HYDRALAZINE HYDROCHLORIDE tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Contract Pharmacy Services-PA

INN (Nome Internazionale):

HYDRALAZINE HYDROCHLORIDE

Composizione:

HYDRALAZINE HYDROCHLORIDE 25 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 25 mg – round, convex, pink film coated tablet engraved with HP above 2 on one side and plain on the other side NDC 67046-270-07 blisterpacks of 7 NDC 67046-270-14 blisterpacks of 14 NDC 67046-270-15 blisterpacks of 15 NDC 67046-270-20 blisterpacks of 20 NDC 67046-270-21 blisterpacks of 21 NDC 67046-270-28 blisterpacks of 28 NDC 67046-270-30 blisterpacks of 30 NDC 67046-270-60 blisterpacks of 60 50 mg – round, convex, pink film coated tablet engraved with HP above 3 on one side and plain on the other side NDC 67046-280-07 blisterpacks of 7 NDC 67046-280-14 blisterpacks of 14 NDC 67046-280-15 blisterpacks of 15 NDC 67046-280-20 blisterpacks of 20 NDC 67046-280-21 blisterpacks of 21 NDC 67046-280-28 blisterpacks of 28 NDC 67046-280-30 blisterpacks of 30 NDC 67046-280-60 blisterpacks of 60 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]. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. MANUFACTURED FOR: Heritage Pharmaceuticals Inc Eatontown, NJ 077241-866-901-DRUG (3784) Issued: 10/13

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

HYDRALAZINE HYDROCHLORIDE- HYDRALAZINE HYDROCHLORIDE TABLET, FILM
COATED
CONTRACT PHARMACY SERVICES-PA
----------
270 HYDRALAZINE 25 MG
280 HYDRALAZINE 50 MG
HYDRALAZINE HYDROCHLORIDE TABLETS, USP
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HYDRALAZINE HYDROCHLORIDE
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE HYDROCHLORIDE) TABLET, FILM
COATED FOR ORAL
USE.
INITIAL U.S. APPROVAL:
DESCRIPTION
HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral
administration. Its chemical name is
1-hydrazinophthalazine monohydrochloride, and its structural formula
is:
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, a