HYDRALAZINE HYDROCHLORIDE tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

NuCare Pharmaceuticals, Inc.

INN (International Name):

HYDRALAZINE HYDROCHLORIDE

Sammensætning:

HYDRALAZINE HYDROCHLORIDE 50 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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

Produkt oversigt:

HydrALAZINE Hydrochloride Tablets, USP 50 mg – round, convex, pink film coated tablet engraved with HP above 3 on one side and plain on the other side NDC 66267-676-30 Bottles of 30 NDC 66267-676-60 Bottles of 60 NDC 66267-676-90 Bottles of 90 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 Eatontown, NJ 07724 1-866-901-DRUG (3784) Issued: 10/13

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

HYDRALAZINE HYDROCHLORIDE- HYDRALAZINE HYDROCHLORIDE TABLET, FILM
COATED
NUCARE PHARMACEUTICALS, INC.
----------
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:
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 leads
to the pr