HYDRALAZINE HYDROCHLORIDE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Cardinal Health 107, LLC

INN (Nome Internazionale):

HYDRALAZINE HYDROCHLORIDE

Composizione:

HYDRALAZINE HYDROCHLORIDE 10 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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

Dettagli prodotto:

Hydralazine Hydrochloride Tablets USP are available as: 25 mg 50 mg Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured in Czech Republic by: TEVA CZECH INDUSTRIES s.r.o. Opava-Komarov, Czech Republic Manufactured for: TEVA PHARMACEUTICALS USA, Inc. North Wales, PA 19454 Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. Distributed by: Cardinal Health Dublin, OH 43017 L41452980324 L41577230224 S-11344 R3 4/20

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

HYDRALAZINE HYDROCHLORIDE- HYDRALAZINE HYDROCHLORIDE TABLET
CARDINAL HEALTH 107, LLC
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HYDRALAZINE HYDROCHLORIDE
TABLETS USP
DESCRIPTION
Hydralazine Hydrochloride Tablets 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 10 mg, 25 mg, 50 mg or
100 mg hydralazine
hydrochloride, USP. Tablets also contain anhydrous lactose, FD&C
yellow no. 6
aluminum lake, microcrystalline cellulose, sodium starch glycolate,
and stearic acid.
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. Hydra