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:

Rebel Distributors Corp

INN (International Name):

Enalapril Maleate

Composition:

Enalapril Maleate 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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/hydrochlorothiazide tablets should be discontinued as soon as possible. See WARNINGS, Pregnancy, Enalapril Maleate, Fetal/Neonatal Morbidity and Mortality. Enalapril maleate/hydrochlorothiazide is indicated for the treatment of hypertension. These fixed dose combinations are not indicated for initial treatment (see DOSAGE AND ADMINISTRATION ). In using enalapril maleate/hydrochlorothiazide, 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/hydrochlorothiazide, it should be noted that black patients receiving ACE inhibitors h

Product summary:

Enalapril Maleate and Hydrochlorothiazide Tablets USP, 10/25 mg , are peach, caplet-shaped, compressed tablets, engraved on one side with T3. Each tablet contains 10 mg of enalapril maleate and 25 mg of hydrochlorothiazide. They are supplied as follows: NDC 21695-780-30 bottles of 30 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°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
REBEL DISTRIBUTORS CORP
----------
ENALAPRIL MALEATE AND
HYDROCHLOROTHIAZIDE
TABLETS, USP
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/HYDROCHLOROTHIAZIDE TABLETS SHOULD BE DISCONTINUED AS SOON AS
POSSIBLE. SEE
WARNINGS, PREGNANCY, ENALAPRIL MALEATE, FETAL/NEONATAL MORBIDITY AND
MORTALITY.
RX ONLY
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/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 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 492.53. 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 empirical formula is C H ClN O S and its structural formula is:
20
28
2
5
4
4
4
7
8
3
4
2
It is a white, or practically white, crystalline powder with a
molecular weight of 29