Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
DOPAMINE HYDROCHLORIDE (UNII: 7L3E358N9L) (DOPAMINE - UNII:VTD58H1Z2X)
Cardinal Health
DOPAMINE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDE 40 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
DOPAMINE is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarctions, trauma, endotoxic septicemia, open heart surgery, renal failure, and chronic cardiac decompensation as in congestive failure. Where appropriate, restoration of blood volume with a suitable plasma expander or whole blood should be instituted or completed prior to administration of DOPAMINE. Patients most likely to respond adequately to DOPAMINE 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 volume correction and DOPAMINE, the better the prognosis. Urine flow appears to be one of the better diagnostic signs by which adequacy of vital organ perfusion can be monitored. Nevertheless, the physician should also observe the patient for signs of reversal of confusio
Dopamine HCl Injection, USP is available as follows: NDC 0517-1805-25 200 mg/5 mL Vial (40 mg/mL) Packages of 25 vials (color-coded WHITE) NDC 0517-1905-25 400 mg/5 mL Vial (80 mg/mL) Packages of 25 vials (color-coded GREEN) NDC 0517-1305-25 800 mg/5 mL Vial (160 mg/mL) Packages of 25 vials (color-coded YELLOW) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). Avoid contact with alkalis (including sodium bicarbonate), oxidizing agents or iron salts. NOTE - Do not use the injection if it is darker than slightly yellow or discolored in any other way. WARNING: NOT FOR DIRECT INTRAVENOUS INJECTION, MUST BE DILUTED BEFORE USE. IV INFUSION ONLY. AMERICAN REGENT, INC. SHIRLEY, NY 11967 IN1805 Rev. 1/09 Cardinal Health Zanesville, OH 43701 IA61620612
Abbreviated New Drug Application
DOPAMINE HCL- DOPAMINE HCL INJECTION, SOLUTION CARDINAL HEALTH ---------- DOPAMINE HYDROCHLORIDE INJECTION, USP RX ONLY DESCRIPTION Dopamine Hydrochloride Injection, USP is a clear, practically colorless, aqueous, additive solution for intravenous infusion after dilution. Each mL contains either 40 mg, 80 mg, or 160 mg dopamine HCl, USP (equivalent to 32.3 mg, 64.6 mg and 129.2 mg dopamine base respectively) in Water for Injection, USP, containing 9 mg sodium metabisulfite as an antioxidant. The pH range (2.5 to 5.0) may be adjusted with citric acid and/or sodium citrate. The solution is sterile and nonpyrogenic. Dopamine HCl, a naturally occurring catecholamine, is an inotropic vasopressor agent. Its chemical name is 3,4 dihydroxyphenethylamine hydrochloride and its chemical structure is: Dopamine HCl is sensitive to alkalis, iron salts and oxidizing agents. DOPAMINE must be diluted in an appropriate, sterile parenteral solution (see DOSAGE AND ADMINISTRATION section) before intravenous administration. CLINICAL PHARMACOLOGY Dopamine is a natural catecholamine formed by the decarboxylation of 3,4-dihydroxyphenylalanine (DOPA). It is a precursor to norepinephrine in noradrenergic nerves and is also a neurotransmitter in certain areas of the central nervous system, especially in the nigrostriatal tract, and in a few peripheral sympathetic nerves. Dopamine produces positive chronotropic and inotropic effects on the myocardium, resulting in increased heart rate and cardiac contractility. This is accomplished directly by exerting an agonist action on beta-adrenoceptors and indirectly by causing release of norepinephrine from storage sites in sympathetic nerve endings. Dopamine’s onset of action occurs within five minutes of intravenous administration, and with dopamine’s plasma half-life of about two minutes, the duration of action is less than ten minutes. If monoamine oxidase (MAO) inhibitors are present, however, the duration may increase to one hour. The drug is widely distributed in the body but does not cros Прочитайте повний документ