Label: DARANIDE- dichlorphenamide tablet
- NDC Code(s): 51672-4144-0, 51672-4144-1, 51672-4144-3, 51672-4144-6
- Packager: Taro Pharmaceuticals U.S.A., Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated February 27, 2012
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- HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use DARANIDE ® (dichlorphenamide tablets USP) safely and effectively. See full prescribing information for DARANIDE ® (dichlorphenamide tablets USP).
DARANIDE ® (dichlorphenamide tablets USP)
Initial U.S. Approval: 1958
INDICATIONS AND USAGE
DARANIDE® (dichlorphenamide tablets USP) is an oral carbonic anhydrase inhibitor indicated for the treatment of elevated intraocular pressure. (1)
DOSAGE AND ADMINISTRATION
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)
DOSAGE FORMS AND STRENGTHS
- Tablets: 50 mg (3)
WARNINGS AND PRECAUTIONS
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.
- High-dose aspirin (7.1)
See 17 for PATIENT COUNSELING INFORMATION.
- FULL PRESCRIBING INFORMATION: CONTENTS*
- Sections or subsections omitted from the full prescribing information are not listed.
- 1 INDICATIONS AND USAGE
DARANIDE® (dichlorphenamide tablets USP) is indicated for the treatment of elevated intraoculr pressure.Close
- 2 DOSAGE AND ADMINISTRATION
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.Close
- 3 DOSAGE FORMS AND STRENGTHS
Round, yellow tablets, scored on one side, engraved with "TARO" on one side and on the other side "D" above the score and "50" below the score, 50 mg each.Close
- 4 CONTRAINDICATIONS
4.1 Hepatic Insufficiency
DARANIDE® (dichlorphenamide tablets USP) is contraindicated in hepatic insufficiency.
4.2 Electrolyte Imbalance
DARANIDE® is contraindicated in renal failure, adrenocortical insufficiency, hyperchloremic acidosis, or in conditions in which serum levels of sodium or potassium are depressed.
4.3 Obstructive Pulmonary Disease
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.
- 5 WARNINGS and PRECAUTIONS
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.
- 6 ADVERSE REACTIONS
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.Close
- 7 DRUG INTERACTIONS
7.1 High-dose Aspirin
Anorexia, tachypnea, lethargy and coma have been rarely reported due to a possible drug interaction with high-dose aspirin.
- 8 USE IN SPECIFIC POPULATIONS
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.
8.3 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.
8.5 Geriatric Use
Metabolic acidosis, which can be severe, may occur in the elderly with reduced renal function.
- 10 OVERDOSAGE
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.Close
- 11 DESCRIPTION
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.Close
- 12 CLINICAL PHARMACOLOGY
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.Close
- 13 NONCLINICAL TOXICOLOGY
13.1 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® (dichlorphenamide tablets USP).
- 16 HOW SUPPLIED/STORAGE AND HANDLING
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
- 17 PATIENT COUNSELING INFORMATION
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.Close
- SPL UNCLASSIFIED SECTION
Mfd. by: Taro Pharmaceutical Industries Ltd.
Haifa Bay, Israel 26110
Dist. by: TaroPharma a division ofClose
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532
Daranide® and TaroPharma® are registered
trademarks of Taro Pharmaceuticals U.S.A., Inc.
Issued: February, 2012
- PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
Tablets USP) 50 mg
Keep this and all medications out
of the reach of children.
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51672-4144 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength dichlorphenamide (UNII: VVJ6673MHY) (dichlorphenamide - UNII:VVJ6673MHY) dichlorphenamide 50 mg Inactive Ingredients Ingredient Name Strength D&C yellow no. 10 (UNII: 35SW5USQ3G) aluminum oxide (UNII: LMI26O6933) lactose monohydrate (UNII: EWQ57Q8I5X) magnesium stearate (UNII: 70097M6I30) Product Characteristics Color YELLOW Score 2 pieces Shape ROUND Size 6mm Flavor Imprint Code TARO;D;50 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51672-4144-6 30 in 1 BOTTLE 2 NDC:51672-4144-1 100 in 1 BOTTLE 3 NDC:51672-4144-3 1000 in 1 BOTTLE 4 NDC:51672-4144-0 10 in 1 BOX, UNIT-DOSE 4 10 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA011366 03/16/2012 Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceutical Industries, Ltd. 600072078 MANUFACTURE(51672-4144)