RETISERT ®is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.

{ "type": "p", "children": [], "text": "RETISERT\n \n ®is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.\n\n " }

RETISERT is implanted into the posterior segment of the affected eye through a pars plana incision.

The implant contains one tablet of 0.59 mg of fluocinolone acetonide. RETISERT is designed to release fluocinolone acetonide at a nominal initial rate of 0.6 mcg/day, decreasing over the first month to a steady state between

0.3-0.4 mcg/day over approximately 30 months. Following depletion of fluocinolone acetonide as evidenced by recurrence of uveitis, RETISERT may be replaced.

Caution should be exercised in handling RETISERT in order to avoid damage to the implant, which may result in an increased rate of drug release from the implant. Thus, RETISERT should be handled only by the suture tab. Care should be taken during implantation and explantation to avoid sheer forces on the implant that could disengage the silicone cup reservoir (which contains a fluocinolone acetonide tablet) from the suture tab. Aseptic technique should be maintained at all times prior to and during the surgical implantation procedure.

RETISERT should not be resterilized by any method. 

0.59 mg fluocinolone acetonide intravitreal implant.

{ "type": "p", "children": [], "text": "0.59 mg fluocinolone acetonide intravitreal implant." }

Surgical placement of RETISERT is contraindicated in active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in active bacterial, mycobacterial or fungal infections of the eye.

Use of corticosteroids may result in posterior subcapsular cataract formation. Based on clinical trials with RETISERT, during the 3-year post-implantation period, nearly all phakic eyes are expected to develop cataracts and require cataract surgery.

Late onset endophthalmitis has been observed. These events are often related to the integrity of the surgical wound site. Careful attention to assure tight closure of the scleral wound and the integrity of the overlying conjunctiva at the wound site is important. 

Potential complications accompanying intraocular surgery to place RETISERT into the vitreous cavity may include, but are not limited to, the following: cataract formation, choroidal detachment, endophthalmitis, hypotony, increased intraocular pressure, exacerbation of intraocular inflammation, retinal detachment, vitreous hemorrhage, vitreous loss, and wound dehiscence.

Following implantation of RETISERT, nearly all patients will experience an immediate and temporary decrease in visual acuity in the implanted eye which lasts for approximately one to four weeks post-operatively.

Prolonged use of corticosteroids may result in elevated IOP and/or glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. Patients must be monitored for elevated IOP. 

Based on clinical trials with RETISERT, within 3-years post-implantation, approximately 77% of patients will require IOP lowering medications to control intraocular pressure and 37% of patients will require filtering procedures to control intraocular pressure [see Adverse Reactions ( 6.1)] .

In vitro stability studies show that the strength of the adhesive bond between the silicone cup reservoir and the suture tab is reduced with prolonged hydration, indicating a potential for the separation of these components. The suture tab composition is a silicone elastomer reinforced with a polyester mesh. Physicians should periodically monitor the integrity of the implant by visual inspection. 

RETISERT should be used with caution in patients with a history of a viral, bacterial, mycobacterial or fungal infection of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia and varicella. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution.

Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections (bacterial, fungal, and viral). In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term application of steroids. The possibility of fungal invasion should be considered in any persistent corneal ulceration where steroid treatment has been used.

Since resistance to infections is known to be reduced by corticosteroids, simultaneous bilateral implantation should not be carried out, in order to limit the potential for bilateral post-operative infection. 

Ocular administration of corticosteroids has also been associated with delayed wound healing and perforation of the globe where there is thinning of the sclera. 

The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.

The available safety data includes exposure to RETISERT in patients with chronic non-infectious uveitis affecting the posterior segment in two multicenter controlled clinical trials. Patients were randomized to dosage regimens of 0.59 mg or 2.1 mg implants.

The most frequently reported ocular adverse events were cataract, increased intraocular pressure, procedural complication, and eye pain. These events occurred in approximately 50 - 90% of patients. Cataract includes aggravated cataract, and posterior capsular opacification. Procedural complications includes post-op complication, post-op wound complication, post-op wound site erythema, and wound dehiscense.

Based on clinical trials with RETISERT, during the 3-year post-implantation period, nearly all phakic eyes are expected to develop cataracts and require cataract surgery. IOP lowering medications to lower intraocular pressure were required in approximately 77% of patients; filtering surgeries were required to control intraocular pressure in 37% of patients. Ocular adverse events occurring in approximately 10 - 40% of patients in decreasing order of incidence were ocular/conjunctival hyperemia, reduced visual acuity, glaucoma, conjunctival hemorrhage, blurred vision, abnormal sensation in the eye, eye irritation, maculopathy, vitreous floaters, hypotony, pruritus, ptosis, increased tearing, vitreous hemorrhage, dry eye, eyelid edema, macular edema and visual disturbance.

Ocular adverse events occurring in approximately 5 - 9% of patients in decreasing order of incidence were eye discharge, photophobia, blepharitis, corneal edema, iris adhesions, choroidal detachment, diplopia, eye swelling, retinal detachment, photopsia, retinal hemorrhage and hyphema.

The most frequently reported non-ocular adverse event was headache (33%). Other non-ocular adverse events occurring in approximately 5-20% of patients in decreasing order of incidence were nasopharyngitis, arthralgia, sinusitis, dizziness, pyrexia, upper respiratory tract infection, influenza, vomiting, nausea, cough, back pain, limb pain, and rash.

Risk Summary

Adequate and well-controlled studies with RETISERT have not been conducted in pregnant women to inform drug-associated risk. Animal reproduction studies have not been conducted with RETISERT. It is not known whether RETISERT can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. RETISERT should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

In the US 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.

Risk Summary

There are no data on the presence of RETISERT in human milk, the effects on the breastfed infant, or the effects on milk production. Systemically administered corticosteroids are present in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other unwanted effects. Clinical or nonclinical lactation studies have not been conducted with RETISERT.

It is not known whether intravitreal treatment with RETISERT could result in sufficient systemic absorption to produce detectable quantities of fluocinolone acetonide in human milk, or affect breastfed infants or milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for RETISERT and any potential adverse effects on the breastfed child from RETISERT or from the underlying maternal condition.  

Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

No overall differences in safety and effectiveness have been observed between elderly and younger patients.

RETISERT ®(fluocinolone acetonide intravitreal implant) 0.59 mg is a sterile implant designed to release fluocinolone acetonide locally to the posterior segment of the eye at a nominal initial rate of 0.6 mcg/day, decreasing over the first month to a steady state between 0.3-0.4 mcg/day over approximately 30 months. The drug substance is the synthetic corticosteroid fluocinolone acetonide, represented by the following structural formula:

{ "type": "p", "children": [], "text": "RETISERT\n \n ®(fluocinolone acetonide intravitreal implant) 0.59 mg is a sterile implant designed to release fluocinolone acetonide locally to the posterior segment of the eye at a nominal initial rate of 0.6 mcg/day, decreasing over the first month to a steady state between 0.3-0.4 mcg/day over approximately 30 months. The drug substance is the synthetic corticosteroid fluocinolone acetonide, represented by the following structural formula:\n\n " }

C 24H 30F 2O 6Mol. Wt. 452.50

{ "type": "p", "children": [], "text": "C\n \n 24H\n \n 30F\n \n 2O\n \n 6Mol. Wt. 452.50\n\n " }

Chemical Name: Pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methyl-ethylidene)bis(oxy)],(6α,11β ,16α)-.

{ "type": "p", "children": [], "text": "Chemical Name: Pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methyl-ethylidene)bis(oxy)],(6α,11β ,16α)-." }

Fluocinolone acetonide is a white crystalline powder, insoluble in water, and soluble in methanol. It has a melting point of 265-266ºC.

{ "type": "p", "children": [], "text": "Fluocinolone acetonide is a white crystalline powder, insoluble in water, and soluble in methanol. It has a melting point of 265-266ºC." }

Each RETISERT consists of a tablet containing 0.59 mg of the active ingredient, Fluocinolone Acetonide, USP, and the following inactives: magnesium stearate, microcrystalline cellulose, and polyvinyl alcohol.

{ "type": "p", "children": [], "text": "Each RETISERT consists of a tablet containing 0.59 mg of the active ingredient, Fluocinolone Acetonide, USP, and the following inactives: magnesium stearate, microcrystalline cellulose, and polyvinyl alcohol." }

Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. 

There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A 2inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2. Corticosteroids are capable of producing a rise in intraocular pressure. 

In a subset of patients who received the intravitreal implant, and had blood samples taken at various times (weeks 1, 4 and 34) after implantation, plasma levels of fluocinolone acetonide were below the limit of detection (0.2 ng/mL) at all times. Aqueous and vitreous humor samples were assayed for fluocinolone acetonide in a further subset of patients. While detectable concentrations of fluocinolone acetonide were seen throughout the observation interval (up to 34 months), the concentrations were highly variable, ranging from below the limit of detection (0.2 ng/mL) to 589 ng/mL. 

Long-term animal studies have not been performed to determine the carcinogenic potential or the effect on fertility of RETISERT.

Fluocinolone acetonide was not genotoxic in vitro in the Ames test (S. typhimurium and E. coli), the mouse lymphoma TK assay, or in vivoin the mouse bone marrow micronucleus assay.

In two randomized, double-masked, multicenter controlled clinical trials, 224 patients with chronic (a one year or greater history) non-infectious uveitis affecting the posterior segment of one or both eyes were randomized to receive a 0.59 mg RETISERT. The primary efficacy endpoint in both trials was the rate of recurrence of uveitis affecting the posterior segment of the study eye in the 34 week pre-implantation period compared to the rate of recurrence in the 34 week post-implantation period. Uveitis recurrence rates at 1, 2, and 3 year post-implantation were also compared to the 34 week pre-implantation period. 

{ "type": "p", "children": [], "text": "In two randomized, double-masked, multicenter controlled clinical trials, 224 patients with chronic (a one year or greater history) non-infectious uveitis affecting the posterior segment of one or both eyes were randomized to receive a 0.59 mg RETISERT. The primary efficacy endpoint in both trials was the rate of recurrence of uveitis affecting the posterior segment of the study eye in the 34 week pre-implantation period compared to the rate of recurrence in the 34 week post-implantation period. Uveitis recurrence rates at 1, 2, and 3 year post-implantation were also compared to the 34 week pre-implantation period. " }

Detailed results are shown in Table 1 below:

{ "type": "p", "children": [], "text": "Detailed results are shown in Table 1 below:" }

Table 1: Uveitis Recurrence Rates

{ "type": "p", "children": [], "text": "\nTable 1: Uveitis Recurrence Rates\n" }

<div class="scrollingtable"><table width="100%"> <col width="33%"/> <col width="33%"/> <col width="33%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" rowspan="3" valign="middle"> <p class="First"> <span class="Bold">TIME POINT</span> </p> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">STUDY 1</span> </p> </td><td align="center" class="Botrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">STUDY 2</span> </p> </td> </tr> <tr> <td align="center" class="Botrule Rrule" valign="top"> <p class="First">N=108</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">N=116</p> </td> </tr> <tr> <td align="center" class="Botrule Rrule" colspan="2" valign="top"> <p class="First">Uveitis Recurrence Rates <span class="Sup">1,2</span> <br/> N (%) </p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">34 Weeks Pre- <br/> implantation </p> </td><td align="center" class="Botrule Rrule" valign="middle"> <p class="First">58 (53.7)</p> </td><td align="center" class="Botrule Rrule" valign="middle"> <p class="First">46 (39.7)</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">34 Weeks Post- <br/> implantation </p> </td><td align="center" class="Botrule Rrule" valign="middle"> <p class="First">2 (1.8)</p> </td><td align="center" class="Botrule Rrule" valign="middle"> <p class="First">15 (12.9)</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">1 Year Post-implantation</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">4 (3.7)</p> </td><td align="center" class="Botrule Rrule" valign="top"> <p class="First">15 (12.9)</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">2 Years Post-implantation</p> </td><td align="center" class="Botrule Rrule" valign="middle"> <p class="First">11 (10.2)</p> </td><td align="center" class="Botrule Rrule" valign="middle"> <p class="First">16 (13.8)</p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">3 Years Post-implantation</p> </td><td align="center" class="Botrule Rrule" valign="middle"> <p class="First">22 (20.4)</p> </td><td align="center" class="Botrule Rrule" valign="middle"> <p class="First">20 (17.2)</p> </td> </tr> <tr class="Last"> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">3 Years <span class="Sup">3</span>Post- <br/> implantation </p> </td><td align="center" class="Botrule Rrule" valign="middle"> <p class="First">33 (30.6)</p> </td><td align="center" class="Botrule Rrule" valign="middle"> <p class="First">28 (24.1)</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col width=\"33%\"/>\n<col width=\"33%\"/>\n<col width=\"33%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" rowspan=\"3\" valign=\"middle\">\n<p class=\"First\">\n<span class=\"Bold\">TIME POINT</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">STUDY 1</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">STUDY 2</span>\n</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">\n<p class=\"First\">N=108</p>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">\n<p class=\"First\">N=116</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Rrule\" colspan=\"2\" valign=\"top\">\n<p class=\"First\">Uveitis Recurrence Rates\n \n <span class=\"Sup\">1,2</span>\n<br/> N (%)\n \n </p>\n</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">34 Weeks Pre- \n <br/> implantation\n </p>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"middle\">\n<p class=\"First\">58 (53.7)</p>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"middle\">\n<p class=\"First\">46 (39.7)</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">34 Weeks Post- \n <br/> implantation\n </p>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"middle\">\n<p class=\"First\">2 (1.8)</p>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"middle\">\n<p class=\"First\">15 (12.9)</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">1 Year Post-implantation</p>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">\n<p class=\"First\">4 (3.7)</p>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\">\n<p class=\"First\">15 (12.9)</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">2 Years Post-implantation</p>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"middle\">\n<p class=\"First\">11 (10.2)</p>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"middle\">\n<p class=\"First\">16 (13.8)</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">3 Years Post-implantation</p>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"middle\">\n<p class=\"First\">22 (20.4)</p>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"middle\">\n<p class=\"First\">20 (17.2)</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"center\" class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">3 Years\n \n <span class=\"Sup\">3</span>Post- \n <br/> implantation\n \n </p>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"middle\">\n<p class=\"First\">33 (30.6)</p>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"middle\">\n<p class=\"First\">28 (24.1)</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

1Recurrence of uveitis for all post-implantation time points was compared to the 34 weeks pre-implantation time point.

{ "type": "p", "children": [], "text": "\n1Recurrence of uveitis for all post-implantation time points was compared to the 34 weeks pre-implantation time point.\n\n " }

2p-value <0.01 from McNemar’s χ 2test.

{ "type": "p", "children": [], "text": "\n2p-value <0.01 from McNemar’s χ\n \n 2test.\n\n " }

3Results presented include imputed recurrences. Recurrences were imputed when a subject was not seen within 10 weeks    of their final scheduled visit.

{ "type": "p", "children": [], "text": "\n3Results presented include imputed recurrences. Recurrences were imputed when a subject was not seen within 10 weeks    of their final scheduled visit.\n\n " }

In assessing the effect of RETISERT on the corneal endothelial cell density in eyes that have been implanted for a minimum of 1 year, the results indicate that eyes containing the RETISERT implant for an average of 3.54 years had a lower mean corneal endothelial cell density (mean paired difference of -435 cells/mm 2) compared with non-implanted eyes (p<0.01).

{ "type": "p", "children": [], "text": "In assessing the effect of RETISERT on the corneal endothelial cell density in eyes that have been implanted for a minimum of 1 year, the results indicate that eyes containing the RETISERT implant for an average of 3.54 years had a lower mean corneal endothelial cell density (mean paired difference of -435 cells/mm\n \n 2) compared with non-implanted eyes (p<0.01).\n\n " }

The implant consists of a tablet encased in a silicone elastomer cup containing a release orifice and a polyvinyl alcohol membrane positioned between the tablet and the orifice. The silicone elastomer cup assembly is attached to a silicone elastomer suture tab with silicone adhesive. Each RETISERT is approximately 3 mm x 2 mm x 5 mm.

{ "type": "p", "children": [], "text": "The implant consists of a tablet encased in a silicone elastomer cup containing a release orifice and a polyvinyl alcohol membrane positioned between the tablet and the orifice. The silicone elastomer cup assembly is attached to a silicone elastomer suture tab with silicone adhesive. Each RETISERT is approximately 3 mm x 2 mm x 5 mm." }

Each implant is stored in a clear polycarbonate case within a foil pouch within a Tyvek peelable overwrap. Each packaged implant is provided in a carton which includes the package insert.

{ "type": "p", "children": [], "text": "Each implant is stored in a clear polycarbonate case within a foil pouch within a Tyvek peelable overwrap. Each packaged implant is provided in a carton which includes the package insert." }

NDC 24208-416-01 0.59 mg 1 count

{ "type": "p", "children": [], "text": "NDC 24208-416-01 0.59 mg 1 count" }

Storage:Store in the original container at 15°C to 25°C (59°F to 77°F). Protect from freezing.

{ "type": "p", "children": [], "text": "\nStorage:Store in the original container at 15°C to 25°C (59°F to 77°F).\n \n Protect from freezing.\n" }

Patients should be advised to have ophthalmologic follow-up examinations of both eyes at appropriate intervals following implantation of RETISERT.

{ "type": "p", "children": [], "text": "Patients should be advised to have ophthalmologic follow-up examinations of both eyes at appropriate intervals following implantation of RETISERT." }

As with any surgical procedure, there is risk involved. Potential complications accompanying intraocular surgery to place RETISERT into the vitreous cavity may include, but are not limited to, the following: cataract formation, choroidal detachment, temporary decreased visual acuity, endophthalmitis, hypotony, increased intraocular pressure, exacerbation of intraocular inflammation, retinal detachment, vitreous hemorrhage, vitreous loss, and wound dehiscence.

{ "type": "p", "children": [], "text": "As with any surgical procedure, there is risk involved. Potential complications accompanying intraocular surgery to place RETISERT into the vitreous cavity may include, but are not limited to, the following: cataract formation, choroidal detachment, temporary decreased visual acuity, endophthalmitis, hypotony, increased intraocular pressure, exacerbation of intraocular inflammation, retinal detachment, vitreous hemorrhage, vitreous loss, and wound dehiscence." }

Following implantation of RETISERT, nearly all patients will experience an immediate and temporary decrease in visual acuity in the implanted eye which lasts for approximately one to four weeks post-operatively.

{ "type": "p", "children": [], "text": "Following implantation of RETISERT, nearly all patients will experience an immediate and temporary decrease in visual acuity in the implanted eye which lasts for approximately one to four weeks post-operatively." }

Based on clinical trials with RETISERT, within 3 years post-implantation, approximately 77% of patients will require IOP lowering medications to control intraocular pressure and 37% of patients will require filtering procedures to control intraocular pressure [see Adverse Reactions ( 6.1)] .

{ "type": "p", "children": [], "text": "Based on clinical trials with RETISERT, within 3 years post-implantation, approximately 77% of patients will require IOP lowering medications to control intraocular pressure and 37% of patients will require filtering procedures to control intraocular pressure\n \n [see Adverse Reactions (\n \n 6.1)]\n \n .\n\n " }

Based on clinical trials with RETISERT, during the 3-year post-implantation period, nearly all phakic eyes are expected to develop cataracts and require cataract surgery.

{ "type": "p", "children": [], "text": "Based on clinical trials with RETISERT, during the 3-year post-implantation period, nearly all phakic eyes are expected to develop cataracts and require cataract surgery." }

Manufactured for: Bausch & Lomb Americas Inc Bridgewater, NJ 08807 USA Manufactured by: Bausch + Lomb Ireland Limited Waterford, Ireland RETISERT is a trademark of Bausch & Lomb Incorporated or its affiliates. © 2025 Bausch & Lomb Incorporated or its affiliates

{ "type": "p", "children": [], "text": "\nManufactured for: \n \nBausch & Lomb Americas Inc \n Bridgewater, NJ 08807 USA \n \n\nManufactured by: \n \nBausch + Lomb Ireland Limited \n Waterford, Ireland \n RETISERT is a trademark of Bausch & Lomb Incorporated or its affiliates. \n © 2025 Bausch & Lomb Incorporated or its affiliates\n\n " }

9028012

{ "type": "p", "children": [], "text": "9028012" }

NDC24208-416-01

{ "type": "p", "children": [], "text": "\n\nNDC24208-416-01\n\n " }

Rx only

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

Retisert ® (fluocinolone acetonide

{ "type": "p", "children": [], "text": "\nRetisert\n \n ®\n\n(fluocinolone acetonide\n" }

intravitreal implant) 0.59 mg

{ "type": "p", "children": [], "text": "\nintravitreal implant) 0.59 mg\n" }

STERILE

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

FOR INTRAVITREAL IMPLANTATION ONLY

{ "type": "p", "children": [], "text": "\nFOR INTRAVITREAL IMPLANTATION ONLY\n" }

Contents:One sterile Retisert ®(fluocinolone acetonide intravitreal implant) 0.59 mg

{ "type": "p", "children": [], "text": "\nContents:One sterile Retisert\n \n ®(fluocinolone acetonide intravitreal implant) \n 0.59 mg\n\n " }

Content sterile in unopened, undamaged package.

{ "type": "p", "children": [], "text": "Content sterile in unopened, undamaged package." }

BAUSCH + LOMB

{ "type": "p", "children": [], "text": "\nBAUSCH + LOMB\n" }

Fluocinolone Acetonide Topical Oil, 0.01% is indicated for the topical treatment of atopic dermatitis in adult patients.

Fluocinolone Acetonide Topical Oil, 0.01% is indicated for the topical treatment of moderate to severe atopic dermatitis in pediatric patients, 3 months and older for up to 4 weeks. Safety and effectiveness in pediatric patients younger than 3 months of age have not been established.

Apply the least amount of Fluocinolone Acetonide Topical Oil, 0.01% needed to cover the affected areas. As with other corticosteroids, Fluocinolone Acetonide Topical Oil, 0.01% should be discontinued when control of disease is achieved. Contact the physician if no improvement is seen within 2 weeks.

Fluocinolone Acetonide Topical Oil, 0.01% should not be applied to the diaper area; diapers or plastic pants may constitute occlusive use.

Fluocinolone Acetonide Topical Oil, 0.01% should not be used on the face, axillae, or groin unless directed by the physician. Application to intertriginous areas should be avoided due to the increased risk of local adverse reactions. [see Adverse Reactions (6) and Use in Specific Populations (8.4)].

Apply Fluocinolone Acetonide Topical Oil, 0.01% as a thin film to the affected areas three times daily.

Moisten skin and apply Fluocinolone Acetonide Topical Oil, 0.01% as a thin film to the affected areas twice daily for up to four weeks.

Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) is supplied in bottles containing 4 fluid ounces.

{ "type": "p", "children": [], "text": "Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) is supplied in bottles containing 4 fluid ounces." }

None

{ "type": "p", "children": [], "text": "None" }

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. Cushing's syndrome, hyperglycemia, and glucosuria can also be produced by systemic absorption of topical corticosteroids. Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. The ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression.

If HPA axis suppression is documented, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids.

Conditions which increase systemic absorption include the use of more potent corticosteroids, use over large surface areas, use over prolonged periods, and use of occlusive dressings. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. [See Use in Specific Populations (8.4)]

Local adverse reactions may occur with use of topical corticosteroids and may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Some local adverse reactions may be irreversible. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. [See Adverse Reactions (6.1)]

Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing.

Concomitant skin infections should be treated with an appropriate antimicrobial agent. If the infection persists unchanged, Fluocinolone Acetonide Topical Oil, 0.01% should be discontinued until the infection has been adequately treated.

Physicians should use caution in prescribing Fluocinolone Acetonide Topical Oil, 0.01% for peanut-sensitive individuals. [See Description (11)]

Should signs of hypersensitivity present (wheal and flare reactions, pruritus, or other manifestations), or should disease exacerbations occur, Fluocinolone Acetonide Topical Oil, 0.01% should be discontinued immediately and appropriate therapy instituted.

An open-label study was conducted in 58 children with moderate to severe atopic dermatitis (2 to 12 years old) to evaluate the safety of fluocinolone acetonide topical oil, 0.01% when applied to the face twice daily for 4 weeks. The following adverse reactions were reported:

<div class="scrollingtable"><table width="100%"> <col width="29%"/> <col width="26%"/> <col width="14%"/> <col width="15%"/> <col width="15%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule" colspan="5" valign="top"> <p class="First"> <span class="Bold">Incidence of Adverse Reactions (%)</span> </p> <p> <span class="Bold">N=58</span> </p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First"> <span class="Bold">Adverse Reaction (AR)*</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold"># of subjects (%)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Day 14</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Day 28**</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First"> <span class="Bold">Day 56***</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Any AE</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">15 (26)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">6 (10)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">7 (12)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">7 (12)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Telangiectasia</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">5 (9)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">3 (5)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">4 (7)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2 (4)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Erythema</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">3 (5)</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">3 (5)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Itching</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">3 (5)</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">3 (5)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Irritation</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">3 (5)</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">3 (5)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Burning</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">3 (5)</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">3 (5)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Hypopigmentation</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2 (4)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2 (4)</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Shiny skin</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1 (2)</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1 (2)</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Secondary atopic dermatitis</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1 (2)</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1 (2)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Papules and pustules</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1 (2)</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1 (2)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Keratosis pilaris</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1 (2)</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1 (2)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Folliculitis</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1 (2)</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1 (2)</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Facial herpes simplex</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1 (2)</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1 (2)</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Acneiform eruption</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1 (2)</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1 (2)</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Ear infection</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1 (2)</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1 (2)</p> </td><td class="Botrule Lrule Rrule Toprule" valign="top"></td> </tr> </tbody> </table></div>

*The number of individual adverse reactions reported does not necessarily reflect the number of individual subjects, since one subject could have multiple reporting of an adverse reaction.

**End of Treatment

***Four Weeks Post Treatment

An open-label safety study was conducted in 29 children to assess the HPA axis by ACTH stimulation testing following use of fluocinolone acetonide topical oil, 0.01% twice daily for 4 weeks. The following adverse reactions were reported in the study [See Use in Specific Populations (8.4)]:

Adverse Reactions (%)

N=30*

<div class="scrollingtable"><table width="100%"> <col width="50%"/> <col width="50%"/> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <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"># of subjects (%)</span> </p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Diarrhea</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1 (3)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Vomiting</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1 (3)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Pyrexia</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">3 (10)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Abscess</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1 (3)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Molluscum</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1 (3)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Nasopharyngitis</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2 (7)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">URI</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1 (3)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Otitis media</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1 (3)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Cough</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">6 (20)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Rhinorrhea</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">4 (13)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Atopic dermatitis</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1 (3)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Eczema</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1 (3)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Hyperpigmentation</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1 (3)</p> </td> </tr> <tr> <td class="Botrule Lrule Rrule" valign="top"> <p class="First">Hypopigmentation</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">2 (7)</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Rash</p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">1 (3)</p> </td> </tr> </tbody> </table></div>

*Includes one subject who withdrew at Week 2

Pregnancy Category C: Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

There are no adequate and well-controlled studies in pregnant women on teratogenic effects from fluocinolone acetonide topical oil, 0.01%. Therefore, Fluocinolone Acetonide Topical Oil, 0.01% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Fluocinolone Acetonide Topical Oil, 0.01% is administered to a nursing woman.

8.4.1 Systemic Adverse Reactions in Pediatric Patients

HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and subnormal response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Because of a higher ratio of skin surface area to body mass, children are at a greater risk for systemic adverse reactions than are adults when treated with topical corticosteroids. [See Warnings and Precautions (5.1)]

8.4.2 Evaluation in Peanut-Sensitive Pediatric Subjects

A clinical study was conducted to assess the safety of fluocinolone acetonide topical oil, 0.01%, which contains refined peanut oil, on subjects with known peanut allergies. The study enrolled 13 subjects with atopic dermatitis, 6 to 17 years of age. Of the 13 subjects, 9 were Radioallergosorbent Test (RAST) positive to peanuts and 4 had no peanut sensitivity (controls). The study evaluated the subjects’ responses to both prick test and patch test utilizing peanut oil NF, fluocinolone acetonide topical oil, 0.01% and histamine/saline controls. Subjects were also treated with fluocinolone acetonide topical oil, 0.01% twice daily for 7 days. Prick test and patch test results for all 13 patients were negative to fluocinolone acetonide topical oil, 0.01% and the refined peanut oil. One of the 9 peanut-sensitive patients experienced an exacerbation of atopic dermatitis after 5 days of fluocinolone acetonide topical oil, 0.01%. The bulk peanut oil NF, used in fluocinolone acetonide topical oil, 0.01% is heated just below 450°F for at least 30 minutes, which should provide for adequate decomposition of allergenic proteins. [See Description (11)]

8.4.3 Evaluation in Pediatric Subjects 2 to 6 years old

Open-label safety studies were conducted on 33 children (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe stable atopic dermatitis. Subjects were treated with fluocinolone acetonide topical oil, 0.01% twice daily for 4 weeks. Baseline body surface area involvement was 50% to 75% in 15 subjects and greater than 75% in 18 subjects. Morning pre-stimulation cortisol and post-ACTH stimulation cortisol levels were obtained in each subject at the beginning of the trial and at the end of 4 weeks of treatment. At the end of treatment, 4 out of 18 subjects aged 2 to 5 years showed low pre-stimulation cortisol levels (3.2 to 6.6 μg/dL; normal: cortisol > 7μg/dL) but all had normal responses to 0.25 mg of ACTH stimulation (cortisol > 18 μg/dL).

8.4.4 Evaluation in Pediatric Subjects 3 months to 2 years old

An open-label safety study was conducted in 29 children (7 subjects ages 3 to 6 months, 7 subjects ages > 6 to 12 months and 15 subjects ages > 12 months to 2 years of age) to assess the HPA axis by ACTH stimulation testing following use of fluocinolone acetonide topical oil, 0.01% twice daily for 4 weeks. All subjects had moderate to severe atopic dermatitis with disease involvement on at least 20% body surface area. Baseline body surface area involvement was 50% to 75% in 11 subjects and greater than 75% in 7 subjects. Morning pre-stimulation and post-ACTH stimulation cortisol levels were obtained in each subject at the beginning of the trial and at the end of 4 weeks of treatment. All subjects had normal responses to 0.125 mg of ACTH stimulation (cortisol > 18 μg/dL).

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects, including under conditions of normal use. [See Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].

{ "type": "p", "children": [], "text": "Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects, including under conditions of normal use. [See Warnings and Precautions (5.1) and Use in Specific Populations (8.4)]." }

Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) contains fluocinolone acetonide [(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17[(1-methylethylidene) bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone], a synthetic corticosteroid for topical dermatologic use. This formulation is also marketed as Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) for use with shower caps for treatment of scalp psoriasis in adults and as Fluocinolone Acetonide Oil, 0.01% (Ear Drops) for treatment of chronic eczematous external otitis.

{ "type": "p", "children": [], "text": "Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) contains fluocinolone acetonide [(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17[(1-methylethylidene) bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone], a synthetic corticosteroid for topical dermatologic use. This formulation is also marketed as Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) for use with shower caps for treatment of scalp psoriasis in adults and as Fluocinolone Acetonide Oil, 0.01% (Ear Drops) for treatment of chronic eczematous external otitis. " }

Chemically, fluocinolone acetonide is C24H30F2O6. It has the following structural formula:

{ "type": "p", "children": [], "text": "Chemically, fluocinolone acetonide is C24H30F2O6. It has the following structural formula:" }

Fluocinolone acetonide in Fluocinolone Acetonide Topical Oil, 0.01% has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water.

{ "type": "p", "children": [], "text": "Fluocinolone acetonide in Fluocinolone Acetonide Topical Oil, 0.01% has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water." }

Each gram of Fluocinolone Acetonide Topical Oil, 0.01% contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF.

{ "type": "p", "children": [], "text": "Each gram of Fluocinolone Acetonide Topical Oil, 0.01% contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF." }

Fluocinolone Acetonide Topical Oil, 0.01% is formulated with 48% refined peanut oil NF. Physicians should use caution in prescribing Fluocinolone Acetonide Topical Oil, 0.01% for peanut-sensitive individuals.

{ "type": "p", "children": [], "text": "Fluocinolone Acetonide Topical Oil, 0.01% is formulated with 48% refined peanut oil NF. Physicians should use caution in prescribing Fluocinolone Acetonide Topical Oil, 0.01% for peanut-sensitive individuals." }

Like other topical corticosteroids, fluocinolone acetonide has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Topical corticosteroids can be absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the product formulation and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may increase percutaneous absorption. The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids may be necessary due to the fact that circulating levels are often below the level of detection. Once absorbed through the skin, topical corticosteroids are metabolized, primarily in the liver, and are then excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile.

Fluocinolone Acetonide Topical Oil, 0.01% is in the low to medium range of potency as compared with other topical corticosteroids in vasoconstrictor studies.

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of Fluocinolone Acetonide Topical Oil, 0.01%. Studies have not been performed to evaluate the mutagenic potential of fluocinolone acetonide, the active ingredient in Fluocinolone Acetonide Topical Oil, 0.01%. Some corticosteroids have been found to be genotoxic in various genotoxicity tests (i.e. the in vitro human peripheral blood lymphocyte chromosome aberration assay with metabolic activation, the in vivo mouse bone marrow micronucleus assay, the Chinese hamster micronucleus test and the in vitro mouse lymphoma gene mutation assay).

Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil)

{ "type": "p", "children": [], "text": "\nFluocinolone Acetonide Topical Oil, 0.01% (Body Oil)\n" }

NDC: 72162-1434-2: 118.28 mL in a BOTTLE

{ "type": "p", "children": [], "text": "NDC: 72162-1434-2: 118.28 mL in a BOTTLE" }

Storage:

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

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

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

Repackaged/Relabeled by:

{ "type": "p", "children": [], "text": "Repackaged/Relabeled by:" }

Bryant Ranch Prepack, Inc.

{ "type": "p", "children": [], "text": "Bryant Ranch Prepack, Inc." }

Burbank, CA 91504

{ "type": "p", "children": [], "text": "Burbank, CA 91504" }

Manufactured By Padagis

Yeruham, Israel

Distributed By Padagis

Allegan, MI 49010

www.padagis.com

Rev 10-22

Fluocino Acetonide 0.01% BodyOil, #118ml

{ "type": "p", "children": [], "text": "Fluocino Acetonide 0.01% BodyOil, #118ml" }

Extended Label

{ "type": "p", "children": [], "text": "Extended Label" }