HYDRALAZINE HYDROCHLORIDE injection

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

General Injectables and Vaccines, Inc.

Rute administrasi :

INTRAVENOUS

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure. Hypersensitivity to hydralazine; coronary artery disease; mitral valvular rheumatic heart disease.

Ringkasan produk:

Hydralazine Hydrochloride Injection USP, 20 mg/mL Storage : Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

HYDRALAZINE HYDROCHLORIDE- HYDRALAZINE HYDROCHLORIDE INJECTION
GENERAL INJECTABLES AND VACCINES, INC.
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HYDRALAZINE HYDROCHLORIDE INJECTION, USP
RX ONLY
DESCRIPTION
Hydralazine Hydrochloride Injection, USP is an antihypertensive
available in a 1 mL vial for intravenous
and intramuscular administration. Hydralazine Hydrochloride Injection,
USP is a sterile, nonpyrogenic
colorless solution.
EACH ML CONTAINS:
ACTIVE: Hydralazine Hydrochloride USP, 20 mg
PRESERVATIVES: Methylparaben NF, 0.65 mg; Propylparaben NF, 0.35 mg
INACTIVES: Propylene Glycol USP, 103.6 mg; Sodium Hydroxide and/or
Hydrochloric Acid USP to
adjust pH (3.4 to 4.4) and Water for Injection.
Hydralazine Hydrochloride USP 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.
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