HYDRALAZINE HYDROCHLORIDE injection, solution

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

XGen Pharmaceuticals DJB, Inc.

INN (International Nazwa):

HYDRALAZINE HYDROCHLORIDE

Skład:

HYDRALAZINE HYDROCHLORIDE 20 mg in 1 mL

Droga podania:

INTRAMUSCULAR

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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.

Podsumowanie produktu:

Hydralazine Hydrochloride Injection, USP (20 mg/mL) 1 mL Single Dose Vial (NDC 39822-0500-1) Packaged in boxes of 25 (NDC 39822-0500-4) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Revised: January 2014, HYDZ-PI-01 Manufactured for: X-GEN Pharmaceuticals, Inc. Big Flats, NY 14814

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

HYDRALAZINE HYDROCHLORIDE- HYDRALAZINE HYDROCHLORIDE INJECTION,
SOLUTION
XGEN PHARMACEUTICALS DJB, INC.
----------
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. Each milliliter of
the sterile,
nonpyrogenic colorless solution contains Hydralazine Hydrochloride
USP, 20 mg,
Propylene Glycol USP, 103.6 mg, and Water for Injection q.s. The pH of
the solution is
3.4 - 4.4. pH may be adjusted with Hydrochloric Acid and/or Sodium
Hydroxide.
Hydralazine Hydrochloride 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 response to reflex sympathetic discharge. This