Isoproterenol Hydrochloride
Generic Name: isoproterenol hydrochloride
Brand Names:
Isoproterenol Hydrochloride
11 DESCRIPTION Isoproterenol hydrochloride injection, USP is 3,4-Dihydroxy-α-[(isopropylamino)methyl] benzyl alcohol hydrochloride, a synthetic sympathomimetic amine that is structurally related to epinephrine but acts almost exclusively on beta receptors. Isoproterenol hydrochloride is white to practically white, crystalline powder and the molecular formula is C 11 H 17 NO 3 · HCl.
Overview
11 DESCRIPTION Isoproterenol hydrochloride injection, USP is 3,4-Dihydroxy-α-[(isopropylamino)methyl] benzyl alcohol hydrochloride, a synthetic sympathomimetic amine that is structurally related to epinephrine but acts almost exclusively on beta receptors. Isoproterenol hydrochloride is white to practically white, crystalline powder and the molecular formula is C 11 H 17 NO 3 · HCl.
Uses
1 INDICATIONS AND USAGE Isoproterenol hydrochloride injection is indicated: To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output For bronchospasm occurring during anesthesia Isoproterenol hydrochloride injection is a beta-adrenergic agonist indicated: To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output ( 1 ) For treatment of bronchospasm occurring during anesthesia ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION Initiate isoproterenol hydrochloride injection at the lowest recommended dose and increase gradually based on patient response ( 2.2 ) Recommended initial dosage: Shock: 0.5 mcg to 5 mcg per minute as an intravenous infusion ( 2.2 ) Bronchospasm: 10 mcg to 20 mcg intravenous injection ( 2.2 ) 2.1 General Considerations 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.
Side Effects
6 ADVERSE REACTIONS 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 Cardiovascular: Tachycardia, tachyarrhythmias, palpitations, angina, ventricular arrhythmias, Adams-Stokes attacks, pulmonary edema Respiratory: Dyspnea Other: Flushing of the skin, sweating, mild tremors, pallor, nausea Common adverse reactions with isoproterenol include tachycardia and palpitations ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Eugia US LLC at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.f...
Interactions
7 DRUG INTERACTIONS Table 1. Clinically Relevant Interactions with Isoproterenol Epinephrine Clinical Impact Both drugs are direct cardiac stimulants, and their combined effects may induce serious arrhythmias upon simultaneous administration. Intervention Isoproterenol hydrochloride injection and epinephrine should not be administered simultaneously. Drugs that may potentiate clinical response of Isoproterenol Clinical Impact The effects of isoproterenol may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium,andcertainantihistamines,notablychlorpheniramine, tripelennamine,anddiphenhydramine.
Warnings
5 WARNINGS AND PRECAUTIONS Cardiac arrhythmias and ischemia may be induced by isoproterenol hydrochloride ( 5.1 ) Sulfite: Isoproterenol hydrochloride contains metabisulfite, which may cause allergic reaction ( 5.2 ) 5.1 Cardiac Arrhythmias and Ischemia Isoproterenol may induce cardiac arrhythmias and myocardial ischemia in patients, especially patients with coronary artery disease, or cardiomyopathy. 5.2 Allergic Reactions associated with Sulfite 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. 4 CONTRAINDICATIONS Isoproterenol hydrochloride is contraindicated in patients with: tachycardia ventricular arrhythmias angina pectoris Isoproterenol hydrochloride is contraindicated in patients with: Tachycardia ( 4 ) Ventricular arrhythmias ( 4 ) Angina pectoris ( 4 )
Pregnancy
8.1 Pregnancy 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.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Isoproterenol hydrochloride injection, USP is a sterile, nonpyrogenic, clear, colorless or practically colorless liquid free from visible particles and is supplied as follows: 0.2 mg per mL: 1 mL Single-Dose Ampuls in a Carton of 25 55150-316-25 1 mg per 5 mL (0.2 mg/mL): 5 mL Single-Dose Ampuls in a Carton of 10 55150-317-10 Protect from light.
Frequently Asked Questions
What is Isoproterenol Hydrochloride used for?▼
1 INDICATIONS AND USAGE Isoproterenol hydrochloride injection is indicated: To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output For bronchospasm occurring during anesthesia Isoproterenol hydrochloride injection is a beta-adrenergic agonist indicated: To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output ( 1 ) For treatment of bronchospasm occurring during anesthesia ( 1 )
What are the side effects of Isoproterenol Hydrochloride?▼
6 ADVERSE REACTIONS 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 Cardiovascular: Tachycardia, tachyarrhythmias, palpitations, angina, ventricular arrhythmias, Adams-Stokes attacks, pulmonary edema Respiratory: Dyspnea Other: Flushing of the skin, sweating, mild tremors, pallor, nausea Common adverse reactions with isoproterenol include tachycardia and palpitations ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Eugia US LLC at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.f...
Can I take Isoproterenol Hydrochloride during pregnancy?▼
8.1 Pregnancy 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.
What are the important warnings for Isoproterenol Hydrochloride?▼
5 WARNINGS AND PRECAUTIONS Cardiac arrhythmias and ischemia may be induced by isoproterenol hydrochloride ( 5.1 ) Sulfite: Isoproterenol hydrochloride contains metabisulfite, which may cause allergic reaction ( 5.2 ) 5.1 Cardiac Arrhythmias and Ischemia Isoproterenol may induce cardiac arrhythmias and myocardial ischemia in patients, especially patients with coronary artery disease, or cardiomyopathy. 5.2 Allergic Reactions associated with Sulfite 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. 4 CONTRAINDICATIONS Isoproterenol hydrochloride is contraindicated in patients with: tachycardia ventricular arrhythmias angina pectoris Isoproterenol hydrochloride is contraindicated in patients with: Tachycardia ( 4 ) Ventricular arrhythmias ( 4 ) Angina pectoris ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.