HYDRALAZINE HYDROCHLORIDE tablet, film coated

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Aphena Pharma Solutions - Tennessee, LLC

SNN (starptautisko nepatentēto nosaukumu):

HYDRALAZINE HYDROCHLORIDE

Kompozīcija:

HYDRALAZINE HYDROCHLORIDE 25 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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

Produktu pārskats:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. HydrALAZINE Hydrochloride Tablets, USP 10 mg – round, convex, pink film coated tablet engraved with HP above 1 on one side and plain on the other side NDC 23155-001-01 Bottles of 100 w/ CRC NDC 23155-001-10 Bottles of 1000 25 mg – round, convex, pink film coated tablet engraved with HP above 2 on one side and plain on the other side NDC 23155-002-01 Bottles of 100 w/ CRC NDC 23155-002-10 Bottles of 1000 50 mg – round, convex, pink film coated tablet engraved with HP above 3 on one side and plain on the other side NDC 23155-003-01 Bottles of 100 w/ CRC NDC 23155-003-10 Bottles of 1000 100 mg – round, convex, pink film coated tablet engraved with HP above 4 on one side and plain on the other side NDC 23155-004-01 Bottles of 100 w/ CRC NDC 23155-004-10 Bottles of 1000 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 07724 1-866-901-DRUG (3784) Issued: 10/13

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

HYDRALAZINE HYDROCHLORIDE - HYDRALAZINE HYDROCHLORIDE TABLET, FILM
COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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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:
C H N ·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