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Drug Catalog - Product Detail

HYDROCHLOROTHIAZIDE CP 12.5MG 100

NDC Mfr Size Str Form
29300-0130-01 UNICHEM PHARMACEUTICALS 100 12.5MG CAPSULE
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Description
DESCRIPTION Hydrochlorothiazide is the 3,4-dihydro derivative of chlorothiazide. Its chemical name is 6-Chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C 7 H 8 ClN 3 O 4 S 2 ; its molecular weight is 297.74; and its structural formula is: It is a white, or practically white, crystalline powder which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Hydrochlorothiazide is supplied as 12.5 mg capsules for oral use. Inactive ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate, gelatin, titanium dioxide, sodium lauryl sulfate and black iron oxide. Structure of Hydrochlorothiazide
How Supplied
HOW SUPPLIED Hydrochlorothiazide capsules, USP 12.5 mg are available as hard gelatin capsules with opaque white cap and opaque white body imprinted with "U" on cap and "130" on the body in grey ink along the horizontal axis Bottle of 100: NDC 29300-130-01 Bottle of 500: NDC 29300-130-05 Bottle of 1000: NDC 29300-130-10 Store at 20 0 to 25 0 C (68 0 to 77 0 F) [see USP Controlled Room Temperature]. Protect from light, moisture, freezing, -20 0 C (-4 0 F). Keep container tightly closed. Rx only
Indications & Usage
INDICATIONS AND USAGE Hydrochlorothiazide capsules are indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. Unlike potassium sparing combination diuretic products, hydrochlorothiazide 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 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. Diuretics are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. 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 harmful to neither the fetus nor 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION For Control of Hypertension: The adult initial dose of hydrochlorothiazide capsules is one capsule given once daily whether given alone or in combination with other antihypertensives. Total daily doses greater than 50 mg are not recommended.