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:

Dr. Reddy's Laboratories Limited

INN (International Name):

enalapril maleate

Composition:

enalapril maleate 5 mg

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, Head and Neck 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 angi

Product summary:

Enalapril maleate and hydrochlorothiazide tablets USP, 5 mg/12.5 mg are white, round, flat compressed tablets with beveled edge, embossed “ C ”                                                                                                                                                                                                                133 on one side and plain on other side and are supplied in bottles of 100’s and 1000’s.         Bottles of 100 (with desiccant)          NDC 55111-133-01.         Bottles of 1000 (with desiccant)        NDC 55111-133-10. Enalapril maleate and hydrochlorothiazide tablets USP, 10 mg/25 mg are white, round, flat compressed tablets with beveled edge, embossed “ C ”                                                                                                                                                                                                                134 on one side and plain on other side and are supplied in bottles of 100’s and 1000’s.         Bottles of 100 (with desiccant)          NDC 55111-134-01.         Bottles of 1000 (with desiccant)        NDC 55111-134-10. Store at 20°– 25°C (68°–77°F); [See USP Controlled Room Temperature]. Keep container tightly closed. Protect from moisture.Dispense in a tight container as per USP, if product package is subdivided.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE- ENALAPRIL MALEATE AND
HYDROCHLOROTHIAZIDE TABLET
DR. REDDY'S LABORATORIES LIMITED
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ENALAPRIL MALEATE AND
HYDROCHLOROTHIAZIDE TABLETS, USP
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-hydrochlorothiazide combines an angiotensin
converting enzyme inhibitor, enalapril
maleate, and a diuretic, 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 molecular 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 492.53. 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 molecular 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 tablets are available in two
tablet combinations of enalapril
maleate with hydrochlorothiazide: Enalapril maleate and
hydrochlorothiazide tablets 5 mg/12.5 mg,
containing 5 mg enalapril maleate and 12.5 mg hydrochlorothia