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Chlorothiazide (Chlorothiazide) - Indications and Dosage

 


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INDICATIONS AND USAGE

Chlorothiazide is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy.

Chlorothiazide has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.

Chlorothiazide is 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.

DOSAGE AND ADMINISTRATION

Therapy should be individualized according to patient response. Use the smallest dosage necessary to achieve the required response.

Adults

For Edema

The usual adult dosage is 0.5 g to 1 g once or twice a day. Many patients with edema respond to intermittent therapy, i.e., administration on alternate days or on three to five days each week. With an intermittent schedule, excessive response and the resulting undesirable electrolyte imbalance are less likely to occur.

For Control of Hypertension

The usual adult starting dosage is 0.5 g or 1 g a day as a single or divided dose. Dosage is increased or decreased according to blood pressure response. Rarely some patients may require up to 2 g a day in divided doses.

Infants and Children

For Diuresis and For Control of Hypertension

The usual pediatric dosage is 5 to 10 mg per pound (10 to 20 mg/kg) per day in single or two divided doses, not to exceed 375 mg per day in infants up to 2 years of age or 1 g per day in children 2 to 12 years of age. In infants less than 6 months of age, doses up to 15 mg per pound (30 mg/kg) per day in two divided doses may be required. (See PRECAUTIONS: Pediatric Use.)

HOW SUPPLIED

Chlorothiazide tablets, USP are available containing 250 mg or 500 mg of Chlorothiazide, USP.

The 250 mg tablets are white, round, scored tablets debossed with M to the left of the score and 50 to the right of the score on one side of the tablet and blank on the other side. They are available as follows:

NDC 0378-0150-01
bottles of 100 tablets

The 500 mg tablets are white, round, scored tablets debossed with MYLAN above the score and 162 below the score on one side of the tablet and blank on the other side. They are available as follows:

NDC 0378-0162-01
bottles of 100 tablets

Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505

CTZ:R13

Page last updated: 2006-04-06

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