ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Mylan Pharmaceuticals Inc.

DCI (Denominação Comum Internacional):

ENALAPRIL MALEATE

Composição:

ENALAPRIL MALEATE 5 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Enalapril maleate and hydrochlorothiazide tablets are 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 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 angioedema

Resumo do produto:

Enalapril Maleate and Hydrochlorothiazide Tablets, USP are available containing enalapril maleate, USP 5 mg and hydrochlorothiazide, USP 12.5 mg or enalapril maleate, USP 10 mg and hydrochlorothiazide, USP 25 mg. The 5 mg/12.5 mg tablets are white, round, unscored tablets debossed with M on one side of the tablet and 712 on the other side. They are available as follows: NDC 0378-0712-01 bottles of 100 tablets The 10 mg/25 mg tablets are white, round, unscored tablets debossed with M on one side of the tablet and 723 on the other side. They are available as follows: NDC 0378-0723-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 9/2020 ENHCT:R10

Status de autorização:

Abbreviated New Drug Application

Características técnicas

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE- ENALAPRIL MALEATE AND
HYDROCHLOROTHIAZIDE TABLET
MYLAN PHARMACEUTICALS INC.
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WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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DESCRIPTION
Enalapril maleate and hydrochlorothiazide tablets, USP combine 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, USP 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:
Hydrochlorothiazide, USP is a white, or practically white, crystalline
powder with a molecular weight
of 297.75, which is slightly soluble in water, but freely soluble in
sodium hydroxide solution.
Each tablet, for oral administration, is available containing 5 mg
enalapril maleate and 12.5 mg
hydrochlorothiazide or 10 mg enalapril maleate and 25 mg
hydrochlorothiazide. In addition, each tablet
also contains the following inactive ingredients: anhydrous lactose,
colloidal silicon dioxide,
magnesium stearate, maleic acid, microcrystalline cellulose,
pregelatinized starch (corn) and sodium
WHEN PREGNANCY IS DETECTED, DISCONTINUE ENALAPRIL MALEATE AND
HYDROCHLOROTHIAZIDE
TABLETS AS SOON AS POSSIBLE.
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANG