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INDICATIONS AND USAGE
Indapamide tablets are indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs.
Indapamide tablets are also indicated for the treatment of salt and fluid retention associated with congestive heart failure.
Usage in Pregnancy
The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard (see PRECAUTIONS).
Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia.
Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Indapamide is indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (however, see PRECAUTIONS). Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is not harmful to either the fetus or the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate.
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DOSAGE AND ADMINISTRATION
Hypertension
The adult starting indapamide dose for hypertension is 1.25 mg as a single daily dose taken in the morning. If the response to 1.25 mg is not satisfactory after four weeks, the daily dose may be increased to 2.5 mg taken once daily. If the response to 2.5 mg is not satisfactory after four weeks, the daily dose may be increased to 5 mg taken once daily, but adding another antihypertensive should be considered.
Edema of congestive heart failure
The adult starting indapamide dose for edema of congestive heart failure is 2.5 mg as a single daily dose taken in the morning. If the response to 2.5 mg is not satisfactory after one week, the daily dose may be increased to 5 mg taken once daily.
If the antihypertensive response to indapamide is insufficient, indapamide may be combined with other antihypertensive drugs, with careful monitoring of blood pressure. It is recommended that the usual dose of other agents be reduced by 50% during initial combination therapy. As the blood pressure response becomes evident, further dosage adjustments may be necessary.
In general, doses of 5 mg and larger have not appeared to provide additional effects on blood pressure or heart failure, but are associated with a greater degree of hypokalemia. There is minimal clinical trial experience in patients with doses greater than 5 mg once a day.
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HOW SUPPLIED
Indapamide Tablets, USP are available as orange, round, unscored, film-coated tablets debossed with company logo and "4262" on one side and “1.25” on the other side, containing 1.25 mg Indapamide, USP packaged in bottles of 30, 100, 500, 1000 and unit-dose boxes of 100 tablets.
Indapamide Tablets, USP are available as white, round, unscored, film-coated tablets debossed with company logo on one side and "4259" on the other side, containing 2.5 mg Indapamide, USP packaged in bottles of 30, 100, 500, 1000 and unit-dose boxes of 100 tablets.
PHARMACIST: Dispense in a tight container as defined in the USP. Use child-resistant closure (as required).
Store at controlled room temperature 15°-30°C (59°-86°F) (See USP).
KEEP CONTAINER TIGHTLY CLOSED
AVOID EXCESSIVE HEAT
MANUFACTURED BY
IVAX PHARMACEUTICALS, INC.
MIAMI, FL 33137
0172
11/03
B8
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