ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE- enalapril maleate and hydrochlorothiazide tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

ENALAPRIL MALEATE (UNII: 9O25354EPJ) (ENALAPRILAT ANHYDROUS - UNII:Q508Q118JM), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Verfügbar ab:

Bryant Ranch Prepack

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Enalapril maleate and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension. These fixed dose combinations are not indicated for initial treatment (see DOSAGE AND ADMINISTRATION ). In using enalapril maleate and hydrochlorothiazide tablets, USP, 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 enalapril does not have a similar risk (see WARNINGS ). In considering use of enalapril maleate and hydrochlorothiazide tablets, USP, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks (see WARNINGS , Head and Neck Angioedema ). Enalapril maleate and hydrochlorothiazide is contraindicated in patients who are hypersensitive to any component of this product and in patients with a history

Produktbesonderheiten:

NDC: 71335-0870-1: 30 Tablets in a BOTTLE NDC: 71335-0870-2: 100 Tablets in a BOTTLE

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE - ENALAPRIL MALEATE AND
HYDROCHLOROTHIAZIDE TABLET
BRYANT RANCH PREPACK
----------
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS, USP
5 MG/12.5 MG AND 10 MG/25 MG
RX ONLY
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE ENALAPRIL MALEATE AND
HYDROCHLOROTHIAZIDE TABLETS 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
Enalapril maleate and hydrochlorothiazide tablets, USP combine an
angiotensin
converting enzyme inhibitor, enalapril maleate, USP and a diuretic,
hydrochlorothiazide,
USP.
Enalapril maleate, USP is the maleate salt of enalapril, the ethyl
ester of a long-acting
angiotensin converting enzyme inhibitor, enalaprilat. Enalapril
maleate, USP is chemically
described as (S)-1-[_N_-
[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (_Z_)-2-
butenedioate salt (1:1). Its structural formula is:
C
H
N O •C H O M.W. 492.53
Enalapril maleate, USP is a white to off-white crystalline powder. It
is sparingly soluble in
water, soluble in ethanol, and freely soluble in methanol.
Enalapril is a pro-drug; following oral administration, it is
bioactivated by hydrolysis of the
ethyl ester to enalaprilat, which is the active angiotensin converting
enzyme inhibitor.
Hydrochlorothiazide, USP is
6-chloro-3,4-dihydro-2_H_-1,2,4-benzo-thiadiazine-7-
sulfonamide 1,1-dioxide. Its structural formula is:
20
28
2
5
4
4
4
C H ClN O S M.W. 297.74
It is a white, or practically white, crystalline powder, which is
slightly soluble in water, but
freely soluble in sodium hydroxide solution.
Enalapril maleate and hydrochlorothiazide tablets, USP are available
in two tablet
combinations: 5 mg/12.5 mg, containing 5 mg enalapril maleate, USP and
12.5 mg
hydrochlorothiazide, USP and 10 mg/25 mg, containing 10 mg enalapril
maleate, USP
and 25 mg hydrochlorothiazide, USP. Inactive ingredients are