Captopril 50 MG Oral Tablet
INDICATIONS AND USAGE Hypertension Captopril tablets, USP are indicated for the treatment of hypertension. In using captopril tablets, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS ). Captopril tablets may be used as initial therapy 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, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations. Captopril tablets are effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive. Heart Failure Captopril tablets are indicated in the treatment of congestive heart failure usually in combination with diuretics and digitalis. The beneficial effect of captopril in heart failure does not require the presence of digitalis, however, most controlled clinical trial experience with captopril has been in patients receiving digitalis, as well as diuretic treatment. Left Ventricular Dysfunction After Myocardial Infarction Captopril tablets are indicated to improve survival following myocardial infarction in clinically stable patients with left ventricular dysfunction manifested as an ejection fraction ≤ 40% and to reduce the incidence of overt heart failure and subsequent hospitalizations for congestive heart failure in these patients. Diabetic Nephropathy Captopril tablets are indicated for the treatment of diabetic nephropathy (proteinuria > 500 mg/day) in patients with type I insulin-dependent diabetes mellitus and retinopathy. Captopril tablets decrease the rate of progression of renal insufficiency and development of serious adverse clinical outcomes (death or need for renal transplantation or dialysis). In considering use of captopril tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS: Head and Neck Angioedema and Intestinal Angioedema ).
sandoz inc.
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HOW SUPPLIED
CAPTOPRIL Tablets, USP are available containing 12.5 mg, 25 mg, 50 mg or 100 mg of
CAPTOPRIL, USP. The 12.5 mg tablets are white to off-white, oval, flat, beveled-edge tablets, debossed with "S1" on one side and partial bisected on both sides. They are available as follows: NDC 0781-8052-01 bottles of 100 tablets NDC 0781-8052-10 bottles of 1000 tablets The 25 mg tablets are white to off-white, round, flat, beveled-edge tablets, debossed with "S2" on one side and quadrisected on the other side. They are available as follows: NDC 0781-8061-01 bottles of 100 tablets NDC 0781-8061-10 bottles of 1000 tablets The 50 mg tablets are white to off-white, round, flat, beveled-edge tablets, debossed with "S3" on one side and bisected on the other side. They are available as follows: NDC 0781-8075-01 bottles of 100 tablets NDC 0781-8075-10 bottles of 1000 tablets The 100 mg tablets are white to off-white, round, flat, beveled-edge tablets, debossed with "S4" on one side and bisected on the other side. They are available as follows: NDC 0781-8080-01 bottles of 100 tablets
CAPTOPRIL tablets, USP may exhibit a slight sulfurous odor. Bottles contain silica gel desiccants. Store at 20o to 25oC (68o to 77oF), excursions permitted to 15o to 30oC (59o to 86oF). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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