Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703)
Proficient Rx LP
BENAZEPRIL HYDROCHLORIDE
BENAZEPRIL HYDROCHLORIDE 5 mg
ORAL
PRESCRIPTION DRUG
Benazepril hydrochloride tablets, USP are indicated for the treatment of hypertension. It 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. Do not co-administer aliskiren with angiotensin receptor blockers, ACE inhibitors, including benazepril hydrochloride in patients with diabetes.
Benazepril hydrochloride tablets, USP, 5 mg, are round, white, film-coated tablets, debossed “S” on one side and “341” on the other side, packaged as follows: NDC 63187-500-30 bottle of 30 tablets (with desiccant) NDC 63187-500-60 bottle of 60 tablets (with desiccant) NDC 63187-500-90 bottle of 90 tablets (with desiccant) Benazepril hydrochloride tablets, USP, 10 mg, are round, red, film-coated tablets, debossed “S” on one side and “342” on the other side, packaged as follows: NDC 63187-499-30 bottle of 30 tablets (with desiccant) NDC 63187-499-60 bottle of 60 tablets (with desiccant) NDC 63187-499-90 bottle of 90 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 Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zhejiang 317024, China Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Version: 01/2014 07713-01
Abbreviated New Drug Application
BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET, COATED PROFICIENT RX LP ---------- BENAZEPRIL HYDROCHLORIDE TABLETS, USP, FILM COATED FOR ORAL USE RX ONLY PRESCRIBING INFORMATION WARNING: FETAL TOXICITY WHEN PREGNANCY IS DETECTED, DISCONTINUE BENAZEPRIL HYDROCHLORIDE TABLETS AS SOON AS POSSIBLE. 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 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 24 28 2 5 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 s Læs hele dokumentet