Indapamide

INDICATIONS 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 below). 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. …

• 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 4 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 4 weeks, the daily dose may be increased to 5.0 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 5.0 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 5.0 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 5.0 mg once a day

• Safety and effectiveness of indapamide
• In pediatric patients have not been established

Clinical studies of indapamide did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. …

• Anuria
• Known hypersensitivity to indapamide or to other sulfonamide-derived drugs

Other Antihypertensives : Indapamide may add to or potentiate the action of other antihypertensive drugs. In limited controlled trials that compared the effect of indapamide combined with other antihypertensive drugs with the effect of the other drugs administered alone, there was no notable change in the nature or frequency of adverse reactions associated with the combined therapy. Lithium : See WARNINGS . Post-Sympathectomy Patient : The antihypertensive effect of the drug may be enhanced in the post-sympathectomized patient. …

Severe cases of hyponatremia, accompanied by hypokalemia have been reported with recommended doses of indapamide. This occurred primarily in elderly females. (See PRECAUTIONS , Geriatric Use .) This appears to be dose related. Also, a large case-controlled pharmacoepidemiology study indicates that there is an increased risk of hyponatremia with indapamide 2.5 mg and 5 mg doses. Hyponatremia considered possibly clinically significant (< 125 mEq/L) has not been observed in clinical trials with the 1.25 mg dosage (see PRECAUTIONS ). Thus, patients should be started at the 1.25 mg dose and maintained at the lowest possible dose. …

Most adverse effects have been mild and transient. The clinical adverse reactions listed in Table 1 represent data from Phase II/III placebo-controlled studies (306 patients given indapamide 1.25 mg). The clinical adverse reactions listed in Table 2 represent data from Phase II placebo-controlled studies and long-term controlled clinical trials (426patients given indapamide 2.5 mg or 5.0 mg). The reactions are arranged into two groups: 1) a cumulative incidence equal to or greater than 5%; 2)a cumulative incidence less than 5%. Reactions are counted regardless of relation to drug. …

Pregnancy : Teratogenic Effects : Reproduction studies have been performed in rats, mice and rabbits at doses up to 6,250 times the therapeutic human dose and have revealed no evidence of impaired fertility or harm to the fetus due to indapamide. Postnatal development in rats and mice was unaffected by pretreatment of parent animals during gestation. There are, however, no adequate and well-controlled studies in pregnant women. …

Symptoms of overdosage include nausea, vomiting, weakness, gastrointestinal disorders and disturbances of electrolyte balance. In severe instances, hypotension and depressed respiration may be observed. If this occurs, support of respiration and cardiac circulation should be instituted. There is no specific antidote. An evacuation of the stomach is recommended by emesis and gastric lavage after which the electrolyte and fluid balance should be evaluated carefully.

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