ENALAPRILAT- enalaprilat injection, solution

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

ENALAPRILAT (UNII: GV0O7ES0R3) (ENALAPRILAT ANHYDROUS - UNII:Q508Q118JM)

Beszerezhető a:

Hospira, Inc.

Az alkalmazás módja:

INTRAVENOUS

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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 s

Termék összefoglaló:

Enalaprilat Injection, USP 1.25 mg per mL, is a clear, colorless solution and is supplied as follows: NDC Container Concentration Fill Quantity 0409-2122-01 Vial 1.25 mg/mL 1 mL 1 per Carton 0409-2122-02 Vial 1.25 mg/mL 2 mL 1 per Carton Store at 20 to 25°C (68 to 77°F). [see USP Controlled Room Temperature.] ***Registered trademark of B. Braun Distributed by Hospira, Inc., Lake Forest, IL 60045 USA                                                                                                                   LAB-0893-3.0 Revised: 06/2018

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

ENALAPRILAT- ENALAPRILAT INJECTION, SOLUTION
HOSPIRA, INC.
----------
ENALAPRILAT INJECTION, USP
Rx
only
WARNING: FETAL TOXICITY
WHEN PREGNANCY IS DETECTED, DISCONTINUE ENALAPRILAT INJECTION AS SOON
AS POSSIBLE.
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO THE
DEVELOPING FETUS. SEE WARNINGS: FETAL TOXICITY.
_DESCRIPTION_
Enalaprilat Injection, USP 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 contains 1.25 mg enalaprilat (anhydrous equivalent);
sodium chloride to adjust tonicity;
benzyl alcohol, 9 mg, added as a preservative. May contain sodium
hydroxide for pH adjustment.
_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 I 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 approximately 0.2
mEq/L were observed. In
patients treated with enalapri