FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FOSINOPRIL SODIUM (UNII: NW2RTH6T2N) (FOSINOPRILAT - UNII:S312EY6ZT8), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Available from:

Glenmark Pharmaceuticals Inc., USA

INN (International Name):

FOSINOPRIL SODIUM

Composition:

FOSINOPRIL SODIUM 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fosinopril sodium and hydrochlorothiazide tablets are indicated for the treatment of hypertension. These fixed dose combinations are not indicated for initial therapy. (See DOSAGE AND ADMINISTRATION) In using fosinopril sodium 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. Available data are insufficient to show that fosinopril does not have a similar risk (see WARNINGS: Neutropenia/Agranulocytosis). ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS: Head and Neck Angioedema and Intestinal Angioedema). Fosinopril sodium and hydrochlorothiazide tablets are contraindicated in patients who are anuric. Fosinopril sodium and hydrochlorothiazide tablets are also contraindicated in patients who are hypersensitive to fosinopril, to any

Product summary:

Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg are white, round biconvex tablets debossed with "I" on one side and "3" on the other and are available in bottles of 30 (NDC 68462-554-30), 100 (NDC 68462-554-01) and 1000 (NDC 68462-554-10). Fosinopril Sodium and Hydrochlorothiazide Tablets, 20 mg/12.5 mg are white, round biconvex tablets debossed with "I 5" on one side and bisect on the other and are available in bottles of 30 (NDC 68462-555-30), 100 (NDC 68462-555-01) and 1000 (NDC 68462-555-10).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE- FOSINOPRIL SODIUM AND
HYDROCHLOROTHIAZIDE TABLET
GLENMARK PHARMACEUTICALS INC., USA
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FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLETS, USP
WARNING: FETAL TOXICITY
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•
DESCRIPTION
Fosinopril sodium, USP is a white to off-white crystalline powder,
soluble (> 100 mg/mL) in water, in
ethanol, and in methanol, and slightly soluble in hexane. Fosinopril
sodium, USP's chemical name is L-
proline, 4-cyclohexyl-1-[[[2- methyl-1-(1-oxopropoxy)-propoxy]-(4
phenylbutyl)-phosphinyl] acetyl]-,
sodium salt, _trans-; _its structural formula is:
Fosinoprilat, the active metabolite of fosinopril, is a non-sulfhydryl
angiotensin-converting enzyme
inhibitor. Fosinopril is converted to fosinoprilat by hepatic cleavage
of the ester group.
Hydrochlorothiazide, USP is a white, or practically white, practically
odorless, crystalline powder. It
is slightly soluble in water; freely soluble in sodium hydroxide
solution, in n-butylamine, and in
dimethylformamide; sparingly soluble in methanol; and insoluble in
ether, in chloroform, and in dilute
mineral acids. Hydrochlorothiazide's chemical name is
6-chloro-3,4-dihydro-2_H_-1 ,2,4-
benzothiadiazine-7-sulfonamide 1,1-dioxide; its structural formula is:
WHEN PREGNANCY IS DETECTED, DISCONTINUE FOSINOPRIL AND
HYDROCHLOROTHIAZIDE AS SOON
AS POSSIBLE.
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH DUE
TO THE DEVELOPING FETUS. SEE WARNINGS: FETAL TOXICITY
Hydrochlorothiazide is a thiazide diuretic.
Fosinopril sodium and hydrochlorothiazide tablets are a combination of
fosinopril sodium and
hydrochlorothiazide, USP. It is available for oral use in two tablet
strengths: fosinopril sodium and
hydrochlorothiazide tablets, 10 mg/12.5 mg, containing 10 mg of
fosinopril sodium and 12.5 mg of
hydrochlorothiazide, USP; and fosinopril sodium and
hydrochlorothiazide tablets, 20 mg/12.5 mg,
containing 20 mg of fosinopril sodium and 12.5 mg of
hydrochlorothiazide, USP. The inactive
ingredients of the tablets include la