></td><td class="Botrule" valign="middle"> <p class="First"> <span class="Bold">Clinical Success Rate <br/> Vancomycin Hydrochloride % (N) </span> </p> </td><td class="Botrule" valign="middle"> <p class="First"> <span class="Bold">95% Confidence Interval</span> </p> </td> </tr> <tr> <td class="Toprule" valign="top"> <p class="First">Trial 1</p> </td><td class="Toprule" valign="top"> <p class="First">81.3 (134)</p> </td><td class="Toprule" valign="top"> <p class="First">(74.4, 88.3)</p> </td> </tr> <tr class="Botrule Last"> <td valign="top"> <p class="First">Trial 2</p> </td><td valign="top"> <p class="First">80.8 (125)</p> </td><td valign="top"> <p class="First">(73.5, 88.1)</p> </td> </tr> </tbody> </table></div>

The median time to resolution of diarrhea was 5 days and 4 days in Trial 1 and Trial 2, respectively. For subjects older than 65 years of age, the median time to resolution was 6 days and 4 days in Trial 1 and Trial 2, respectively. In subjects with diarrhea resolution at end‑of‑treatment with vancomycin hydrochloride, recurrence of CDAD during the following four weeks occurred in 25 of 107 (23%) and 18 of 102 (18%) in Trial 1 and Trial 2, respectively.

Restriction Endonuclease Analysis (REA) was used to identify C. difficilebaseline isolates in the BI group. In Trial 1, the vancomycin hydrochloride‑treated subjects were classified at baseline as follows: 31 (23%) with BI strain, 69 (52%) with non‑BI strain, and 34 (25%) with unknown strain. Clinical success rates were 87% for BI strain, 81% for non‑BI strain, and 76% for unknown strain. In subjects with diarrhea resolution at end‑of‑treatment with vancomycin hydrochloride, recurrence of CDAD during the following four weeks occurred in 7 of 26 subjects with BI strain, 12 of 56 subjects with non‑BI strain, and 6 of 25 subjects with unknown strain.

How Supplied

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Each FIRVANQ kit contains a bottle of vancomycin hydrochloride USP, as white to almost white or tan to brown powder for oral solution, and a bottle of pre‑measured Grape‑Flavored Diluent, in the strengths and volumes listed in Table 5.

{ "type": "p", "children": [], "text": "Each FIRVANQ kit contains a bottle of vancomycin hydrochloride USP, as white to almost white or tan to brown powder for oral solution, and a bottle of pre‑measured Grape‑Flavored Diluent, in the strengths and volumes listed in\n \n Table 5.\n\n " }

<div class="scrollingtable"><table cellpadding="3.6pt" width="75%"> <caption> <span>Table 5: Vancomycin Strength, Diluent Volume and National Drug Code (NDC) Numbers</span> </caption> <col width="28%"/> <col width="28%"/> <col width="28%"/> <thead> <tr class="First Last"> <th align="left" class="Botrule" valign="middle"><span class="Bold">Vancomycin Strength per Bottle</span></th><th align="left" class="Botrule" valign="middle"><span class="Bold">Diluent Volume for FIRVANQ</span></th><th align="left" class="Botrule" valign="middle"><span class="Bold">NDC Numbers</span></th> </tr> </thead> <tbody> <tr class="First"> <td class="Toprule" valign="top"> <p class="First">3.75 g</p> </td><td class="Toprule" valign="top"> <p class="First">147 mL</p> </td><td class="Toprule" valign="top"> <p class="First">65628‑204‑05</p> </td> </tr> <tr> <td valign="top"> <p class="First">7.5 g</p> </td><td valign="top"> <p class="First">295 mL</p> </td><td valign="top"> <p class="First">65628‑205‑10</p> </td> </tr> <tr> <td valign="top"> <p class="First">7.5 g</p> </td><td valign="top"> <p class="First">145 mL</p> </td><td valign="top"> <p class="First">65628‑206‑05</p> </td> </tr> <tr class="Last"> <td valign="top"> <p class="First">15.0 g</p> </td><td valign="top"> <p class="First">289 mL</p> </td><td valign="top"> <p class="First">65628‑208‑10</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table cellpadding=\"3.6pt\" width=\"75%\">\n<caption>\n<span>Table 5: Vancomycin Strength, Diluent Volume and National Drug Code (NDC) Numbers</span>\n</caption>\n<col width=\"28%\"/>\n<col width=\"28%\"/>\n<col width=\"28%\"/>\n<thead>\n<tr class=\"First Last\">\n<th align=\"left\" class=\"Botrule\" valign=\"middle\"><span class=\"Bold\">Vancomycin Strength per Bottle</span></th><th align=\"left\" class=\"Botrule\" valign=\"middle\"><span class=\"Bold\">Diluent Volume for FIRVANQ</span></th><th align=\"left\" class=\"Botrule\" valign=\"middle\"><span class=\"Bold\">NDC Numbers</span></th>\n</tr>\n</thead>\n<tbody>\n<tr class=\"First\">\n<td class=\"Toprule\" valign=\"top\">\n<p class=\"First\">3.75 g</p>\n</td><td class=\"Toprule\" valign=\"top\">\n<p class=\"First\">147 mL</p>\n</td><td class=\"Toprule\" valign=\"top\">\n<p class=\"First\">65628‑204‑05</p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">7.5 g</p>\n</td><td valign=\"top\">\n<p class=\"First\">295 mL</p>\n</td><td valign=\"top\">\n<p class=\"First\">65628‑205‑10</p>\n</td>\n</tr>\n<tr>\n<td valign=\"top\">\n<p class=\"First\">7.5 g</p>\n</td><td valign=\"top\">\n<p class=\"First\">145 mL</p>\n</td><td valign=\"top\">\n<p class=\"First\">65628‑206‑05</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td valign=\"top\">\n<p class=\"First\">15.0 g</p>\n</td><td valign=\"top\">\n<p class=\"First\">289 mL</p>\n</td><td valign=\"top\">\n<p class=\"First\">65628‑208‑10</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Storage and Handling

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Store the FIRVANQ kit at refrigerated conditions, 2°C to 8°C (36°F to 46°F).

{ "type": "p", "children": [], "text": "Store the FIRVANQ kit at refrigerated conditions, 2°C to 8°C (36°F to 46°F)." }

Store reconstituted solutions of FIRVANQ at 2°C to 8°C [ see Dosage and Administration ( 2.4) ].

{ "type": "p", "children": [], "text": "Store reconstituted solutions of FIRVANQ at 2°C to 8°C [\n \n see Dosage and Administration (\n \n 2.4)\n \n ].\n\n " }

Do not freeze. Keep container tightly closed. Protect from light.

{ "type": "p", "children": [], "text": "Do not freeze. Keep container tightly closed. Protect from light." }

Severe Dermatologic Reactions

{ "type": "p", "children": [], "text": "\nSevere Dermatologic Reactions\n" }

Advise patients about the signs and symptoms of serious skin manifestations. Instruct patients to stop taking FIRVANQ immediately and promptly seek medical attention at the first signs or symptoms of skin rash, mucosal lesions or blisters, [ see Warnings and Precautions ( 5.5) ].

{ "type": "p", "children": [], "text": "Advise patients about the signs and symptoms of serious skin manifestations. Instruct patients to stop taking FIRVANQ immediately and promptly seek medical attention at the first signs or symptoms of skin rash, mucosal lesions or blisters, [\n \n see Warnings and Precautions (\n \n 5.5)\n \n ].\n\n " }

Antibacterial Resistance

{ "type": "p", "children": [], "text": "\nAntibacterial Resistance\n" }

Patients should be counseled that antibacterial drugs including FIRVANQ should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When FIRVANQ is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by FIRVANQ or other antibacterial drugs in the future.

{ "type": "p", "children": [], "text": "Patients should be counseled that antibacterial drugs including FIRVANQ should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When FIRVANQ is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by FIRVANQ or other antibacterial drugs in the future." }

Important Administration and Storage Instructions

{ "type": "p", "children": [], "text": "\nImportant Administration and Storage Instructions\n" }

Instruct the patient or caregiver to [ see Dosage and Administration ( 2.4) ]:

{ "type": "p", "children": [], "text": "Instruct the patient or caregiver to [\n \n see Dosage and Administration (\n \n 2.4)\n \n ]:\n\n " }

{ "type": "ul", "children": [ "Shake the reconstituted solutions of FIRVANQ well before each use and to use an oral dosing device that measures the appropriate volume of the oral solution in milliliters.", "Store the reconstituted solutions of FIRVANQ at refrigerated conditions, 2° C to 8° C (36° F to 46° F) when not in use.", "Discard reconstituted solutions of FIRVANQ after 14 days, or if it appears hazy or contains particulates." ], "text": "" }

FIRVANQ is a registered trademark of Azurity Pharmaceuticals, Inc.

{ "type": "p", "children": [], "text": "FIRVANQ is a registered trademark of Azurity Pharmaceuticals, Inc." }

Manufactured for:

{ "type": "p", "children": [], "text": "\nManufactured for:\n" }

Wilmington, MA 01887 USA

{ "type": "p", "children": [], "text": "\nWilmington, MA 01887 USA\n" }

Patent: https://azurity.com/patents

{ "type": "p", "children": [], "text": "Patent: https://azurity.com/patents" }

This product's labeling may have been updated. For current Full Prescribing Information, please visit www.FIRVANQ.com

{ "type": "p", "children": [], "text": "This product's labeling may have been updated. For current Full Prescribing Information, please visit\n \n www.FIRVANQ.com\n" }

PN: 65628-0120 REV: 05

{ "type": "p", "children": [], "text": "PN: 65628-0120 \n REV: 05\n " }

NDC 65628-204-05

{ "type": "p", "children": [], "text": "\nNDC 65628-204-05\n" }

Rx ONLY

{ "type": "p", "children": [], "text": "\nRx ONLY\n" }

FIRVANQ ® (vancomycin hydrochloride for oral solution)

{ "type": "p", "children": [], "text": "\nFIRVANQ\n \n ®\n (vancomycin hydrochloride for oral solution)\n \n \n" }

FOR ORAL USE ONLY

{ "type": "p", "children": [], "text": "\nFOR ORAL USE ONLY\n" }

Vancomycin 25 mg/mL Kit

{ "type": "p", "children": [], "text": "\nVancomycin 25 mg/mL Kit\n" }

EACH KIT INCLUDES:

{ "type": "p", "children": [], "text": "\nEACH KIT INCLUDES:\n" }

{ "type": "ul", "children": [ "1 bottle containing 3.84 g Vancomycin Hydrochloride USP,\n \n powder for oral solution, \n equivalent to 3.75 g Vancomycin\n \n ", "1 bottle conatining 147 mL\n \n Grape Flavored Diluentfor reconstitution\n \n " ], "text": "" }

When reconstituted, each mL contains 25 mg Vancomycin

{ "type": "p", "children": [], "text": "\nWhen reconstituted, each mL contains 25 mg Vancomycin\n" }

MUST BE REFRIGERATED

{ "type": "p", "children": [], "text": "\nMUST BE \n REFRIGERATED\n \n" }

azurity ® pharmaceuticals

{ "type": "p", "children": [], "text": "\nazurity\n \n ®\n\npharmaceuticals\n\n " }

150 mL final volume after reconstitution

{ "type": "p", "children": [], "text": "\n150 mL \n \nfinal volume after reconstitution\n\n " }

NDC 65628-204-05

{ "type": "p", "children": [], "text": "\nNDC 65628-204-05\n" }

Rx ONLY

{ "type": "p", "children": [], "text": "\nRx ONLY\n" }

TO THE PHARMACIST

{ "type": "p", "children": [], "text": "\nTO THE PHARMACIST\n" }

STOP IMPORTANT:

{ "type": "p", "children": [], "text": "\nSTOP IMPORTANT:\n" }

{ "type": "ul", "children": [ "When reconstituted each mL contains 25 mg Vancomycin", "Add liquid contents of the Diluent bottle to the bottle containing \n Vancomycin Hydrochloride powder according to the preparation steps \n in the Full Prescribing Information\n ", "Instruct patient to store reconstituted formulation at refrigerated temperature, \n 2°-8°C (36°-46°F) [see USP]\n ", "\nDiscard 14 days after reconstitution or if the solution appears hazy\n" ], "text": "" }

MANUFACTURED FOR: azurity © pharmaceuticals

{ "type": "p", "children": [], "text": "MANUFACTURED FOR: \n \nazurity\n \n ©\n\npharmaceuticals\n\n " }

WILMINGTON, MA 01887 USA

{ "type": "p", "children": [], "text": "WILMINGTON, MA 01887 USA" }

www.azurity.com

{ "type": "p", "children": [], "text": "\nwww.azurity.com\n" }

RECONSTITUTE BEFORE DISPENSING

{ "type": "p", "children": [], "text": "\nRECONSTITUTE \n BEFORE DISPENSING\n \n" }

{ "type": "ul", "children": [ "For oral use only", "Avoid contact with eyes", "Keep container tightly closed", "Protect from light", "Protect from freezing", "\nStore kit at refrigerated \n temperature, 2°-8°C (36°-46°F) \n [see USP]\n \n" ], "text": "" }

NDC 65628-205-10

{ "type": "p", "children": [], "text": "\nNDC 65628-205-10\n" }

Rx ONLY

{ "type": "p", "children": [], "text": "\nRx ONLY\n" }

FIRVANQ ® (vancomycin hydrochloride for oral solution)

{ "type": "p", "children": [], "text": "\nFIRVANQ\n \n ®\n (vancomycin hydrochloride for oral solution)\n \n \n" }

FOR ORAL USE ONLY

{ "type": "p", "children": [], "text": "\nFOR ORAL USE ONLY\n" }

Vancomycin 25 mg/mL Kit

{ "type": "p", "children": [], "text": "\nVancomycin 25 mg/mL Kit\n" }

EACH KIT INCLUDES:

{ "type": "p", "children": [], "text": "\nEACH KIT INCLUDES:\n" }

{ "type": "ul", "children": [ "1 bottle containing 7.7 g Vancomycin Hydrochloride USP,\n \n powder for oral solution, \n equivalent to 7.5 g Vancomycin\n \n ", "1 bottle conatining 295 mL\n \n Grape Flavored Diluentfor reconstitution\n \n " ], "text": "" }

When reconstituted, each mL contains 25 mg Vancomycin

{ "type": "p", "children": [], "text": "\nWhen reconstituted, each mL contains 25 mg Vancomycin\n" }

MUST BE REFRIGERATED

{ "type": "p", "children": [], "text": "\nMUST BE \n REFRIGERATED\n \n" }

azurity ® pharmaceuticals

{ "type": "p", "children": [], "text": "\nazurity\n \n ®\n\npharmaceuticals\n\n " }

300 mL final volume after reconstitution

{ "type": "p", "children": [], "text": "\n300 mL \n \nfinal volume after reconstitution\n\n " }

NDC 65628-205-10

{ "type": "p", "children": [], "text": "NDC 65628-205-10" }

Rx ONLY

{ "type": "p", "children": [], "text": "\nRx ONLY\n" }

TO THE PHARMACIST

{ "type": "p", "children": [], "text": "\nTO THE PHARMACIST\n" }

STOP IMPORTANT:

{ "type": "p", "children": [], "text": "\nSTOP IMPORTANT:\n" }

{ "type": "ul", "children": [ "When reconstituted each mL contains 25 mg Vancomycin", "Add liquid contents of the Diluent bottle to the bottle containing \n Vancomycin Hydrochloride powder according to the preparation steps \n in the Full Prescribing Information\n ", "Instruct patient to store reconstituted formulation at refrigerated temperature, \n 2°-8°C (36°-46°F) [see USP]\n ", "\nDiscard 14 days after reconstitution or if the solution appears hazy\n" ], "text": "" }

MANUFACTURED FOR: azurity ® pharmaceuticals

{ "type": "p", "children": [], "text": "MANUFACTURED FOR: \n \nazurity\n \n ®\n\npharmaceuticals\n\n " }

WILMINGTON, MA 01887 USA

{ "type": "p", "children": [], "text": "WILMINGTON, MA 01887 USA" }

www.azurity.com

{ "type": "p", "children": [], "text": "\nwww.azurity.com\n" }

RECONSTITUTE BEFORE DISPENSING

{ "type": "p", "children": [], "text": "\nRECONSTITUTE \n BEFORE DISPENSING\n \n" }

{ "type": "ul", "children": [ "For oral use only", "Avoid contact with eyes", "Keep container tightly closed", "Protect from light", "Protect from freezing", "\nStore kit at refrigerated \n temperature, 2°-8°C (36°-46°F) \n [see USP]\n \n" ], "text": "" }

NDC 65628-206-05

{ "type": "p", "children": [], "text": "\nNDC 65628-206-05\n" }

Rx ONLY

{ "type": "p", "children": [], "text": "\nRx ONLY\n" }

FIRVANQ ® (vancomycin hydrochloride for oral solution)

{ "type": "p", "children": [], "text": "\nFIRVANQ\n \n ®\n (vancomycin hydrochloride for oral solution)\n \n \n" }

FOR ORAL USE ONLY

{ "type": "p", "children": [], "text": "\nFOR ORAL USE ONLY\n" }

Vancomycin 50 mg/mL Kit

{ "type": "p", "children": [], "text": "\nVancomycin 50 mg/mL Kit\n" }

EACH KIT INCLUDES:

{ "type": "p", "children": [], "text": "\nEACH KIT INCLUDES:\n" }

{ "type": "ul", "children": [ "1 bottle containing 7.7 g Vancomycin Hydrochloride USP,\n \n powder for oral solution, \n equivalent to 7.5 g Vancomycin\n \n ", "1 bottle conatining 145 mL\n \n Grape Flavored Diluentfor reconstitution\n \n " ], "text": "" }

When reconstituted, each mL contains 50 mg Vancomycin

{ "type": "p", "children": [], "text": "\nWhen reconstituted, each mL contains 50 mg Vancomycin\n" }

MUST BE REFRIGERATED

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azurity ® pharmaceuticals

{ "type": "p", "children": [], "text": "\nazurity\n \n ®\n\npharmaceuticals\n\n " }

150 mL final volume after reconstitution

{ "type": "p", "children": [], "text": "\n150 mL \n \nfinal volume after reconstitution\n\n " }

NDC 65628-206-05

{ "type": "p", "children": [], "text": "\nNDC 65628-206-05\n" }

Rx ONLY

{ "type": "p", "children": [], "text": "\nRx ONLY\n" }

TO THE PHARMACIST

{ "type": "p", "children": [], "text": "\nTO THE PHARMACIST\n" }

STOP IMPORTANT:

{ "type": "p", "children": [], "text": "\nSTOP IMPORTANT:\n" }

{ "type": "ul", "children": [ "When reconstituted each mL contains 50 mg Vancomycin", "Add liquid contents of the Diluent bottle to the bottle containing \n Vancomycin Hydrochloride powder according to the preparation steps \n in the Full Prescribing Information\n ", "Instruct patient to store reconstituted formulation at refigerated temperature, \n 2°-8°C (36°-46°F) [see USP]\n ", "\nDiscard 14 days after reconstitution or if the solution appears hazy\n" ], "text": "" }

MANUFACTURED FOR: azurity © pharmaceuticals

{ "type": "p", "children": [], "text": "MANUFACTURED FOR: \n \nazurity\n \n ©\n\npharmaceuticals\n\n " }

WILMINGTON, MA 01887 USA

{ "type": "p", "children": [], "text": "WILMINGTON, MA 01887 USA" }

www.azurity.com

{ "type": "p", "children": [], "text": "\nwww.azurity.com\n" }

RECONSTITUTE BEFORE DISPENSING

{ "type": "p", "children": [], "text": "\nRECONSTITUTE \n BEFORE DISPENSING\n \n" }

{ "type": "ul", "children": [ "For oral use only", "Avoid contact with eyes", "Keep container tightly closed", "Protect from light", "Protect from freezing", "\nStore kit at refrigerated \n temperature, 2°-8°C (36°-46°F) \n [see USP]\n \n" ], "text": "" }

NDC 65628-208-10

{ "type": "p", "children": [], "text": "\nNDC 65628-208-10\n" }

Rx ONLY

{ "type": "p", "children": [], "text": "\nRx ONLY\n" }

FIRVANQ ® (vancomycin hydrochloride for oral solution)

{ "type": "p", "children": [], "text": "\nFIRVANQ\n \n ®\n (vancomycin hydrochloride for oral solution)\n \n \n" }

FOR ORAL USE ONLY

{ "type": "p", "children": [], "text": "\nFOR ORAL USE ONLY\n" }

Vancomycin 50 mg/mL Kit

{ "type": "p", "children": [], "text": "\nVancomycin 50 mg/mL Kit\n" }

EACH KIT INCLUDES:

{ "type": "p", "children": [], "text": "\nEACH KIT INCLUDES:\n" }

{ "type": "ul", "children": [ "1 bottle containing 15.4 g Vancomycin Hydrochloride USP,\n \n powder for oral solution, \n equivalent to 15.0 g Vancomycin\n \n ", "1 bottle conatining 289 mL\n \n Grape Flavored Diluentfor reconstitution\n \n " ], "text": "" }

When reconstituted, each mL contains 50 mg Vancomycin

{ "type": "p", "children": [], "text": "\nWhen reconstituted, each mL contains 50 mg Vancomycin\n" }

MUST BE REFRIGERATED

{ "type": "p", "children": [], "text": "\nMUST BE \n REFRIGERATED\n \n" }

azurity ® pharmaceuticals

{ "type": "p", "children": [], "text": "\nazurity\n \n ®\n\npharmaceuticals\n\n " }

300 mL final volume after reconstitution

{ "type": "p", "children": [], "text": "\n300 mL \n \nfinal volume after reconstitution\n\n " }

NDC 65628-208-10

{ "type": "p", "children": [], "text": "\nNDC 65628-208-10\n" }

Rx ONLY

{ "type": "p", "children": [], "text": "\nRx ONLY\n" }

TO THE PHARMACIST

{ "type": "p", "children": [], "text": "\nTO THE PHARMACIST\n" }

STOP IMPORTANT:

{ "type": "p", "children": [], "text": "\nSTOP IMPORTANT:\n" }

{ "type": "ul", "children": [ "When reconstituted each mL contains 50 mg Vancomycin", "Add liquid contents of the Diluent bottle to the bottle containing \n Vancomycin Hydrochloride powder according to the preparation steps \n in the Full Prescribing Information\n ", "Instruct patient to store reconstituted formulation at refigerated temperature, \n 2°-8°C (36°-46°F) [see USP]\n ", "\nDiscard 14 days after reconstitution or if the solution appears hazy\n" ], "text": "" }

MANUFACTURED FOR: azurity ® pharmaceuticals

{ "type": "p", "children": [], "text": "MANUFACTURED FOR: \n \nazurity\n \n ®\n\npharmaceuticals\n\n " }

WILMINGTON, MA 01887 USA

{ "type": "p", "children": [], "text": "WILMINGTON, MA 01887 USA" }

www.azurity.com

{ "type": "p", "children": [], "text": "\nwww.azurity.com\n" }

RECONSTITUTE BEFORE DISPENSING

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{ "type": "ul", "children": [ "For oral use only", "Avoid contact with eyes", "Keep container tightly closed", "Protect from light", "Protect from freezing", "\nStore kit at refrigerated \n temperature, 2°-8°C (36°-46°F) \n [see USP]\n \n" ], "text": "" }

Vancomycin Injection is indicated in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2) and Use in Specific Populations (8.4)] for the treatment of septicemia due to:

Vancomycin Injection is indicated in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2) and Use in Specific Populations (8.4)] for the treatment of infective endocarditis due to:

Vancomycin Injection is indicated in adults and pediatric patients for the treatment of early-onset prosthetic valve endocarditis caused by Staphylococcus epidermidis in combination with rifampin and an aminoglycoside.

Vancomycin Injection is indicated in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2) and Use in Specific Populations (8.4)] for the treatment of skin and skin structure infections due to:

Vancomycin Injection is indicated in adults and pediatric patients (and older) for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2) and Use in Specific Populations (8.4)] for the treatment of bone infections due to:

Vancomycin Injection is indicated in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2) and Use in Specific Populations (8.4)] for the treatment of lower respiratory tract infections due to:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Injection and other antibacterial drugs, Vancomycin Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

The usual daily intravenous dosage of Vancomycin Injection is 2 grams (g) divided either as 500 mg every 6 hours or 1 g every 12 hours. Administer each dose by intravenous infusion over a period of 60 minutes or greater. Other patient factors, such as age or obesity, may call for modification of the usual intravenous daily dose. The initial daily dose should be no less than 15 mg/kg.

If a dose of Vancomycin Injection is required that does not equal 500 mg, 750 mg, 1 g, 1.25 g or 1.5 g, this product is not recommended for use and an alternative formulation of vancomycin should be considered [see Use in Specific Populations (8.4)].

Pediatric Patients (Aged 1 Month and Older)

The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every 6 hours. Each dose should be administered over a period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin may be warranted in these patients.

Pediatric Patients (Younger than 1 Month Old)

In pediatric patients up to the age of 1 month, the total daily intravenous dosage may be lower. In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the 1st week of life and every 8 hours thereafter up to the age of 1 month. Each dose should be administered over 60 minutes. In premature infants, vancomycin clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants. Close monitoring of serum concentrations of vancomycin is recommended in these patients.

Dosage adjustment must be made in patients with renal impairment. The initial dose should be no less than 15 mg/kg in patients with any degree of renal impairment. Measure trough vancomycin serum concentrations to guide therapy, especially in seriously ill patients with changing renal function.

For functionally anephric patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. Measure vancomycin serum concentrations at 24 hours following the first dose to guide further intravenous therapy.

Administration Instructions

Vancomycin Injection, in GALAXY plastic container is for intravenous administration only. Intermittent infusion is the recommended method of administration.

Store the frozen Vancomycin Injection container in a freezer capable of maintaining a temperature at or below -20°C (-4°F) [see How Supplied/Storage and Handling (16)].

Preparation for Intravenous Administration:

Thawing of Plastic Containers

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

Do not use plastic containers in series connections. Such use could result in an embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

Injection: Vancomycin Injection USP, is a frozen, iso-osmotic, sterile, nonpyrogenic premixed solution available in the following strengths:

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Hypotension including shock and cardiac arrest, wheezing, dyspnea, urticaria or pruritus, muscular and chest pain may occur with rapid Vancomycin Injection administration. (e.g., over several minutes). The reactions may be more severe in pediatric patients [see Use in Specific Populations (8.4)].

Rapid intravenous administration of Vancomycin Injection may also be associated with “vancomycin infusion reaction”, which manifests as pruritus and erythema that involves the face, neck and upper body or pain and muscle spasm of the chest and back. There have been reports that the frequency of infusion-related reactions (including hypotension, flushing, erythema, urticaria, and pruritus) increases with the concomitant administration of anesthetic agents.

Infusion-related adverse reactions are related to both the concentration and the rate of administration of Vancomycin for Injection. Infusion-related adverse reactions may occur, however, at any rate or concentration.

Administer Vancomycin Injection over a period of 60 minutes or greater to reduce the risk of rapid-infusion-related adverse reactions. In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used; use of such higher concentrations may increase the risk of infusion-related adverse reactions.

Administer Vancomycin Injection as a 60-minute infusion prior to administration of anesthetic agents when feasible to minimize infusion-related adverse reactions. Stop the infusion if a reaction occurs because this usually results in prompt cessation of these reactions.

Vancomycin Injection can result in acute kidney injury (AKI), including acute renal failure, mainly due to interstitial nephritis or less commonly acute tubular necrosis. AKI is manifested by increasing blood urea nitrogen (BUN) and serum creatinine (Cr). The risk of AKI increases with higher vancomycin serum levels, prolonged exposure, concomitant administration of other nephrotoxic drugs, concomitant administration of piperacillin-tazobactam [see Drug Interactions (7.2)], volume depletion, pre-existing renal impairment and in critically ill patients and patients with co-morbid conditions that predispose to renal impairment.

Monitor serum vancomycin concentrations and renal function in all patients receiving Vancomycin Injection. More frequent monitoring is recommended in patients with comorbidities that predispose to impairment in renal function or are concomitantly receiving other nephrotoxic drugs, in critically ill patients, in patients with changing renal function, and in patients requiring higher therapeutic vancomycin levels. If acute kidney injury occurs, discontinue Vancomycin Injection, or reduce the dose [see Dosage and Administration (2.4)].

Ototoxicity has occurred in patients receiving Vancomycin Injection. It may be reversible or permanent. Ototoxicity manifests as tinnitus, hearing loss, dizziness or vertigo. The risk is higher in older patients, patients who are receiving higher doses, who have an underlying hearing loss, who are receiving concomitant therapy with another ototoxic agent, such as an aminoglycoside or who have underlying renal impairment. Monitor for signs and symptoms of ototoxicity during therapy. Monitor serum vancomycin concentrations and renal function in all patients receiving parenteral vancomycin. Discontinue Vancomycin Injection if ototoxicity occurs. Dosage of Vancomycin Injection must be adjusted for patients with renal impairment [see Dosage and Administration (2.4)].

Serial tests of auditory function may be helpful in order to minimize the risk of ototoxicity.

Severe dermatologic reactions such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and linear IgA bullous dermatosis (LABD) have been reported in association with the use of vancomycin. Cutaneous signs or symptoms reported include skin rashes (including exfoliative dermatitis), mucosal lesions, and blisters.

Discontinue Vancomycin Injection at the first appearance of signs and symptoms of TEN, SJS, DRESS, AGEP, or LABD.

Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Vancomycin Injection, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Prolonged use of vancomycin may result in the overgrowth of nonsusceptible microorganisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken. In rare instances, there have been reports of pseudomembranous colitis due to C. difficile developing in patients who received intravenous vancomycin.

Hemorrhagic occlusive retinal vasculitis, including permanent loss of vision, occurred in patients receiving intracameral or intravitreal administration of vancomycin during or after cataract surgery. The safety and efficacy of vancomycin administered by the intracameral or the intravitreal route have not been established by adequate and well-controlled trials. Vancomycin is not indicated for prophylaxis of endophthalmitis.

Reversible neutropenia has been reported in patients receiving vancomycin [see Adverse Reactions (6.1)]. Patients who will undergo prolonged therapy with vancomycin or those who are receiving concomitant drugs that may cause neutropenia should have periodic monitoring of the leukocyte count.

Reversible neutropenia, usually starting 1 week or more after onset of therapy with vancomycin or after a total dosage of more than 25 g, has been reported for several dozen patients. Neutropenia appears to be promptly reversible when vancomycin is discontinued. Thrombocytopenia has been reported. Although a causal relationship has not been established, reversible agranulocytosis (granulocytes <500/mm3) has been reported.

Inflammation at the injection site has been reported. Vancomycin is irritating to tissue and must be given by a secure intravenous route of administration. Thrombophlebitis may occur, the frequency and severity of which can be minimized by slow infusion of the drug and by rotation of venous access sites.

Administration of Vancomycin Injection by intramuscular (IM), intraperitoneal, intrathecal intraventricular, or intravitreal routes has not been approved and is not recommended. The safety and efficacy of vancomycin administered by these routes of administration have not been established by adequate and well controlled trials. Pain, tenderness, and necrosis occur with intramuscular (IM) injection of vancomycin or with inadvertent extravasation. There have been reports that the frequency of infusion-related events (including hypotension, flushing, erythema, urticaria, and pruritus) increases with the concomitant administration of anesthetic agents. Infusion-related events may be minimized by the administration of vancomycin as a 60-minute infusion prior to anesthetic induction.

Administration of sterile vancomycin by the intraperitoneal route during continuous ambulatory peritoneal dialysis (CAPD) has been reported to result in a syndrome of chemical peritonitis. Manifestations of this syndrome range from a cloudy dialysate alone to a cloudy dialysate accompanied by variable degrees of abdominal pain and fever. This syndrome appears to be resolved after discontinuation of intraperitoneal vancomycin.

About 60% of an intraperitoneal dose of vancomycin administered during peritoneal dialysis is absorbed systemically in 6 hours. Serum concentrations of about 10 mcg/mL are achieved by intraperitoneal injection of 30 mg/kg of vancomycin. However, the safety and efficacy of the intraperitoneal use of vancomycin has not been established in adequate and well-controlled trials.

Prescribing Vancomycin Injection in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Each 100 mL solution of Vancomycin Injection contains 354 mg of sodium, each 150 mL solution of Vancomycin Injection contains 531 mg of sodium, and each 200 mL solution of Vancomycin Injection contains 708 mg of sodium. Avoid use of Vancomycin Injection, in patients with congestive heart failure, elderly patients and patients requiring restricted sodium intake.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following adverse reactions associated with the use of vancomycin were identified in clinical trials:

Immune System Disorders: Anaphylaxis and “vancomycin infusion reaction”

Renal and urinary Disorders: Acute kidney injury and interstitial nephritis

Ear and Labyrinth Disorders: Hearing loss, vertigo, and tinnitus

Skin and subcutaneous tissue disorders: Rashes including exfoliative dermatitis, and Stevens-Johnson syndrome (SJS)

Gastrointestinal Disorders: Clostridioides difficile colitis, nausea

Blood and Lymphatic System Disorders: Agranulocytosis, neutropenia, pancytopenia, leukopenia, thrombocytopenia, eosinophilia

Cardiac Disorders: Cardiac arrest, chest pain

General Disorders and Administration Site Conditions: General discomfort, drug fever, chills, phlebitis, injection site irritation, injection site pain and necrosis following intramuscular injection, chemical peritonitis following intraperitoneal administration (Vancomycin Injection is not approved for intramuscular and intraperitoneal administration)

Laboratory Abnormalities: Elevated blood urea nitrogen, elevated serum creatinine

Musculoskeletal and connective tissue disorders: Muscle pain

Nervous system disorders: Dizziness

Respiratory, thoracic and mediastinal disorders: Wheezing, dyspnea

Vascular disorders: Hypotension, shock, vasculitis

The following adverse reactions have been identified during postmarketing use of vancomycin. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune System Disorders:Acute myocardial ischemia with or without myocardial infarction may occur as part of an allergic reaction.

Skin and Subcutaneous Tissue Disorders: Severe dermatologic reactions such as toxic epidermal necrolysis (TEN), Drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and linear IgA bullous dermatosis (LABD).

Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].

Studies have detected an increased incidence of acute kidney injury in patients administered concomitant piperacillin/tazobactam and vancomycin as compared to vancomycin alone. Monitor kidney function in patients receiving concomitant piperacillin/tazobactam and Vancomycin Injection. No pharmacokinetic interactions have been noted between piperacillin/tazobactam and vancomycin.

Concurrent and/or sequential systemic or topical use of other potentially neurotoxic and/or nephrotoxic drugs with Vancomycin Injection requires more frequent monitoring of renal function.

Risk Summary

Available data over several decades of vancomycin use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). Vancomycin did not show adverse developmental effects when administered intravenously to pregnant rats and rabbits during organogenesis at doses less than or equal to the recommended maximum human dose (see Data).

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data

Human Data

A published study evaluated hearing loss and nephrotoxicity in infants of 10 pregnant intravenous drug users treated with intravenously administered vancomycin for suspected or documented methicillin-resistant Staphylococcus-aureus (MRSA) in the second or third trimester. The comparison groups were 10 non-intravenous drug-dependent patients who received no treatment, and 10 untreated intravenous drug-dependent patients who served as substance abuse controls. No infant in the vancomycin exposed group had abnormal sensorineural hearing at 3 months of age or nephrotoxicity.

A published prospective study assessed outcomes in 55 pregnant women with a positive Group B streptococcus (GBS) culture and a high-risk penicillin allergy with resistance to clindamycin or unknown sensitivity who were administered vancomycin at the time of delivery. Vancomycin dosing ranged from the standard 1 g intravenously every 12 hours to 20 mg/kg intravenous every 8 hours (maximum individual dose 2 g). No major adverse reactions were recorded either in the mothers or their newborns.

None of the newborns had sensorineural hearing loss. Neonatal renal function was not examined, but all of the newborns were discharged in good condition.

Animal Data

Vancomycin did not cause fetal malformations when administered during organogenesis to pregnant rats (gestation days 6 to 15) and rabbits (gestation days 6 to 18) at the equivalent recommended maximum human dose (based on body surface area comparisons) of 200 mg/kg/day IV to rats or 120 mg/kg/day IV to rabbits. No effects on fetal weight or development were seen in rats at the highest dose tested or in rabbits given 80 mg/kg/day (approximately 1 and 0.8 times the recommended maximum human dose based on body surface area, respectively). Maternal toxicity was observed in rats (at doses 120 mg/kg and above) and rabbits (at 80 mg/kg and above).1

Risk Summary

Vancomycin is present in human milk following intravenous administration, however, there are insufficient data to inform the levels. There are no data on the effects of vancomycin on the breastfed infant or milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for vancomycin and any potential adverse effects on the breastfed infant from vancomycin or from the underlying maternal condition.

Vancomycin Injection is indicated in pediatric patients for the treatment of septicemia, infective endocarditis, skin and skin structure infections, bone infections and lower respiratory tract infections for whom appropriate dosing with this formulation can be achieved [see Indications and Usage (1.1 to 1.5) and Dosage and Administration (2.1, 2.3)].

Because of the limitations of the available strengths and administration requirements (i.e., administration of fractional doses is not recommended) of Vancomycin Injection, and to avoid unintentional overdose, this product is not recommended for use if a dose of Vancomycin Injection that does not equal 500 mg, 750 mg, 1 g, 1.25 g or 1.5 g is required, and an alternative formulation of vancomycin should be considered [see Dosage and Administration (2.1, 2.3)].

More severe infusion related reactions related to vancomycin administration may occur in pediatric patients. In pediatric patients, monitor vancomycin serum concentration and renal function when administering Vancomycin injection [see Dosage and Administration (2.3) and Warnings and Precautions (5.2)]. Concomitant administration of vancomycin and intravenous anesthetic agents has been associated with erythema and histamine-like flushing in all patients including pediatric patients [see Warnings and Precautions (5.1)].

Vancomycin injection is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection [see Dosage and Administration (2.4)], and it may be useful to monitor renal function [see Warnings and Precautions (5.2)].

Dosage adjustment of Vancomycin Injection must be made in patients with impaired renal function [see Dosage and Administration (2.4)]. Measure trough vancomycin serum concentrations to guide intravenous therapy, especially in patients with impaired renal function or fluctuating renal function.

Supportive care is advised, with maintenance of glomerular filtration. Vancomycin is poorly removed by dialysis.

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Hemofiltration and hemoperfusion with polysulfone resin have been reported to result in increased vancomycin clearance.

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For current information on the management of overdosage, contact the National Poison Control Center at 1-800-222-1222 or www.poison.org.

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Vancomycin Injection USP, in the GALAXY plastic container contains vancomycin, added as Vancomycin Hydrochloride USP. It is a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name of vancomycin hydrochloride is (Sa)-(3S, 6R, 7R, 22R, 23S, 26S, 36R, 38aR)-44-[[2-O-(3-Amino-2, 3, 6-trideoxy-3-Cmethyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)- 10,19dichloro 2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6[(2R)-4-methyl-2-(methylamino) valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno23, 36-(iminomethano)-13, 16:31, 35-dimetheno-1H, 16H-[l, 6, 9] oxadiazacyclohexadecino [4, 5-m] [10, 2, 16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24·HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula:

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Vancomycin Injection, USP in the GALAXY container is a frozen, iso-osmotic, sterile, nonpyrogenic, premixed single-dose formulation. The composition of Vancomycin Injection, USP, available in the following strengths are:

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The pH of the solution may have been adjusted with hydrochloric acid and/or sodium hydroxide. Thawed solutions have a pH in the range of 3.0 to 5.0. After thawing to room temperature, this solution is intended for intravenous use only.

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This GALAXY container is fabricated from a specially designed multilayer plastic. Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

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Vancomycin is an antibacterial drug [see Microbiology (12.4)].

Based on animal models of infection, the antimicrobial activity of vancomycin appears to correlate with the AUC/MIC (area under the concentration-time curve/minimum inhibitory concentration) ratio for certain pathogens, including methicillin resistant Staphylococcus aureus. The principal pharmacokinetic/pharmacodynamic parameter best associated with clinical and microbiological cure has not been elucidated in clinical trials2,3.

General Pharmacokinetics

In subjects with normal kidney function, multiple intravenous dosing of 1 g of vancomycin (15 mg/kg) infused over 60 minutes produces mean plasma concentrations of approximately 63 mcg/mL immediately after the completion of infusion, mean plasma concentrations of approximately 23 mcg/mL 2 hours after infusion, and mean plasma concentrations of approximately 8 mcg/mL 11 hours after the end of the infusion. Multiple dosing of 500 mg infused over 30 minutes produces mean plasma concentrations of about 49 mcg/mL at the completion of infusion, mean plasma concentrations of about 19 mcg/mL 2 hours after infusion, and mean plasma concentrations of about 10 mcg/mL 6 hours after infusion. The plasma concentrations during multiple dosing are similar to those after a single dose.

Distribution

The distribution coefficient is from 0.3 to 0.43 L/kg. Vancomycin is approximately 55% serum protein bound as measured by ultrafiltration at vancomycin serum concentrations of 10 to 100 mcg/mL. After IV administration of vancomycin, inhibitory concentrations are present in pleural, pericardial, ascitic, and synovial fluids; in urine; in peritoneal dialysis fluid; and in atrial appendage tissue. Vancomycin does not readily diffuse across normal meninges into the spinal fluid; but, when the meninges are inflamed, penetration into the spinal fluid occurs.

Elimination

Mean plasma clearance is about 0.058 L/kg/h, and mean renal clearance is about 0.048 L/kg/h. The mean elimination half-life of vancomycin from plasma is 4 to 6 hours in subjects with normal renal function. In anephric patients, the average half-life of elimination is 7.5 days. Total systemic and renal clearance of vancomycin may be reduced in the elderly.

Metabolism

There is no apparent metabolism of vancomycin.

Excretion

In the first 24 hours, about 75% of an administered dose of vancomycin is excreted in urine by glomerular filtration. Renal dysfunction slows excretion of vancomycin.

Mechanism of Action

The bactericidal action of vancomycin results primarily from inhibition of cell-wall biosynthesis. In addition, vancomycin alters bacterial-cell-membrane permeability and RNA synthesis.

Resistance

There is no cross-resistance between vancomycin and other antibacterial(s). Vancomycin is not active in vitro against gram-negative bacilli, mycobacteria, or fungi.

Interaction With Other Antimicrobials

The combination of vancomycin and an aminoglycoside acts synergistically in vitro against many isolates of Staphylococcus aureus, Streptococcus gallolyticus (previously known as Streptococcus bovis), Enterococcus spp, and the viridans group streptococci.

Antimicrobial Activity

Vancomycin has been shown to be active against most isolates of the following bacteria, both in vitro and in clinical infections [see Indications and Usage section (1)].

Aerobic bacteria

Gram-positive bacteria

The following in vitro data are available, but their clinical significance is unknown. At least 90 percent of the following bacteria exhibit an in vitro minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoint for vancomycin against isolates of similar genus or organism group. However, the efficacy of vancomycin in treating clinical infections caused by these bacteria has not been established in adequate and well-controlled clinical trials.

Aerobic bacteria

Gram-positive bacteria

Anaerobic bacteria

Gram-positive bacteria

Susceptibility Testing

For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.

No long-term studies in animals have been performed to evaluate carcinogenic potential. No definitive fertility studies have been performed.

In animal studies, hypotension and bradycardia occurred in dogs receiving an intravenous infusion of vancomycin 25 mg/kg, at a concentration of 25 mg/mL and an infusion rate of 13.3 mL/min.

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How Supplied

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Vancomycin Injection, USP is supplied as a frozen, iso-osmotic, premixed solution packaged in a single-dose GALAXY plastic container and is available as follows:

{ "type": "p", "children": [], "text": "Vancomycin Injection, USP is supplied as a frozen, iso-osmotic, premixed solution packaged in a single-dose GALAXY plastic container and is available as follows:" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col width="47%"/> <col width="33%"/> <col width="17%"/> <tbody class="Headless"> <tr> <td align="center" class="Botrule Lrule Rrule Toprule" colspan="3" valign="middle"> <p class="First">Supply Information for Vancomycin Injection, in 5% Dextrose</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">Strength</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">Number of Containers/ Carton</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">NDC</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">500 mg of vancomycin / 100 mL (5 mg/mL)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">12 count</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">0338-3551-48</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">750 mg of vancomycin / 150 mL (5 mg/mL)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">6 count</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">0338-3580-48</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">1 g of vancomycin / 200 mL (5mg/mL)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">6 count</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">0338-3552-48</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">1.25 g of vancomycin / 250 mL (5 mg/mL)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">4 count</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">0338-0122-04</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">1.5 g of vancomycin / 300 mL (5 mg/mL)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">4 count</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">0338-0124-04</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col width=\"47%\"/>\n<col width=\"33%\"/>\n<col width=\"17%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\" valign=\"middle\">\n<p class=\"First\">Supply Information for Vancomycin Injection, in 5% Dextrose</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">Strength</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">Number of Containers/ Carton</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">NDC</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">500 mg of vancomycin / 100 mL (5 mg/mL)</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">12 count</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">0338-3551-48</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">750 mg of vancomycin / 150 mL (5 mg/mL)</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">6 count</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">0338-3580-48</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">1 g of vancomycin / 200 mL (5mg/mL)</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">6 count</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">0338-3552-48</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">1.25 g of vancomycin / 250 mL (5 mg/mL)</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">4 count</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">0338-0122-04</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">1.5 g of vancomycin / 300 mL (5 mg/mL)</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">4 count</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">0338-0124-04</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table class="Noautorules" width="100%"> <col width="56%"/> <col width="25%"/> <col width="19%"/> <tbody class="Headless"> <tr> <td align="center" class="Botrule Lrule Rrule Toprule" colspan="3" valign="middle"> <p class="First">Supply Information for Vancomycin Injection, in 0.9% Sodium Chloride</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="middle"> <p class="First">Strength</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">Number of Containers/ Carton</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">NDC</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">500 mg of vancomycin / 100 mL (5 mg/mL)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">12 count</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">0338-3581-01</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="middle"> <p class="First">750 mg vancomycin / 150 mL (5 mg/mL)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">6 count</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">0338-3582-01</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">1 g of vancomycin / 200 mL (5mg/mL)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">6 count</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First">0338-3583-01</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"100%\">\n<col width=\"56%\"/>\n<col width=\"25%\"/>\n<col width=\"19%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"3\" valign=\"middle\">\n<p class=\"First\">Supply Information for Vancomycin Injection, in 0.9% Sodium Chloride</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">Strength</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">Number of Containers/ Carton</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">NDC</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">500 mg of vancomycin / 100 mL (5 mg/mL)</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">12 count</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">0338-3581-01</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" valign=\"middle\">\n<p class=\"First\">750 mg vancomycin / 150 mL (5 mg/mL)</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">6 count</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">0338-3582-01</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">1 g of vancomycin / 200 mL (5mg/mL)</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">6 count</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"middle\">\n<p class=\"First\">0338-3583-01</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Storage

{ "type": "p", "children": [], "text": "\nStorage\n" }

Store Vancomycin Injection at or below -20°C (-4°F) or Store in a freezer capable of maintaining a temperature at or below -20°C (-4°F). Storage of the thawed solution is described elsewhere in the labeling [see Dosage and Administration (2.5)]

{ "type": "p", "children": [], "text": "Store Vancomycin Injection at or below -20°C (-4°F) or Store in a freezer capable of maintaining a temperature at or below -20°C (-4°F). Storage of the thawed solution is described elsewhere in the labeling [see Dosage and Administration (2.5)]\n" }

Handling

{ "type": "p", "children": [], "text": "\nHandling\n" }

Handle frozen product containers with care. Product containers may be fragile in the frozen state.

{ "type": "p", "children": [], "text": "Handle frozen product containers with care. Product containers may be fragile in the frozen state." }

Infusion Reactions During or After Intravenous Use

{ "type": "p", "children": [], "text": "\nInfusion Reactions During or After Intravenous Use\n" }

Advise patients that generalized skin redness, skin rash, itching, flushing, muscle pain, chest pain, shortness of breath, wheezing, or dizziness may occur during intravenous infusion of Vancomycin Injection. [see Warnings and Precautions (5.1)].

{ "type": "p", "children": [], "text": "Advise patients that generalized skin redness, skin rash, itching, flushing, muscle pain, chest pain, shortness of breath, wheezing, or dizziness may occur during intravenous infusion of Vancomycin Injection. [see Warnings and Precautions (5.1)].\n" }

Acute Kidney Injury

{ "type": "p", "children": [], "text": "\nAcute Kidney Injury\n" }

Advise patients that Vancomycin Injection can result in kidney damage and that blood tests are required to monitor vancomycin blood levels and kidney function during therapy [see Warnings and Precautions (5.2)].

{ "type": "p", "children": [], "text": "Advise patients that Vancomycin Injection can result in kidney damage and that blood tests are required to monitor vancomycin blood levels and kidney function during therapy [see Warnings and Precautions (5.2)].\n" }

Hearing Loss or Balance Problems

{ "type": "p", "children": [], "text": "\nHearing Loss or Balance Problems\n" }

Advise patients that Vancomycin injection may result in decreased hearing and to report hearing loss or balance problems to their healthcare provider [see Warnings and Precautions (5.3)].

{ "type": "p", "children": [], "text": "Advise patients that Vancomycin injection may result in decreased hearing and to report hearing loss or balance problems to their healthcare provider [see Warnings and Precautions (5.3)].\n" }

Severe Dermatologic Reactions

{ "type": "p", "children": [], "text": "\nSevere Dermatologic Reactions\n" }

Advise patients about the signs and symptoms of serious skin manifestations. Instruct patients to stop Vancomycin Injection immediately and promptly seek medical attention at the first signs or symptoms of skin rash, mucosal lesions and blisters [see Warnings and Precautions (5.4)].

{ "type": "p", "children": [], "text": "Advise patients about the signs and symptoms of serious skin manifestations. Instruct patients to stop Vancomycin Injection immediately and promptly seek medical attention at the first signs or symptoms of skin rash, mucosal lesions and blisters [see Warnings and Precautions (5.4)].\n" }

Diarrhea

{ "type": "p", "children": [], "text": "\nDiarrhea\n" }

Diarrhea is a common problem caused by antibacterial drugs, including Vancomycin Injection, which usually ends when the antibacterial drug is discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial drug. If this occurs, patients should contact their physician as soon as possible [see Warnings and Precautions (5.5)].

{ "type": "p", "children": [], "text": "Diarrhea is a common problem caused by antibacterial drugs, including Vancomycin Injection, which usually ends when the antibacterial drug is discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial drug. If this occurs, patients should contact their physician as soon as possible [see Warnings and Precautions (5.5)].\n" }

Antibacterial Resistance

{ "type": "p", "children": [], "text": "\nAntibacterial Resistance\n" }

Patients should be counseled that antibacterial drugs including Vancomycin Injection, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Vancomycin Injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Vancomycin Injection or other antibacterial drugs in the future.

{ "type": "p", "children": [], "text": "Patients should be counseled that antibacterial drugs including Vancomycin Injection, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Vancomycin Injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Vancomycin Injection or other antibacterial drugs in the future." }

Manufactured by, Packed by, Distributed by:

{ "type": "p", "children": [], "text": "Manufactured by, Packed by, Distributed by:" }

Baxter Healthcare Corporation Deerfield, IL 60015 USAMade in the USA

{ "type": "p", "children": [], "text": "\nBaxter Healthcare Corporation\nDeerfield, IL 60015 USAMade in the USA" }

07-19-08-903

{ "type": "p", "children": [], "text": "07-19-08-903" }

Baxter and Galaxy are trademarks of Baxter International Inc. or its subsidiaries.

{ "type": "p", "children": [], "text": "Baxter and Galaxy are trademarks of Baxter International Inc. or its subsidiaries." }

Container Label

{ "type": "p", "children": [], "text": "\nContainer Label\n" }

NDC 0338-3551-48

{ "type": "p", "children": [], "text": "\nNDC 0338-3551-48\n" }

Vancomycin Injection, USP in 5% Dextrose

{ "type": "p", "children": [], "text": "\nVancomycin Injection, USP\n\nin 5% Dextrose\n" }

500 mg per 100 mL (5 mg/mL)

{ "type": "p", "children": [], "text": "\n500 mg per 100 mL\n(5 mg/mL)" }

GALAXY Single-Dose Container Discard unused portion

{ "type": "p", "children": [], "text": "\nGALAXY\n\nSingle-Dose Container\n\nDiscard unused portion\n" }

Code 2G3551 Sterile Nonpyrogenic Iso-osmotic

{ "type": "p", "children": [], "text": "\nCode 2G3551\n\nSterile Nonpyrogenic \n\nIso-osmotic\n" }

Each 100 mL contains: Vancomycin Hydrochloride, USP equivalent to500 mg vancomycin with approx. 5 g Dextrose Hydrous, USP in Water forInjection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide.

{ "type": "p", "children": [], "text": "Each 100 mL contains: Vancomycin Hydrochloride, USP equivalent to500 mg vancomycin with approx. 5 g Dextrose Hydrous, USP in Water forInjection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide." }

Dosage: For intravenous use only. See prescribing information.

{ "type": "p", "children": [], "text": "Dosage: For intravenous use only. See prescribing information. " }

Cautions: Do not add supplementary medication or additives.

{ "type": "p", "children": [], "text": "Cautions: Do not add supplementary medication or additives." }

Rx Only Store at or below -20°C (-4°F). Thaw at room temperature(25°C/77°F) or under refrigeration (5°C/41°F). Product should not be thawed by immersion in water baths or by microwave irradiation. Do not force thaw. Thawed solution is stable for 30 days underrefrigeration or 72 hours at room temperature. Do not refreeze.

{ "type": "p", "children": [], "text": "\nRx Only\nStore at or below -20°C (-4°F). Thaw at room temperature(25°C/77°F) or under refrigeration (5°C/41°F). Product should not be thawed by immersion in water baths or by microwave irradiation.\nDo not force thaw. Thawed solution is stable for 30 days underrefrigeration or 72 hours at room temperature. Do not refreeze." }

PL 2040 Plastic

{ "type": "p", "children": [], "text": "PL 2040 Plastic" }

Baxter Logo

{ "type": "p", "children": [], "text": "\nBaxter Logo\n" }

Baxter and Galaxy are trademarks of Baxter International Inc. Baxter Healthcare Corporation, Deerfield, IL 60015 USA

{ "type": "p", "children": [], "text": "Baxter and Galaxy are trademarks of Baxter International Inc.\nBaxter Healthcare Corporation, Deerfield, IL 60015 USA" }

07-34-74-761

{ "type": "p", "children": [], "text": "07-34-74-761" }

Carton Label

{ "type": "p", "children": [], "text": "\nCarton Label\n" }

Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). Product should not be thawed by immersion in water baths or by microware irradiation. Do not force thaw. The thawed solution in GALAXY plastic container (PL 2040) remains chemically stable for 72 hours at room temperature or for 30 days when stored under refrigeration. Do not refreeze.

{ "type": "p", "children": [], "text": "Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). Product should not be thawed by immersion in water baths or by microware irradiation. Do not force thaw. The thawed solution in GALAXY plastic container (PL 2040) remains chemically stable for 72 hours at room temperature or for 30 days when stored under refrigeration. Do not refreeze.\n" }

Handle frozen product containers with care. Product containers may be fragile in the frozen state.

{ "type": "p", "children": [], "text": "Handle frozen product containers with care. Product containers may be fragile in the frozen state." }

PL 2040 Plastic 07-04-74-764

{ "type": "p", "children": [], "text": "PL 2040 Plastic 07-04-74-764" }

Vancomycin Injection, USP in 5% Dextrose 500 mg per 100 mL (5 mg/ mL)Contains 6 Single-Use bags. Each bag contains 100 mL. Iso-osmotic. Store at or below -20°C/-4°F.

{ "type": "p", "children": [], "text": "\nVancomycin Injection, USP in 5% Dextrose \n\n500 mg per 100 mL (5 mg/ mL)Contains 6 Single-Use bags. Each bag contains 100 mL. Iso-osmotic. Store at or below -20°C/-4°F.\n" }

Rx Only

{ "type": "p", "children": [], "text": "\nRx Only\n" }

NDC 0338-3551-48 Code 2G3551

{ "type": "p", "children": [], "text": "\nNDC 0338-3551-48\n\nCode 2G3551\n" }

*FOR BAR CODE POSITION ONLY(01) 20303383551485

{ "type": "p", "children": [], "text": "*FOR BAR CODE POSITION ONLY(01) 20303383551485" }

GALAXY Container

{ "type": "p", "children": [], "text": "\nGALAXY Container " }

Sterile Nonpyrogenic

{ "type": "p", "children": [], "text": "Sterile Nonpyrogenic" }

Each 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. 5 g Dextrose Hydrous, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide.

{ "type": "p", "children": [], "text": "Each 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. 5 g Dextrose Hydrous, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide." }

Dosage: For intravenous use only. See prescribing information.Cautions: Do not add supplementary medication or additives.

{ "type": "p", "children": [], "text": "Dosage: For intravenous use only. See prescribing information.Cautions: Do not add supplementary medication or additives." }

Baxter Logo

{ "type": "p", "children": [], "text": "\nBaxter Logo\n" }

Baxter and Galaxy are registered trademarks of Baxter International Inc. Baxter Healthcare Corporation, Deerfield, IL 60015 USA

{ "type": "p", "children": [], "text": "Baxter and Galaxy are registered trademarks of Baxter International Inc. \nBaxter Healthcare Corporation, Deerfield, IL 60015 USA" }

{ "type": "", "children": [], "text": "" }

NDC 0338-3552-48

{ "type": "p", "children": [], "text": "\nNDC 0338-3552-48\n" }

Vancomycin Injection, USP in 5% Dextrose

{ "type": "p", "children": [], "text": "\nVancomycin Injection, USP \n\nin 5% Dextrose\n" }

1 g per 200 mL (5 mg/mL)

{ "type": "p", "children": [], "text": "\n1 g per 200 mL\n(5 mg/mL)" }

GALAXY Single-Dose Container Discard unused portion

{ "type": "p", "children": [], "text": "\nGALAXY \n\nSingle-Dose Container \n\nDiscard unused portion \n" }

Code 2G3552 Sterile Nonpyrogenic Iso-osmotic

{ "type": "p", "children": [], "text": "\nCode 2G3552\n\nSterile Nonpyrogenic \n\nIso-osmotic\n" }

Each 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. 5 g Dextrose Hydrous, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide.

{ "type": "p", "children": [], "text": "Each 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. 5 g Dextrose Hydrous, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide." }

Dosage: For intravenous use only. See prescribing information.

{ "type": "p", "children": [], "text": "Dosage: For intravenous use only. See prescribing information. " }

Cautions: Do not add supplementary medication or additives.

{ "type": "p", "children": [], "text": "Cautions: Do not add supplementary medication or additives." }

Rx Only Store at or below -20°C (-4°F). Thaw at room temperature(25°C/77°F) or under refrigeration (5°C/41°F). Product should not be thawed by immersion in water baths or by microwave irradiation. Do not force thaw. Thawed solution is stable for 30 days under refrigeration or 72 hours at room temperature. Do not refreeze.

{ "type": "p", "children": [], "text": "\nRx Only\nStore at or below -20°C (-4°F). Thaw at room temperature(25°C/77°F) or under refrigeration (5°C/41°F). Product should not be thawed by immersion in water baths or by microwave irradiation. Do not force thaw. Thawed solution is stable for 30 days under refrigeration or 72 hours at room temperature. \nDo not refreeze." }

PL 2040 Plastic

{ "type": "p", "children": [], "text": "PL 2040 Plastic" }

Baxter Logo

{ "type": "p", "children": [], "text": "\nBaxter Logo\n" }

Baxter and Galaxy are trademarks of Baxter International Inc. Baxter Healthcare Corporation, Deerfield, IL 60015 USA

{ "type": "p", "children": [], "text": "Baxter and Galaxy are trademarks of Baxter International Inc.\nBaxter Healthcare Corporation, Deerfield, IL 60015 USA" }

07-34-74-763

{ "type": "p", "children": [], "text": "07-34-74-763" }

{ "type": "", "children": [], "text": "" }

Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). Product should not be thawed by immersion in water baths or by microware irradiation. Do not force thaw. The thawed solution in GALAXY plastic container (PL 2040) remains chemically stable for 72 hours at room temperature or for 30 days when stored under refrigeration. Do not refreeze.

{ "type": "p", "children": [], "text": "Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). Product should not be thawed by immersion in water baths or by microware irradiation. Do not force thaw. The thawed solution in GALAXY plastic container (PL 2040) remains chemically stable for 72 hours at room temperature or for 30 days when stored under refrigeration. Do not refreeze.\n" }

Handle frozen product containers with care. Product containers may be fragile in the frozen state.

{ "type": "p", "children": [], "text": "Handle frozen product containers with care. Product containers may be fragile in the frozen state." }

PL 2040 Plastic 07-04-74-766

{ "type": "p", "children": [], "text": "PL 2040 Plastic 07-04-74-766" }

Vancomycin Injection, USP in 5% Dextrose 1 g per 200 mL (5 mg/ mL)Contains 3 Single-Use bags. Each bag contains 200 mL. Iso-osmotic. Store at or below -20°C/-4°F.

{ "type": "p", "children": [], "text": "\nVancomycin Injection, USP in 5% Dextrose \n\n1 g per 200 mL (5 mg/ mL)Contains 3 Single-Use bags. Each bag contains 200 mL. Iso-osmotic. Store at or below -20°C/-4°F.\n" }

Rx Only

{ "type": "p", "children": [], "text": "\nRx Only\n" }

NDC 0338-3552-48 Code 2G3552

{ "type": "p", "children": [], "text": "\nNDC 0338-3552-48\n\nCode 2G3552\n" }

*FOR BAR CODE POSITION ONLY(01) 20303383552482

{ "type": "p", "children": [], "text": "*FOR BAR CODE POSITION ONLY(01) 20303383552482" }

GALAXY Container

{ "type": "p", "children": [], "text": "\nGALAXY Container " }

Sterile Nonpyrogenic

{ "type": "p", "children": [], "text": "Sterile Nonpyrogenic" }

Each 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. 5 g Dextrose Hydrous, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide.

{ "type": "p", "children": [], "text": "Each 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. 5 g Dextrose Hydrous, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide." }

Dosage: For intravenous use only. See prescribing information.Cautions: Do not add supplementary medication or additives.

{ "type": "p", "children": [], "text": "Dosage: For intravenous use only. See prescribing information.Cautions: Do not add supplementary medication or additives." }

Baxter Logo

{ "type": "p", "children": [], "text": "\nBaxter Logo\n" }

Baxter and Galaxy are registered trademarks of Baxter International Inc. Baxter Healthcare Corporation, Deerfield, IL 60015 USA

{ "type": "p", "children": [], "text": "Baxter and Galaxy are registered trademarks of Baxter International Inc. \nBaxter Healthcare Corporation, Deerfield, IL 60015 USA" }

Container Label

{ "type": "p", "children": [], "text": "\nContainer Label\n" }

NDC 0338-3580-48

{ "type": "p", "children": [], "text": "\nNDC 0338-3580-48\n" }

Vancomycin Injection, USP in 5% Dextrose

{ "type": "p", "children": [], "text": "\nVancomycin Injection, USP\n\nin 5% Dextrose\n" }

750 mg per 150 mL (5 mg/mL)

{ "type": "p", "children": [], "text": "\n750 mg per 150 mL\n(5 mg/mL)" }

GALAXY Single-Dose Container Discard unused portion

{ "type": "p", "children": [], "text": "\nGALAXY\nSingle-Dose Container Discard unused portion" }

Code 2G3580Sterile NonpyrogenicIso-osmotic

{ "type": "p", "children": [], "text": "Code 2G3580Sterile NonpyrogenicIso-osmotic" }

Each 100 mL contains: Vancomycin Hydrochloride, USPequivalent to 500 mg vancomycin with approx. 5 g DextroseHydrous, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide.

{ "type": "p", "children": [], "text": "Each 100 mL contains: Vancomycin Hydrochloride, USPequivalent to 500 mg vancomycin with approx. 5 g DextroseHydrous, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. " }

Dosage: For intravenous use only. See prescribing information.

{ "type": "p", "children": [], "text": "Dosage: For intravenous use only. See prescribing information. " }

Cautions: Do not add supplementary medication or additives.

{ "type": "p", "children": [], "text": "Cautions: Do not add supplementary medication or additives." }

Rx Only Store at or below -20°C (-4°F). Thaw at room temperature(25°C/77°F) or under refrigeration (5°C/41°F). Product should not be thawed by immersion in water baths or by microwave irradiation. Do not force thaw. Thawed solution is stable for 30 days under refrigeration or 72 hours at room temperature. Do not refreeze.

{ "type": "p", "children": [], "text": "\nRx Only\nStore at or below -20°C (-4°F). Thaw at room temperature(25°C/77°F) or under refrigeration (5°C/41°F). Product should not be thawed by immersion in water baths or by microwave irradiation. Do not force thaw. Thawed solution is stable for 30 days under refrigeration or 72 hours at room temperature. \nDo not refreeze." }

PL 2040 Plastic

{ "type": "p", "children": [], "text": "PL 2040 Plastic" }

Baxter Logo

{ "type": "p", "children": [], "text": "\nBaxter Logo\n" }

Baxter and Galaxy are trademarks of Baxter International Inc. Baxter Healthcare Corporation, Deerfield, IL 60015 USA

{ "type": "p", "children": [], "text": "Baxter and Galaxy are trademarks of Baxter International Inc.\nBaxter Healthcare Corporation, Deerfield, IL 60015 USA" }

07-34-74-762

{ "type": "p", "children": [], "text": "07-34-74-762" }

Carton Labels

{ "type": "p", "children": [], "text": "\nCarton Labels\n" }

Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). Product should not be thawed by immersion in water baths or by microware irradiation. Do not force thaw. The thawed solution in GALAXY plastic container (PL 2040) remains chemically stable for 72 hours at room temperature or for 30 days when stored under refrigeration. Do not refreeze.

{ "type": "p", "children": [], "text": "Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). Product should not be thawed by immersion in water baths or by microware irradiation. Do not force thaw. The thawed solution in GALAXY plastic container (PL 2040) remains chemically stable for 72 hours at room temperature or for 30 days when stored under refrigeration. Do not refreeze.\n" }

Handle frozen product containers with care. Product containers may be fragile in the frozen state.

{ "type": "p", "children": [], "text": "Handle frozen product containers with care. Product containers may be fragile in the frozen state." }

PL 2040 Plastic 07-04-74-765

{ "type": "p", "children": [], "text": "PL 2040 Plastic 07-04-74-765" }

Vancomycin Injection, USP in 5% Dextrose 750 mg per 150 mL (5 mg/ mL)Contains 3 Single-Use bags. Each bag contains 150 mL. Iso-osmotic. Store at or below -20°C/-4°F.

{ "type": "p", "children": [], "text": "\nVancomycin Injection, USP in 5% Dextrose \n\n750 mg per 150 mL (5 mg/ mL)Contains 3 Single-Use bags. Each bag contains 150 mL. Iso-osmotic. Store at or below -20°C/-4°F.\n" }

Rx Only

{ "type": "p", "children": [], "text": "\nRx Only\n" }

NDC 0338-3580-48 Code 2G3580

{ "type": "p", "children": [], "text": "\nNDC 0338-3580-48\n\nCode 2G3580\n" }

*FOR BAR CODE POSITION ONLY(01) 20303383580485

{ "type": "p", "children": [], "text": "*FOR BAR CODE POSITION ONLY(01) 20303383580485" }

GALAXY Container

{ "type": "p", "children": [], "text": "\nGALAXY Container " }

Sterile Nonpyrogenic

{ "type": "p", "children": [], "text": "Sterile Nonpyrogenic" }

Each 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. 5 g Dextrose Hydrous, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide.

{ "type": "p", "children": [], "text": "Each 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. 5 g Dextrose Hydrous, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide." }

Dosage: For intravenous use only. See prescribing information.Cautions: Do not add supplementary medication or additives.

{ "type": "p", "children": [], "text": "Dosage: For intravenous use only. See prescribing information.Cautions: Do not add supplementary medication or additives." }

Baxter Logo

{ "type": "p", "children": [], "text": "\nBaxter Logo\n" }

Baxter and Galaxy are registered trademarks of Baxter International Inc. Baxter Healthcare Corporation, Deerfield, IL 60015 USA

{ "type": "p", "children": [], "text": "Baxter and Galaxy are registered trademarks of Baxter International Inc. \nBaxter Healthcare Corporation, Deerfield, IL 60015 USA" }

{ "type": "", "children": [], "text": "" }

NDC 0338-3581-01

{ "type": "p", "children": [], "text": "\nNDC 0338-3581-01\n" }

Vancomycin Injection, USP in 0.9% Sodium Chloride

{ "type": "p", "children": [], "text": "\nVancomycin Injection, USP\n\nin 0.9% Sodium Chloride\n" }

500 mg per 100 mL (5 mg/mL)

{ "type": "p", "children": [], "text": "\n500 mg per 100 mL\n(5 mg/mL)" }

GALAXY Single-Dose Container Discard unused portion

{ "type": "p", "children": [], "text": "\nGALAXY\nSingle-Dose Container Discard unused portion" }

Code 2G3590Sterile NonpyrogenicIso-osmotic

{ "type": "p", "children": [], "text": "Code 2G3590Sterile NonpyrogenicIso-osmotic" }

Each 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. 0.9 g Sodium Chloride, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide.

{ "type": "p", "children": [], "text": "Each 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. 0.9 g Sodium Chloride, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. " }

Dosage: For intravenous use only. See prescribing information.

{ "type": "p", "children": [], "text": "Dosage: For intravenous use only. See prescribing information. " }

Cautions: Do not add supplementary medication or additives.

{ "type": "p", "children": [], "text": "Cautions: Do not add supplementary medication or additives." }

Rx Only Store at or below -20°C (-4°F). Thaw at room temperature(25°C/77°F) or under refrigeration (5°C/41°F). Product should not be thawed by immersion in water baths or by microwave irradiation. Do not force thaw. Thawed solution is stable for 30 days under refrigeration or 72 hours at room temperature. Do not refreeze.

{ "type": "p", "children": [], "text": "\nRx Only\nStore at or below -20°C (-4°F). Thaw at room temperature(25°C/77°F) or under refrigeration (5°C/41°F). Product should not be thawed by immersion in water baths or by microwave irradiation. \nDo not force thaw. Thawed solution is stable for 30 days under refrigeration or 72 hours at room temperature. Do not refreeze." }

PL 2040 Plastic

{ "type": "p", "children": [], "text": "PL 2040 Plastic" }

Baxter Logo

{ "type": "p", "children": [], "text": "\nBaxter Logo\n" }

Baxter and Galaxy are trademarks of Baxter International Inc. Baxter Healthcare Corporation, Deerfield, IL 60015 USA

{ "type": "p", "children": [], "text": "Baxter and Galaxy are trademarks of Baxter International Inc.\nBaxter Healthcare Corporation, Deerfield, IL 60015 USA" }

07-34-74-548

{ "type": "p", "children": [], "text": "07-34-74-548" }

{ "type": "", "children": [], "text": "" }

Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). Product should not be thawed by immersion in water baths or by microware irradiation. Do not force thaw. The thawed solution in GALAXY plastic container (PL 2040) remains chemically stable for 72 hours at room temperature or for 30 days when stored under refrigeration. Do not refreeze.

{ "type": "p", "children": [], "text": "Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). Product should not be thawed by immersion in water baths or by microware irradiation. Do not force thaw. The thawed solution in GALAXY plastic container (PL 2040) remains chemically stable for 72 hours at room temperature or for 30 days when stored under refrigeration. Do not refreeze.\n" }

Handle frozen product containers with care. Product containers may be fragile in the frozen state.

{ "type": "p", "children": [], "text": "Handle frozen product containers with care. Product containers may be fragile in the frozen state." }

PL 2040 Plastic 07-04-77-715

{ "type": "p", "children": [], "text": "PL 2040 Plastic 07-04-77-715" }

Vancomycin Injection, USP in 0.9% Sodium Chloride 500 mg per 100 mL (5 mg/ mL)Contains 6 Single-Dose bags. Each bag contains 100 mL. Iso-osmotic. Store at or below -20°C/-4°F.

{ "type": "p", "children": [], "text": "\nVancomycin Injection, USP in 0.9% Sodium Chloride \n\n500 mg per 100 mL (5 mg/ mL)Contains 6 Single-Dose bags. Each bag contains 100 mL. Iso-osmotic. Store at or below -20°C/-4°F.\n" }

Rx Only

{ "type": "p", "children": [], "text": "\nRx Only\n" }

NDC 0338-3581-01 Code 2G3590

{ "type": "p", "children": [], "text": "\nNDC 0338-3581-01\n\nCode 2G3590\n" }

*FOR BAR CODE POSITION ONLY(01) 20303383581017

{ "type": "p", "children": [], "text": "*FOR BAR CODE POSITION ONLY(01) 20303383581017" }

GALAXY Container

{ "type": "p", "children": [], "text": "\nGALAXY Container " }

Sterile Nonpyrogenic

{ "type": "p", "children": [], "text": "Sterile Nonpyrogenic" }

Each 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. 0.9 Sodium Chloride, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide.

{ "type": "p", "children": [], "text": "Each 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. 0.9 Sodium Chloride, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide." }

Dosage: For intravenous use only. See prescribing information.Cautions: Do not add supplementary medication or additives.

{ "type": "p", "children": [], "text": "Dosage: For intravenous use only. See prescribing information.Cautions: Do not add supplementary medication or additives." }

Baxter Logo

{ "type": "p", "children": [], "text": "\nBaxter Logo\n" }

Baxter and Galaxy are registered trademarks of Baxter International Inc. Baxter Healthcare Corporation, Deerfield, IL 60015 USA

{ "type": "p", "children": [], "text": "Baxter and Galaxy are registered trademarks of Baxter International Inc. \nBaxter Healthcare Corporation, Deerfield, IL 60015 USA" }

Container Label

{ "type": "p", "children": [], "text": "\nContainer Label\n" }

NDC 0338-3582-01

{ "type": "p", "children": [], "text": "\nNDC 0338-3582-01\n" }

Vancomycin Injection, USP in 0.9% Sodium Chloride

{ "type": "p", "children": [], "text": "\nVancomycin Injection, USP\n\nin 0.9% Sodium Chloride\n" }

750 mg per 150 mL (5 mg/mL)

{ "type": "p", "children": [], "text": "\n750 mg per 150 mL\n(5 mg/mL)" }

GALAXY Single-Dose Container Discard unused portion

{ "type": "p", "children": [], "text": "\nGALAXY\nSingle-Dose Container Discard unused portion" }

Code 2G3591Sterile NonpyrogenicIso-osmotic

{ "type": "p", "children": [], "text": "Code 2G3591Sterile NonpyrogenicIso-osmotic" }

Each 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. 0.9 g Sodium Chloride, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide.

{ "type": "p", "children": [], "text": "Each 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. 0.9 g Sodium Chloride, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. " }

Dosage: For intravenous use only. See prescribing information.

{ "type": "p", "children": [], "text": "Dosage: For intravenous use only. See prescribing information. " }

Cautions: Do not add supplementary medication or additives.

{ "type": "p", "children": [], "text": "Cautions: Do not add supplementary medication or additives." }

Rx Only Store at or below -20°C (-4°F). Thaw at room temperature(25°C/77°F) or under refrigeration (5°C/41°F). Product should not be thawed by immersion in water baths or by microwave irradiation. Do not force thaw. Thawed solution is stable for 30 days under refrigeration or 72 hours at room temperature. Do not refreeze.

{ "type": "p", "children": [], "text": "\nRx Only\nStore at or below -20°C (-4°F). Thaw at room temperature(25°C/77°F) or under refrigeration (5°C/41°F). Product should not be thawed by immersion in water baths or by microwave irradiation. Do not force thaw. Thawed solution is stable for 30 days under refrigeration or 72 hours at room temperature. \nDo not refreeze." }

PL 2040 Plastic

{ "type": "p", "children": [], "text": "PL 2040 Plastic" }

Baxter Logo

{ "type": "p", "children": [], "text": "\nBaxter Logo\n" }

Baxter and Galaxy are trademarks of Baxter International Inc. Baxter Healthcare Corporation, Deerfield, IL 60015 USA

{ "type": "p", "children": [], "text": "Baxter and Galaxy are trademarks of Baxter International Inc.\nBaxter Healthcare Corporation, Deerfield, IL 60015 USA" }

07-34-74-551

{ "type": "p", "children": [], "text": "07-34-74-551" }

{ "type": "", "children": [], "text": "" }

Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). Product should not be thawed by immersion in water baths or by microware irradiation. Do not force thaw. The thawed solution in GALAXY plastic container (PL 2040) remains chemically stable for 72 hours at room temperature or for 30 days when stored under refrigeration. Do not refreeze.

{ "type": "p", "children": [], "text": "Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). Product should not be thawed by immersion in water baths or by microware irradiation. Do not force thaw. The thawed solution in GALAXY plastic container (PL 2040) remains chemically stable for 72 hours at room temperature or for 30 days when stored under refrigeration. Do not refreeze.\n" }

Handle frozen product containers with care. Product containers may be fragile in the frozen state.

{ "type": "p", "children": [], "text": "Handle frozen product containers with care. Product containers may be fragile in the frozen state." }

PL 2040 Plastic 07-04-77-715

{ "type": "p", "children": [], "text": "PL 2040 Plastic 07-04-77-715" }

Vancomycin Injection, USP in 0.9 Sodium Chloride 750 mg per 150 mL (5 mg/ mL)Contains 3 Single-Dose bags. Each bag contains 150 mL. Iso-osmotic. Store at or below -20°C/-4°F.

{ "type": "p", "children": [], "text": "\nVancomycin Injection, USP in 0.9 Sodium Chloride \n\n750 mg per 150 mL (5 mg/ mL)Contains 3 Single-Dose bags. Each bag contains 150 mL. Iso-osmotic. Store at or below -20°C/-4°F.\n" }

Rx Only

{ "type": "p", "children": [], "text": "\nRx Only\n" }

NDC 0338-3582-01 Code 2G3591

{ "type": "p", "children": [], "text": "\nNDC 0338-3582-01\n\nCode 2G3591\n" }

*FOR BAR CODE POSITION ONLY(01) 20303383582014

{ "type": "p", "children": [], "text": "*FOR BAR CODE POSITION ONLY(01) 20303383582014" }

GALAXY Container

{ "type": "p", "children": [], "text": "\nGALAXY Container " }

Sterile Nonpyrogenic

{ "type": "p", "children": [], "text": "Sterile Nonpyrogenic" }

Each 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. 0.9 Sodium Chloride, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide.

{ "type": "p", "children": [], "text": "Each 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. 0.9 Sodium Chloride, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide." }

Dosage: For intravenous use only. See prescribing information.Cautions: Do not add supplementary medication or additives.

{ "type": "p", "children": [], "text": "Dosage: For intravenous use only. See prescribing information.Cautions: Do not add supplementary medication or additives." }

Baxter Logo

{ "type": "p", "children": [], "text": "\nBaxter Logo\n" }

Baxter and Galaxy are registered trademarks of Baxter International Inc. Baxter Healthcare Corporation, Deerfield, IL 60015 USA

{ "type": "p", "children": [], "text": "Baxter and Galaxy are registered trademarks of Baxter International Inc. \nBaxter Healthcare Corporation, Deerfield, IL 60015 USA" }

Container Label

{ "type": "p", "children": [], "text": "\nContainer Label\n" }

NDC 0338-3583-01

{ "type": "p", "children": [], "text": "\nNDC 0338-3583-01\n" }

Vancomycin Injection, USP in 0.9% Sodium Chloride

{ "type": "p", "children": [], "text": "\nVancomycin Injection, USP\n\nin 0.9% Sodium Chloride\n" }

1 g per 200 mL (5 mg/mL)

{ "type": "p", "children": [], "text": "\n1 g per 200 mL\n(5 mg/mL)" }

GALAXY Single-Dose Container Discard unused portion

{ "type": "p", "children": [], "text": "\nGALAXY\nSingle-Dose Container Discard unused portion" }

Code 2G3592Sterile NonpyrogenicIso-osmotic

{ "type": "p", "children": [], "text": "Code 2G3592Sterile NonpyrogenicIso-osmotic" }

Each 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. 0.9 g Sodium Chloride, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide.

{ "type": "p", "children": [], "text": "Each 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. 0.9 g Sodium Chloride, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. " }

Dosage: For intravenous use only. See prescribing information.

{ "type": "p", "children": [], "text": "Dosage: For intravenous use only. See prescribing information." }

Cautions: Do not add supplementary medication or additives.

{ "type": "p", "children": [], "text": "Cautions: Do not add supplementary medication or additives." }

Rx Only Store at or below -20°C (-4°F). Thaw at room temperature(25°C/77°F) or under refrigeration (5°C/41°F). Product should not be thawed by immersion in water baths or by microwave irradiation. Do not force thaw. Thawed solution is stable for 30 days under refrigeration or 72 hours at room temperature. Do not refreeze.

{ "type": "p", "children": [], "text": "\nRx Only\nStore at or below -20°C (-4°F). Thaw at room temperature(25°C/77°F) or under refrigeration (5°C/41°F). Product should not be thawed by immersion in water baths or by microwave irradiation. Do not force thaw. Thawed solution is stable for 30 days under refrigeration or 72 hours at room temperature. \nDo not refreeze." }

PL 2040 Plastic

{ "type": "p", "children": [], "text": "PL 2040 Plastic" }

Baxter Logo

{ "type": "p", "children": [], "text": "\nBaxter Logo\n" }

Baxter and Galaxy are trademarks of Baxter International Inc. Baxter Healthcare Corporation, Deerfield, IL 60015 USA

{ "type": "p", "children": [], "text": "Baxter and Galaxy are trademarks of Baxter International Inc.\nBaxter Healthcare Corporation, Deerfield, IL 60015 USA" }

07-34-74-553

{ "type": "p", "children": [], "text": "07-34-74-553" }

{ "type": "", "children": [], "text": "" }

Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). Product should not be thawed by immersion in water baths or by microware irradiation. Do not force thaw. The thawed solution in GALAXY plastic container (PL 2040) remains chemically stable for 72 hours at room temperature or for 30 days when stored under refrigeration. Do not refreeze.

{ "type": "p", "children": [], "text": "Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). Product should not be thawed by immersion in water baths or by microware irradiation. Do not force thaw. The thawed solution in GALAXY plastic container (PL 2040) remains chemically stable for 72 hours at room temperature or for 30 days when stored under refrigeration. Do not refreeze.\n" }

Handle frozen product containers with care. Product containers may be fragile in the frozen state.

{ "type": "p", "children": [], "text": "Handle frozen product containers with care. Product containers may be fragile in the frozen state." }

PL 2040 Plastic 07-04-77-717

{ "type": "p", "children": [], "text": "PL 2040 Plastic 07-04-77-717" }

Vancomycin Injection, USP in 0.9 Sodium Chloride 1 g per 200 mL (5 mg/ mL)Contains 3 Single-Dose bags. Each bag contains 200 mL. Iso-osmotic. Store at or below -20°C/-4°F.

{ "type": "p", "children": [], "text": "\nVancomycin Injection, USP in 0.9 Sodium Chloride \n\n1 g per 200 mL (5 mg/ mL)Contains 3 Single-Dose bags. Each bag contains 200 mL. Iso-osmotic. Store at or below -20°C/-4°F.\n" }

Rx Only

{ "type": "p", "children": [], "text": "\nRx Only\n" }

NDC 0338-3583-01 Code 2G3592

{ "type": "p", "children": [], "text": "\nNDC 0338-3583-01\n\nCode 2G3592\n" }

*FOR BAR CODE POSITION ONLY(01) 20303383583011

{ "type": "p", "children": [], "text": "*FOR BAR CODE POSITION ONLY(01) 20303383583011" }

GALAXY Container

{ "type": "p", "children": [], "text": "\nGALAXY Container " }

Sterile Nonpyrogenic

{ "type": "p", "children": [], "text": "Sterile Nonpyrogenic" }

Each 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. 0.9 Sodium Chloride, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide.

{ "type": "p", "children": [], "text": "Each 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx. 0.9 Sodium Chloride, USP in Water for Injection, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide." }

Dosage: For intravenous use only. See prescribing information.Cautions: Do not add supplementary medication or additives.

{ "type": "p", "children": [], "text": "Dosage: For intravenous use only. See prescribing information.Cautions: Do not add supplementary medication or additives." }

Baxter Logo

{ "type": "p", "children": [], "text": "\nBaxter Logo\n" }

Baxter and Galaxy are registered trademarks of Baxter International Inc. Baxter Healthcare Corporation, Deerfield, IL 60015 USA

{ "type": "p", "children": [], "text": "Baxter and Galaxy are registered trademarks of Baxter International Inc. \nBaxter Healthcare Corporation, Deerfield, IL 60015 USA" }

{ "type": "", "children": [], "text": "" }

NDC 0338-0122-04

{ "type": "p", "children": [], "text": "\nNDC 0338-0122-04\n" }

1.25 g

{ "type": "p", "children": [], "text": "\n1.25 g\n" }

Vancomycin Injection, USP in 5% Dextrose

{ "type": "p", "children": [], "text": "\nVancomycin Injection, USP\nin 5% Dextrose" }

1.25 g per 250 mL (5 mg/mL)

{ "type": "p", "children": [], "text": "\n1.25 g per 250 mL (5 mg/mL)" }

For Intravenous Infusion OnlySingle-Dose GALAXY ContainerDiscard Unused Portion

{ "type": "p", "children": [], "text": "\nFor Intravenous Infusion OnlySingle-Dose GALAXY ContainerDiscard Unused Portion\n" }

Rx OnlySterile

{ "type": "p", "children": [], "text": "\nRx OnlySterile\n" }

Each 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mgvancomycin with approx. 5 g Dextrose Hydrous, USP in Water for Injection, USP.Dosage: See prescribing information.

{ "type": "p", "children": [], "text": "Each 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mgvancomycin with approx. 5 g Dextrose Hydrous, USP in Water for Injection, USP.Dosage: See prescribing information." }

Store frozen at or below -20°C /-4°F.

{ "type": "p", "children": [], "text": "\nStore frozen at or below -20°C /-4°F.\n" }

Thaw at room temperature 20°C to 25°C (68°F to 77°F) or under refrigeration 2°C to 8°C (36°F to 46°F)and store thawed solution as follows:– Refrigerated Storage: Use within 30 days– Room Temperature Storage: Use within 72 hoursDo not force thaw. Do not refreeze the thawed solution.Do not add supplemental medication or additives.

{ "type": "p", "children": [], "text": "Thaw at room temperature 20°C to 25°C (68°F to 77°F) or under refrigeration 2°C to 8°C (36°F to 46°F)and store thawed solution as follows:– Refrigerated Storage: Use within 30 days– Room Temperature Storage: Use within 72 hoursDo not force thaw. Do not refreeze the thawed solution.Do not add supplemental medication or additives." }

Code 2G3557

{ "type": "p", "children": [], "text": "Code 2G3557" }

Baxter Logo

{ "type": "p", "children": [], "text": "\nBaxter Logo\n" }

Baxter and Galaxy are trademarks of Baxter International Inc. or its subsidiaries. Baxter Healthcare Corporation, Deerfield, IL 60015 USA

{ "type": "p", "children": [], "text": "Baxter and Galaxy are trademarks of Baxter International Inc. or its subsidiaries.\nBaxter Healthcare Corporation, Deerfield, IL 60015 USA" }

07-34-00-1841

{ "type": "p", "children": [], "text": "07-34-00-1841" }

*UPC-A BAR CODEPOSITION ONLY

{ "type": "p", "children": [], "text": "*UPC-A BAR CODEPOSITION ONLY" }

309440495057

{ "type": "p", "children": [], "text": "309440495057" }

{ "type": "", "children": [], "text": "" }

Store frozen at or below -20°C /-4°F. Thaw at room temperature 20°C to 25°C (68°F to 77°F) or under refrigeration2°C to 8°C (36°F to 46°F) and store thawed solution as follows:– Refrigerated Storage: Use within 30 days – Room Temperature Storage: Use within 72 hoursDo not force thaw. Do not refreeze the thawed solutionHandle frozen product containers with care. Product containers may be fragile in the frozen state.

{ "type": "p", "children": [], "text": "\nStore frozen at or below -20°C /-4°F. Thaw at room temperature 20°C to 25°C (68°F to 77°F) or under refrigeration2°C to 8°C (36°F to 46°F) and store thawed solution as follows:– Refrigerated Storage: Use within 30 days – Room Temperature Storage: Use within 72 hoursDo not force thaw. Do not refreeze the thawed solutionHandle frozen product containers with care. Product containers may be fragile in the frozen state." }

07-04-00-0961

{ "type": "p", "children": [], "text": "07-04-00-0961" }

1.25 g

{ "type": "p", "children": [], "text": "\n1.25 g \n" }

Vancomycin Injection, USPin 5% Dextrose

{ "type": "p", "children": [], "text": "\nVancomycin Injection, USPin 5% Dextrose\n" }

1.25 g per 250 mL (5 mg/mL)

{ "type": "p", "children": [], "text": "\n1.25 g per 250 mL (5 mg/mL)" }

For Intravenous Infusion Only.

{ "type": "p", "children": [], "text": "\nFor Intravenous Infusion Only. \n" }

Contains 2 units of Single-Dose bags. Each bag contains 250 mL. Store at or below -20°C/-4°F.

{ "type": "p", "children": [], "text": "Contains 2 units of Single-Dose bags. Each bag contains 250 mL. \nStore at or below -20°C/-4°F.\n" }

Rx Only

{ "type": "p", "children": [], "text": "\nRx Only\n" }

NDC 0338-0122-04Code 2G3557

{ "type": "p", "children": [], "text": "\nNDC 0338-0122-04Code 2G3557\n" }

*FOR BAR CODE POSITION ONLY(01)00000000000000

{ "type": "p", "children": [], "text": "*FOR BAR CODE POSITION ONLY(01)00000000000000" }

GALAXY Container Sterile

{ "type": "p", "children": [], "text": "\nGALAXY Container Sterile" }

Each 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx.5 g Dextrose Hydrous, USP in Water for Injection, USP.

{ "type": "p", "children": [], "text": "Each 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx.5 g Dextrose Hydrous, USP in Water for Injection, USP. " }

Dosage: See prescribing information.Do not add supplementary medication or additives.

{ "type": "p", "children": [], "text": "Dosage: See prescribing information.Do not add supplementary medication or additives." }

Baxter Logo

{ "type": "p", "children": [], "text": "\nBaxter Logo\n" }

Baxter and Galaxy are trademarks of Baxter International Inc. or its subsidiaries. Baxter Healthcare Corporation, Deerfield, IL 60015 USA

{ "type": "p", "children": [], "text": "Baxter and Galaxy are trademarks of Baxter International Inc. or its subsidiaries.\nBaxter Healthcare Corporation, Deerfield, IL 60015 USA" }

{ "type": "", "children": [], "text": "" }

NDC 0338-0124-04

{ "type": "p", "children": [], "text": "\nNDC 0338-0124-04\n" }

1.5 g

{ "type": "p", "children": [], "text": "\n1.5 g \n" }

Vancomycin Injection, USP in 5% Dextrose

{ "type": "p", "children": [], "text": "\nVancomycin Injection, USP\nin 5% Dextrose" }

1.5 g per 300 mL (5 mg/mL)

{ "type": "p", "children": [], "text": "\n1.5 g per 300 mL (5 mg/mL)" }

For Intravenous Infusion OnlySingle-Dose GALAXY ContainerDiscard Unused Portion

{ "type": "p", "children": [], "text": "\nFor Intravenous Infusion OnlySingle-Dose GALAXY ContainerDiscard Unused Portion\n" }

Rx OnlySterile

{ "type": "p", "children": [], "text": "\nRx OnlySterile\n" }

Each 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mgvancomycin with approx. 5 g Dextrose Hydrous, USP in Water for Injection, USP.Dosage: See prescribing information.

{ "type": "p", "children": [], "text": "Each 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mgvancomycin with approx. 5 g Dextrose Hydrous, USP in Water for Injection, USP.Dosage: See prescribing information." }

Store frozen at or below -20°C /-4°F.

{ "type": "p", "children": [], "text": "\nStore frozen at or below -20°C /-4°F.\n" }

Thaw at room temperature 20°C to 25°C (68°F to 77°F) or under refrigeration 2°C to 8°C (36°F to 46°F)and store thawed solution as follows:– Refrigerated Storage: Use within 30 days– Room Temperature Storage: Use within 72 hoursDo not force thaw. Do not refreeze the thawed solution.Do not add supplemental medication or additives.

{ "type": "p", "children": [], "text": "Thaw at room temperature 20°C to 25°C (68°F to 77°F) or under refrigeration 2°C to 8°C (36°F to 46°F)and store thawed solution as follows:– Refrigerated Storage: Use within 30 days– Room Temperature Storage: Use within 72 hoursDo not force thaw. Do not refreeze the thawed solution.Do not add supplemental medication or additives." }

Code 2G3558

{ "type": "p", "children": [], "text": "Code 2G3558" }

Baxter Logo

{ "type": "p", "children": [], "text": "\nBaxter Logo\n" }

Baxter and Galaxy are trademarks of Baxter International Inc. or its subsidiaries. Baxter Healthcare Corporation, Deerfield, IL 60015 USA

{ "type": "p", "children": [], "text": "Baxter and Galaxy are trademarks of Baxter International Inc. or its subsidiaries.\nBaxter Healthcare Corporation, Deerfield, IL 60015 USA" }

07-34-00-1842

{ "type": "p", "children": [], "text": "07-34-00-1842" }

*UPC-A BAR CODEPOSITION ONLY

{ "type": "p", "children": [], "text": "*UPC-A BAR CODEPOSITION ONLY" }

309440495057

{ "type": "p", "children": [], "text": "309440495057" }

{ "type": "", "children": [], "text": "" }

Store frozen at or below -20°C /-4°F. Thaw at room temperature 20°C to 25°C (68°F to 77°F) or under refrigeration2°C to 8°C (36°F to 46°F) and store thawed solution as follows: – Refrigerated Storage: Use within 30 days – Room Temperature Storage: Use within 72 hoursDo not force thaw. Do not refreeze the thawed solutionHandle frozen product containers with care. Product containers may be fragile in the frozen state.

{ "type": "p", "children": [], "text": "\nStore frozen at or below -20°C /-4°F. Thaw at room temperature 20°C to 25°C (68°F to 77°F) or under refrigeration2°C to 8°C (36°F to 46°F) and store thawed solution as follows: – Refrigerated Storage: Use within 30 days – Room Temperature Storage: Use within 72 hoursDo not force thaw. Do not refreeze the thawed solutionHandle frozen product containers with care. Product containers may be fragile in the frozen state." }

07-04-00-0962

{ "type": "p", "children": [], "text": "07-04-00-0962" }

1.5 g

{ "type": "p", "children": [], "text": "\n1.5 g \n" }

Vancomycin Injection, USPin 5% Dextrose

{ "type": "p", "children": [], "text": "\nVancomycin Injection, USPin 5% Dextrose\n" }

1.5 g per 300 mL (5 mg/mL)

{ "type": "p", "children": [], "text": "\n1.5 g per 300 mL (5 mg/mL)" }

For Intravenous Infusion Only.

{ "type": "p", "children": [], "text": "\nFor Intravenous Infusion Only. \n" }

Contains 2 units of Single-Dose bags.Each bag contains 300 mL. Store at or below -20°C/-4°F.

{ "type": "p", "children": [], "text": "Contains 2 units of Single-Dose bags.Each bag contains 300 mL.\nStore at or below -20°C/-4°F.\n" }

Rx Only

{ "type": "p", "children": [], "text": "\nRx Only\n" }

NDC 0338-0124-04Code 2G3558

{ "type": "p", "children": [], "text": "\nNDC 0338-0124-04Code 2G3558\n" }

*FOR BAR CODE POSITION ONLY(01)00000000000000

{ "type": "p", "children": [], "text": "*FOR BAR CODE POSITION ONLY(01)00000000000000" }

GALAXY Container Sterile

{ "type": "p", "children": [], "text": "\nGALAXY Container Sterile" }

Each 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx.5 g Dextrose Hydrous, USP in Water for Injection, USP.Dosage: See prescribing information.Do not add supplementary medication or additives.

{ "type": "p", "children": [], "text": "Each 100 mL contains: Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin with approx.5 g Dextrose Hydrous, USP in Water for Injection, USP.Dosage: See prescribing information.Do not add supplementary medication or additives." }

Baxter Logo

{ "type": "p", "children": [], "text": "\nBaxter Logo\n" }

Baxter and Galaxy are trademarks of Baxter International Inc. or its subsidiaries. Baxter Healthcare Corporation, Deerfield, IL 60015 USA

{ "type": "p", "children": [], "text": "Baxter and Galaxy are trademarks of Baxter International Inc. or its subsidiaries.\nBaxter Healthcare Corporation, Deerfield, IL 60015 USA" }

Vancomycin Hydrochloride Capsules are indicated for the treatment of Clostridioides difficile-associated diarrhea. Vancomycin Hydrochloride Capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus(including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age.

{ "type": "p", "children": [], "text": "Vancomycin Hydrochloride Capsules are indicated for the treatment of\n \n Clostridioides difficile-associated diarrhea. Vancomycin Hydrochloride Capsules are also used for the treatment of enterocolitis caused by\n \n Staphylococcus aureus(including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age.\n\n " }

Limitations of Use

{ "type": "p", "children": [], "text": "\nLimitations of Use\n" }

{ "type": "ul", "children": [ "Parenteral administration of vancomycin is not effective for the above infections; therefore, Vancomycin Hydrochloride Capsules must be given orally for these infections.", "Orally administered Vancomycin Hydrochloride Capsules are not effective for other types of infections." ], "text": "" }

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride Capsules and other antibacterial drugs, Vancomycin Hydrochloride Capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

{ "type": "p", "children": [], "text": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride Capsules and other antibacterial drugs, Vancomycin Hydrochloride Capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy." }

Vancomycin Hydrochloride Capsules are used in treating C. difficile-associated diarrhea and staphylococcal enterocolitis.

For both C. difficile-associated diarrhea and staphylococcal enterocolitis, the usual daily dosage is 40 mg/kg in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g.

Vancomycin Hydrochloride Capsules USP, 125 mg (equivalent to vancomycin) have an opaque blue cap and opaque brown body imprinted with “3125” on the cap and “VANCOCIN HCL 125 MG” on the body in white ink.

{ "type": "p", "children": [], "text": "Vancomycin Hydrochloride Capsules USP, 125 mg (equivalent to vancomycin) have an opaque blue cap and opaque brown body imprinted with “3125” on the cap and “VANCOCIN HCL 125 MG” on the body in white ink." }

Vancomycin Hydrochloride Capsules USP, 250 mg (equivalent to vancomycin) have an opaque blue cap and opaque lavender body imprinted with “3126” on the cap and “VANCOCIN HCL 250 MG” on the body in white ink.

{ "type": "p", "children": [], "text": "Vancomycin Hydrochloride Capsules USP, 250 mg (equivalent to vancomycin) have an opaque blue cap and opaque lavender body imprinted with “3126” on the cap and “VANCOCIN HCL 250 MG” on the body in white ink." }

Vancomycin Hydrochloride Capsules are contraindicated in patients with known hypersensitivity to vancomycin.

{ "type": "p", "children": [], "text": "Vancomycin Hydrochloride Capsules are contraindicated in patients with known hypersensitivity to vancomycin." }

Vancomycin Hydrochloride Capsules for the treatment of colitis are for oral use only and are not systemically absorbed. Vancomycin Hydrochloride Capsules must be given orally for treatment of staphylococcal enterocolitis and Clostridioides difficile-associated diarrhea. Orally administered Vancomycin Hydrochloride Capsules are not effective for other types of infections.

Parenteral administration of vancomycin is noteffective for treatment of staphylococcal enterocolitis and C. difficile-associated diarrhea. If parenteral vancomycin therapy is desired, use an intravenous preparation of vancomycin and consult the package insert accompanying that preparation.

Clinically significant serum concentrations have been reported in some patients who have taken multiple oral doses of Vancomycin Hydrochloride Capsules for active C. difficile-associated diarrhea. Some patients with inflammatory disorders of the intestinal mucosa also may have significant systemic absorption of vancomycin. These patients may be at risk for the development of adverse reactions associated with higher doses of Vancomycin Hydrochloride Capsules; therefore, monitoring of serum concentrations of vancomycin may be appropriate in some instances, e.g., in patients with renal insufficiency and/or colitis or in those receiving concomitant therapy with an aminoglycoside antibiotic.

Nephrotoxicity (e.g., reports of renal failure, renal impairment, blood creatinine increased) has occurred following oral Vancomycin Hydrochloride Capsules therapy in randomized controlled clinical studies, and can occur either during or after completion of therapy. The risk of nephrotoxicity is increased in patients >65 years of age [see Adverse Reactions ( 6.1) and Use in Specific Populations ( 8.5)] .

In patients >65 years of age, including those with normal renal function prior to treatment, renal function should be monitored during and following treatment with Vancomycin Hydrochloride Capsules to detect potential vancomycin induced nephrotoxicity.

Ototoxicity has occurred in patients receiving vancomycin. It may be transient or permanent. It has been reported mostly in patients who have been given excessive intravenous doses, who have an underlying hearing loss, or who are receiving concomitant therapy with another ototoxic agent, such as an aminoglycoside. Serial tests of auditory function may be helpful in order to minimize the risk of ototoxicity [see Adverse Reactions ( 6.2)]

Severe dermatologic reactions such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and linear IgA bullous dermatosis (LABD) have been reported in association with the use of vancomycin. Cutaneous signs or symptoms reported include skin rashes, mucosal lesions, and blisters.

Discontinue Vancomycin Hydrochloride Capsules at the first appearance of signs and symptoms of TEN, SJS, DRESS, AGEP, or LABD.

Prescribing Vancomycin Hydrochloride Capsules in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria.

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to vancomycin in 260 adult subjects in two Phase 3 clinical trials for the treatment of diarrhea associated with C. difficile. In both trials, subjects received vancomycin 125 mg orally four times daily. The mean duration of treatment was 9.4 days. The median age of patients was 67, ranging between 19 and 96 years of age. Patients were predominantly Caucasian (93%) and 52% were male.

Adverse reactions occurring in ≥ 5% of vancomycin-treated subjects are shown in Table 1. The most common adverse reactions associated with vancomycin (≥ 10%) were nausea, abdominal pain, and hypokalemia.

Table 1: Common (≥ 5%) Adverse Reactions afor Vancomycin Reported in Clinical Trials for Treatment of Diarrhea Associated with C. difficile

<div class="scrollingtable"><table width="85.94%"> <col width="43%"/> <col width="26%"/> <col width="30%"/> <tfoot> <tr class="First Last"> <td align="left" class="Botrule" colspan="3" valign="top">  <span class="Sup">a</span>Adverse reaction rates were derived from the incidence of treatment-emergent adverse events. </td> </tr> </tfoot> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">System/Organ Class</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="middle"> <p class="First"> <span class="Bold">Adverse Reaction</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Vancomycin <br/> % (N=260) </span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Gastrointestinal disorders</span> </p> </td><td class="Botrule Lrule Rrule" valign="top"> <p class="First">Nausea <br/> Abdominal pain <br/> Vomiting <br/> Diarrhea <br/> Flatulence </p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">17 <br/> 15 <br/> 9 <br/> 9 <br/> 8 </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">General disorders and administration site conditions</span> </p> </td><td class="Botrule Lrule Rrule" valign="top"> <p class="First">Pyrexia <br/> Edema peripheral <br/> Fatigue </p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">9 <br/> 6 <br/> 5 </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Infections and infestations</span> </p> </td><td class="Botrule Lrule Rrule" valign="top"> <p class="First">Urinary tract infection</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">8</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Metabolism and nutrition disorders</span> </p> </td><td class="Botrule Lrule Rrule" valign="top"> <p class="First">Hypokalemia</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">13</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Musculoskeletal and connective tissue disorders</span> </p> </td><td class="Botrule Lrule Rrule" valign="top"> <p class="First">Back pain</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">6</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Nervous system disorders</span> </p> </td><td class="Botrule Lrule Rrule" valign="top"> <p class="First">Headache</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">7</p> </td> </tr> </tbody> </table></div>

Nephrotoxicity (e.g., reports of renal failure, renal impairment, blood creatinine increased) occurred in 5% of subjects treated with vancomycin. Nephrotoxicity following vancomycin typically first occurred within one week after completion of treatment (median day of onset was Day 16). Nephrotoxicity following vancomycin occurred in 6% of subjects >65 years of age and 3% of subjects ≤65 years of age [see Warnings and Precautions ( 5.3)] .

The incidences of hypokalemia, urinary tract infection, peripheral edema, insomnia, constipation, anemia, depression, vomiting, and hypotension were higher among subjects >65 years of age than in subjects ≤65 years of age [see Use in Specific Populations ( 8.5)] .

Discontinuation of study drug due to adverse events occurred in 7% of subjects treated with vancomycin. The most common adverse events leading to discontinuation of vancomycin were C. difficilecolitis (<1%), nausea (<1%), and vomiting (<1%).

The following adverse reactions have been identified during post-approval use of vancomycin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Ototoxicity: Cases of hearing loss associated with intravenously administered vancomycin have been reported. Most of these patients had kidney dysfunction or a preexisting hearing loss or were receiving concomitant treatment with an ototoxic drug [see Warnings and Precautions ( 5.4)] . Vertigo, dizziness, and tinnitus have been reported.

Skin and Subcutaneous Tissue Disorders:Severe dermatologic reactions such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and linear IgA bullous dermatosis (LABD) [see Warnings and Precautions ( 5.5)] , rashes (including exfoliative dermatitis).

Hematopoietic: Reversible neutropenia, usually starting 1 week or more after onset of intravenous therapy with vancomycin or after a total dose of more than 25 g, has been reported for several dozen patients. Neutropenia appears to be promptly reversible when vancomycin is discontinued. Thrombocytopenia has been reported.

Miscellaneous: Patients have been reported to have had anaphylaxis, drug fever, chills, nausea, eosinophilia, and cases of vasculitis in association with the administration of vancomycin.

A condition has been reported that is similar to the IV–induced syndrome with symptoms consistent with anaphylactoid reactions, including hypotension, wheezing, dyspnea, urticaria, pruritus, flushing of the upper body (“vancomycin infusion reaction”), pain and muscle spasm of the chest and back. These reactions usually resolve within 20 minutes but may persist for several hours.

No drug interaction studies have been conducted.

{ "type": "p", "children": [], "text": "No drug interaction studies have been conducted." }

Risk Summary

Systemic absorption of vancomycin is low following oral administration of Vancomycin Hydrochloride Capsules; however, absorption may vary depending on various factors [see Clinical Pharmacology ( 12.3)]. There are no available data on vancomycin use in pregnant women to assess a risk of major birth defects or miscarriage. Available published data on intravenous vancomycin use in pregnancy during the second and third trimesters have not shown an association with adverse maternal or fetal outcomes (see Data).

Vancomycin did not show adverse developmental effects when administered intravenously to pregnant rats and rabbits during organogenesis at doses less than or equal to the recommended maximum human dose (see Data).

Data

Human Data

There are no available data on first trimester use of vancomycin in pregnant women to assess a risk of major birth defects or miscarriage.

A published study evaluated hearing loss and nephrotoxicity in infants of 10 pregnant intravenous drug users treated with intravenous vancomycin for suspected or documented methicillin-resistant Staphylococcal aureusin the second or third trimester. The comparison groups were 10 uninfected non-intravenous drug-dependent patients who received no treatment and 10 uninfected untreated intravenous drug-dependent patients. No infant in the vancomycin exposed group had abnormal sensorineural hearing at 3 months of age or nephrotoxicity.

A published prospective study assessed outcomes in 55 pregnant women with a positive Group B streptococcus culture and a high-risk penicillin allergy with resistance to clindamycin or unknown sensitivity who were administered intravenous vancomycin at the time of delivery. Vancomycin dosing ranged from the standard dose of 1 g intravenously every 12 hours to a dose of 20 mg/kg intravenously every 8 hours (maximum individual dose 2 g). No major adverse reactions were recorded either in the mothers or their newborns. None of the newborns had sensorineural hearing loss. Neonatal renal function was not examined, but all of the newborns were discharged in good condition.

Animal Data

Vancomycin did not cause fetal malformation when administered intravenously during organogenesis to pregnant rats (gestation days 6 to 15) and rabbits (gestation days 6 to 18) at the equivalent recommended maximum human dose of 200 mg/kg/day to rats or 120 mg/kg/day to rabbits. No effects on fetal weight or development were seen in rats at the highest dose tested or in rabbits given 80 mg/kg/day (approximately 1 and 0.8 times the recommended maximum human dose based on body surface area). Maternal toxicity was observed in rats (at doses 120 mg/kg and above) and rabbits (at 80 mg/kg and above).

Risk Summary

There are no data on the presence of vancomycin in human milk, the effects on the breastfed infant, or the effect on milk production following oral administration. Systemic absorption of vancomycin is low following oral administration of Vancomycin Hydrochloride Capsules [see Clinical Pharmacology ( 12.3)] ; therefore, it is unlikely to result in clinically relevant exposure in breastfeeding infants. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Vancomycin Hydrochloride Capsules and any potential adverse effects on the breastfed infant from Vancomycin Hydrochloride Capsules or from the underlying maternal condition.

Vancomycin Hydrochloride Capsules are indicated in pediatric patients less than 18 years of age for the treatment of C. difficile-associated diarrhea and enterocolitis caused by S. aureus(including methicillin-resistant strains) [see Indications and Usage ( 1) and Dosage and Administration ( 2.2)] .

In clinical trials, 54% of vancomycin-treated subjects were >65 years of age. Of these, 40% were between the ages of >65 and 75, and 60% were >75 years of age.

Clinical studies with vancomycin in diarrhea associated with Clostridioides difficilehave demonstrated that geriatric subjects are at increased risk of developing nephrotoxicity following treatment with oral vancomycin, which may occur during or after completion of therapy. In patients >65 years of age, including those with normal renal function prior to treatment, renal function should be monitored during and following treatment with vancomycin to detect potential vancomycin induced nephrotoxicity [see Warnings and Precautions ( 5.3), Adverse Reactions ( 6.1), and Clinical Studies ( 14.1)] .

Patients >65 years of age may take longer to respond to therapy compared to patients ≤65 years of age [see Clinical Studies ( 14.1)] . Clinicians should be aware of the importance of appropriate duration of vancomycin treatment in patients >65 years of age and not discontinue or switch to alternative treatment prematurely.

Supportive care is advised, with maintenance of glomerular filtration. Vancomycin is poorly removed by dialysis. Hemofiltration and hemoperfusion with polysulfone resin have been reported to result in increased vancomycin clearance.

{ "type": "p", "children": [], "text": "Supportive care is advised, with maintenance of glomerular filtration. Vancomycin is poorly removed by dialysis. Hemofiltration and hemoperfusion with polysulfone resin have been reported to result in increased vancomycin clearance." }

To obtain current information about the treatment of overdose, contact a certified Poison Control Center (1-800-222-1222 or www.poison.org). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics.

{ "type": "p", "children": [], "text": "To obtain current information about the treatment of overdose, contact a certified Poison Control Center (1-800-222-1222 or www.poison.org). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics." }

Vancomycin Hydrochloride Capsules USP for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis(formerly Nocardia orientalis), which has the chemical formula C 66H 75Cl 2N 9O 24•HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol.

{ "type": "p", "children": [], "text": "Vancomycin Hydrochloride Capsules USP for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from\n \n Amycolatopsis orientalis(formerly\n \n Nocardia orientalis), which has the chemical formula C\n \n 66H\n \n 75Cl\n \n 2N\n \n 9O\n \n 24•HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol.\n\n " }

Each capsule contains 125 mg vancomycin (equivalent to 128 mg vancomycin hydrochloride) or 250 mg vancomycin (equivalent to 256 mg vancomycin hydrochloride). The capsules also contain FD&C Blue No. 2, gelatin, iron oxide, polyethylene glycol, titanium dioxide, and other inactive ingredients.

{ "type": "p", "children": [], "text": "Each capsule contains 125 mg vancomycin (equivalent to 128 mg vancomycin hydrochloride) or 250 mg vancomycin (equivalent to 256 mg vancomycin hydrochloride). The capsules also contain FD&C Blue No. 2, gelatin, iron oxide, polyethylene glycol, titanium dioxide, and other inactive ingredients." }

Vancomycin hydrochloride has the structural formula:

{ "type": "p", "children": [], "text": "Vancomycin hydrochloride has the structural formula:" }

Vancomycin is an antibacterial drug [see Microbiology ( 12.4)] .

Vancomycin is poorly absorbed after oral administration. During multiple dosing of 250 mg every 8 hours for 7 doses, fecal concentrations of vancomycin in volunteers exceeded 100 mg/kg in the majority of samples. No blood concentrations were detected and urinary recovery did not exceed 0.76%. In anephric subjects with no inflammatory bowel disease who received vancomycin oral solution 2 g for 16 days, blood concentrations of vancomycin were less than or equal to 0.66 mcg/mL in 2 of 5 subjects. No measurable blood concentrations were attained in the other 3 subjects. Following doses of 2 g daily, concentrations of drug were >3100 mg/kg in the feces and <1 mcg/mL in the serum of subjects with normal renal function who had C. difficile-associated diarrhea. After multiple-dose oral administration of vancomycin, measurable serum concentrations may occur in patients with active C. difficile-associated diarrhea, and, in the presence of renal impairment, the possibility of accumulation exists. It should be noted that the total systemic and renal clearances of vancomycin are reduced in the elderly [see Use in Specific Populations ( 8.5)] .

Mechanism of Action

The bactericidal action of vancomycin against Staphylococcus aureusand the vegetative cells of Clostridioides difficileresults primarily from inhibition of cell-wall biosynthesis. In addition, vancomycin alters bacterial-cell-membrane permeability and RNA synthesis.

Resistance       Staphylococcus aureus       S. aureusisolates with vancomycin minimal inhibitory concentrations (MICs) as high as 1024 mcg/mL have been reported.      The exact mechanism of this resistance is not clear but is believed to be due to cell wall thickening and potentially the transfer of genetic material.

Vancomycin has been shown to be active against most isolates of the following microorganisms, both in vitroand in clinical infections [see Indications and Usage ( 1)] .

Gram-positive bacteria      Staphylococcus aureus(including methicillin-resistant isolates )associated with enterocolitis.

Anaerobic gram-positive bacteria      Clostridioides difficileisolates associated with C. difficileassociated diarrhea.

No long-term carcinogenesis studies in animals have been conducted.

At concentrations up to 1000 mcg/mL, vancomycin had no mutagenic effect in vitroin the mouse lymphoma forward mutation assay or the primary rat hepatocyte unscheduled DNA synthesis assay. The concentrations tested in vitrowere above the peak plasma vancomycin concentrations of 20 to 40 mcg/mL usually achieved in humans after slow infusion of the maximum recommended dose of 1 g. Vancomycin had no mutagenic effect in vivoin the Chinese hamster sister chromatid exchange assay (400 mg/kg IP) or the mouse micronucleus assay (800 mg/kg IP).

No definitive fertility studies have been conducted.

In two trials, vancomycin 125 mg orally four times daily for 10 days was evaluated in 266 adult subjects with C. difficile-associated diarrhea (CDAD). Enrolled subjects were 18 years of age or older and received no more than 48 hours of treatment with oral vancomycin or oral/intravenous metronidazole in the 5 days preceding enrollment. CDAD was defined as ≥3 loose or watery bowel movements within the 24 hours preceding enrollment, and the presence of either C. difficiletoxin A or B, or pseudomembranes on endoscopy within the 72 hours preceding enrollment. Subjects with fulminant C. difficiledisease, sepsis with hypotension, ileus, peritoneal signs or severe hepatic disease were excluded.

Efficacy analyses were performed on the Full Analysis Set (FAS), which included randomized subjects who received at least one dose of vancomycin and had any post-dosing investigator evaluation data (N=259; 134 in Trial 1 and 125 in Trial 2).

The demographic profile and baseline CDAD characteristics of enrolled subjects were similar in the two trials. Vancomycin-treated subjects had a median age of 67 years, were mainly white (93%), and male (52%). CDAD was classified as severe (defined as 10 or more unformed bowel movements per day or WBC ≥15000/mm 3) in 25% of subjects, and 47% were previously treated for CDAD.

Efficacy was assessed by using clinical success, defined as diarrhea resolution and the absence of severe abdominal discomfort due to CDAD, on Day 10. An additional efficacy endpoint was the time to resolution of diarrhea, defined as the beginning of diarrhea resolution that was sustained through the end of the prescribed active treatment period.

The results for clinical success for vancomycin-treated subjects in both trials are shown in Table 2.

Table 2: Clinical Success Rates (Full Analysis Set)

<div class="scrollingtable"><table width="75%"> <col width="18%"/> <col width="36%"/> <col width="32%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule Toprule" rowspan="2" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Clinical Success Rate</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">95% Confidence Interval</span> </p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Vancomycin % (N)</span> </p> </td><td class="Botrule Lrule Rrule" valign="top"> <p class="First"> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Trial 1</span> </p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">81.3 (134)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">(74.4, 88.3)</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Trial 2</span> </p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">80.8 (125)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">(73.5, 88.1)</p> </td> </tr> </tbody> </table></div>

The median time to resolution of diarrhea was 5 days and 4 days in Trial 1 and Trial 2, respectively. For subjects older than 65 years of age, the median time to resolution was 6 days and 4 days in Trial 1 and Trial 2, respectively. In subjects with diarrhea resolution at end-of-treatment with vancomycin, recurrence of CDAD during the following four weeks occurred in 25 of 107 (23%) and 18 of 102 (18%) in Trial 1 and Trial 2, respectively.

Restriction Endonuclease Analysis (REA) was used to identify C. difficilebaseline isolates in the BI group. In Trial 1, the vancomycin-treated subjects were classified at baseline as follows 31 (23%) with BI strain, 69 (52%) with non-BI strain, and 34 (25%) with unknown strain. Clinical success rates were 87% for BI strain, 81% for non-BI strain, and 76% for unknown strain. In subjects with diarrhea resolution at end-of treatment with vancomycin, recurrence of CDAD during the following four weeks occurred in 7 of 26 subjects with BI strain, 12 of 56 subjects with non-BI strain, and 6 of 25 subjects with unknown strain.

1. Byrd RA., Gries CL, Buening M.: Developmental Toxicology Studies of Vancomycin Hydrochloride Administered Intravenously to Rats and Rabbits. Fundam Appl Toxicol 1994; 23: 590-597.

{ "type": "p", "children": [], "text": "1. Byrd RA., Gries CL, Buening M.: Developmental Toxicology Studies of Vancomycin Hydrochloride Administered Intravenously to Rats and Rabbits. Fundam Appl Toxicol 1994; 23: 590-597." }

Vancomycin Hydrochloride Capsules USP are available in:

{ "type": "p", "children": [], "text": "Vancomycin Hydrochloride Capsules USP are available in:" }

The 125 mg (equivalent to vancomycin) capsules have an opaque blue cap and opaque brown body imprinted with “3125” on the cap and “VANCOCIN HCL 125 MG” on the body in white ink. NDC 62559-390-20: Carton containing 2 blister packs. Each blister pack contains 10 capsules for a total of 20 capsules per carton. NDC 62559-390-50: Bottle of 50 capsules.

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The 250 mg (equivalent to vancomycin) capsules have an opaque blue cap and opaque lavender body imprinted with “3126” on the cap and “VANCOCIN HCL 250 MG” on the body in white ink. NDC 62559-391-20: Carton containing 2 blister packs. Each blister pack contains 10 capsules for a total of 20 capsules per carton. NDC 62559-391-50: Bottle of 50 capsules.

{ "type": "p", "children": [], "text": "The 250 mg (equivalent to vancomycin) capsules have an opaque blue cap and opaque lavender body imprinted with “3126” on the cap and “VANCOCIN HCL 250 MG” on the body in white ink. \n NDC 62559-391-20: Carton containing 2 blister packs. Each blister pack contains 10 capsules for a total of 20 capsules per carton. \n NDC 62559-391-50: Bottle of 50 capsules.\n " }

Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

{ "type": "p", "children": [], "text": "Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]." }

Severe Dermatologic Reactions

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Advise patients about the signs and symptoms of serious skin manifestations. Instruct patients to stop taking Vancomycin Hydrochloride Capsules immediately and promptly seek medical attention at the first signs or symptoms of skin rash, mucosal lesions or blisters [see Warnings and Precautions ( 5.5)].

{ "type": "p", "children": [], "text": "Advise patients about the signs and symptoms of serious skin manifestations. Instruct patients to stop taking Vancomycin Hydrochloride Capsules immediately and promptly seek medical attention at the first signs or symptoms of skin rash, mucosal lesions or blisters\n \n [see Warnings and Precautions (\n \n 5.5)].\n \n \n" }

Antibacterial Resistance

{ "type": "p", "children": [], "text": "\nAntibacterial Resistance\n" }

Patients should be counseled that antibacterial drugs including Vancomycin Hydrochloride Capsules should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Vancomycin Hydrochloride Capsules are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Vancomycin Hydrochloride Capsules or other antibacterial drugs in the future.

{ "type": "p", "children": [], "text": "Patients should be counseled that antibacterial drugs including Vancomycin Hydrochloride Capsules should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Vancomycin Hydrochloride Capsules are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Vancomycin Hydrochloride Capsules or other antibacterial drugs in the future." }

Manufactured by: ANI Pharmaceuticals, Inc. Baudette, MN 56623

{ "type": "p", "children": [], "text": "Manufactured by: \n ANI Pharmaceuticals, Inc. \n Baudette, MN 56623 \n \n" }

NDC 62559-390-20 Vancomycin Hydrochloride Capsules USP 125 mg* Rx only Not a Child Resistant Container 20 Capsules

{ "type": "p", "children": [], "text": "\nNDC 62559-390-20 \n Vancomycin Hydrochloride Capsules USP \n 125 mg* \n Rx only \n Not a Child Resistant Container \n 20 Capsules \n \n\n\n" }

NDC 62559-391-20 Vancomycin Hydrochloride Capsules USP 250 mg* Rx only Not a Child Resistant Container 20 Capsules

{ "type": "p", "children": [], "text": "\nNDC 62559-391-20 \n Vancomycin Hydrochloride Capsules USP \n 250 mg* \n Rx only \n Not a Child Resistant Container \n 20 Capsules\n \n\n\n\n" }