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DARANIDE (Taro Pharmaceuticals U.S.A., Inc.)

Available Formats

Dosage Form Package Information Links
TABLET 30 TABLET in 1 BOTTLE (51672-4144-6) Label Information
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 100 TABLET in 1 BOTTLE (51672-4144-1) Label Information

Complete DARANIDE Information

  • 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)

    CONTRAINDICATIONS

    • Hepatic insufficiency (4.1)
    • Renal failure (4.2)
    • Adrenocortical insufficiency (4.2)
    • Acidosis (Hyperchloremic or Respiratory) (4.2)
    • Hyponatremia or hypokalemia (4.2)
    • Severe Pulmonary obstruction (4.3)
    • Hypersensitivity (4.4)

    WARNINGS AND PRECAUTIONS

    • Potassium excretion is increased by DARANIDE® (5.1)
    • Hypokalemia may develop with brisk diuresis (5.1)

    ADVERSE REACTIONS

    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.

    DRUG INTERACTIONS

    • High-dose aspirin (7.1)

    See 17 for PATIENT COUNSELING INFORMATION.

    Revised: 2/2012


  • FULL PRESCRIBING INFORMATION: CONTENTS*
  • 1 INDICATIONS AND USAGE

    DARANIDE® (dichlorphenamide tablets USP) is indicated for the treatment of elevated intraoculr pressure.


  • 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.


  • 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.


  • 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.

    4.4 Hypersensitivity

    DARANIDE® is contraindicated in patients who are hypersensitive to this product.


  • 5 WARNINGS and PRECAUTIONS

    5.1 Hypokalemia

    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.


  • 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

    8.1 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® (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.

    8.4 Pediatric Use

    Safety and effectiveness in pediatric patients have not been established.

    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.


  • 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:

    Chemical Structure

    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.


  • 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.


  • 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

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


  • 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.


  • SPL UNCLASSIFIED SECTION

    Mfd. by: Taro Pharmaceutical Industries Ltd.
    Haifa Bay, Israel 26110

    Dist. by: TaroPharma a division of
    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

    NDC 51672-4144-1
    100 Tablets

    Daranide®
    (Dichlorphenamide
    Tablets USP) 50 mg

    Keep this and all medications out
    of the reach of children.
    Rx only

    PRINCIPAL DISPLAY PANEL - 100 Tablet  Bottle Label

  • INGREDIENTS AND APPEARANCE
    DARANIDE 
    dichlorphenamide tablet
    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)