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:

NuCare Pharmaceuticals,Inc.

INN (International Name):

ENALAPRIL MALEATE

Composition:

ENALAPRIL MALEATE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Enalapril maleate and hydrochlorothiazide is indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial treatment (see DOSAGE AND ADMINISTRATION ). In using enalapril maleate and 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 and hydrochlorothiazide, 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 of an

Product summary:

nalapril Maleate and Hydrochlorothiazide Tablets USP, 10/25 mg , are peach colored, capsule shaped, tablets. One side scored and engraved T to the left of the score and 3 to the right of the score. Other side scored. Each tablet contains 10 mg of enalapril maleate and 25 mg of hydrochlorothiazide. They are supplied as follows: NDC 68071-4144-3 Bottles of 30 NDC 68071-4144-6 Bottles of 60 NDC 68071-4144-9 Bottles of 90 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 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
NUCARE PHARMACEUTICALS,INC.
----------
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS, USP
RX ONLY
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE ENALAPRIL MALEATE AND
HYDROCHLOROTHIAZIDE 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 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 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
5/12.5 mg, containing 5 mg enalapril maleate and 12.5 mg
hydrochlorothiazide and
contain t