enalaprilat- Enalaprilat injection, solution

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

enalaprilat (UNII: GV0O7ES0R3) (enalaprilat - UNII:GV0O7ES0R3)

Boleh didapati daripada:

Mayne Pharma (USA) Inc.

INN (Nama Antarabangsa):

Enalaprilat

Borang farmaseutikal:

INJECTION, SOLUTION

Komposisi:

1.25 mg in 1 mL

Laluan pentadbiran:

INTRAVENOUS

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Enalaprilat injection is indicated for the treatment of hypertension when oral therapy is not practical. Enalaprilat injection has been studied with only one other antihypertensive agent, furosemide, which showed approximately additive effects on blood pressure. Enalapril, the pro-drug of enalaprilat, has been used extensively with a variety of other antihypertensive agents, without apparent difficulty except for occasional hypotension. In using enalaprilat injection, consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that enalaprilat injection does not have a similar risk (See WARNINGS ). In considering use of enalaprilat injection, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, it sho

Ringkasan produk:

Enalaprilat injection, 1.25 mg/mL, is a clear, colorless solution and is supplied in vials containing 1 mL and 2 mL. NDC 61703-237-44  1.25 mg/1 mL (1 mL fill in 2 mL vial) NDC 61703-237-16  2.5 mg/2 mL (2 mL fill in 2 mL vial) Store below 30°C (86°F). Manufactured for: Mayne Pharma (USA) Inc. Paramus, NJ  07652 By: Mayne Pharma (PR) Inc. Aguadilla, Puerto Rico 00604 Rev. March 2004                    PI046/KC

Ciri produk

ENALAPRILAT- ENALAPRILAT INJECTION, SOLUTION
MAYNE PHARMA (USA) INC.
----------
RX ONLY
USE IN PREGNANCY
WHEN USED IN PREGNANCY DURING THE SECOND AND THIRD TRIMESTERS, ACE
INHIBITORS CAN CAUSE
INJURY AND EVEN DEATH TO THE DEVELOPING FETUS.When pregnancy is
detected, enalaprilat injection
should be discontinued as soon as possible. See WARNINGS,
FETAL/NEONATAL MORBIDITY AND
MORTALITY.
DESCRIPTION
Enalaprilat injection is a sterile aqueous solution for intravenous
administration. Enalaprilat is an
angiotensin converting enzyme inhibitor. It is chemically described as
(S)-1-[N-(1-carboxy-3-
phenylpropyl)-L-alanyl]-L-proline dihydrate. Its molecular formula is
C
H N O •2H O and its
structural formula is:
Enalaprilat is a white to off-white, crystalline powder with a
molecular weight of 384.43. It is sparingly
soluble in methanol and slightly soluble in water.
Each milliliter of enalaprilat injection contains 1.25 mg enalaprilat
(anhydrous equivalent); sodium
chloride to adjust tonicity; sodium hydroxide to adjust pH; Water for
Injection, q.s.; with benzyl alcohol,
9 mg, added as a preservative.
CLINICAL PHARMACOLOGY
Enalaprilat, an angiotensin-converting enzyme (ACE) inhibitor when
administered intravenously, is the
active metabolite of the orally administered pro-drug, enalapril
maleate. Enalaprilat is poorly absorbed
orally.
MECHANISM OF ACTION
Intravenous enalaprilat, or oral enalapril, after hydrolysis to
enalaprilat, inhibits ACE in human subjects
and animals. ACE is a peptidyl dipeptidase that catalyzes the
conversion of angiotensin 1 to the
vasoconstrictor substance, angiotensin II. Angiotensin II also
stimulates aldosterone secretion by the
adrenal cortex. Inhibition of ACE results in decreased plasma
angiotensin II, which leads to decreased
vasopressor activity and to decreased aldosterone secretion. Although
the latter decrease is small, it
results in small increases of serum potassium. In hypertensive
patients treated with enalapril alone for
up to 48 weeks, mean increases in serum potassium of approxima