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|TABLET||10 BLISTER PACK in 1 BOX, UNIT-DOSE (51672-4144-0) > 10 TABLET in 1 BLISTER PACK||Label Information|
|TABLET||1000 TABLET in 1 BOTTLE (51672-4144-3)||Label Information|
|TABLET||30 TABLET in 1 BOTTLE (51672-4144-6)||Label Information|
|TABLET||100 TABLET in 1 BOTTLE (51672-4144-1)||Label Information|
DARANIDE® (dichlorphenamide tablets USP) is an oral carbonic anhydrase inhibitor indicated for the treatment of elevated intraocular pressure. (1)
The recommended initial dosage for adults is 2 to 4 tablets (100-200 mg). Two tablets (100 mg) should be given every 12 hours until the desired dose response is obtained. The recommended maintenence dosage for adults is one-half to 1 tablet (25-50 mg) one to three times daily. (2)
In acute angle-closure glaucoma, it may be used together with miotics and osmotic agents in an attempt to reduce intraocular pressure rapidly. (2)
Most common adverse reactions include gastrointestinal disturbances (anorexia, nausea, and vomiting), drowsiness and paresthesias. (6)
To report SUSPECTED ADVERSE REACTIONS, call the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION.
The recommended initial dosage for adults is 2 to 4 tablets (100-200 mg). Two tablets (100 mg) should be given every 12 hours until the desired dose response is obtained. The recommended maintenence dosage for adults is one-half to 1 tablet (25-50 mg) one to three times daily.
In acute angle-closure glaucoma, it may be used together with miotics and osmotic agents in an attempt to reduce intraocular pressure rapidly.
DARANIDE® (dichlorphenamide tablets USP) is contraindicated in hepatic insufficiency.
DARANIDE® is contraindicated in renal failure, adrenocortical insufficiency, hyperchloremic acidosis, or in conditions in which serum levels of sodium or potassium are depressed.
DARANIDE® should not be used in patients with severe pulmonary obstruction who are unable to increase their alveolar ventilation since their acidosis may be increased.
DARANIDE® is contraindicated in patients who are hypersensitive to this product.
Potassium excretion is increased by DARANIDE® (dichlorphenamide tablets USP) and hypokalemia may develop.
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.
The most common adverse reactions include gastrointestinal disturbances (anorexia, nausea, and vomiting), drowsiness and paresthesias.
Certain adverse reactions characteristic of carbonic anhydrase inhibitors may result with DARANIDE® (dichlorphenamide tablets USP), particularly with increasing doses. The following are adverse reactions which have been reported with systemic carbonic anhydrase inhibitors. The pharmacological similarities among the carbonic anhydrase inhibitors make it advisable to consider the following reactions when dichlorphenamide is administered: agranulocytosis, ataxia, confusion, constipation, depression, disorientation, dizziness, electrolyte imbalance (hypokalemia, hyperchloremia), fever, globus hystericus, headache, hepatic insufficiency, hyperuricemia, kidney stones, lassitude, leucopenia, metabolic acidosis, nervousness, phosphaturia, pruritus, renal colic, skin eruptions, thrombocytopenia, tinnitus, tremor, urinary frequency, weakness, and weight loss.
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® (dichlorphenamide tablets USP) 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.
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.
Metabolic acidosis, which can be severe, may occur in the elderly with reduced renal function.
Symptoms of overdosage or toxicity may include drowsiness, anorexia, nausea, vomiting, dizziness, paresthesias, ataxia, tremor and tinnitus.
In the event of overdosage, induce emesis or perform gastric lavage. The electrolyte disturbance most likely to be encountered from overdosage is hyperchloremic acidosis that may respond to bicarbonate administrations. Potassium supplementation may be required. The patient should be carefully observed and given supportive treatment.
DARANIDE® (dichlorphenamide tablets USP) is an oral carbonic anhydrase inhibitor. Dichlorphenamide, a dichlorinated benzenedisulfonamide, is known chemically as 4,5-dichloro-1,3-benzenedisulfonamide. Its empirical formula is C6H6Cl2N2O4S2 and its structural formula is:
Dichlorphenamide USP is a white or practically white, crystalline compound with a molecular weight of 305.16. It is very slightly soluble in water but soluble in dilute solutions of sodium carbonate and sodium hydroxide. Dilute alkaline solutions of dichlorphenamide are stable at room temperature.
DARANIDE® (dichlorphenamide tablets USP) is supplied as tablets, for oral administration, each containing 50 mg dichlorphenamide. Inactive ingredients are D&C yellow lake #10, lactose monohydrate, magnesium stearate and pregelatinized starch.
Carbonic anhydrase inhibitors reduce intraocular pressure by partially suppressing the secretion of aqueous humor (inflow), although the mechanism by which they do this is not fully understood. Evidence suggests that bicarbonate ions are produced in the ciliary body by hydration of carbon dioxide under the influence of carbonic anhydrase and diffuse into the posterior chamber with sodium ions. The aqueous fluid contains more sodium and bicarbonate ions than does plasma and consequently is hypertonic. Water is attracted to the posterior chamber by osmosis. Systemic administration of a carbonic anhydrase inhibitor has been shown to inactivate carbonic anhydrase in the ciliary body of the rabbit's eye and to reduce the high concentration of bicarbonate ions in ocular fluids. As is the case with all carbonic anhydrase inhibitors, DARANIDE® (dichlorphenamide tablets USP) in high doses causes some decreases in renal blood flow and glomerular filtration rate.
In man, DARANIDE® (dichlorphenamide tablets USP) begins to act within an hour and maximal effect is observed in two to four hours. The lowered intraocular tension may be maintained for approximately 6 to 12 hours.
Each DARANIDE® (dichlorphenamide tablets USP), 50 mg - round, yellow tablet, scored on one side, engraved with "TARO" on one side and on the other side "D" above the score and "50" below the score.
DARANIDE® (dichlorphenamide tablets USP) is supplied as follows:
|Bottles of 30||NDC 51672-4144-6|
|Bottles of 100||NDC 51672-4144-1|
|Bottles of 1000||NDC 51672-4144-3|
|Unit Dose of 100 (10 ×10)||NDC 51672-4144-0|
Patients should be advised that adverse reactions common to all sulfonamide derivatives may occur, including anaphylaxis, fever, rash (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), crystalluria, renal calculus, bone marrow depression, thrombocytopenic purpura, hemolytic anemia, leucopenia, pancytopenia, and agranulocytosis. If such reactions occur, the drug should be discontinued and appropriate therapy instituted.
Patients should be advised on the potential for anorexia, tachypnea, lethargy, coma, and death with the concomitant use of high-dose aspirin and DARANIDE® (dichlorphenamide tablets USP).
Dichlorphenamide may cause drowsiness/fatigue and myopia in some patients. Patients should be cautioned on the potential for impaired ability to drive and operate machinery.
|Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)|
|Taro Pharmaceutical Industries, Ltd.||600072078||MANUFACTURE(51672-4144)|