No information provided.

General

Potassium excretion is increased by DARANIDE and hypokalemia may develop with brisk diuresis, when severe cirrhosis is present, or during concomitant use of steroids or ACTH.

Interference with adequate oral electrolyte intake will also contribute to hypokalemia. Hypokalemia can sensitize or exaggerate the response of the heart to the toxic effects of digitalis (e.g., increased ventricular irritability). Hypokalemia may be avoided or treated by use of potassium supplements such as foods with a high potassium content. DARANIDE should be used with caution in patients with respiratory acidosis.

Drug Interactions

Caution is advised in patients receiving concomitant high-dose aspirin and carbonic anhydrase inhibitors, as anorexia, tachypnea, lethargy and coma have been rarely reported due to a possible drug interaction.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate the effects upon fertility or carcinogenic potential of DARANIDE.

Pregnancy

Pregnancy Category C. Dichlorphenamide has been shown to be teratogenic in the rat (skeletal anomalies) when given in doses 100 times the human dose. There are no adequate and well-controlled studies in pregnant women. DARANIDE should not be used in women of childbearing age or in pregnancy, especially during the first trimester, unless the potential benefits outweigh the potential risks.

Nursing Mothers

It is not known whether dichlorphenamide is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when dichlorphenamide is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children have not been established.

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