chlorthalidone tablet
INDICATIONS AND USAGE Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Usage in Pregnancy: The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. 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. Chlorthalidone is indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (however, see PRECAUTIONS , below). 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 that is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but that 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 that is not relieved by rest. In these cases, a short course of diuretics may provide relief and be appropriate.
jubilant cadista pharmaceuticals,inc.
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HOW SUPPLIED
CHLORTHALIDONE Tablets, USP are available containing 25 mg or 50 mg of
CHLORTHALIDONE, USP. The 25 mg tablets are light-yellow colored, round shaped, uncoated, flat, bevelled edge tablets, debossed with '103'on one side of the tablet and blank on the other side. They are available as follows: NDC 59746-760-01 Bottles of 100 with child-resistant closure NDC 59746-760-36 Bottles of 1000 with child-resistant closure The 50 mg tablets are light-green colored, round shaped, uncoated, flat, bevelled edge scored tablets, debossed with 'I' to the left and '3'to the right of the score on one side of the tablet and blank on the other side. They are available as follows: NDC 59746-761-01 Bottles of 100 with child-resistant closure Store at 20 to 25° C (68 to 77° F). [See USP Controlled Room Temperature]. Protect from light. Keep container tightly closed. Avoid excessive heat. Dispense in a tight container as defined in the USP. Keep out of the reach of children. This product should be dispensed in a container with a child-resistant cap. Manufactured by: Inventia Healthcare Limited, F1-F1/1-F75/1, Additional Ambernath M.I.D.C., Ambernath (East)-421506, Dist. Thane, Maharashtra, India Distributed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA. ATE0614L/02 REVISED: February 2022
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