Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
Benazepril hydrochloride (UNII: N1SN99T69T) (Benazeprilat - UNII:JRM708L703)
Trigen Laboratories, Inc.
Benazepril hydrochloride
Benazepril hydrochloride 5 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. Benazepril hydrochloride tablets are contraindicated in patients who are hypersensitive to benazepril or to any other ACE inhibitor. Benazepril hydrochloride tablets are also contraindicated in patients with a history of angioedema with or without previous ACE inhibitor treatment.
Benazepril hydrochloride tablets, USP, 5 mg, are round, white, film-coated tablets, debossed "627" on one side and plain on the other side, packaged as follows: NDC 13811-627-10 bottle of 100 tablets (with desiccant) Benazepril hydrochloride tablets, USP, 10 mg, are round, red, film-coated tablets, debossed "628" on one side and plain on the other side, packaged as follows: NDC 13811-628-10 bottle of 100 tablets (with desiccant) NDC 13811-628-50 bottle of 500 tablets (with desiccant) Benazepril hydrochloride tablets, USP, 20 mg, are round, grey, film-coated tablets, debossed "629" on one side and plain on the other side, packaged as follows: NDC 13811-629-10 bottle of 100 tablets (with desiccant) NDC 13811-629-50 bottle of 500 tablets (with desiccant) Benazepril hydrochloride tablets, USP, 40 mg, are round, blue, film-coated tablets, debossed "630" on one side and plain on the other side, packaged as follows: NDC 13811-630-10 bottle of 100 tablets (with desiccant) NDC 13811-630-50 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).
Abbreviated New Drug Application
BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED TRIGEN LABORATORIES, INC. ---------- BENAZEPRIL HYDROCHLORIDE TABLETS, USP Trigen Laboratories, Inc. RX ONLY PRESCRIBING INFORMATION WARNING: FETAL TOXICITY WHEN PREGNANCY IS DETECTED, DISCONTINUE BENAZEPRIL HYDROCHLORIDE TABLETS 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 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 benazepril 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 round, 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. 24 28 2 5 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 catalyze Leggi il documento completo