País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
FOSINOPRIL SODIUM (UNII: NW2RTH6T2N) (FOSINOPRILAT - UNII:S312EY6ZT8)
Eon Labs, Inc.
FOSINOPRIL SODIUM
FOSINOPRIL SODIUM 10 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE- FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET EON LABS, INC. ---------- FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLETS RX ONLY WARNING: FETAL TOXICITY • • DESCRIPTION Fosinopril sodium 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 is designated chemically as L- proline, 4-cyclohexyl-1-[[[2-methyl-1-(1-oxopropoxy)- propoxy](4-phenylbutyl)phosphinyl]acetyl]-, sodium salt, _trans-_; its structural formula is: Its empirical formula is C H NNaO P, and its molecular weight is 585.65. 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 is designated chemically as 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 TO THE DEVELOPING FETUS. SEE WARNINGS, FETAL TOXICITY. 30 45 7 Its empirical formula is C H ClN O S and its molecular weight is 297.73. 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 10/12.5, containing 10 mg of fosinopril sodium and 12.5 mg of hydrochlorothiazide, USP; and fosinopril sodium-hydrochlorothiazide tablets 20/12.5, containing Leer el documento completo