HYDRALAZINE HYDROCHLORIDE injection, solution

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

Hydralazine Hydrochloride (UNII: FD171B778Y) (Hydralazine - UNII:26NAK24LS8)

Pieejams no:

General Injectables & Vaccines, Inc

SNN (starptautisko nepatentēto nosaukumu):

Hydralazine Hydrochloride

Kompozīcija:

Hydralazine Hydrochloride 20 mg in 1 mL

Ievadīšanas:

INTRAMUSCULAR

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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.

Produktu pārskats:

Product No.        NDC No. 601401               63323-614-01 Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL single dose vial, 25 vials per tray. Vial stoppers do not contain natural rubber latex. Store at 20 degrees C to 25 degrees C (68 degrees F to 77 degrees F) [see USP Controlled Room Temperature]. APP APP Pharmaceuticals, LLC Schaumburg, IL 60173 45854D Revised: September 2017

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

HYDRALAZINE HYDROCHLORIDE- HYDRALAZINE HYDROCHLORIDE INJECTION,
SOLUTION
GENERAL INJECTABLES & VACCINES, INC
----------
HYDRALAZINE HCL 20MG/ML 1ML SINGLE DOSE VIAL
DESCRIPTION
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 degrees 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. Hydralzine
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