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:

Aphena Pharma Solutions - Tennessee, LLC

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 are available as: 10 mg Orange, round, convex, unscored tablets, debossed with “PLIVA 398” on one side and plain on the other side. Available in bottles of 100 (NDC 50111-398-01) and 1000 (NDC 50111-398-03). 25 mg Orange, round, convex, unscored tablets, debossed with “PLIVA 327” on one side and plain on the other side. Available in bottles of 100 (NDC 50111-327-01) and 1000 (NDC 50111-327-03). 50 mg Orange, round, convex, unscored tablets, debossed with “PLIVA 328” on one side and plain on the other side. Available in bottles of 100 (NDC 50111-328-01) and 1000 (NDC 50111-328-03). 100 mg Orange, round, convex, unscored tablets, debossed with “PLIVA 397” on one side and plain on the other side. Available in bottles of 100 (NDC 50111-397-01). 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. 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 Rev. F 2/2016

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

HYDRALAZINE HYDROCHLORIDE- HYDRALAZINE HYDROCHLORIDE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, 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 rea