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Naturetin (Bendroflumethiazide) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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

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

NATURETIN tablets 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.

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. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (however, see PRECAUTIONS, Pregnancy: Nonteratogenic Effects 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 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

Therapy should be individualized according to patient response and titrated to obtain maximal therapeutic response as well as the lowest dose possible to maintain that therapeutic response and minimize side effects.

Diuretic

The usual dose is 5 mg once daily, preferably given in the morning. To initiate therapy, doses up to 20 mg may be given once daily or divided into two doses. A single daily dose of 2.5 to 5 mg should suffice for maintenance.

Alternatively, intermittent therapy may be advantageous in many patients. By administering the preparation every other day or on a three to five day per week schedule, electrolyte imbalance is less likely to occur; however, the possibility still exists.

In general, the lowest dosage that achieves the therapeutic response should be employed.

Antihypertensive

The suggested initial dosage is 5 to 20 mg daily. Maintenance dosage may range from 2.5 to 15 mg per day depending on the individual response of the patient. When the diuretic is used with other antihypertensive agents, lower maintenance doses for each drug are usually sufficient.

HOW SUPPLIED

NATURETIN ® (Bendroflumethiazide Tablets USP)

5 mg/tablet: bottles of 100 (NDC 0003-0606-50).

Each green, round, biconvex tablet with bisect bar is imprinted with identification number 606.

10 mg/tablet: bottles of 100 (NDC 0003-0618-50).

Each orange, round, biconvex tablet with bisect bar is imprinted with identification number 618.

Storage

Dispense in tight containers. Store at room temperature; avoid excessive heat.

APOTHECON ®

A Bristol-Myers Squibb Company

Princeton, NJ 08540 USA

1017988A1
Revised August 2000

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