HYDRALAZINE HYDROCHLORIDE tablet, film coated

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Major Pharmaceuticals

INN (International Nazwa):

HYDRALAZINE HYDROCHLORIDE

Skład:

HYDRALAZINE HYDROCHLORIDE 10 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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

Podsumowanie produktu:

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 Carton of 100 tablets (10 tablets per blister card x 10), NDC 0904-6440-61 25 mg - round, convex, pink film-coated tablet engraved with HP above 2 on one side and plain on the other side Carton of 100 tablets (10 tablets per blister card x 10), NDC 0904-6441-61 50 mg - round, convex, pink film-coated tablet engraved with HP above 3 on one side and plain on the other side Carton of 100 tablets (10 tablets per blister card x 10), NDC 0904-6442-61 100 mg - round, convex, pink film-coated tablet engraved with HP above 4 on one side and plain on the other side Carton of 100 tablets (10 tablets per blister card x 10), NDC 0904-6443-61 Bottle of 1000 tablets, NDC 0904-6443-10 Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 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. Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1-866-901-DRUG (3784) Distributed by: MAJOR® PHARMACEUTICALS Livonia, MI 48152 USA Refer to package label for Distributor's NDC Number 51U000000172US05 Revised: 08/2021

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

HYDRALAZINE HYDROCHLORIDE- HYDRALAZINE HYDROCHLORIDE TABLET, FILM
COATED
MAJOR PHARMACEUTICALS
----------
RX ONLY
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, 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