Country: United States
Language: English
Source: NLM (National Library of Medicine)
HYDRALAZINE HYDROCHLORIDE (UNII: FD171B778Y) (HYDRALAZINE - UNII:26NAK24LS8)
NuCare Pharmaceuticals,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 10 mg - round, convex, pink film coated tablet engraved with HP above 1 on one side and plain on the other side NDC 68071-4490-3 BOTTLES OF 30 NDC 68071-4490-6 BOTTLES OF 60 NDC 68071-4490-9 BOTTLES OF 90 Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. MANUFACTURED FOR: Heritage Pharmaceuticals Inc East Brunswick, NJ 08816 1-866-901-DRUG (3784) 51U000000172US03 Issued: 05/18
Abbreviated New Drug Application
HYDRALAZINE HYDROCHLORIDE- HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED NUCARE PHARMACEUTICALS,INC. ---------- HYDRALAZINE HYDROCHLORIDE TABLETS, USP THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE HYDRALAZINE HYDROCHLORIDE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE HYDROCHLORIDE) TABLET, FILM COATED FOR ORAL USE. INITIAL U.S. APPROVAL: DESCRIPTION HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is: 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. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide. 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 hypote Read the complete document