HYDRALAZINE HYDROCHLORIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Institutional LLC

INN (International Name):

HYDRALAZINE HYDROCHLORIDE

Composition:

HYDRALAZINE HYDROCHLORIDE 20 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Hydralazine Hydrochloride Injection USP, 20 mg/mL, is available in: NDC 67457-291-00 1 mL Single-Dose vial and NDC 67457-291-01 carton containing 25 Single-Dose vials Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Preservative Free. Discard unused portion. Manufactured for: Mylan Institutional LLC Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Institutional Galway, Ireland 1015L101 Revised: 7/2020 MI:HYDRIJ:R3

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDRALAZINE HYDROCHLORIDE- HYDRALAZINE HYDROCHLORIDE INJECTION,
SOLUTION
MYLAN INSTITUTIONAL LLC
----------
HYDRALAZINE HYDROCHLORIDE INJECTION, USP
20 MG/ML
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 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 reflex sympathetic discharge. This incr