HYDRALAZINE HYDROCHLORIDE injection, solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Physicians Total Care, Inc.

INN (Nome Internazionale):

HYDRALAZINE HYDROCHLORIDE

Composizione:

HYDRALAZINE HYDROCHLORIDE 20 mg in 1 mL

Via di somministrazione:

INTRAMUSCULAR

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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.

Dettagli prodotto:

Hydralazine Hydrochloride Injection USP, 20 mg/mL Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Manufactured by: Akorn Inc. Lake Forest, IL 60045 HY00N Rev. 04/09 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK      74146

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

HYDRALAZINE HYDROCHLORIDE - HYDRALAZINE HYDROCHLORIDE INJECTION,
SOLUTION
PHYSICIANS TOTAL CARE, INC.
----------
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:
Molecular Formula 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.
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