Hydrochlorothiazide 12.5 MG Oral Tablet
INDICATIONS AND USAGE Hydrochlorothiazide tablets USP are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets USP have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets USP are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension. Use in pregnancy Routine use of diuretics during normal pregnancy 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 toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see PRECAUTIONS, Pregnancy ). Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary. During normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate.
leading pharma, llc
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HOW SUPPLIED
HYDROCHLOROTHIAZIDE tablets USP, 12.5 mg are available as peach color, round, flat face, beveled edge tablets, debossed “EP” above and “155” below on one side, and plain on the other side containing 12.5 mg of
HYDROCHLOROTHIAZIDE USP, packaged in bottles of 100 (NDC 69315-155-01) and 1000 (NDC 69315-155-10) tablets.
HYDROCHLOROTHIAZIDE tablets USP, 25 mg are available as peach color, round, flat face, beveled edge bisected tablets, debossed "EP" above bisect and "131" below bisect on one side and plain on the other side containing 25 mg of hydrochlorothioazide USP, packaged in bottles of 100 (NDC 69315-131-01), 1000 (NDC 69315-131-10) and 5000 (NDC 69315-131-50) tablets.
HYDROCHLOROTHIAZIDE tablets USP, 50 mg are available as peach color, round, flat face, beveled edge, bisected tablets, debossed "EP" above bisect and "130" below bisect on one side and plain on the other side containing 50 mg of
HYDROCHLOROTHIAZIDE USP, packaged in bottles of 100 (NDC 69315-130-01) and 1000 (NDC 69315-130-10) tablets. Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 Rev.06 04/24
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