País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
FOSINOPRIL SODIUM (UNII: NW2RTH6T2N) (FOSINOPRILAT - UNII:S312EY6ZT8), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Physicians Total Care, Inc.
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
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: Fosinopril Sodium and Hydrochlorothiazide Tablets, 20 mg/12.5 mg are white, round biconvex tablets debossed with "15" on one side and bisect on the other and are available in:
Abbreviated New Drug Application
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE - FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET PHYSICIANS TOTAL CARE, INC. ---------- FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLETS, USP RX ONLY USE IN PREGNANCY WHEN USED IN PREGNANCY DURING THE SECOND AND THIRD TRIMESTERS, ACE INHIBITORS CAN CAUSE INJURY AND EVEN DEATH TO THEDEVELOPING FETUS. When pregnancy is detected, fosinopril sodium and hydrochlorothiazide tablets, USP should be discontinued as soon as possible. See WARNINGS: FETAL/NEONATAL MORBIDITY AND MORTALITY. 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- methyl1-( 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-2H-1 ,2,4- benzothiadiazine-7-sulfonamide 1,1-dioxide; its structural formula is: 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 hydrochloroth Leer el documento completo