HYDRALAZINE HYDROCHLORIDE- hydralazine hydrochloride tablet, film coated

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Safecor Health, LLC

INN (International Adı):

HYDRALAZINE HYDROCHLORIDE

Kompozisyon:

HYDRALAZINE HYDROCHLORIDE 25 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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

Ürün özeti:

HydrALAZINE Hydrochloride Tablets, USP 25 mg – round, convex, pink film coated tablet engraved with HP above 2 on one side and plain on the other side Box of 100, Robot-Rx® 1 Unit Dose NDC 48433-309-10 (Unit-Dose NDC 48433-309-01) This package is not child resistant. For institutional use only. Packaging meets USP specifications for light resistance. 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. The product contained in this package is from NDC#23155-002 Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 Packaged and Distributed by: Safecor Health, LLC 317 New Boston Street Woburn, MA 01801 Safecor Health, LLC 4060 Business Park Drive Columbus, OH 43204 Questions or Comments? 1-800-447-1006 Rev: 309-00 08/2014

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

HYDRALAZINE HYDROCHLORIDE- HYDRALAZINE HYDROCHLORIDE TABLET, FILM
COATED
SAFECOR HEALTH, LLC
----------
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:
C8H8N4 ·HCL
C8H8N4·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 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