Country: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
FOSINOPRIL SODIUM (UNII: NW2RTH6T2N) (FOSINOPRILAT - UNII:S312EY6ZT8), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals 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, 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 is also contraindicated in patients who are hypersensitive to fosinopril, to any other ACE inhibi
Fosinopril sodium and hydrochlorothiazide tablets, USP are available as follows: 10 mg / 12.5 mg – Each orange and white colored, speckled, round, biconvex uncoated tablet debossed with "HP60" on one side and plain on the other side contains 10 mg fosinopril sodium, USP and 12.5 mg hydrochlorothiazide, USP. Tablets are supplied in bottles of 30, 100 and 500. 20 mg / 12.5 mg – Each orange and white colored, speckled, round, biconvex uncoated tablet debossed with "HP61" separated by a score line on one side and plain on the other side contains 20 mg fosinopril sodium, USP and 12.5 mg hydrochlorothiazide, USP. Tablets are supplied in bottles of 30, 100 and 500. Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture by keeping bottle tightly closed. Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India. Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ07724 1.866.901.DRUG (3784)
Abbreviated New Drug Application
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE- FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC. ---------- RX ONLY BOXED WARNING WARNING: FETAL TOXICITY WHEN PREGNANCY IS DETECTED, DISCONTINUE FOSINOPRIL AND HYDROCHLOROTHIAZIDE AS SOON AS POS S IBLE. DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND DEATH TO THE DEVELOPING FETUS. SEE WARNINGS: 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 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-2H-1,2,4- benzothiadi-azine-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, USP is a combination of fosinopril sodium and hydrochlorothiazide, USP. It is available for oral use in two tablet strengths: fosinopril sodium and hydrochlorothiazide 10 mg/12.5 mg, containing 10 mg of fosinopril sodium, USP and 12.5 mg of hydrochlorothiazide, USP; and fosinopril sodium and hydrochlorothiazide Прочитајте комплетан документ