ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE- enalapril maleate and hydrochlorothiazide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cosette Pharmaceuticals, Inc.

INN (International Name):

ENALAPRIL MALEATE

Composition:

ENALAPRIL MALEATE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Enalapril maleate and hydrochlorothiazide tablets, USP are available as follows: 5 mg/12.5 mg - white, convex caplet debossed “1044” on one side and plain on the other side, in bottles of 100 (NDC 0713-1044-01) tablets. 10 mg/25 mg - rust, convex caplet debossed “1052” on one side and bisected on the other side, in bottles of 100  (NDC 0713-1052-01) tablets. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep container tightly closed. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Manufactured by: G&W Laboratories, Inc. South Plainfield, NJ 07080  Rev. 08/2017  8-ENALGWSV2                 

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE - ENALAPRIL MALEATE AND
HYDROCHLOROTHIAZIDE TABLET
COSETTE PHARMACEUTICALS, INC.
----------
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
ingredi