Drugplain

Isoproterenol Hydrochloride .2 mg/mL

Isoproterenol Hydrochloride · INJECTION, SOLUTION · Nordic Pharma, Inc.

1 Recall on Record
Plain English

Isoproterenol Hydrochloride is a injection, solution containing isoproterenol hydrochloride at .2 mg/mL, taken intracardiac. Manufactured by Nordic Pharma, Inc..

Key Facts

Brand Name
Isoproterenol Hydrochloride
Generic Name
Isoproterenol Hydrochloride
NDC Code (Product)
69918-735
Manufacturer
Nordic Pharma, Inc.
Strength
.2 mg/mL
Dosage Form
INJECTION, SOLUTION
Route
INTRACARDIAC, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Marketing Status
Application #
ANDA211237
Marketing Start
06/01/2024

Recall History

1 Recall on Record
Class II11/14/2014

Attix Pharmaceuticals

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective39 reports
toxic epidermal necrolysis20 reports
off label use18 reports
ventricular fibrillation13 reports
torsade de pointes11 reports
atrial fibrillation10 reports
drug interaction10 reports
electrocardiogram qt prolonged10 reports
toxicity to various agents10 reports
acute kidney injury7 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 & Administration

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. 2.2 Recommended Dosage 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: Route of Administration Preparation of Dilution Concentrations up to 10 times greater have been used when limitation of volume is essential. Infusion Rate Rates over 30 mcg per minute have been used in advanced stages of shock. Intravenous infusion Dilute 5 mL (1 mg) in 500 mL of 5% Dextrose Injection, USP 0.5 mc…

Contraindications

4 CONTRAINDICATIONS Isoproterenol hydrochloride injection is contraindicated in patients with: tachycardia ventricular arrhythmias angina pectoris Isoproterenol hydrochloride injection is contraindicated in patients with: Tachycardia ( 4 ) Ventricular arrhythmias ( 4 ) Angina pectoris ( 4 )

Drug 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, levothyroxinesodium, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine. Intervention Monitor hemodynamic parameters in patients who concurrently are taking tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium and certain antihistamines. Adjust doses appropriately. Drugs that may reduce clinical response of Isoproterenol Clinical Impact The cardiostimulating and bronchodilating effects of isoproterenol are antagonized by beta-adrenergic blocking drugs, such as propranolol. Intervention Monitor for hemodynamic response and relief of bronchospasm and adjust dose appropriately. Do not administe…

Adverse Reactions

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 Nordic Pharma, Inc. at 1-844-267-4641 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Frequently Asked Questions

What is Isoproterenol Hydrochloride used for?

Isoproterenol Hydrochloride contains Isoproterenol Hydrochloride. It is a injection, solution taken intracardiac. Consult your doctor for specific uses.

Is Isoproterenol Hydrochloride a controlled substance?

Isoproterenol Hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for Isoproterenol Hydrochloride?

The generic name for Isoproterenol Hydrochloride is Isoproterenol Hydrochloride. There are 5 other brand versions of Isoproterenol Hydrochloride.

What is the NDC code for Isoproterenol Hydrochloride .2 mg/mL?

The NDC (National Drug Code) for Isoproterenol Hydrochloride .2 mg/mL is 69918-735, listed by Nordic Pharma, Inc..

Product NDC

69918-735

Package NDC

69918-735-11

Other Isoproterenol Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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