Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
HYDRALAZINE HYDROCHLORIDE (UNII: FD171B778Y) (HYDRALAZINE - UNII:26NAK24LS8)
REMEDYREPACK INC.
ORAL
PRESCRIPTION DRUG
Essential hypertension, alone or as an adjunct. Hypersensitivity to hydralazine; coronary artery disease; mitral valvular rheumatic heart disease.
Hydralazine Hydrochloride Tablets USP are available as: 10 mg Orange, round, convex, unscored tablets, debossed with “PLIVA 398” on one side and plain on the other side. Available in bottles of 100 (NDC 50111-398-01) and 1000 (NDC 50111-398-03). 25 mg Orange, round, convex, unscored tablets, debossed with “PLIVA 327” on one side and plain on the other side. Available in bottles of 100 (NDC 50111-327-01) and 1000 (NDC 50111-327-03). 50 mg Orange, round, convex, unscored tablets, debossed with “PLIVA 328” on one side and plain on the other side. Available in bottles of 100 (NDC 50111-328-01) and 1000 (NDC 50111-328-03). 100 mg Orange, round, convex, unscored tablets, debossed with “PLIVA 397” on one side and plain on the other side. Available in bottles of 100 (NDC 50111-397-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In Czech Republic By: TEVA CZECH INDUSTRIES s.r.o. Opava-Komarov, Czech Republic Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. F 2/2016
Abbreviated New Drug Application
HYDRALAZINE HYDROCHLORIDE- HYDRALAZINE HYDROCHLORIDE TABLET REMEDYREPACK INC. ---------- HYDRALAZINE HYDROCHLORIDE TABLETS USP DESCRIPTION Hydralazine Hydrochloride Tablets USP is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is: C H N ·HCL M.W. 196.64 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. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydralazine hydrochloride, USP. Tablets also contain anhydrous lactose, FD&C yellow no. 6 aluminum lake, microcrystalline cellulose, sodium starch glycolate, and stearic acid. 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 reflex sympathetic discharge. This increase in renin activity leads to the production of angiotensin II, which then causes stimulation of aldosterone and consequent sodium reabsorption. Hydralazine Прочитать полный документ