Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Dapsone Tablets USP, 25 mg are available as white to creamy white, uncoated round shaped tablets, debossed with “N” above the bisect and “135” below the bisect and plain on other side. Bottle of 30 tablets NDC 70954-135-10 Bottle of 100 tablets NDC 70954-135-20 Dapsone Tablets USP, 100 mg are available as white to creamy white, uncoated round shaped tablets, debossed with “N” above the bisect and “136” below the bisect and plain on other side. Bottle of 30 tablets NDC 70954-136-10 Bottle of 100 tablets NDC 70954-136-20; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL PRINCIPAL DISPLAY PANEL-25 MG CONTAINER LABEL NDC 70954- 135 -10 Dapsone Tablets USP, 25 mg Rx only 30 Tablets NDC 70954- 135 -20 Dapsone Tablets USP, 25 mg Rx only 100 Tablets dap-25mg-30counts dap-25mg-100counts PRINCIPAL DISPLAY PANEL-100 MG CONTAINER LABEL NDC 70954- 136 -10 Dapsone Tablets USP, 100 mg Rx only 30 Tablets NDC 70954- 136 -20 Dapsone Tablets USP, 100 mg Rx only 100 Tablets dap-100mg-30counts dap-100mg-100counts
- HOW SUPPLIED Dapsone Tablets USP, 25 mg are available as white to creamy white, uncoated round shaped tablets, debossed with “N” above the bisect and “135” below the bisect and plain on other side. Bottle of 30 tablets NDC 70954-135-10 Bottle of 100 tablets NDC 70954-135-20 Dapsone Tablets USP, 100 mg are available as white to creamy white, uncoated round shaped tablets, debossed with “N” above the bisect and “136” below the bisect and plain on other side. Bottle of 30 tablets NDC 70954-136-10 Bottle of 100 tablets NDC 70954-136-20
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL PRINCIPAL DISPLAY PANEL-25 MG CONTAINER LABEL NDC 70954- 135 -10 Dapsone Tablets USP, 25 mg Rx only 30 Tablets NDC 70954- 135 -20 Dapsone Tablets USP, 25 mg Rx only 100 Tablets dap-25mg-30counts dap-25mg-100counts PRINCIPAL DISPLAY PANEL-100 MG CONTAINER LABEL NDC 70954- 136 -10 Dapsone Tablets USP, 100 mg Rx only 30 Tablets NDC 70954- 136 -20 Dapsone Tablets USP, 100 mg Rx only 100 Tablets dap-100mg-30counts dap-100mg-100counts
Overview
Dapsone-USP, 4,4'-diaminodiphenylsulfone (DDS), is a primary treatment for Dermatitis herpetiformis. It is an antibacterial drug for susceptible cases of leprosy. It is a white to yellow crystalline powder. Sparingly soluble in alcohol; Soluble in acetone and in dilute mineral acids; practically insoluble in water. Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use. Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch, Magnesium Stearate and Microcrystalline Cellulose. USP Dissolution Test Pending. STRUCTURE
Dosage & Administration
Not available
Warnings & Precautions
WARNINGS The patient should be warned to respond to the presence of clinical signs such as sore throat, fever, pallor, purpura or jaundice. Deaths associated with the administration of Dapsone have been reported from agranulocytosis, aplastic anemia and other blood dyscrasias. Complete blood counts should be done frequently in patients receiving Dapsone. The FDA Dermatology Advisory Committee recommended that, when feasible, counts should be done weekly for the first month, monthly for six months and semi-annually thereafter. If a significant reduction in leucocytes, platelets or hemopoiesis is noted, Dapsone should be discontinued and the patient followed intensively. Folic acid antagonists have similar effects and may increase the incidence of hematologic reactions; if coadministered with Dapsone the patient should be monitored more frequently. Patients on weekly pyrimethamine and Dapsone have developed agranulocytosis during the second and third month of therapy. Severe anemia should be treated prior to initiation of therapy and hemoglobin monitored. Hemolysis and methemoglobin may be poorly tolerated by patients with severe cardiopulmonary disease. Cutaneous reactions, especially bullous, include exfoliative dermatitis and are probably one of the most serious, though rare, complications of sulfone therapy. They are directly due to drug sensitization. Such reactions include toxic erythema, erythema multiforme, toxic epidermal necrolysis, morbilliform and scarlatiniform reactions, urticaria and erythema nodosum. If new or toxic dermatologic reactions occur, sulfone therapy must be promptly discontinued and appropriate therapy instituted. Leprosy reactional states, including cutaneous, are not hypersensitivity reactions to Dapsone and do not require discontinuation. See special section.
Contraindications
Hypersensitivity to Dapsone and/or its derivatives.
Adverse Reactions
In addition to the warnings listed above, the following syndromes and serious reactions have been reported in patients on Dapsone. Hematologic Effects: Dose-related hemolysis is the most common adverse effect and is seen in patients with or without G6PD deficiency. Almost all patients demonstrate the inter-related changes of a loss of 1 to 2g of hemoglobin, an increase in the reticulocytes (2 to 12%), a shortened red cell life span and a rise in methemoglobin. G6PD deficient patients have greater responses. Nervous System Effects: Peripheral neuropathy is a definite but unusual complication of Dapsone therapy in non-leprosy patients. Motor loss is predominant. If muscle weakness appears, Dapsone should be withdrawn. Recovery on withdrawal is usually substantially complete. The mechanism of recovery is reported by axonal regeneration. Some recovered patients have tolerated retreatment at reduced dosage. In leprosy this complication may be difficult to distinguish from a leprosy reactional state. Falsely Reduced HbA1c Falsely reduced HbA1c measurements have been reported with dapsone use. Alternate measures of glycemic control (e.g., fructosamine and/or more frequent blood glucose monitoring) are recommended when a discordance between HbA1c and blood glucose concentrations are observed or suspected. Falsely reduced HbA1c may occur without overt evidence of hemolysis or anemia. Body As A Whole: In addition to the warnings and adverse effects reported above, additional adverse reactions include: nausea, vomiting, abdominal pains, pancreatitis, vertigo, blurred vision, tinnitus, insomnia, fever, headache, psychosis, phototoxicity, pulmonary eosinophilia, tachycardia, albuminuria, the nephrotic syndrome, hypoalbuminemia without proteinuria, renal papillary necrosis, male infertility, drug-induced Lupus erythematosus and an infectious mononucleosis-like syndrome. In general, with the exception of the complications of severe anoxia from overdosage (retinal and optic nerve damage, etc.) these adverse reactions have regressed off drug.
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