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언어: 영어
출처: NLM (National Library of Medicine)
BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703)
Physicians Total Care, Inc.
BENAZEPRIL HYDROCHLORIDE
BENAZEPRIL HYDROCHLORIDE 5 mg
ORAL
PRESCRIPTION DRUG
Benazepril hydrochloride tablets USP are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics. In using benazepril hydrochloride, 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 hydrochloride does not have a similar risk (see WARNINGS ). Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in nonblacks. Benazepril hydrochloride tablets are contraindicated in patients who are hypersensitive to this product or to any other ACE inhibitor. Benazepril hydrochloride tablets are also contraindicated in patients with a history of angioe
Benazepril hydrochloride tablets USP, 5 mg are light yellow, arc triangle-coated tablets, debossed with the number “93” on one side and “5124” on the other. Tablets are packaged in Benazepril hydrochloride tablets USP, 10 mg are mustard yellow, arc triangle-coated tablets, debossed with the number “93” on one side and “5125” on the other. Tablets are packaged in Benazepril hydrochloride tablets USP, 20 mg are pink, arc triangle-coated tablets, debossed with the number “93” on one side and “5126” on the other. Tablets are packaged in Benazepril hydrochloride tablets USP, 40 mg are pink to light red, arc triangle-coated tablets, debossed with the number “93” on one side and “5127” on the other. Tablets are packaged in Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Manufactured In India By: EMCURE PHARMACEUTICALS LTD. Hinjwadi, Pune, India Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. M 9/2011 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146
Abbreviated New Drug Application
BENAZEPRIL HYDROCHLORIDE - BENAZEPRIL HYDROCHLORIDE TABLET, COATED PHYSICIANS TOTAL CARE, INC. ---------- BENAZEPRIL HYDROCHLORIDE TABLETS USP, 5 MG, 10 MG, 20 MG AND 40 MG 5124 5125 5126 5127 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 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. Its chemical name is 3-[[1-(ethoxy-carbonyl)-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 C H N O •HCl M.W. 460.96 Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Benazepril hydrochloride is supplied as tablets containing 5 mg, 10 mg, 20 mg, and 40 mg of benazepril hydrochloride for oral administration. The inactive ingredients are: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, starch, titanium dioxide, and triacetin. Additionally, the 5 mg strength contains talc, the 20 mg strength contains iron oxide black and iron oxide red, and the 40 mg strength contains iron oxide red. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Benazepril and benazeprilat inhibit angiotensin-converting enzyme (ACE) in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. 24 28 2 5 Inhibition of ACE results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and 전체 문서 읽기