Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Physicians Total Care, Inc.
BENAZEPRIL HYDROCHLORIDE
BENAZEPRIL HYDROCHLORIDE 10 mg
ORAL
PRESCRIPTION DRUG
Benazepril hydrochloride and hydrochlorothiazide tablets are indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION). In using benazepril hydrochloride 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 benazepril does not have a similar risk (see WARNINGS, Neutropenia/Agranulocytosis ). Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks. Benazepril hydrochloride and hydrochlorothiazide is contraindicated in patients who are anuric. Benazepril hydrochloride and hydrochlorothiazide is also contraindicated in patients who are hypersensitive to benazepril, to any other ACE inhibitor, to hydrochlorothiazi
Benazepril Hydrochloride and Hydrochlorothiazide Tablets, for oral administration, are available as: 10 mg/12.5 mg: Pink, oblong, film-coated tablets, debossed "E 204" on one side and scored on the other side and supplied as: 20 mg/12.5 mg: Lavender, oblong, film-coated tablets, debossed "E 211" on one side and scored on the other side and supplied as: 20 mg/25 mg: Maroon, oblong, film-coated tablets, debossed "E 277" on one side and scored on the other side and supplied as: Each strength is supplied in bottles that contain a desiccant. Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Sandoz Inc. Princeton, NJ 08540 OS8023 Rev. 07/11 MF0124REV07/11 MG #18758 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK 74146
Abbreviated New Drug Application
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE - BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED PHYSICIANS TOTAL CARE, INC. ---------- BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS RX ONLY USE IN PREGNANCY WHEN USED IN PREGNANCY, ACE INHIBITORS CAN CAUSE INJURY AND EVEN DEATH TO THE DEVELOPING FETUS. When pregnancy is detected, benazepril hydrochloride and hydrochlorothiazide should be discontinued as soon as possible. See WARNINGS, FETAL/NEONATAL MORBIDITY AND MORTALITY. DESCRIPTION Benazepril hydrochloride is a white to off-white crystalline powder, soluble (> 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl- (1S)-propyl]amino]-2,3,4,5- tetrahydro-2-oxo-1_H_-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is: Its empirical formula is C H N O •HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme inhibitor. Benazepril is converted to benazeprilat 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: Its empirical formula is C H ClN O S and its molecular weight is 297.73. Hydrochlorothiazide is a thiazide diuretic. The tablets are a combination of benazepril hydrochloride and hydrochlorothiazide USP. They are formulated for oral administration with a combination of 5 mg, 10 mg, or 20 mg of benazepril 24 28 2 5 7 8 3 4 2 hydrochloride and 6.25 mg, 12.5 mg, or 25 mg of hydrochlorothiazide USP. The inactive ingredients of the tablets are colloidal si Přečtěte si celý dokument