ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ENALAPRIL MALEATE (UNII: 9O25354EPJ) (ENALAPRIL - UNII:69PN84IO1A), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Available from:

Physicians Total Care, Inc.

INN (International Name):

ENALAPRIL MALEATE

Composition:

ENALAPRIL MALEATE 5 g

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Enalapril maleate and hydrochlorothiazide tablets 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, 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, 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: Angioedema ). Enalapril maleate and hydrochlorothiazide tablets are contraindicated in patients who are hypersensitive to any component of this product and in patients with a history of angioedema

Product summary:

Enalapril Maleate and Hydrochlorothiazide Tablets USP 5/12.5 mg are available for oral administration as reddish-brown, round, unscored tablets, imprinted "APO" on one side and "5" over "12.5" on the other side.  They are supplied as follows: Bottles of 30 (NDC 54868-5100-1) Bottles of 90 (NDC 54868-5100-2) Bottles of 100 (NDC 54868-5100-0) Enalapril Maleate and Hydrochlorothiazide Tablets USP 10/25 mg are available for oral administration as reddish-brown, round, unscored tablets, imprinted "APO" on one side and "10" over "25" on the other side.  They are supplied as follows: Bottles of 30 (NDC 54868-5503-0) Bottles of 90 (NDC 54868-5503-1) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].  Protect from moisture. Dispense in a tight, light-resistant container [see USP]. APOTEX INC. ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS USP 5/12.5 mg and 10/25 mg Manufactured for: Apotex Corp. Weston, Florida USA 33326 Revised: November 2006 Rev. 3

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE - ENALAPRIL MALEATE AND
HYDROCHLOROTHIAZIDE TABLET
PHYSICIANS TOTAL CARE, INC.
----------
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, enalapril maleate
and hydrochlorothiazide tablets should be discontinued as soon as
possible (see WARNINGS:
_Pregnancy, Enalapril Maleate, Fetal/Neonatal Morbidity and
Mortality)_.
DESCRIPTION
Enalapril maleate and hydrochlorothiazide
Enalapril maleate is the maleate salt of enalapril, the ethyl ester of
a long-acting angiotensin converting
enzyme inhibitor, enalaprilat. Enalapril maleate is chemically
described as (_S_)-1-[_N_-[1-
(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline,
(_Z_)-2-butenedioate salt (1:1). Its empirical
formula is C
H N O •C H O , and its structural formula is:
Enalapril maleate is a white to off-white crystalline powder with a
molecular weight of 492.52. 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 is
6-chloro-3,4-dihydro-2_H_-1,2,4-benzothiadiazine-7-sulfonamide
1,1-dioxide.
Its empirical formula is C H ClN O S and its structural formula is:
It is a white, or practically white, crystalline powder with a
molecular weight of 297.74, which is
slightly soluble in water, but freely soluble in sodium hydroxide
solution.
Enalapril Maleate and Hydrochlorothiazide is available in two tablet
combinations of enalapril maleate
with hydrochlorothiazide: Enalapril Maleate and Hydrochlorothiazide
Tablets 5/12.5, containing 5 mg
enalapril maleate and 12.5 mg hydrochlorothiazide and Enalapril
Maleate and Hydrochlorothiazide
Tablets 10/25, containing 10 mg enalapril maleate and 25 mg
hydrochlorothiazide. Inactive ingredients
combines an angiotensin con