Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
HYDRALAZINE HYDROCHLORIDE (UNII: FD171B778Y) (HYDRALAZINE - UNII:26NAK24LS8)
American Regent, Inc.
HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDE 20 mg in 1 mL
INTRAMUSCULAR
PRESCRIPTION DRUG
Severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure. Hypersensitivity to hydralazine; coronary artery disease; mitral valvular rheumatic heart disease.
HydrALAZINE Hydrochloride Injection, USP (20 mg/mL) NDC 0517-0901-25 1 mL Single Dose Vial Packaged in boxes of 25 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). AMERICAN REGENT, INC. SHIRLEY, NY 11967 IN0901 Rev. 10/18 MG # 11928
Abbreviated New Drug Application
HYDRALAZINE HYDROCHLORIDE- HYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION AMERICAN REGENT, INC. ---------- HYDRALAZINE HYDROCHLORIDE INJECTION, USP RX ONLY DESCRIPTION HydrALAZINE Hydrochloride Injection, USP is an antihypertensive available in a 1 mL vial for intravenous and intramuscular administration. Each milliliter of the sterile, nonpyrogenic colorless solution contains Hydralazine Hydrochloride, 20 mg, Methylparaben, 0.65 mg, Propylparaben, 0.35 mg, Propylene Glycol, 103.6 mg, and Water for Injection q.s. The pH of the solution is 3.4 to 4.4. pH may be adjusted with Hydrochloric Acid and/or Sodium Hydroxide. Hydralazine Hydrochloride is 1- Hydrazinophthalazine monohydrochloride, and its structural formula is: Molecular Formula C H N HCl Hydralazine Hydrochloride USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. CLINICAL PHARMACOLOGY Although the precise mechanism of action of hydralazine is not fully understood, the major effects are on the cardiovascular system. Hydralazine apparently lowers blood pressure by exerting a peripheral vasodilating effect through a direct relaxation of vascular smooth muscle. Hydralazine, by altering cellular calcium metabolism, interferes with the calcium movements within the vascular smooth muscle that are responsible for initiating or maintaining the contractile state. The peripheral vasodilating effect of hydralazine results in decreased arterial blood pressure (diastolic more than systolic); decreased peripheral vascular resistance; and an increased heart rate, stroke volume, and cardiac output. The preferential dilatation of arterioles, as compared to veins, minimizes postural hypotension and promotes the increase in cardiac output. Hydralazine usually increases renin activity in plasma, presumably as a result of increased secretion of renin by the renal juxtaglomerular cells in response to re Leggi il documento completo