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DAPSONE
Overview
What is DAPSONE?
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.
What does DAPSONE look like?
What are the available doses of DAPSONE?
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What should I talk to my health care provider before I take DAPSONE?
Sorry No records found
How should I use DAPSONE?
Dermatitis herpetiformis: (D.H.)
Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.
Dermatitis
herpetiformis
:
Dapsone levels are influenced by acetylation rates. Patients with high acetylation rates, or who are receiving treatment affecting acetylation may require an adjustment in dosage.
A strict gluten free diet is an option for the patient to elect, permitting many to reduce or eliminate the need for Dapsone; the average time for dosage reduction is 8 months with a range of 4 months to 2 1/2 years and for dosage elimination 29 months with a range of 6 months to 9 years.
Lepros
y:
In bacteriologically negative tuberculoid and indeterminate disease, the recommendation is the coadministration of Dapsone 100 mg daily with six months of Rifampin 600 mg daily. Under WHO, daily Rifampin may be replaced by 600 mg Rifampin monthly, if supervised. The Dapsone is continued until all signs of clinical activity are controlled - usually after an additional six months. Then Dapsone should be continued for an additional three years for tuberculoid and indeterminate patients and for five years for borderline tuberculoid patients.
In lepromatous and borderline lepromatous patients, the recommendation is the coadministration of Dapsone 100 mg daily with two years of Rifampin 600 mg daily. Under WHO daily Rifampin may be replaced by 600 mg Rifampin monthly, if supervised. One may elect the concurrent administration of a third anti-leprosy drug, usually either Clofazamine 50 to 100 mg daily or Ethionamide 250 to 500 mg daily. Dapsone 100 mg daily is continued 3 to 10 years until all signs of clinical activity are controlled with skin scrapings and biopsies negative for one year. Dapsone should then be continued for an additional 10 years for borderline patients and for life for lepromatous patients.
Secondary Dapsone resistance should be suspected whenever a lepromatous or borderline lepromatous patient receiving Dapsone treatment relapses clinically and bacteriologically, solid staining bacilli being found in the smears taken from the new active lesions. If such cases show no response to regular and supervised Dapsone therapy within three to six months or good compliance for the past 3 to 6 months can be assured, Dapsone resistance should be considered confirmed clinically. Determination of drug sensitivity using the mouse footpad method is recommended and, after prior arrangement, is available without charge from the USPHS, Carville, LA. Patients with proven Dapsone resistance should be treated with other drugs.
What interacts with DAPSONE?
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What are the warnings of DAPSONE?
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What are the precautions of DAPSONE?
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What are the side effects of DAPSONE?
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What should I look out for while using DAPSONE?
Hypersensitivity to Dapsone and/or its derivatives.
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.
What might happen if I take too much DAPSONE?
Nausea, vomiting, hyperexcitability can appear a few minutes up to 24 hours after ingestion of an overdosage. Methemoglobin induced depression, convulsions or severe cyanosis requires prompt treatment. In normal and methemoglobin reductase deficient patients, methylene blue, 1 to 2 mg/kg of body weight, given slowly intravenously, is the treatment of choice. The effect is complete in 30 minutes, but may have to be repeated if methemoglobin reaccumulates. For non-emergencies, if treatment is needed, methylene blue may be given orally in doses of 3 to 5 mg/kg every 4 to 6 hours. Methylene blue reduction depends on G6PD and should not be given to fully expressed G6PD deficient patients.
How should I store and handle DAPSONE?
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Preserve in tight, light-resistant containers as defined in the USP.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Preserve in tight, light-resistant containers as defined in the USP.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 Bottle of 100 tabletsNDC 10135-0654-30NDC 10135-0654-01Dapsone 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 Bottle of 100 tabletsNDC 10135-0655-30NDC 10135-0655-01Dapsone 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 Bottle of 100 tabletsNDC 10135-0654-30NDC 10135-0654-01Dapsone 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 Bottle of 100 tabletsNDC 10135-0655-30NDC 10135-0655-01Dapsone 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 Bottle of 100 tabletsNDC 10135-0654-30NDC 10135-0654-01Dapsone 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 Bottle of 100 tabletsNDC 10135-0655-30NDC 10135-0655-01Dapsone 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 Bottle of 100 tabletsNDC 10135-0654-30NDC 10135-0654-01Dapsone 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 Bottle of 100 tabletsNDC 10135-0655-30NDC 10135-0655-01Dapsone 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 Bottle of 100 tabletsNDC 10135-0654-30NDC 10135-0654-01Dapsone 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 Bottle of 100 tabletsNDC 10135-0655-30NDC 10135-0655-01Dapsone 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 Bottle of 100 tabletsNDC 10135-0654-30NDC 10135-0654-01Dapsone 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 Bottle of 100 tabletsNDC 10135-0655-30NDC 10135-0655-01Dapsone 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 Bottle of 100 tabletsNDC 10135-0654-30NDC 10135-0654-01Dapsone 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 Bottle of 100 tabletsNDC 10135-0655-30NDC 10135-0655-01Dapsone 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 Bottle of 100 tabletsNDC 10135-0654-30NDC 10135-0654-01Dapsone 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 Bottle of 100 tabletsNDC 10135-0655-30NDC 10135-0655-01
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Actions:
Mycobacterium
leprae
Absorption and Excretion:
Blood
Levels
:
Repeat tests in the same individual are constant. Daily administration (50 to 100 mg) in leprosy patients will provide blood levels in excess of the usual minimum inhibitory concentration even for patients with a short Dapsone half-life.
Non-Clinical Toxicology
Hypersensitivity to Dapsone and/or its derivatives.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.
Rifampin lowers Dapsone levels 7 to 10-fold by accelerating plasma clearance; in leprosy this reduction has not required a change in dosage. Folic acid antagonists such as pyrimethamine may increase the likelihood of hematologic reactions.
A modest interaction has been reported for patients receiving 100 mg Dapsone daily in combination with trimethoprim 5 mg/kg q6h. On Day 7, the serum Dapsone levels averaged 2.1 ± 1.0 mcg/mL in comparison to 1.5 ± 0.5 mcg/mL for Dapsone alone. On Day 7, trimethoprim levels averaged 18.4 ± 5.2 mcg/mL in comparison to 12.4 ± 4.5 mcg/mL for patients not receiving Dapsone. Thus, there is a mutual interaction between Dapsone and trimethoprim in which each raises the level of the other about 1.5 times.
A crossover studydesigned to assess the potential of a drug interaction between Dapsone, 100 mg/day and trimethoprim, 200 mg every 12 hours, in eight asymptomatic HIV positive volunteers (average CD4 count 524 cells/mm) demonstrated that there was not a significant drug intreraction between Dapsone and trimethoprim. However, an earlier reportalso by Lee et al, in 78 HIV infected patients with acute pneumonia, receiving Dapsone, 100 mg/day and higher trimethoprim dose, 20 mg/kg/day, demonstrated that the serum levels of Dapsone were increased by 40% and trimethoprim levels were increased by 48% when the drugs were administered concurrently.
Hemolysis and Heinz body formation may be exaggerated in individuals with a glucose-6-phosphate dehydrogenase (G6PD) deficiency, or methemoglobin reductase deficiency, or hemoglobin M. This reaction is frequently dose-related. Dapsone should be given with caution to these patients or if the patient is exposed to other agents or conditions such as infection or diabetic ketosis capable of producing hemolysis. Drugs or chemicals which have produced significant hemolysis in G6PD or methemoglobin reductase deficient patients include Dapsone, sulfanilamide, nitrite, aniline, phenylhydrazine, napthalene, niridazole, nitro-furantoin and 8-amino-antimalarials such as primaquine.
Toxic hepatitis and cholestatic jaundice have been reported early in therapy. Hyperbilirubinemia may occur more often in G6PD deficient patients. When feasible, baseline and subsequent monitoring of liver function is recommended; if abnormal, Dapsone should be discontinued until the source of the abnormality is established.
In addition to the warnings listed above, the following syndromes and serious reactions have been reported in patients on Dapsone.
Hematologic
Effects:
Nervous
System Effects:
Body
As
A
Whole:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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