HYDRALAZINE HYDROCHLORIDE tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

NuCare Pharmaceuticals, Inc.

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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

Ringkasan produk:

HydrALAZINE Hydrochloride Tablets, USP: 50 mg - Orange, round, unscored tablets debossed with ‘H’ on one side and ‘40’ on the other side in bottles of 30 NDC 68071-1940-3 bottles of 60 NDC 68071-1940-6 bottles of 90 NDC 68071-1940-9 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]. Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Drugs Limited 2005566-00 Jeedimetla, Hyderabad- 500 055, India

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

HYDRALAZINE HYDROCHLORIDE- HYDRALAZINE HYDROCHLORIDE TABLET
NUCARE PHARMACEUTICALS, INC.
----------
HYDRALAZINE HYDROCHLORIDE TABLETS, USP
RX ONLY
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
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 275oC, 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 anhydrous
lactose,
microcrystalline cellulose, sodium starch glycolate, stearic acid and
FD&C Yellow # 6.
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 re