Country: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
FOSINOPRIL SODIUM (UNII: NW2RTH6T2N) (FOSINOPRILAT - UNII:S312EY6ZT8), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Glenmark Pharmaceuticals Inc., USA
FOSINOPRIL SODIUM
FOSINOPRIL SODIUM 10 mg
ORAL
PRESCRIPTION DRUG
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
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).
Abbreviated New Drug Application
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE- FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET GLENMARK PHARMACEUTICALS INC., USA ---------- FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLETS, USP WARNING: FETAL TOXICITY • • 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 Aqra d-dokument sħiħ