HYDRALAZINE HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

INN (International Name):

HYDRALAZINE HYDROCHLORIDE

Composition:

HYDRALAZINE HYDROCHLORIDE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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 63187-901-30 Bottles of 30 NDC 63187-901-60 Bottles of 60 NDC 63187-901-90 Bottles of 90 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) Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Issued: 10/13

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDRALAZINE HYDROCHLORIDE- HYDRALAZINE HYDROCHLORIDE TABLET, FILM
COATED
PROFICIENT RX LP
----------
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:
CHN·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 hypotens