Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (Hydrochlorothiazide - UNII:0J48LPH2TH)
Apotex Corp.
BENAZEPRIL HYDROCHLORIDE
BENAZEPRIL HYDROCHLORIDE 5 mg
ORAL
PRESCRIPTION DRUG
Benazepril hydrochloride and hydrochlorothiazide tablets 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 and
Benazepril hydrochloride and hydrochlorothiazide tablets 5 mg/6.25 mg are available for administration as white to off-white, round tablets, scored and engraved “APO” on one side, “5” over bisect “6.25” on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-0261-3) Bottles of 100 (NDC 60505-0261-1) Bottles of 1,000 (NDC 60505-0261-8) Benazepril hydrochloride and hydrochlorothiazide tablets 10 mg/12.5 mg are available for administration as light pink, round, scored tablets, engraved “APO” on one side, “10” over bisect “12.5” on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-0262-3) Bottles of 100 (NDC 60505-0262-1) Bottles of 1,000 (NDC 60505-0262-8) Benazepril hydrochloride and hydrochlorothiazide tablets 20 mg/12.5 mg are available for administration as greyish-violet, round, scored tablets, engraved “APO” on one side, “20” over bisect “12.5” on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-0263-3) Bottles of 100 (NDC 60505-0263-1) Bottles of 1,000 (NDC 60505-0263-8) Benazepril hydrochloride and hydrochlorothiazide tablets 20 mg/25 mg are available for administration as reddish brown, round, scored tablets, engraved “APO” on one side, “20” over bisect “25” on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-0264-3) Bottles of 100 (NDC 60505-0264-1) Bottles of 1,000 (NDC 60505-0264-8) Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Dispense in a tight, light-resistant container [see USP]. APOTEX INC. BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS 5 mg/6.25 mg, 10 mg/12.5 mg, 20 mg/12.5 mg and 20 mg/25 mg Rev. 13 September 2020
Abbreviated New Drug Application
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE- BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET APOTEX CORP. ---------- BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS 5 MG/6.25 MG, 10 MG/12.5 MG, 20 MG/12.5 MG AND 20 MG/25 MG RX ONLY 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 molecular formula is C H N O ·HCl, and its molecular weight is 460.96 g/mol. 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 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 24 28 2 5 Its molecular formula is C H ClN O S , and its molecular weight is 297.74 g/mol. Hydrochlorothiazide is a thiazide diuretic. Benazepril hydrochloride and hydrochlorothiazide tablets 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 hydrochloride, USP Soma hati kamili