Isoproterenol Hydrochloride

ISOPROTERENOL HYDROCHLORIDE- isoproterenol hydrochloride injection, solution
KVK-Tech, Inc.

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

2 DOSAGE AND ADMINISTRATION

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.

*
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 shock and hypoperfusion states:

Route of Administration

Preparation of Dilution *

Infusion Rate

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)

Recommended dosage for adults with bronchospasm occurring during anesthesia:

Route of

Subsequent

Administration

Preparation of Dilution

Initial Dose

Dose

Bolus

intravenous

injection

Dilute 1 mL (0.2 mg) to 10 mL with Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP

10 mcg to 20 mcg (0.5 mL to 1 mL of diluted solution)

The initial dose may be

repeated when necessary

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.

3 DOSAGE FORMS AND STRENGTHS

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

• 5 mL containing 1 mg/5 mL (0.2 mg/mL)

4 CONTRAINDICATIONS

Isoproterenol hydrochloride injection is contraindicated in patients with:

• tachycardia

• ventricular arrhythmias

• angina pectoris

5 WARNINGS AND PRECAUTIONS

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.

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

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, 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.

8 USE IN SPECIFIC POPULATIONS

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. 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.

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