Country: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
ANI Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
Benazepril hydrochloride and hydrochlorothiazide tablets USP are indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION) . Benazepril hydrochloride and hydrochlorothiazide tablets are contraindicated in patients who are anuric. Benazepril hydrochloride and hydrochlorothiazide tablets are also contraindicated in patients who are hypersensitive to benazepril, to any other ACE inhibitor, to hydrochlorothiazide, or to other sulfonamide-derived drugs. Hypersensitivity reactions are more likely to occur in patients with a history of allergy or bronchial asthma. Benazepril hydrochloride and hydrochlorothiazide tablets are also contraindicated in patients with a history of angioedema with or without previous ACE inhibitor treatment. Benazepril hydrochloride and hydrochlorothiazide tablets are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer benazepril hydrochloride
Benazepril Hydrochloride and Hydrochlorothiazide Tablets USP are available in four different strengths: 5 mg/6.25 mg: White, capsule shaped, film-coated tablet, scored on one side and debossed “AN 14” on the other side. Each tablet contains 5 mg of benazepril hydrochloride USP and 6.25 mg of hydrochlorothiazide USP and is supplied as bottles of 100 tablets (NDC 62559-414-01). 10 mg/12.5 mg: Purple, capsule shaped, film-coated tablet, scored on one side and debossed “AN 15” on the other side. Each tablet contains 10 mg of benazepril hydrochloride USP and 12.5 mg of hydrochlorothiazide USP and is supplied as bottles of 100 tablets (NDC 62559-415-01). 20 mg/12.5 mg: Pink, capsule shaped, film-coated tablet, scored on one side and debossed “AN 16” on the other side. Each tablet contains 20 mg of benazepril hydrochloride USP and 12.5 mg of hydrochlorothiazide USP and is supplied as bottles of 100 tablets (NDC 62559-416-01). 20 mg/25 mg: Red, capsule shaped, film-coated tablet, scored on one side and debossed “AN 17” on the other side. Each tablet contains 20 mg of benazepril hydrochloride USP and 25 mg of hydrochlorothiazide USP and is supplied as bottles of 100 tablets (NDC 62559-417-01). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Dispense in a tight, light-resistant container as defined in the USP. Manufactured by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 10559 Rev 09/22
Abbreviated New Drug Application
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE- BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET ANI PHARMACEUTICALS, INC. ---------- BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS USP COMBINATION TABLETS 5 MG/6.25 MG 10 MG/12.5 MG 20 MG/12.5 MG 20 MG/25 MG PRESCRIBING INFORMATION WARNING: FETAL TOXICITY WHEN PREGNANCY IS DETECTED, DISCONTINUE BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 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 USP 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 24 28 2 5 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. Benazepril Hydrochloride and Hydrochlorothiazide Tablets USP are a combination of benazepril hydrochloride USP and hydrochlorothiazide USP. The tablets are formulated for oral administration with a combination of 5, 10 or 20 mg of benazepril hydrochlor Прочитајте комплетан документ