Product Description.:
M 83
tablet , peach , double-scored , round round
Biconvex
CAPOZIDE? (captopril and hydrochlorothiazide tablets, USP) for oral administration combines two antihypertensive agents: CAPOTEN? (captopril) and hydrochlorothiazide. Captopril, the first of a new class of antihypertensive agents, is a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Hydrochlorothiazide is a benzothiadiazide (thiazide) diuretic-antihypertensive. CAPOZIDE? tablets are available in four combinations of captopril with hydrochlorothiazide: 25 mg with 15 mg, 25 mg with 25 mg, 50 mg with 15 mg, and 50 mg with 25 mg. Inactive ingredients: microcrystalline cellulose, colorant (FD&C Yellow No. 6), lactose, magnesium stearate, pregelatinized starch, and stearic acid.
Captopril is a white to off-white crystalline powder that may have a slight sulfurous odor it is soluble in water (approx. 160 mg/mL), methanol, and ethanol and sparingly soluble in chloroform and ethyl acetate.
Hydrochlorothiazide is a white crystalline powder slightly soluble in water but freely soluble in sodium hydroxide solution.
INDICATIONS
CAPOZIDE? (captopril and hydrochlorothiazide tablets, USP) is indicated for the treatment of hypertension. The blood pressure lowering effects of captopril and thiazides are approximately additive.
This fixed combination drug may be used as initial therapy or substituted for previously titrated doses of the individual components.
When captopril and hydrochlorothiazide are given together it may not be necessary to administer captopril in divided doses to attain blood pressure control at trough (before the next dose). Also, with such a combination, a daily dose of 15 mg of hydrochlorothiazide may be adequate.
Treatment may, therefore, be initiated with CAPOZIDE? 25 mg/15 mg once daily. Subsequent titration should be with additional doses of the components (captopril, hydrochlorothiazide) as single agents or as CAPOZIDE? 50 mg/15 mg, 25 mg/25 mg, or 50 mg/25 mg (see DOSAGE AND ADMINISTRATION).
In using CAPOZIDE?, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS).
CAPOZIDE? may be used for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, CAPOZIDE? should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to other drug combinations.
SIDE EFFECTS
Captopril
Reported incidences are based on clinical trials involving approximately 7000 patients.
Renal: About one of 100 patients developed proteinuria (see WARNINGS).
Each of the following has been reported in approximately 1 to 2 of 1000 patients and are of uncertain relationship to drug use: renal insufficiency, renal failure, nephrotic syndrome, polyuria, oliguria, and urinary frequency.
