Dopamine Hydrochloride

Indications

INDICATIONS AND USAGE Dopamine Hydrochloride, USP is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarction, trauma, endotoxic septicemia, open-heart surgery, renal failure, and chronic cardiac decompensation as in congestive failure. Patients most likely to respond adequately to Dopamine Hydrochloride, USP are those in whom physiological parameters, such as urine flow, myocardial function, and blood pressure, have not undergone profound deterioration. Multiclinic trials indicate that the shorter the time interval between onset of signs and symptoms and initiation of therapy with blood volume correction and Dopamine Hydrochloride, USP, the better the prognosis. Where appropriate, blood volume restoration with a suitable plasma expander or whole blood should be accomplished prior to administration of Dopamine Hydrochloride, USP. Poor Perfusion of Vital Organs – Urine flow appears to be one of the better diagnostic signs by which adequacy of vital organ perfusion can be monitored.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION WARNING: This is a potent drug; it must be diluted before administration to the patient. Dopamine hydrochloride injection is administered (only after dilution) by intravenous infusion. Suggested Dilution – For the 40 mg/mL preparation, transfer by aseptic technique the contents containing either 5 mL, 200 mg or 10 mL, 400 mg of dopamine hydrochloride to either a 250 mL or 500 mL bottle of one of the sterile I.V. solutions listed below. For the 80 mg/mL preparation, transfer by aseptic technique the contents containing 10 mL, 800 mg of dopamine hydrochloride to a 250 mL, 500 mL or 1000 mL bottle of one of the following sterile I.V.

Contraindications

CONTRAINDICATIONS Dopamine HCl should not be used in patients with pheochromocytoma. Dopamine HCl should not be administered to patients with uncorrected tachyarrhythmias or ventricular fibrillation.

Warnings and precautions

WARNINGS Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people. Do NOT add dopamine HCl to any alkaline diluent solution since the drug is inactivated in alkaline solution.

Pregnancy

Pregnancy Teratogenic Effects: Pregnancy Category C Animal studies have revealed no evidence of teratogenic effects due to dopamine. However, in one study, administration of dopamine HCl to pregnant rats resulted in a decreased survival rate of the newborn and a potential for cataract formation in the survivors.

Storage and supply

HOW SUPPLIED Dopamine Hydrochloride Injection, USP is a clear, colorless to slightly yellow aqueous solution supplied as follows: Strength Packaged NDC No. 200 mg/5 mL (40 mg/mL) Carton of 25 vials 0143-9252-25 400 mg/5 mL (80 mg/mL) Carton of 25 vials 0143-9253-25 400 mg/10 mL (40 mg/mL) Carton of 25 vials 0143-9254-25 800 mg/10 mL (80 mg/mL) Cart…

Source: Dopamine Hydrochloride (Dopamine Hydrochloride) — US FDA prescribing information, 2023-11-02, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.