Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703)
Blenheim Pharmacal, Inc.
BENAZEPRIL HYDROCHLORIDE
BENAZEPRIL HYDROCHLORIDE 40 mg
ORAL
PRESCRIPTION DRUG
Benazepril hydrochloride tablets, USP are indicated for the treatment of hypertension. Benazepril hydrochloride tablets may be used alone or in combination with thiazide diuretics. In using benazepril 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 tablets do 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
Benazepril hydrochloride tablets, USP, 5 mg, are round, white, film-coated tablets, debossed “341” on one side and plain on the other side, packaged as follows: NDC 63304-337-01 bottle of 100 tablets (with desiccant) Benazepril hydrochloride tablets, USP, 10 mg, are round, red, film-coated tablets, debossed “342” on one side and plain on the other side, packaged as follows: NDC 63304-338-01 bottle of 100 tablets (with desiccant) NDC 63304-338-05 bottle of 500 tablets (with desiccant) Benazepril hydrochloride tablets, USP, 20 mg, are round, grey, film-coated tablets, debossed “343” on one side and plain on the other side, packaged as follows: NDC 63304-339-01 bottle of 100 tablets (with desiccant) NDC 63304-339-05 bottle of 500 tablets (with desiccant) Benazepril hydrochloride tablets, USP, 40 mg, are round, blue, film-coated tablets, debossed “344” on one side and plain on the other side, packaged as follows: NDC 63304-340-01 bottle of 100 tablets (with desiccant) NDC 63304-340-05 bottle of 500 tablets (with desiccant) Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container (USP). You may report side effects to FDA at 1-800-FDA-1088 Manufactured for: Ranbaxy Pharmaceutical Inc. Jacksonville, FL 32257 USA Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd Linhai, Zhejiang, China Version: 04/2010
Abbreviated New Drug Application
BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED BLENHEIM PHARMACAL, INC. ---------- RX ONLY PRESCRIBING INFORMATION 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 TABLETS SHOULD BE DISCONTINUED AS SOON AS POSSIBLE. SEE WARNINGS, FETAL/NEONATAL MORBIDITY AND MORTALITY. DESCRIPTION Benazepril hydrochloride, USP 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: Its empirical formula is C H N O •HCl, and its molecular weight is 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, USP is supplied as film-coated tablets containing 5 mg, 10 mg, 20 mg, and 40 mg of benazepril hydrochloride for oral administration. The inactive ingredients are carnauba wax, colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, titanium dioxide, and triacetin. The 10 mg tablet also contains FD&C Red No. 40 aluminum lake. The 20 mg tablet also contains black iron oxide and yellow iron oxide. The 40 mg tablet also contains FD&C Blue No. 2 aluminum lake. Benazepril hydrochloride tablets USP, 5 mg, 10 mg, 20 mg and 40 mg meet USP Dissolution Test 2. 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 Lue koko asiakirja