HYDRALAZINE HYDROCHLORIDE tablet, film coated

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

REMEDYREPACK INC.

ІПН (Міжнародна Ім'я):

HYDRALAZINE HYDROCHLORIDE

Склад:

HYDRALAZINE HYDROCHLORIDE 50 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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

Огляд продуктів:

HydrALAZINE Hydrochloride Tablets, USP 50 mg - round, convex, pink film-coated tablet engraved with HP above 3 on one side and plain on the other side NDC: 70518-0666-00 NDC: 70518-0666-01 NDC: 70518-0666-02 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 90 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BLISTER PACK Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

HYDRALAZINE HYDROCHLORIDE- HYDRALAZINE HYDROCHLORIDE TABLET, FILM
COATED
REMEDYREPACK INC.
----------
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.
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 causes stimulation of
aldosterone and
con