Isoproterenol hydrochloride injection is indicated:

{ "type": "p", "children": [], "text": "Isoproterenol hydrochloride injection is indicated:" }

{ "type": "ul", "children": [ "To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output", "For bronchospasm occurring during anesthesia" ], "text": "" }

Inspect visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the injection is pinkish or darker than slightly yellow or contains a precipitate. Discard any unused portion.

Diluted solution should be used immediately. Unused material should be discarded.

Dosage should generally be started at the lowest recommended dose and increased gradually based on patient response.

Recommended dosage for adults with shock and hypoperfusion states:

<div class="scrollingtable"><table width="100%"> <tbody class="Headless"> <tr class="First"> <td align="left" class="Botrule Lrule Rrule Toprule"> Route of Administration</td><td class="Botrule Lrule Rrule Toprule"> Preparation of Dilution<span class="Sup">†</span></td><td class="Botrule Lrule Rrule Toprule"> Infusion Rate<span class="Sup">††</span></td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule Toprule"> Intravenous infusion </td><td class="Botrule Lrule Rrule Toprule"> Dilute 5 mL (1 mg) in 500 mL of 5% Dextrose Injection, USP</td><td class="Botrule Lrule Rrule Toprule"> 0.5 mcg to 5 mcg per minute<br/> (0.25 mL to 2.5 mL of diluted solution)</td> </tr> </tbody> </table></div>

†Concentrations up to 10 times greater have been used when limitation of volume is essential.

††Rates over 30 mcg per minute have been used in advanced stages of shock. Adjust the rate of infusion based on heart rate, central venous pressure, systemic blood pressure, and urine flow. If the heart rate exceeds 110 beats per minute, consider decreasing or temporarily discontinuing the infusion.

Recommended dosage for adults with bronchospasm occurring during anesthesia:   

<div class="scrollingtable"><table cellpadding="0" cellspacing="0" width="100%"> <colgroup> <col width="21.5%"/> <col width="34.1%"/> <col width="21.68%"/> <col width="22.72%"/> </colgroup> <tbody class="Headless"> <tr class="Botrule First First"> <td align="left" class="Lrule Rrule" valign="top">Route of Administration</td><td align="left" class="Rrule" valign="top">Preparation of Dilution</td><td align="left" class="Rrule" valign="top">Initial Dose</td><td align="left" class="Rrule" valign="top">Subsequent Dose</td> </tr> <tr class="Last"> <td align="left" class="Lrule Rrule" valign="top">Bolus intravenous injection</td><td align="left" class="Rrule" valign="top">Dilute 1 mL (0.2 mg) to 10 mL with Sodium<br/>Chloride Injection, USP, or 5% Dextrose<br/>Injection, USP</td><td align="left" class="Rrule" valign="top">10 mcg to 20 mcg (0.5 mL to 1 mL of diluted solution)</td><td align="left" class="Rrule" valign="top">The initial dose may be repeated when necessary       </td> </tr> </tbody> </table></div>

There are no well-controlled studies in children to establish appropriate dosing; however, the American Heart Association recommends an initial infusion rate of 0.1 mcg/kg/min, with the usual range being 0.1 mcg/kg/min to 1 mcg/kg/min.

Injection solution: single-dose, clear glass ampules containing isoproterenol in a clear, colorless to slightly yellow color solution;

{ "type": "p", "children": [], "text": "Injection solution: single-dose, clear glass ampules containing isoproterenol in a clear, colorless to slightly yellow color solution;" }

{ "type": "ul", "children": [ "5 mL containing 1 mg/5 mL (0.2 mg/mL)" ], "text": "" }

Isoproterenol hydrochloride injection is contraindicated in patients with:

{ "type": "p", "children": [], "text": "Isoproterenol hydrochloride injection is contraindicated in patients with:" }

{ "type": "ul", "children": [ "tachycardia", "ventricular arrhythmias", "angina pectoris" ], "text": "" }

Isoproterenol may induce cardiac arrhythmias and myocardial ischemia in patients, especially patients with coronary artery disease, or cardiomyopathy.

Isoproterenol hydrochloride injection contains sodium metabisulfite, which may cause mild to severe allergic reactions including anaphylaxis or asthmatic episodes, particularly in patients with a history of allergies. However, the presence of metabisulfite in this product should not preclude its use for treatment in emergency situations, even if the patient is sulfite-sensitive, as the alternatives to using isoproterenol in a life-threatening situation may not be satisfactory.

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

{ "type": "p", "children": [], "text": "The following adverse reactions have been associated with use of isoproterenol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure." }

Nervous system disorders: Nervousness, headache, dizziness, visual blurring

{ "type": "p", "children": [], "text": "\nNervous system disorders: Nervousness, headache, dizziness, visual blurring" }

Cardiovascular: Tachycardia, tachyarrhythmias, palpitations, angina, ventricular arrhythmias, Adams-Stokes attacks, pulmonary edema

{ "type": "p", "children": [], "text": "\nCardiovascular: Tachycardia, tachyarrhythmias, palpitations, angina, ventricular arrhythmias, Adams-Stokes attacks, pulmonary edema" }

Respiratory: Dyspnea

{ "type": "p", "children": [], "text": "\nRespiratory: Dyspnea" }

Other: Flushing of the skin, sweating, mild tremors, pallor, nausea

{ "type": "p", "children": [], "text": "\nOther: Flushing of the skin, sweating, mild tremors, pallor, nausea" }

Table 1. Clinically Relevant Interactions with Isoproterenol

{ "type": "p", "children": [], "text": "\nTable 1. Clinically Relevant Interactions with Isoproterenol\n" }

<div class="scrollingtable"><table width="100%"> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule" colspan="2"> <p class="First"> <span class="Italics"> Epinephrine</span> </p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule">Clinical Impact </td><td class="Botrule Rrule">Both drugs are direct cardiac stimulants, and their combined effects may induce serious arrhythmias upon simultaneous administration.</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule"> Intervention</td><td class="Botrule Rrule"> Isoproterenol hydrochloride injection and epinephrine should not be administered simultaneously.</td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2"> <p class="First"> <span class="Italics"> Drugs that may potentiate clinical response of Isoproterenol</span> </p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule">Clinical Impact </td><td class="Botrule Rrule">The effects of isoproterenol may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine.</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule">Intervention </td><td class="Botrule Rrule">Monitor hemodynamic parameters in patients who concurrently are taking tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium and certain antihistamines. Adjust doses appropriately.</td> </tr> <tr> <td class="Botrule Lrule Rrule" colspan="2"> <p class="First"> <span class="Italics"> Drugs that may reduce clinical response of Isoproterenol</span> </p> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule"> Clinical Impact</td><td class="Botrule Rrule"> The cardiostimulating and bronchodilating effects of isoproterenol are antagonized by beta-adrenergic blocking drugs, such as propranolol.</td> </tr> <tr class="Last"> <td align="center" class="Lrule Rrule">Intervention </td><td class="Rrule"> Monitor for hemodynamic response and relief of bronchospasm and adjust dose appropriately.</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\">\n<p class=\"First\">\n<span class=\"Italics\"> Epinephrine</span>\n</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\">Clinical Impact </td><td class=\"Botrule Rrule\">Both drugs are direct cardiac stimulants, and their combined effects may induce serious arrhythmias upon simultaneous administration.</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\"> Intervention</td><td class=\"Botrule Rrule\"> Isoproterenol hydrochloride injection and epinephrine should not be administered simultaneously.</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\">\n<p class=\"First\">\n<span class=\"Italics\"> Drugs that may potentiate clinical response of Isoproterenol</span>\n</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\">Clinical Impact </td><td class=\"Botrule Rrule\">The effects of isoproterenol may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine.</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\">Intervention </td><td class=\"Botrule Rrule\">Monitor hemodynamic parameters in patients who concurrently are taking tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium and certain antihistamines. Adjust doses appropriately.</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\" colspan=\"2\">\n<p class=\"First\">\n<span class=\"Italics\"> Drugs that may reduce clinical response of Isoproterenol</span>\n</p>\n</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\"> Clinical Impact</td><td class=\"Botrule Rrule\"> The cardiostimulating and bronchodilating effects of isoproterenol are antagonized by beta-adrenergic blocking drugs, such as propranolol.</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"center\" class=\"Lrule Rrule\">Intervention </td><td class=\"Rrule\"> Monitor for hemodynamic response and relief of bronchospasm and adjust dose appropriately.</td>\n</tr>\n</tbody>\n</table></div>" }

Risk Summary

Prolonged experience with isoproterenol use in pregnant women over several decades, based on published literature, do not identify a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. However, there are risks to the mother and fetus associated with isoproterenol use during labor or delivery (see Clinical Considerations).

The estimated 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 United States 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.

Clinical Considerations

Hypotension associated with shock is a medical emergency in pregnancy which can be fatal if left untreated. Delaying treatment in pregnant women with hypotension associated with shock may increase the risk of maternal and fetal morbidity and mortality. Life-sustaining therapy for the pregnant woman should not be withheld due to potential concerns regarding the effects of isoproterenol on the fetus.

Labor and Delivery

Isoproterenol usually inhibits spontaneous or oxytocin induced contractions of the pregnant human uterus and may delay the second stage of labor. Avoid isoproterenol during the second stage of labor. Avoid isoproterenol in obstetrics when maternal blood pressure exceeds 130/80 mmHg.

Although isoproterenol may improve maternal hypotension associated with shock, it may result in uterine vasoconstriction, decreased uterine blood flow, uterine atony with hemorrhage, and fetal anoxia.

Risk Summary

There is no information regarding the presence of isoproterenol in milk or the effects of isoproterenol on the breastfed infant or on milk production. However, due to its short half-life, isoproterenol exposure is expected to be very low in the breastfed infant.

Safety and efficacy of isoproterenol in pediatric patients have not been established.

Intravenous infusions of isoproterenol in refractory asthmatic children at rates of 0.05 to 2.7 mcg/kg/min have caused clinical deterioration, myocardial necrosis, congestive heart failure and death. The risks of cardiac toxicity appear to be increased by some factors [acidosis, hypoxemia, coadministration of corticosteroids, coadministration of methylxanthines (theophylline, theobromine) or aminophylline] that are especially likely to be present in these patients. If I.V. isoproterenol is used in children with refractory asthma, patient monitoring must include continuous assessment of vital signs, frequent electrocardiography, and daily measurements of cardiac enzymes, including CPKMB.

Clinical studies of isoproterenol hydrochloride injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects in clinical circumstances. There are, however, some data that suggest that elderly healthy or hypertensive patients are less responsive to beta-adrenergic stimulation than are younger subjects. In general, dose selection for elderly patients should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant diseases or other drug therapy.

Overdosage of isoproterenol can cause tachycardia or other arrhythmias, palpitations, angina, hypotension, or hypertension. In case of overdosage, reduce the rate of administration or discontinue isoproterenol hydrochloride injection until patient's condition stabilizes. Monitor blood pressure, pulse, respiration, and EKG.

{ "type": "p", "children": [], "text": "Overdosage of isoproterenol can cause tachycardia or other arrhythmias, palpitations, angina, hypotension, or hypertension. In case of overdosage, reduce the rate of administration or discontinue isoproterenol hydrochloride injection until patient's condition stabilizes. Monitor blood pressure, pulse, respiration, and EKG." }

It is not known whether isoproterenol hydrochloride is dialyzable.

{ "type": "p", "children": [], "text": "It is not known whether isoproterenol hydrochloride is dialyzable." }

Isoproterenol hydrochloride is 3,4-Dihydroxy-α-[(isopropylamino)methyl] benzyl alcohol hydrochloride, a beta-adrenergic agonist and a synthetic sympathomimetic amine that is structurally related to epinephrine. The molecular formula is C11H17NO3•HCl. It has a molecular weight of 247.72 and the following structural formula:

{ "type": "p", "children": [], "text": "Isoproterenol hydrochloride is 3,4-Dihydroxy-α-[(isopropylamino)methyl] benzyl alcohol hydrochloride, a beta-adrenergic agonist and a synthetic sympathomimetic amine that is structurally related to epinephrine. The molecular formula is C11H17NO3•HCl. It has a molecular weight of 247.72 and the following structural formula:" }

Isoproterenol hydrochloride is a racemic compound.

{ "type": "p", "children": [], "text": "\nIsoproterenol hydrochloride is a racemic compound.\n" }

<div class="scrollingtable"><table width="70%"> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule"> Each milliliter of the sterile solution contains:</td><td class="Botrule Rrule"></td> </tr> <tr> <td class="Botrule Lrule Rrule"> Isoproterenol hydrochloride, USP</td><td class="Botrule Rrule"> 0.2 mg</td> </tr> <tr> <td class="Botrule Lrule Rrule"> Edetate Disodium (EDTA) Dihydrate</td><td class="Botrule Rrule"> 0.2 mg</td> </tr> <tr> <td class="Botrule Lrule Rrule"> Tri Sodium Citrate Dihydrate</td><td class="Botrule Rrule"> 2.07 mg</td> </tr> <tr> <td class="Botrule Lrule Rrule"> Citric Acid, Anhydrous</td><td class="Botrule Rrule"> 2.5 mg</td> </tr> <tr> <td class="Botrule Lrule Rrule"> Sodium Chloride</td><td class="Botrule Rrule"> 7.0 mg</td> </tr> <tr class="Last"> <td class="Lrule Rrule"> Water for Injection</td><td class="Rrule"> qs 1.0 mL</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"70%\">\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td class=\"Botrule Lrule Rrule\"> Each milliliter of the sterile solution contains:</td><td class=\"Botrule Rrule\"></td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\"> Isoproterenol hydrochloride, USP</td><td class=\"Botrule Rrule\"> 0.2 mg</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\"> Edetate Disodium (EDTA) Dihydrate</td><td class=\"Botrule Rrule\"> 0.2 mg</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\"> Tri Sodium Citrate Dihydrate</td><td class=\"Botrule Rrule\"> 2.07 mg</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\"> Citric Acid, Anhydrous</td><td class=\"Botrule Rrule\"> 2.5 mg</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule Rrule\"> Sodium Chloride</td><td class=\"Botrule Rrule\"> 7.0 mg</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Lrule Rrule\"> Water for Injection</td><td class=\"Rrule\"> qs 1.0 mL</td>\n</tr>\n</tbody>\n</table></div>" }

The pH is adjusted between 3.0 and 3.5 with hydrochloric acid and/or sodium hydroxide. The sterile solution is nonpyrogenic and can be administered by the intravenous route.

{ "type": "p", "children": [], "text": "\nThe pH is adjusted between 3.0 and 3.5 with hydrochloric acid and/or sodium hydroxide. The sterile solution is nonpyrogenic and can be administered by the intravenous route.\n" }

Isoproterenol is a potent nonselective beta-adrenergic agonist with very low affinity for alpha-adrenergic receptors.

Intravenous infusion of isoproterenol in man lowers peripheral vascular resistance, primarily in skeletal muscle but also in renal and mesenteric vascular beds. Diastolic pressure falls. Renal blood flow is decreased in normotensive subjects but is increased markedly in shock. Systolic blood pressure may remain unchanged or rise, although mean arterial pressure typically falls. Cardiac output is increased because of the positive inotropic and chronotropic effects of the drug in the face of diminished peripheral vascular resistance.

Isoproterenol relaxes almost all varieties of smooth muscle when the tone is high, but this action is most pronounced on bronchial and gastrointestinal smooth muscle. It prevents or relieves bronchoconstriction, but tolerance to this effect develops with overuse of the drug.

In man, isoproterenol causes less hyperglycemia than does epinephrine. Isoproterenol and epinephrine are equally effective in stimulating the release of free fatty acids and energy production.

Absorption

Isoproterenol is readily absorbed when given parenterally or as an aerosol.

Elimination

Isoproterenol is metabolized primarily in the liver and other tissues by COMT. Isoproterenol is a relatively poor substrate for MAO and is not taken up by sympathetic neurons to the same extent as are epinephrine and norepinephrine. The duration of action of isoproterenol may therefore be longer than that of epinephrine but is still brief.

Long-term studies in animals to evaluate the carcinogenic potential of isoproterenol hydrochloride have not been done. Mutagenic potential and effect on fertility have not been determined. There is no evidence from human experience that isoproterenol hydrochloride injection may be carcinogenic or mutagenic or that it impairs fertility.

Isoproterenol Hydrochloride Injection, USP is a sterile, clear, colorless to slightly yellow color solution. Each mL contains 0.2 mg of isoproterenol hydrochloride, USP.

{ "type": "p", "children": [], "text": "Isoproterenol Hydrochloride Injection, USP is a sterile, clear, colorless to slightly yellow color solution. Each mL contains 0.2 mg of isoproterenol hydrochloride, USP." }

<div class="scrollingtable"><table width="100%"> <tbody class="Headless"> <tr class="First"> <td align="center" class="Botrule Lrule Rrule Toprule">Strength and Total Volume</td><td align="center" class="Botrule Lrule Rrule Toprule">Pack Size</td><td align="center" class="Botrule Lrule Rrule Toprule">NDC code</td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule Toprule" rowspan="2"> 1 mg/5 mL (0.2 mg/mL) (5 mL) </td><td align="center" class="Botrule Lrule Rrule Toprule"> 5 mL Ampule</td><td align="center" class="Botrule Lrule Rrule Toprule"> 72485-113-01</td> </tr> <tr class="Last"> <td align="center"> 10 pack carton x 5 mL</td><td align="center" class="Botrule Lrule Rrule Toprule"> 72485-113-10</td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">Strength and Total Volume</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">Pack Size</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\">NDC code</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" rowspan=\"2\"> 1 mg/5 mL (0.2 mg/mL) (5 mL) </td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> 5 mL Ampule</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> 72485-113-01</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"center\"> 10 pack carton x 5 mL</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"> 72485-113-10</td>\n</tr>\n</tbody>\n</table></div>" }

Protect from light. Keep in opaque container until used. Store at 20oc to 25oc (68o to 77oF). [See USP Controlled Room Temperature.]

{ "type": "p", "children": [], "text": "Protect from light. Keep in opaque container until used. Store at 20oc to 25oc (68o to 77oF). [See USP Controlled Room Temperature.]\n" }

Do not use if the injection is pinkish or darker than slightly yellow or contains a precipitate. Discard unused portion.

{ "type": "p", "children": [], "text": "Do not use if the injection is pinkish or darker than slightly yellow or contains a precipitate. Discard unused portion." }

Usual Dosage: See insert.

{ "type": "p", "children": [], "text": "\nUsual Dosage: See insert." }

These ampules bear a color band signifying that they are Easy Break Ampules. The top snap off at the constriction, regardless of the position of the color band.

{ "type": "p", "children": [], "text": "\nThese ampules bear a color band signifying that they are Easy Break Ampules. The top snap off at the constriction, regardless of the position of the color band.\n" }

Manufactured by: Micro Labs Limited Bangalore – 560099, INDIA.

{ "type": "p", "children": [], "text": "Manufactured by:\nMicro Labs Limited\nBangalore – 560099, INDIA." }

M. L. No.: KTK/28/357/2006

{ "type": "p", "children": [], "text": "M. L. No.: KTK/28/357/2006" }

Distributed by: Armas Pharmaceuticals, Inc. Freehold, NJ 07728 (USA)

{ "type": "p", "children": [], "text": "Distributed by:\nArmas Pharmaceuticals, Inc.\nFreehold, NJ 07728 (USA)" }

Rev. 11/2022

{ "type": "p", "children": [], "text": "\nRev. 11/2022\n" }

Isoproterenol hydrochloride injection is indicated:

{ "type": "p", "children": [], "text": "\nIsoproterenol hydrochloride injection is indicated:" }

{ "type": "ul", "children": [ "To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output", "For bronchospasm occurring during anesthesia" ], "text": "" }

Inspect visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the injection is pinkish or darker than slightly yellow or contains a precipitate. Discard any unused portion.

Diluted solution should be used immediately. Unused material should be discarded.

Dosage should generally be started at the lowest recommended dose and increased gradually based on patient response.

<div class="scrollingtable"><table class="Noautorules" width="101%"> <caption> <span> Recommended dosage for adults with shock and hypoperfusion states: </span> </caption> <col width="192"/> <col width="192"/> <col width="240"/> <tfoot> <tr> <td align="left" colspan="3"> <dl class="Footnote"> <dt> <a href="#footnote-reference-1" name="footnote-1">*</a> </dt> <dd>Concentrations up to 10 times greater have been used when limitation of volume is essential.</dd> <dt> <a href="#footnote-reference-2" name="footnote-2">†</a> </dt> <dd>Rates over 30 mcg per minute have been used in advanced stages of shock. Adjust the rate of infusion based on heart rate, central venous pressure, systemic blood pressure, and urine flow. If the heart rate exceeds 110 beats per minute, consider decreasing or temporarily discontinuing the infusion.</dd> </dl> </td> </tr> </tfoot> <tbody class="Headless"> <tr> <td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold"> Route of Administration</span> <br/> </td><td align="center" class="Botrule Rrule Toprule"><span class="Bold"> Preparation of Dilution<a class="Sup" href="#footnote-1" name="footnote-reference-1">*</a></span> <br/> </td><td align="center" class="Botrule Rrule Toprule"><span class="Bold"> Infusion Rate<a class="Sup" href="#footnote-2" name="footnote-reference-2">†</a></span> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"> Intravenous infusion<br/> </td><td align="left" class="Botrule Rrule" valign="top"> Dilute 5 mL (1 mg) in 500 mL of 5% Dextrose Injection, USP<br/> </td><td align="left" class="Botrule Rrule" valign="top"> 0.5 mcg to 5 mcg per minute<br/> (0.25 mL to 2.5 mL of diluted solution)<br/> </td> </tr> </tbody> </table></div>

<div class="scrollingtable"><table class="Noautorules" width="100%"> <caption> <span> Recommended dosage for adults with bronchospasm occurring during anesthesia: </span> </caption> <col width="249"/> <col width="449"/> <col width="278"/> <col width="246"/> <tbody class="Headless"> <tr> <td align="center" class="Botrule Lrule Rrule Toprule"> Route of Administration<br/> </td><td align="center" class="Botrule Rrule Toprule"> Preparation of Dilution<br/> </td><td align="center" class="Botrule Rrule Toprule"> Initial Dose<br/> </td><td align="center" class="Botrule Rrule Toprule"> Subsequent Dose<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule"> Bolus intravenous injection<br/> </td><td align="left" class="Botrule Rrule"> Dilute 1 mL (0.2 mg) to 10 mL with Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP<br/> </td><td align="left" class="Botrule Rrule"> 10 mcg to 20 mcg (0.5 mL to 1 mL of diluted solution)<br/> </td><td align="left" class="Botrule Rrule"> The initial dose may be repeated when necessary<br/> </td> </tr> </tbody> </table></div>

There are no well-controlled studies in children to establish appropriate dosing; however, the American Heart Association recommends an initial infusion rate of 0.1 mcg/kg/min, with the usual range being 0.1 mcg/kg/min to 1 mcg/kg/min.

Injection solution: single dose, clear glass ampules containing isoproterenol in a clear, colorless solution;

{ "type": "p", "children": [], "text": "\nInjection solution: single dose, clear glass ampules containing isoproterenol in a clear, colorless solution;" }

{ "type": "ul", "children": [ "1 mL containing 0.2 mg/1 mL (0.2 mg/mL)", "5 mL containing 1 mg/5 mL (0.2 mg/mL)" ], "text": "" }

Isoproterenol hydrochloride is contraindicated in patients with:

{ "type": "p", "children": [], "text": "\nIsoproterenol hydrochloride is contraindicated in patients with:" }

{ "type": "ul", "children": [ "tachycardia", "ventricular arrhythmias", "angina pectoris" ], "text": "" }

Isoproterenol may induce cardiac arrhythmias and myocardial ischemia in patients, especially patients with coronary artery disease, or cardiomyopathy.

Isoproterenol hydrochloride contains sodium metabisulfite, which may cause mild to severe allergic reactions including anaphylaxis or asthmatic episodes, particularly in patients with a history of allergies. However, the presence of metabisulfite in this product should not preclude its use for treatment in emergency situations, even if the patient is sulfite-sensitive, as the alternatives to using isoproterenol in a life-threatening situation may not be satisfactory.

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

{ "type": "p", "children": [], "text": "\nThe following adverse reactions have been associated with use of isoproterenol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure." }

Nervous system disorders: Nervousness, headache, dizziness, visual blurring

{ "type": "p", "children": [], "text": "\nNervous system disorders: Nervousness, headache, dizziness, visual blurring" }

Cardiovascular: Tachycardia, tachyarrhythmias, palpitations, angina, ventricular arrhythmias, Adams-Stokes attacks, pulmonary edema

{ "type": "p", "children": [], "text": "\nCardiovascular: Tachycardia, tachyarrhythmias, palpitations, angina, ventricular arrhythmias, Adams-Stokes attacks, pulmonary edema" }

Respiratory: Dyspnea

{ "type": "p", "children": [], "text": "\nRespiratory: Dyspnea" }

Other: Flushing of the skin, sweating, mild tremors, pallor, nausea

{ "type": "p", "children": [], "text": "\nOther: Flushing of the skin, sweating, mild tremors, pallor, nausea" }

<div class="scrollingtable"><table class="Noautorules" width="590"> <caption> <span> Table 1. Clinically Relevant Interactions with Isoproterenol </span> </caption> <col width="205"/> <col width="385"/> <tbody class="Headless"> <tr> <td align="left" class="Botrule Lrule Rrule Toprule" colspan="2" valign="top"><span class="Italics">Epinephrine</span> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"> Clinical Impact<br/> </td><td align="left" class="Botrule Rrule" valign="top"> Both drugs are direct cardiac stimulants, and their combined effects may induce serious arrhythmias upon simultaneous administration.<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"> Intervention<br/> </td><td align="left" class="Botrule Rrule" valign="top"> Isoproterenol hydrochloride injection and epinephrine should not be administered simultaneously.<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"><span class="Italics">Drugs that may potentiate clinical response of Isoproterenol</span> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"> Clinical Impact<br/> </td><td align="left" class="Botrule Rrule" valign="top"> The effects of isoproterenol may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine.<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"> Intervention<br/> </td><td align="left" class="Botrule Rrule" valign="top"> Monitor hemodynamic parameters in patients who concurrently are taking tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium and certain antihistamines. Adjust doses appropriately.<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" colspan="2" valign="top"><span class="Italics">Drugs that may reduce clinical response of Isoproterenol</span> <br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"> Clinical Impact<br/> </td><td align="left" class="Botrule Rrule" valign="top"> The cardiostimulating and bronchodilating effects of isoproterenol are antagonized by beta-adrenergic blocking drugs, such as propranolol.<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule" valign="top"> Intervention<br/> </td><td align="left" class="Botrule Rrule" valign="top"> Monitor for hemodynamic response and relief of bronchospasm and adjust dose appropriately.<br/> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"590\">\n<caption>\n<span> Table 1. Clinically Relevant Interactions with Isoproterenol </span>\n</caption>\n<col width=\"205\"/>\n<col width=\"385\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\"><span class=\"Italics\">Epinephrine</span>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"> Clinical Impact<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\"> Both drugs are direct cardiac stimulants, and their combined effects may induce serious arrhythmias upon simultaneous administration.<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"> Intervention<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\"> Isoproterenol hydrochloride injection and epinephrine should not be administered simultaneously.<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><span class=\"Italics\">Drugs that may potentiate clinical response of Isoproterenol</span>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"> Clinical Impact<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\"> The effects of isoproterenol may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine.<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"> Intervention<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\"> Monitor hemodynamic parameters in patients who concurrently are taking tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium and certain antihistamines. Adjust doses appropriately.<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" colspan=\"2\" valign=\"top\"><span class=\"Italics\">Drugs that may reduce clinical response of Isoproterenol</span>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"> Clinical Impact<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\"> The cardiostimulating and bronchodilating effects of isoproterenol are antagonized by beta-adrenergic blocking drugs, such as propranolol.<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\" valign=\"top\"> Intervention<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\"> Monitor for hemodynamic response and relief of bronchospasm and adjust dose appropriately.<br/>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Risk Summary

Prolonged experience with isoproterenol use in pregnant women over several decades, based on published literature, do not identify a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. However, there are risks to the mother and fetus associated with isoproterenol use during labor or delivery (see Clinical Considerations).

The estimated 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 United States 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.

Clinical Considerations

Hypotension associated with shock is a medical emergency in pregnancy which can be fatal if left untreated. Delaying treatment in pregnant women with hypotension associated with shock may increase the risk of maternal and fetal morbidity and mortality. Life-sustaining therapy for the pregnant woman should not be withheld due to potential concerns regarding the effects of isoproterenol on the fetus.

Labor and Delivery

Isoproterenol usually inhibits spontaneous or oxytocin induced contractions of the pregnant human uterus and may delay the second stage of labor. Avoid isoproterenol during the second stage of labor. Avoid isoproterenol in obstetrics when maternal blood pressure exceeds 130/80 mmHg.

Although isoproterenol may improve maternal hypotension associated with shock, it may result in uterine vasoconstriction, decreased uterine blood flow, uterine atony with hemorrhage, and fetal anoxia.

Risk Summary

There is no information regarding the presence of isoproterenol in milk or the effects of isoproterenol on the breastfed infant or on milk production. However, due to its short half-life, isoproterenol exposure is expected to be very low in the breastfed infant.

Safety and efficacy of isoproterenol in pediatric patients have not been established.

Intravenous infusions of isoproterenol in refractory asthmatic children at rates of 0.05 μg/kg/min to 2.7 μg/kg/min have caused clinical deterioration, myocardial necrosis, congestive heart failure and death. The risks of cardiac toxicity appear to be increased by some factors [acidosis, hypoxemia, coadministration of corticosteroids, coadministration of methylxanthines (theophylline, theobromine) or aminophylline] that are especially likely to be present in these patients. If I.V. isoproterenol is used in children with refractory asthma, patient monitoring must include continuous assessment of vital signs, frequent electrocardiography, and daily measurements of cardiac enzymes, including CPK-MB.

Clinical studies of Isoproterenol hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects in clinical circumstances. There are, however, some data that suggest that elderly healthy or hypertensive patients are less responsive to beta-adrenergic stimulation than are younger subjects. In general, dose selection for elderly patients should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant diseases or other drug therapy.

Overdosage of isoproterenol can cause tachycardia or other arrhythmias, palpitations, angina, hypotension, or hypertension. In case of overdosage, reduce the rate of administration or discontinue isoproterenol hydrochloride injection until patient's condition stabilizes. Monitor blood pressure, pulse, respiration, and EKG.

{ "type": "p", "children": [], "text": "\nOverdosage of isoproterenol can cause tachycardia or other arrhythmias, palpitations, angina, hypotension, or hypertension. In case of overdosage, reduce the rate of administration or discontinue isoproterenol hydrochloride injection until patient's condition stabilizes. Monitor blood pressure, pulse, respiration, and EKG." }

It is not known whether isoproterenol hydrochloride is dialyzable.

{ "type": "p", "children": [], "text": "It is not known whether isoproterenol hydrochloride is dialyzable." }

Isoproterenol hydrochloride is 3,4-Dihydroxy-α-[(isopropylamino)methyl] benzyl alcohol hydrochloride, a beta-adrenergic agonist and a synthetic sympathomimetic amine that is structurally related to epinephrine. The molecular formula is C11H17NO3 · HCl. It has a molecular weight of 247.72 and the following structural formula:

{ "type": "p", "children": [], "text": "\nIsoproterenol hydrochloride is 3,4-Dihydroxy-α-[(isopropylamino)methyl] benzyl alcohol hydrochloride, a beta-adrenergic agonist and a synthetic sympathomimetic amine that is structurally related to epinephrine. The molecular formula is C11H17NO3 · HCl. It has a molecular weight of 247.72 and the following structural formula:" }

Isoproterenol hydrochloride is a racemic compound.

{ "type": "p", "children": [], "text": "Isoproterenol hydrochloride is a racemic compound." }

<div class="scrollingtable"><table class="Noautorules" width="590"> <col width="469"/> <col width="121"/> <tbody class="Headless"> <tr> <td align="left" class="Lrule Rrule Toprule" colspan="2" valign="top"> Each milliliter of the sterile solution contains:<br/> </td> </tr> <tr> <td align="left" class="Lrule" valign="top"> Isoproterenol hydrochloride USP<br/> </td><td align="left" class="Rrule" valign="top"> 0.2 mg<br/> </td> </tr> <tr> <td align="left" class="Lrule" valign="top"> Edetate Disodium (EDTA) USP<br/> </td><td align="left" class="Rrule" valign="top"> 0.2 mg<br/> </td> </tr> <tr> <td align="left" class="Lrule" valign="top"> Sodium Citrate, Dihydrate USP<br/> </td><td align="left" class="Rrule" valign="top"> 2.07 mg<br/> </td> </tr> <tr> <td align="left" class="Lrule" valign="top"> Citric Acid, Anhydrous USP<br/> </td><td align="left" class="Rrule" valign="top"> 2.5 mg<br/> </td> </tr> <tr> <td align="left" class="Lrule" valign="top"> Sodium Chloride USP<br/> </td><td align="left" class="Rrule" valign="top"> 7.0 mg<br/> </td> </tr> <tr> <td align="left" class="Botrule Lrule" valign="top"> Water for Injection<br/> </td><td align="left" class="Botrule Rrule" valign="top"> qs 1.0 mL<br/> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"590\">\n<col width=\"469\"/>\n<col width=\"121\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"left\" class=\"Lrule Rrule Toprule\" colspan=\"2\" valign=\"top\"> Each milliliter of the sterile solution contains:<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" valign=\"top\"> Isoproterenol hydrochloride USP<br/>\n</td><td align=\"left\" class=\"Rrule\" valign=\"top\"> 0.2 mg<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" valign=\"top\"> Edetate Disodium (EDTA) USP<br/>\n</td><td align=\"left\" class=\"Rrule\" valign=\"top\"> 0.2 mg<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" valign=\"top\"> Sodium Citrate, Dihydrate USP<br/>\n</td><td align=\"left\" class=\"Rrule\" valign=\"top\"> 2.07 mg<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" valign=\"top\"> Citric Acid, Anhydrous USP<br/>\n</td><td align=\"left\" class=\"Rrule\" valign=\"top\"> 2.5 mg<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule\" valign=\"top\"> Sodium Chloride USP<br/>\n</td><td align=\"left\" class=\"Rrule\" valign=\"top\"> 7.0 mg<br/>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule\" valign=\"top\"> Water for Injection<br/>\n</td><td align=\"left\" class=\"Botrule Rrule\" valign=\"top\"> qs 1.0 mL<br/>\n</td>\n</tr>\n</tbody>\n</table></div>" }

The pH is adjusted between 3.5 and 4.5 with hydrochloric acid NF and/or sodium hydroxide NF. The sterile solution is nonpyrogenic and can be administered by the intravenous route.

{ "type": "p", "children": [], "text": "\nThe pH is adjusted between 3.5 and 4.5 with hydrochloric acid NF and/or sodium hydroxide NF. The sterile solution is nonpyrogenic and can be administered by the intravenous route." }

Isoproterenol is a potent nonselective beta-adrenergic agonist with very low affinity for alpha-adrenergic receptors.

Intravenous infusion of isoproterenol in man lowers peripheral vascular resistance, primarily in skeletal muscle but also in renal and mesenteric vascular beds. Diastolic pressure falls. Renal blood flow is decreased in normotensive subjects but is increased markedly in shock. Systolic blood pressure may remain unchanged or rise, although mean arterial pressure typically falls. Cardiac output is increased because of the positive inotropic and chronotropic effects of the drug in the face of diminished peripheral vascular resistance.

Isoproterenol relaxes almost all varieties of smooth muscle when the tone is high, but this action is most pronounced on bronchial and gastrointestinal smooth muscle. It prevents or relieves bronchoconstriction, but tolerance to this effect develops with overuse of the drug.

In man, isoproterenol causes less hyperglycemia than does epinephrine. Isoproterenol and epinephrine are equally effective in stimulating the release of free fatty acids and energy production.

Absorption

Isoproterenol is readily absorbed when given parenterally or as an aerosol.

Elimination

Isoproterenol is metabolized primarily in the liver and other tissues by COMT. Isoproterenol is a relatively poor substrate for MAO and is not taken up by sympathetic neurons to the same extent as are epinephrine and norepinephrine. The duration of action of isoproterenol may therefore be longer than that of epinephrine but is still brief.

Long-term studies in animals to evaluate the carcinogenic potential of isoproterenol hydrochloride have not been done. Mutagenic potential and effect on fertility have not been determined. There is no evidence from human experience that isoproterenol hydrochloride injection may be carcinogenic or mutagenic or that it impairs fertility.

<div class="scrollingtable"><table class="Noautorules" width="62%"> <col width="20%"/> <col width="17%"/> <col width="18%"/> <col width="18%"/> <col width="24%"/> <tbody class="Headless"> <tr> <td align="center" class="Botrule Lrule Rrule Toprule"><span class="Bold"> NDC Number</span> <br/> </td><td align="center" class="Botrule Rrule Toprule"><span class="Bold"> Container</span> <br/> </td><td align="center" class="Botrule Rrule Toprule"><span class="Bold"> Concentration</span> <br/> </td><td align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold"> Fill</span> <br/> </td><td align="center" class="Botrule Rrule Toprule" valign="top"><span class="Bold"> Quantity</span> <br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule"> 70710-1708-6<br/> </td><td align="center" class="Botrule Rrule"><span class="Bold"> Single-dose vials</span> <br/> </td><td align="center" class="Botrule Rrule"> 0.2 mg/mL<br/> </td><td align="center" class="Botrule Rrule" valign="top"> 1 mL<br/> </td><td align="center" class="Botrule Rrule" valign="top"> 10 Single-dose vials per Carton<br/> </td> </tr> <tr> <td align="center" class="Botrule Lrule Rrule"> 70710-1709-6<br/> </td><td align="center" class="Botrule Rrule"><span class="Bold"> Single-dose vials</span> <br/> </td><td align="center" class="Botrule Rrule"> 1 mg/5 mL (0.2 mg/mL)<br/> </td><td align="center" class="Botrule Rrule" valign="top"> 5 mL<br/> </td><td align="center" class="Botrule Rrule" valign="top"> 10 Single-dose vials per Carton<br/> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table class=\"Noautorules\" width=\"62%\">\n<col width=\"20%\"/>\n<col width=\"17%\"/>\n<col width=\"18%\"/>\n<col width=\"18%\"/>\n<col width=\"24%\"/>\n<tbody class=\"Headless\">\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule Toprule\"><span class=\"Bold\"> NDC Number</span>\n<br/>\n</td><td align=\"center\" class=\"Botrule Rrule Toprule\"><span class=\"Bold\"> Container</span>\n<br/>\n</td><td align=\"center\" class=\"Botrule Rrule Toprule\"><span class=\"Bold\"> Concentration</span>\n<br/>\n</td><td align=\"center\" class=\"Botrule Rrule Toprule\" valign=\"top\"><span class=\"Bold\"> Fill</span>\n<br/>\n</td><td align=\"center\" class=\"Botrule Rrule Toprule\" valign=\"top\"><span class=\"Bold\"> Quantity</span>\n<br/>\n</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\"> 70710-1708-6<br/>\n</td><td align=\"center\" class=\"Botrule Rrule\"><span class=\"Bold\"> Single-dose vials</span>\n<br/>\n</td><td align=\"center\" class=\"Botrule Rrule\"> 0.2 mg/mL<br/>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\"> 1 mL<br/>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\"> 10 Single-dose vials per Carton<br/>\n</td>\n</tr>\n<tr>\n<td align=\"center\" class=\"Botrule Lrule Rrule\"> 70710-1709-6<br/>\n</td><td align=\"center\" class=\"Botrule Rrule\"><span class=\"Bold\"> Single-dose vials</span>\n<br/>\n</td><td align=\"center\" class=\"Botrule Rrule\"> 1 mg/5 mL (0.2 mg/mL)<br/>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\"> 5 mL<br/>\n</td><td align=\"center\" class=\"Botrule Rrule\" valign=\"top\"> 10 Single-dose vials per Carton<br/>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Protect from light. Keep in opaque container until used.

{ "type": "p", "children": [], "text": "\nProtect from light. Keep in opaque container until used. " }

Store at 20ºC to 25ºC (68ºF to 77ºF). [See USP Controlled Room Temperature.]

{ "type": "p", "children": [], "text": "Store at 20ºC to 25ºC (68ºF to 77ºF). [See USP Controlled Room Temperature.] " }

Do not use if the injection is pinkish or darker than slightly yellow or contains a precipitate.

{ "type": "p", "children": [], "text": "Do not use if the injection is pinkish or darker than slightly yellow or contains a precipitate. " }

Discard unused portion.

{ "type": "p", "children": [], "text": "Discard unused portion." }

Manufactured by:

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

Zydus Lifesciences Ltd.

{ "type": "p", "children": [], "text": "\nZydus Lifesciences Ltd.\n" }

Vadodara, India

{ "type": "p", "children": [], "text": "Vadodara, India" }

Distributed by:

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

Zydus Pharmaceuticals (USA) Inc.

{ "type": "p", "children": [], "text": "\nZydus Pharmaceuticals (USA) Inc.\n" }

Pennington, NJ 08534

{ "type": "p", "children": [], "text": "Pennington, NJ 08534" }

Rev.: 04/23

{ "type": "p", "children": [], "text": "Rev.: 04/23" }

NDC 70710-1708-1

{ "type": "p", "children": [], "text": "\nNDC 70710-1708-1" }

Isoproterenol Hydrochloride Injection USP, 0.2 mg/mL

{ "type": "p", "children": [], "text": "Isoproterenol Hydrochloride Injection USP, 0.2 mg/mL" }

1 mL Vial

{ "type": "p", "children": [], "text": "1 mL Vial" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

NDC 70710-1708-6

{ "type": "p", "children": [], "text": "\nNDC 70710-1708-6" }

Isoproterenol Hydrochloride Injection USP, 0.2 mg/mL

{ "type": "p", "children": [], "text": "Isoproterenol Hydrochloride Injection USP, 0.2 mg/mL" }

10 x 1 mL Vial

{ "type": "p", "children": [], "text": "10 x 1 mL Vial" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

NDC 70710-1709-1

{ "type": "p", "children": [], "text": "\nNDC 70710-1709-1" }

Isoproterenol Hydrochloride Injection USP, 1 mg/ 5 mL (0.2 mg/mL)

{ "type": "p", "children": [], "text": "Isoproterenol Hydrochloride Injection USP, 1 mg/ 5 mL (0.2 mg/mL)" }

5 mL Vial

{ "type": "p", "children": [], "text": "5 mL Vial" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

NDC 70710-1709-6

{ "type": "p", "children": [], "text": "\nNDC 70710-1709-6" }

Isoproterenol Hydrochloride Injection USP, 1 mg/ 5 mL (0.2 mg/mL)

{ "type": "p", "children": [], "text": "Isoproterenol Hydrochloride Injection USP, 1 mg/ 5 mL (0.2 mg/mL)" }

10 x 5 mL Vial

{ "type": "p", "children": [], "text": "10 x 5 mL Vial" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }