pharmacopeia
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/api/v1/drug/isoproterenol

Mechanism of action

Sourced from openFDA

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

Indications

Sourced from openFDA
  • 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 )

Contraindications

Sourced from openFDA
  • 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 )contraindicated

Dosage & administration

Sourced from openFDA

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 mcg to 5 mcg per minute (0.25 mL to 2.5 mL of diluted solution) 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.

Warnings & precautions

Sourced from openFDA

Cardiac arrhythmias and ischemia may be induced by isoproterenol hydrochloride injection ( 5.1 ) Sulfite: Isoproterenol hydrochloride injection 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 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.

Adverse reactions

Sourced from openFDA

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 .

Use in specific populations

Sourced from openFDA

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. In the United States general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, 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.

Pharmacokinetics

Sourced from openFDA
Metabolism
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.

Overdosage

Sourced from openFDA

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.

Approval history

Sourced from openFDA
  • Aug 2, 2017ANDAANDA206961Nexus
  • Jun 12, 2018ANDAANDA210322Cipla
  • Jun 18, 2018ANDAANDA210106Amphastar Pharms Inc
  • Oct 17, 2018ANDAANDA210576Amneal
  • Feb 9, 2021ANDAANDA211864Eugia Pharma
  • Feb 16, 2021ANDAANDA210845Micro Labs
  • May 19, 2021ANDAANDA211237Amring Pharms
  • Nov 19, 2021ANDAANDA212189Avet Lifesciences

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
414 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective11428%
  2. 2Torsade De Pointes399.4%
  3. 3Off Label Use389.2%
  4. 4Ventricular Tachycardia276.5%
  5. 5Electrocardiogram Qt Prolonged235.6%
  6. 6Cardiogenic Shock215.1%
  7. 7Toxic Epidermal Necrolysis204.8%
  8. 8Ventricular Fibrillation204.8%
  9. 9Cardiac Arrest194.6%
  10. 10Drug Interaction194.6%
  11. 11Toxicity To Various Agents194.6%
  12. 12Condition Aggravated184.3%
  13. 13Drug Ineffective For Unapproved Indication174.1%
  14. 14Bradycardia163.9%
  15. 15Hypotension163.9%

Literature

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Recent PubMed references pinned to Isoproterenol as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 47 ClinicalTrials.gov registrations naming Isoproterenol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Isoproterenol work?
Isoproterenol is a potent nonselective beta-adrenergic agonist with very low affinity for alpha-adrenergic receptors.
What is Isoproterenol used for?
According to FDA labeling, Isoproterenol carries indications including: 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 ). This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Isoproterenol?
Isoproterenol is classified as Adrenergic and dopaminergic agents, Non-selective beta-adrenoreceptor agonists, beta-Adrenergic Agonist, Adrenergic beta-Agonists, Adrenergic beta1-Agonists, Adrenergic beta2-Agonists, Bronchodilation, Decreased Blood Pressure, Muscular Arterial Vasodilation, Positive Chronotropy, Positive Inotropy.
What are the brand names for Isoproterenol?
Isoproterenol is marketed under brand names including Isuprel.
What are the contraindications for Isoproterenol?
Isoproterenol labeling lists contraindications including: 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 ). Always consult the full prescribing information and a clinician.
Note. Data for isoproterenol is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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