HYDRALAZINE- hydralazine hydrochloride tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

REMEDYREPACK INC.

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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

Podsumowanie produktu:

HydrALAZINE Hydrochloride Tablets USP are available as: 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

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

HYDRALAZINE- HYDRALAZINE HYDROCHLORIDE TABLET
REMEDYREPACK INC.
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HYDRALAZINE HYDROCHLORIDE TABLETS, USP
NIVAGEN PHARMACEUTICALS, INC.
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.
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 25 mg, 50 mg or 100 mg
HydrALAZINE hydrochloride
USP. Tablets also contain mannitol, 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
reabsorption. HydrALAZINE also maintains or