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:

American Regent, 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:

HydrALAZINE Hydrochloride Injection, USP (20 mg/mL) NDC 0517-0901-25     1 mL Single Dose Vial        Packaged in boxes of 25 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). AMERICAN REGENT, INC. SHIRLEY, NY 11967 IN0901 Rev. 10/18 MG # 11928

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

HYDRALAZINE HYDROCHLORIDE- HYDRALAZINE HYDROCHLORIDE INJECTION,
SOLUTION
AMERICAN REGENT, 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, 20 mg, Methylparaben,
0.65 mg, Propylparaben, 0.35 mg,
Propylene Glycol, 103.6 mg, and Water for Injection 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:
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 re