Drug Catalog - Product Detail
BENAZEPRIL HCL & HCTZ TB 5/6.25MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00378-4725-01 | MYLAN | 100 | 5-6.25MG | TABLET |
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Description
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 24 H 28 N 2 O 5 • 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 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 molecular formula is C 7 H 8 ClN 3 O 4 S 2 , and its molecular weight is 297.73. Hydrochlorothiazide is a thiazide diuretic. Benazepril hydrochloride and hydrochlorothiazide tablets are a combination of benazepril hydrochloride and hydrochlorothiazide. The tablets are formulated for oral administration with a combination of 5 mg, 10 mg or 20 mg of benazepril hydrochloride and 6.25 mg, 12.5 mg or 25 mg of hydrochlorothiazide USP. The inactive ingredients are anhydrous lactose, black iron oxide, colloidal silicon dioxide, crospovidone, hypromellose, polydextrose, polyethylene glycol, pregelatinized starch, stearic acid, talc, titanium dioxide, triacetin and yellow iron oxide. Benazepril HCl Structural Formula HCTZ Structural Formula
How Supplied
HOW SUPPLIED Benazepril Hydrochloride and Hydrochlorothiazide Tablets are available containing benazepril hydrochloride USP, 5 mg and hydrochlorothiazide USP, 6.25 mg; benazepril hydrochloride USP, 10 mg and hydrochlorothiazide USP, 12.5 mg; benazepril hydrochloride USP, 20 mg and hydrochlorothiazide USP, 12.5 mg; or benazepril hydrochloride USP, 20 mg and hydrochlorothiazide USP, 25 mg. The 5 mg/6.25 mg tablets are beige film-coated, oval, scored tablets debossed with M 725 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-4725-01 bottles of 100 tablets NDC 0378-4725-05 bottles of 500 tablets The 10 mg/12.5 mg tablets are beige film-coated, round, scored tablets debossed with M above the score and 735 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4735-01 bottles of 100 tablets NDC 0378-4735-05 bottles of 500 tablets The 20 mg/12.5 mg tablets are beige film-coated, capsule-shaped, scored tablets debossed with M to the left of the score and 745 to the right of the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4745-01 bottles of 100 tablets NDC 0378-4745-05 bottles of 500 tablets The 20 mg/25 mg tablets are beige film-coated, oval, scored tablets debossed with M to the left of the score and 775 to the right of the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4775-01 bottles of 100 tablets NDC 0378-4775-05 bottles of 500 tablets 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 using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. REVISED NOVEMBER 2012 BZHCTZ:R3
Indications & Usage
INDICATIONS AND USAGE 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 ).
Dosage and Administration
DOSAGE AND ADMINISTRATION Dose once daily. The dosage may then be increased after 2 to 3 weeks as needed to help achieve blood pressure goals. The maximum recommended dose is 20 mg/25 mg. Switch Therapy A patient whose blood pressure is not adequately controlled with benazapril alone or with hydrochlorothiazide alone may be switched to combination therapy with benazepril hydrochloride and hydrochlorothiazide. The usual recommended starting dose is 10 mg/12.5 mg once daily to control blood pressure. Replacement Therapy The combination may be substituted for the titrated individual components.