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Basic Drug Info
Drug Name:Indapamide
Manufacturer:Actavis Elizabeth LLC
Other Info:



Clinical Trials:


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.
Hypertensive disease -- Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more.

Congestive heart failure -- complication of heart diseases; defective cardiac filling and/or impaired contraction and emptying, resulting in the heart's inability to pump a sufficient amount of blood to meet the needs of the body tissues or to be able to do so only with an elevated filling pressure.

Pre-Eclampsia -- A complication of PREGNANCY, characterized by a complex of symptoms including maternal HYPERTENSION and PROTEINURIA with or without pathological EDEMA. Symptoms may range between mild and severe. Pre-eclampsia usually occurs after the 20th week of gestation, but may develop before this time in the presence of trophoblastic disease.

Edema -- Abnormal fluid accumulation in TISSUES or body cavities. Most cases of edema are present under the SKIN in SUBCUTANEOUS TISSUE.

Fluid overload -- abnormal increase in the volume of circulating fluid (plasma) in the body.

Cardiovascular Diseases -- Pathological conditions involving the CARDIOVASCULAR SYSTEM including the HEART; the BLOOD VESSELS; or the PERICARDIUM.

GENERALIZED EDEMA --

Sensory Discomfort -- A feeling of mental or physical uneasiness, pain, or distress.

Contraindications

Anuria.

Known hypersensitivity to indapamide or to other sulfonamide-derived drugs.
Anuria -- Absence of urine formation. It is usually associated with complete bilateral ureteral (URETER) obstruction, complete lower urinary tract obstruction, or unilateral ureteral obstruction when a solitary kidney is present.

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

Severe cases of hyponatremia, accompanied by hypokalemia, have been reported with recommended doses of indapamide.

This occurred primarily in elderly females.

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 (less than 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.

(See DOSAGE AND ADMINISTRATION).Hypokalemia occurs commonly with diuretics (see ADVERSE REACTIONS), and electrolyte monitoring is essential, particularly in patients who would be at increased risk from hypokalemia, such as those with cardiac arrhythmias or who are receiving concomitant cardiac glycosides.In general, diuretics should not be given concomitantly with lithium because they reduce its renal clearance and add a high risk of lithium toxicity.

Read prescribing information for lithium preparations before use of such concomitant therapy.
Branded Drugs
The following US Branded drugs contain Indapamide


LOZOL -- SANOFI AVENTIS US LLC


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