HYDRALAZINE HYDROCHLORIDE- hydralazine hydrochloride tablet, film coated

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

HYDRALAZINE HYDROCHLORIDE (UNII: FD171B778Y) (HYDRALAZINE - UNII:26NAK24LS8)

可用日期:

Cardinal Health

INN（国际名称）:

HYDRALAZINE HYDROCHLORIDE

组成:

HYDRALAZINE HYDROCHLORIDE 10 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Essential hypertension, alone or as an adjunct. Hypersensitivity to hydrALAZINE; coronary artery disease; mitral valvular rheumatic heart disease.

產品總結:

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 23155-001-01 Bottles of 100 w/ CRC NDC 23155-001-10 Bottles of 1000 25 mg – round, convex, pink film coated tablet engraved with HP above 2 on one side and plain on the other side NDC 23155-002-01 Bottles of 100 w/ CRC NDC 23155-002-10 Bottles of 1000 50 mg – round, convex, pink film coated tablet engraved with HP above 3 on one side and plain on the other side NDC 23155-003-01 Bottles of 100 w/ CRC NDC 23155-003-10 Bottles of 1000 100 mg – round, convex, pink film coated tablet engraved with HP above 4 on one side and plain on the other side NDC 23155-004-01 Bottles of 100 w/ CRC NDC 23155-004-10 Bottles of 1000 Dispense in a tight, light-resistant container as defined in the USP. 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 Edison, NJ 08837 1.866.901.DRUG (3784) Issued: 02/11

授权状态:

Abbreviated New Drug Application

产品特点

HYDRALAZINE HYDROCHLORIDE- HYDRALAZINE HYDROCHLORIDE TABLET, FILM
COATED
CARDINAL HEALTH
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HYDRALAZINE HYDROCHLORIDE TABLETS, USP
DESCRIPTION
HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral
administration. Its chemical name is
1-hydrazinophthalazine monohydrochloride, and its structural formula
is:
C H N ·HCL
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.
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 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 lead