Country: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
Fosinopril Sodium (UNII: NW2RTH6T2N) (Fosinopril - UNII:R43D2573WO), Hydrochlorothiazide (UNII: 0J48LPH2TH) (Hydrochlorothiazide - UNII:0J48LPH2TH)
Andrx Pharmaceuticals, Inc.
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
TABLET
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-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 Angiodema .) Fosinopril sodium and hydrochlorothiazide tablets are contraindicated in patients who are anuric. Fosinopril sodium and hydrochlorothiazide tablets is also contraindicated in patients who are hypersensitive to fosinopril, to any
Fosinopril sodium and hydrochlorothiazide tablets is available in two different strengths. Dosage strengths of both components, tablet characteristics, and available quantities/packaging are identified below. Store at 25° C (77° F); excursions permitted to 15°–30° C (59°–86° F) [see USP Controlled Room temperature]. Protect from moisture by keeping bottle tightly closed. Manufactured by: Andrx Pharmaceuticals, Inc. Ft. Lauderdale, FL 33314 Rev date: 01/04 7439
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE- FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET ANDRX PHARMACEUTICALS, INC. ---------- FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLETS RX ONLY USE IN PREGNANCY WHEN USED IN PREGNANCY DURING THE SECOND AND THIRD TRIMESTERS, ACE INHIBITORS CAN CAUSE INJURY AND EVEN DEATH TO THE DEVELOPING FETUS. When pregnancy is detected, fosinopril sodium and hydrochlorothiazide tablets should be discontinued as soon as possible. SEE WARNINGS: FETAL/NEONATAL MORBIDITY AND MORTALITY. 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'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: 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's chemical name is 6-chloro-3,4-dihydro-2_H_-1,2,4- benzothiadiazine-7-sulfonamide 1,1-dioxide; its structural formula is: 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 fosino Прочитајте комплетан документ