HYDRALAZINE HYDROCHLORIDE injection

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

A-S Medication Solutions

Via di somministrazione:

INTRAVENOUS

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:

Product: 50090-4518 NDC: 50090-4518-0 1 mL in a VIAL, SINGLE-DOSE

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

HYDRALAZINE HYDROCHLORIDE - HYDRALAZINE HYDROCHLORIDE INJECTION
A-S MEDICATION SOLUTIONS
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HYDRALAZINE HYDROCHLORIDE INJECTION, USP
DESCRIPTION:
Rx only
Hydralazine Hydrochloride Injection, USP is an antihypertensive
available in a 2 mL vial
for intravenous and intramuscular administration. Each mL of the
sterile, nonpyrogenic
colorless solution contains hydralazine hydrochloride USP, 20 mg;
methylparaben NF,
0.65 mg; propylparaben NF, 0.35 mg; propylene glycol USP, 103.6 mg,
and Water for
Injection USP q.s. The pH of the solution is 3.4 to 4.4. pH may be
adjusted with
hydrochloric acid and/or sodium hydroxide. Hydralazine hydrochloride
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.
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 le