Trade Name: Isoproterenol Hydrochloride

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Amneal Biosciences LLC

Presentation: INJECTION, SOLUTION, HUMAN PRESCRIPTION DRUG

Strength: 1 mg/5mL

Storage and handling

ISOPROTERENOL HYDROCHLORIDE Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Isoproterenol Hydrochloride (Isoproterenol Hydrochloride) which is also known as Isoproterenol Hydrochloride and Manufactured by Amneal Biosciences LLC. It is available in strength of 1 mg/5mL.

Isoproterenol Hydrochloride (Isoproterenol Hydrochloride) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

  • No data
  • Isoproterenol hydrochloride is 3,4-Dihydroxy-u03b1-[(isopropylamino)methyl] benzyl alcohol hydrochloride, a synthetic sympathomimetic amine that is structurally related to epinephrine but acts almost exclusively on beta receptors. The molecular formula is CHNO u2022 HCl. It has a molecular weight of 247.72 and the following structural formula:
  • Isoproterenol hydrochloride is a racemic compound.
  • Isoproterenol hydrochloride, USP is white to practically white crystalline powder and freely soluble in water, soluble in alcohol, less soluble in dehydrated alcohol, insoluble in chloroform and in ether.
  • Each milliliter of the sterile solution contains:
  • The sterile solution is nonpyrogenic and can be administered by the intravenous, intramuscular, subcutaneous, or intracardiac routes.
  • 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. The cardiac effects of isoproterenol may lead to palpitations, sinus tachycardia, and more serious arrhythmias; large doses of isoproterenol may cause myocardial necrosis in animals.
  • 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, Fate and Excretion
  • Isoproterenol hydrochloride injection is indicated:
  • Use of isoproterenol hydrochloride injection is contraindicated in patients with tachyarrhythmias; tachycardia or heart block caused by digitalis intoxication; ventricular arrhythmias which require inotropic therapy; and angina pectoris.
  • Isoproterenol hydrochloride injection, by increasing myocardial oxygen requirements while decreasing effective coronary perfusion, may have a deleterious effect on the injured or failing heart. Most experts discourage its use as the initial agent in treating cardiogenic shock following myocardial infarction. However, when a low arterial pressure has been elevated by other means, isoproterenol hydrochloride injection may produce beneficial hemodynamic and metabolic effects.
  • In a few patients, presumably with organic disease of the AV node and its branches, isoproterenol hydrochloride injection has paradoxically been reported to worsen heart block or to precipitate Adams- Stokes attacks during normal sinus rhythm or transient heart block.
  • No data
  • The following reactions to isoproterenol hydrochloride injection have been reported:
  • CNS:
  • Cardiovascular:
  • In a few patients, presumably with organic disease of the AV node and its branches, isoproterenol hydrochloride injection has been reported to precipitate Adams-Stokes seizures during normal sinus rhythm or transient heart block.
  • Respiratory:
  • Other:
  • To report SUSPECTED ADVERSE REACTIONS, contact Amneal Biosciences at n- 1-855-266-3251 or FDA at 1-800-FDA-1088 or n- www.fda.gov/medwatch.
  • The acute toxicity of isoproterenol hydrochloride in animals is much less than that of epinephrine.
  • Excessive doses in animals or man can cause a striking drop in blood pressure, and repeated large doses in animals may result in cardiac enlargement and focal myocarditis.
  • In case of accidental overdosage as evidenced mainly by tachycardia or other arrhythmias, palpitations, angina, hypotension, or hypertension, reduce rate of administration or discontinue isoproterenol hydrochloride injection until patientu2019s condition stabilizes. Blood pressure, pulse, respiration, and ECG should be monitored.
  • It is not known whether isoproterenol hydrochloride is dialyzable.
  • The oral LD of isoproterenol hydrochloride in mice is 3,850 mg/kg u00b1 1,190 mg/kg of pure drug in solution.
  • Start isoproterenol hydrochloride injection at the lowest recommended dose and increase the rate of administration gradually if necessary while carefully monitoring the patient. The usual route of administration is by intravenous infusion or bolus intravenous injection. In dire emergencies, the drug may be administered by intracardiac injection. If time is not of the utmost importance, initial therapy by intramuscular or subcutaneous injection is preferred.
  • Recommended dosage for adults with heart block, Adams-Stokes attacks, and cardiac arrest:
  • 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.
  • Recommended dosage for adults with shock and hypoperfusion states:
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Such solution should not be used.
  • Isoproterenol Hydrochloride Injection, USP is clear, colorless or practically colorless to slightly yellow color liquid. Each mL contains Isoproterenol Hydrochloride USP, .
  • It is available as follows:
  • Arrayn- 0.2 mg/mL (1 mL)
  • 1 mL Single-Dose Vial: u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1604-1
  • 10 Vials in a Carton: u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1604-7 n
  • Arrayn- 1 mg/5 mL (0.2 mg/mL) (5 mL)
  • 5 mL Single-Dose Vial: u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1605-1
  • 10 Vials in a Carton: u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1605-7
  • Store at 20u00ba to 25u00baC (68u00ba to 77u00baF) [see USP Controlled Room Temperature].
  • Protect from light. Keep in opaque container until used.
  • Do not use if the injection is pinkish or darker than slightly yellow or contains a precipitate.
  • Manufactured by:
  • Amneal Pharmaceuticals Pvt. Ltd.
  • Parenteral Unit
  • Ahmedabad 382213, INDIA
  • Distributed by:
  • Amneal Biosciences LLC
  • Bridgewater, NJ 08807
  • Rev. 08-2018-00
  • NDC 70121-1604-1
  • Isoproterenol Hydrochloride Injection USP, 0.2 mg/mLn
  • Rx only
  • Vial Label
  • Amneal Biosciences LLC
  • Arrayn- Array
  • NDC 70121-1604-7
  • Isoproterenol Hydrochloride Injection USP, 0.2 mg/mLn
  • Rx only
  • Carton Label
  • Amneal Biosciences LLC
  • Arrayn- Array
  • NDC 70121-1605-1
  • Isoproterenol Hydrochloride Injection USP, 1 mg/ 5 mLn
  • Rx only
  • Vial Label
  • Amneal Biosciences LLC
  • u00a0
  • NDC 70121-1605-7
  • Isoproterenol Hydrochloride Injection USP, 1 mg/ 5 mLn
  • Rx only
  • Carton Label
  • Amneal Biosciences LLC

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