Hydrochlorothiazide 12.5 MG Oral Capsule
INDICATIONS AND USAGE HydrochloroÂthiazide capsules are indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. Unlike potassium sparing combinaÂtion diuretic products, hydrochloroÂthiazide capsules may be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ACE inhibitors. Usage in Pregnancy: The rouÂtine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecesÂsary hazard. Diuretics do not prevent development of toxÂemia 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. Diuretics are indiÂcated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent edema in pregnanÂcy 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 unnecesÂsary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disÂease), but which is associated with edema, including generalÂized edema in the majority of pregnant women. If this edema produces discomfort, inÂcreased 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.
Aurobindo Pharma Limited
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HOW SUPPLIED
HYDROCHLOROTHIAZIDE capsules USP 12.5 mg are blue/blue size ‘4’ hard gelatin capsules, imprinted with ‘D’ on blue cap and ‘26’ on blue body with black edible ink, filled with white to off-white powder. Bottles of 100 NDC 65862-113-01 Bottles of 300 NDC 65862-113-33 Bottles of 500 NDC 65862-113-05 Bottles of 1,000 NDC 65862-113-99 Dispense in a tight, light-resistant container as defined in the USP. Keep out of reach of children. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light, moisture, freezing, -20°C (-4°F). Keep container tightly closed. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 10/2022
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