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DAPSONE tablet


  1. No Title 1572548445
  2. Description
  3. Clinical Pharmacology
  4. Indications And Usage
  5. Contraindication
  6. Warnings
  7. Precautions
  8. Adverse Reactions
  9. Overdosage
  10. Dosage And Administration
  11. How Supplied
  12. References
  13. Dapsone Tablet
  14. Package Labeling (55695-005-00)
  15. Description
  16. Clinical Pharmacology
  17. Indications And Usage
  18. Contraindication
  19. Warnings
  20. Precautions
  21. Adverse Reactions
  22. Overdosage
  23. Dosage And Administration
  24. Leprosy Reactional States
  25. How Supplied
  26. References
  27. Repackaging Information
  28. Principal Display Panel - 25 Mg Tablet Bottle Label
  29. Principal Display Panel - 100 Mg Tablet Bottle Label
  30. Dapsone Tablets, Usp 25 Mg And 100 Mg
  31. Contraindications
  32. No Title 1572455368
  33. Rx Only Description

No Title 1572548445 

NDC 47781-334-31

Dapsone Tablets, USP

100 mg

30 Tablets (2 X 15 unit-of-use)

To be sold as a single unit
Rx only

100-mg-carton

DAPSONE
dapsone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47781-333
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
dapsone (UNII: 8W5C518302) (dapsone - UNII:8W5C518302) dapsone 25 mg
Inactive Ingredients
Ingredient Name Strength
croscarmellose sodium (UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
magnesium stearate (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
silicon dioxide (UNII: ETJ7Z6XBU4)
Product Characteristics
Color white (white) Score 2 pieces
Shape ROUND (ROUND) Size 6mm
Flavor Imprint Code F19;25
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:47781-333-31 2 in 1 CARTON 06/13/2016
1 15 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205429 06/13/2016
DAPSONE
dapsone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47781-334
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
dapsone (UNII: 8W5C518302) (dapsone - UNII:8W5C518302) dapsone 100 mg
Inactive Ingredients
Ingredient Name Strength
croscarmellose sodium (UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
magnesium stearate (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
silicon dioxide (UNII: ETJ7Z6XBU4)
Product Characteristics
Color white (white) Score 2 pieces
Shape ROUND (ROUND) Size 9mm
Flavor Imprint Code F20;100
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:47781-334-31 2 in 1 CARTON 06/13/2016
1 15 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205429 06/13/2016
Labeler - Alvogen Inc. (008057330)

Revised: 9/2019 Alvogen Inc.

Description  

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, odorless crystalline powder, practically in-soluble in water and insoluble in fixed and vegetable oils.

Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use.

Figure

Inactive Ingredients: Colloidal silicone dioxide, magnesium stearate, microcrystalline cellulose and corn starch.

Clinical Pharmacology  

Actions: The mechanism of action in Dermatitis herpetiformis has not been established. By the kinetic method in mice, Dapsone is bactericidal as well as bacteriostatic against Mycobacterium leprae.

Absorption and Excretion: Dapsone, when given orally, is rapidly and almost completely absorbed. About 85 percent of the daily intake is recoverable from the urine mainly in the form of water-soluble metabolites. Excretion of the drug is slow and a constant blood level can be maintained with the usual dosage.

Blood Levels: Detected a few minutes after ingestion, the drug reaches peak concentration in 4-8 hours. Daily administration for at least eight days is necessary to achieve a plateau level. With doses of 200 mg daily, this level averaged 2.3 g/ml with a range of 0.1-7.0 g/ml. The half-life in the plasma in different individuals varies from ten hours to fifty hours and averages twenty-eight hours. Repeat tests in the same individual are constant. Daily administration (50 - 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.

Indications And Usage  

Dermatitis herpetiformis: (D.H.)

Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.

Contraindication  

Hypersensitivity to Dapsone and/or its derivatives.

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 co-administered 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.

Precautions  

General: 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.

Drug Interactions: 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 study 1 designed 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 3) demonstrated that there was not a significant drug intreraction between Dapsone and trimethoprim. However, an earlier report 2 also by Lee et al, in 78 HIV infected patients with acute Pneumocystis carinii 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.

Carcinogenesis, mutagenesis: Dapsone has been found carcinogenic (sarcomagenic) for male rats and female mice causing mesenchymal tumors in the spleen and peritoneum, and thyroid carcinoma in female rats. Dapsone is not mutagenic with or without microsomal activation in S. typhimurium tester strains 1535, 1537, 1538, 98, or 100.

Pregnancy: Teratogenic Effects. Pregnancy Category C: Animal reproduction studies have not been conducted with Dapsone. Extensive, but uncontrolled experience and two published surveys on the use of Dapsone in pregnant women have not shown that Dapsone increases the risk of fetal abnormalities if administered during all trimesters of pregnancy or can affect reproduction capacity. Because of the lack of animal studies or controlled human experience, Dapsone should be given to a pregnant woman only if clearly needed. In general, for leprosy, USPHS at Carville recommends maintenance of Dapsone. Dapsone has been important for the management of some pregnant D.H. patients.

Nursing Mothers: Dapsone is excreted in breast milk in substantial amounts. Hemolytic reactions can occur in neonates. See section on hemolysis. Because of the potential for tumorgenicity shown for Dapsone in animal studies a decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of drug to the mother.

Pediatric Use: Pediatric patients are treated on the same schedule as adults but with correspondingly smaller doses. Dapsone is generally not considered to have an effect on the later growth, development and functional development of the pediatric patient.

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.

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.

Overdosage  

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.

Dosage And Administration  

Dermatitis herpetiformis: The dosage should be individually titrated starting in adults with 50 mg daily and correspondingly smaller doses in children. If full control is not achieved within the range of 50 to 300 mg daily, higher doses may be tried. Dosage should be reduced to a minimum maintenance level as soon as possible. In responsive patients there is a prompt reduction in pruritus followed by clearance of skin lesions. There is no effect on the gastrointestinal component of the disease. 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.

Leprosy: In order to reduce secondary Dapsone resistance, the WHO Expert Committee on Leprosy and the USPHS at Carville, LA, recommended that Dapsone should be commenced in combination with one or more anti-leprosy drugs. In the multidrug program Dapsone should be maintained at the full dosage of 100 mg daily without interruption (with corresponding smaller doses for children) and provided to all patients who have sensitive organisms with new or recrudescent disease or who have not yet completed a two year course of Dapsone monotherapy. For advice and other drugs, the USPHS at Carville, LA (1-800-642-2477) should be contacted. Before using other drugs consult appropriate product labeling.

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 co-administration 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 to100 mg daily or Ethionamide 250 to 500 mg daily. Dapsone 100 mg daily is continued 3 to10 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.

How Supplied  

Dapsone Tablets USP, 25 mg are available as round white scored tablets, debossed 25 above and 102 below the score and on the obverse JACOBUS in a Unit of Use carton of 30 tablets (2 x 15). The blisters are light and child-resistant. NDC 49938-102-30.

Dapsone Tablets USP, 100 mg are available as round white scored tablets, debossed 100 above and 101 below the score and on the obverse JACOBUS in a Unit of Use carton of 30 tablets (2 x 15).The blisters are light and child-resistant. NDC 49938-101-30.

Dapsone Tablets USP, 25 mg are available as round white scored tablets, debossed 25 above and 102 below the score and on the obverse JACOBUS in a Unit of Use carton of 28 tablets (2 x 14). The blisters are light and child-resistant. NDC 49938-102-28.

Dapsone Tablets USP, 100 mg are available as round white scored tablets, debossed 100" above and 101 below the score and on the obverse JACOBUS in a Unit of Use carton of 28 tablets (2 x 14). The blisters are light and child-resistant. NDC 49938-101-28.

References  

  1. Lee, B., et al., Zidovudine, Trimethoprim, and Dapsone Pharmacokinetic Interactions in Patients with HIV Infection. Antimicrobial Agents and Chemotherapy, May 1996; 1231-1236.
  2. Lee, B., et al., Dapsone, Trimethoprim, and Sulfamethoxazole Plasma Levels During Treatment of Pneumocystis Carinii Pneumonia in Patients with AIDS, Annals of Internal Medicine, 1989; 110:606-611.

Rx Only.

Manufactured by:
Nostrum Laboratories Inc.
Kansas City, MO 64120

Marketed/ Packaged by:
GSMS, Inc.
Camarillo, CA 93012 USA

Rev: 00

November 2013

Principal Display Panel 25 mg Bottle Label

NDC 60429-495-30

DAPSONE Tablets USP

25 mg

30 Tablets

Rx Only

60429-495-30OL - DAPSONE 25 MG TABS - REV NOV 2013.jpg

Principal Display Panel 100 mg Bottle Label

NDC 60429-496-30

DAPSONE Tablets USP

100 mg

30 Tablets

Rx Only

60429-496-30OL - DAPSONE 100 MG TABS - REV NOV 2013.jpg

DAPSONE
dapsone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-495(NDC:29033-036)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DAPSONE (UNII: 8W5C518302) (DAPSONE - UNII:8W5C518302) DAPSONE 25 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
Product Characteristics
Color white (white to off-white) Score 2 pieces
Shape OVAL Size 8mm
Flavor Imprint Code ND2
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:60429-495-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/09/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203887 05/09/2016
DAPSONE
dapsone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-496(NDC:29033-037)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DAPSONE (UNII: 8W5C518302) (DAPSONE - UNII:8W5C518302) DAPSONE 100 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
Product Characteristics
Color white (white to off-white) Score 2 pieces
Shape OVAL Size 13mm
Flavor Imprint Code ND1
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:60429-496-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/09/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203887 05/09/2016
Labeler - Golden State Medical Supply, Inc. (603184490)
Establishment
Name Address ID/FEI Business Operations
Golden State Medical Supply, Inc. 603184490 repack(60429-495, 60429-496) , relabel(60429-495, 60429-496)

Revised: 11/2018 Golden State Medical Supply, Inc.

Dapsone Tablet 

Label Image
DAPSONE
dapsone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68151-2693(NDC:13925-504)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DAPSONE (UNII: 8W5C518302) (DAPSONE - UNII:8W5C518302) DAPSONE 25 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
Product Characteristics
Color white (white) Score 2 pieces
Shape ROUND (ROUND) Size 6mm
Flavor Imprint Code 25;102;JACOBUS
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68151-2693-1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 12/28/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086841 03/04/2016
Labeler - Carilion Materials Management (079239644)
Establishment
Name Address ID/FEI Business Operations
Carilion Materials Management 079239644 REPACK(68151-2693)

Revised: 12/2017 Carilion Materials Management

Package Labeling (55695-005-00) 

Label1

DAPSONE
dapsone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55695-025(NDC:49938-101)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DAPSONE (UNII: 8W5C518302) (DAPSONE - UNII:8W5C518302) DAPSONE 100 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
Product Characteristics
Color white (white) Score 2 pieces
Shape ROUND (ROUND) Size 8mm
Flavor Imprint Code JACOBUS;100;101
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55695-025-00 2 in 1 CARTON
1 15 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086842 08/15/2008
DAPSONE
dapsone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55695-005(NDC:49938-102)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DAPSONE (UNII: 8W5C518302) (DAPSONE - UNII:8W5C518302) DAPSONE 25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
Product Characteristics
Color white (white) Score 2 pieces
Shape ROUND (ROUND) Size 6mm
Flavor Imprint Code JACOBUS;25;102
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55695-005-00 2 in 1 CARTON
1 15 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086841 08/15/2008
Labeler - Department of State Health Services, Pharmacy Branch (781992540)

Revised: 3/2016 Department of State Health Services, Pharmacy Branch

Description 

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, odorless crystalline powder, practically in-soluble in water and insoluble in fixed and vegetable oils.

Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use.

Figure

Inactive Ingredients: Croscarmellose sodium, magnesium stearate and silicified microcrystalline cellulose.

Clinical Pharmacology 

Actions: The mechanism of action in Dermatitis herpetiformis has not been established. By the kinetic method in mice, Dapsone is bactericidal as well as bacteriostatic against Mycobacterium leprae.

Absorption and Excretion: Dapsone, when given orally, is rapidly and almost completely absorbed. About 85 percent of the daily intake is recoverable from the urine mainly in the form of water-soluble metabolites. Excretion of the drug is slow and a constant blood level can be maintained with the usual dosage.

Blood Levels: Detected a few minutes after ingestion, the drug reaches peak concentration in 4 to 8 hours. Daily administration for at least eight days is necessary to achieve a plateau level. With doses of 200 mg daily, this level averaged 2.3 mcg/ml with a range of 0.1 to 7.0 mcg/ml. The half-life in the plasma in different individuals varies from ten hours to fifty hours and averages twenty-eight hours. 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.

Indications And Usage 

Dermatitis herpetiformis: (D.H.)

Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.

Contraindication 

Hypersensitivity to Dapsone and/or its derivatives.

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 patients followed intensively. Folic acid antagonists have similar effects and may increase the incidence of hematologic reactions; if co-administered 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.

Precautions 

General

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, naphthalene, 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.

Drug Interactions

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, 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 study 1 designed 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 3) demonstrated that there was not a significant drug interaction between Dapsone and trimethoprim. However, an earlier report 2 also by Lee et al, in 78 HIV infected patients with acute Pneumocystis carinii 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.

Carcinogenesis, mutagenesis

Dapsone has been found carcinogenic (sarcomagenic) for male rats and female mice causing mesenchymal tumors in the spleen and peritoneum, and thyroid carcinoma in female rats. Dapsone is not mutagenic with or without microsomal activation in S. typhimurium tester strains 1535, 1537, 1538, 98, or 100.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Dapsone. Extensive, but uncontrolled experience and two published surveys on the use of Dapsone in pregnant women have not shown that Dapsone increases the risk of fetal abnormalities if administered during all trimesters of pregnancy or can affect reproduction capacity. Because of the lack of animal studies or controlled human experience, Dapsone should be given to a pregnant woman only if clearly needed. In general, for leprosy, USPHS at Carville recommends maintenance of Dapsone. Dapsone has been important for the management of some pregnant D.H. patients.

Nursing Mothers

Dapsone is excreted in breast milk in substantial amounts. Hemolytic reactions can occur in neonates. See section on hemolysis. Because of the potential for tumorgenicity shown for Dapsone in animal studies a decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of drug to the mother.

Pediatric Use

Pediatric patients are treated on the same schedule as adults but with correspondingly smaller doses. Dapsone is generally not considered to have an effect on the later growth, development and functional development of the pediatric patient.

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 or 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.

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.

Overdosage 

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.

To report SUSPECTED ADVERSE REACTIONS contact AvKARE, Inc. at 1-855-361-3993; email drugsafety@avkare.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Dosage And Administration 

Dermatitis herpetiformis

The dosage should be individually titrated starting in adults with 50 mg daily and correspondingly smaller doses in children. If full control is not achieved within the range of 50 to 300 mg daily, higher doses may be tried. Dosage should be reduced to a minimum maintenance level as soon as possible. In responsive patients there is a prompt reduction in pruritus followed by clearance of skin lesions. There is no effect on the gastrointestinal component of the disease. 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 years and for dosage elimination 29 months with a range of 6 months to 9 years.

Leprosy

In order to reduce secondary Dapsone resistance, the WHO Expert Committee on Leprosy and the USPHS at Carville, LA, recommended that Dapsone should be commenced in combination with one or more anti-leprosy drugs. In the multidrug program Dapsone should be maintained at the full dosage of 100 mg daily without interruption (with corresponding smaller doses for children) and provided to all patients who have sensitive organisms with new or recrudescent disease or who have not yet completed a two year course of Dapsone monotherapy. For advice and other drugs, the USPHS at Carville, LA (1-800-642-2477) should be contacted. Before using other drugs consult appropriate product labeling.

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 co-administration 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 Clofazimine 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 are 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.

Leprosy Reactional States  

Abrupt changes in clinical activity occur in leprosy with any effective treatment and are known as reactional states. The majority can be classified into two groups. The Reversal reaction (Type 1) may occur in borderline or tuberculoid leprosy patients often soon after chemotherapy is started. The mechanism is presumed to result from a reduction in the antigenic load: the patient is able to mount an enhanced delayed hypersensitivity response to residual infection leading to swelling ( Reversal ) of existing skin and nerve lesions. If severe, or if neuritis is present, large doses of steroids should always be used. If severe, the patient should be hospitalized. In general anti-leprosy treatment is continued and therapy to suppress the reaction is indicated such as analgesics, steroids, or surgical decompression of swollen nerve trunks. USPHS at Carville, LA should be contacted for advice in management.

Erythema nodosum leprosum (ENL) (lepromatous reaction) (Type 2 reaction) occurs mainly in lepromatous patients and small numbers of borderline patients. Approximately 50% of treated patients show this reaction in the first year. The principal clinical features are fever and tender erythematous skin nodules sometimes associated with malaise, neuritis, orchitis, albuminuria, joint swelling, iritis, epistaxis or depression. Skin lesions can become pustular and/or ulcerate. Histologically there is a vasculitis with an intense polymorphonuclear infiltrate. Elevated circulating immune complexes are considered to be the mechanism of reaction. If severe, patients should be hospitalized. In general, anti-leprosy treatment is continued. Analgesics, steroids, and other agents available from USPHS, Carville, LA, are used to suppress the reaction.

How Supplied 

Dapsone Tablets USP, 25 mg are available as White to Off-white, Oval shaped Tablets Debossed with ND2 on one side and scored on other side in a bottle of 30 tablets. NDC 60429-495-30.

Dapsone Tablets USP, 100 mg are available as White to Off-white, Oval shaped Tablets Debossed with ND1 on one side and scored on other side in a bottle of 30 tablets. NDC 60429-496-30.

Store at 20 to 25 C (68 to 77 F). [see USP Controlled Room Temperature]. Protect from light.
As with all medications, keep out of reach of children.

References 

  1. Lee, B., et al., Zidovudine, Trimethoprim, and Dapsone Pharmacokinetic Interactions in Patients with HIV Infection. Antimicrobial Agents and Chemotherapy, May 1996; 1231-1236.
  2. Lee, B., et al., Dapsone, Trimethoprim, and Sulfamethoxazole Plasma Levels During Treatment of Pneumocystis Carinii Pneumonia in Patients with AIDS, Annals of Internal Medicine, 1989; 110:606-611.

Rx only

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

Mfg. Rev. 03/16
AV 05/17 (P)



Repackaging Information 

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count 25mg
30 43353-222-30
Count 100mg
30 43353-223-30

Store between 20 -25 C (68 -77 F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions - TN
Cookeville, TN 38506

20171025JH

Principal Display Panel - 25 Mg Tablet Bottle Label 

AvKARE
NDC 42291-298-90
Dapsone Tablets, USP
25 mg
90 Tablets
Rx Only

Each tablet contains:
25 mg Dapsone, USP.
Usual Dosage: Read accompanying literature.
Store at 20 to 25 C (68 to 77 F) [See USP Controlled Room Temperature]. Protect from light.

Keep out of the reach of children.
Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

Mfg. Rev. 03/16
AV 05/17 (P)

N3 4229129890 3

3

Principal Display Panel - 100 Mg Tablet Bottle Label 

AvKARE
NDC 42291-299-90
Dapsone Tablets, USP
100 mg
90 Tablets
Rx Only

Each tablet contains:
100 mg Dapsone, USP
Usual Dosage: Read accompanying literature.
Store at 20 to 25 C (68 to 77 F) [See USP Controlled Room Temperature]. Protect from light.

Keep out of the reach of children.
Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

Mfg. Rev. 03/16
AV 05/17 (P)

N3 4229129990 0

22
DAPSONE
dapsone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-298(NDC:69543-150)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DAPSONE (UNII: 8W5C518302) (DAPSONE - UNII:8W5C518302) DAPSONE 25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
Product Characteristics
Color white (white to off-white) Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code 25;102;NCP
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42291-298-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/17/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204074 05/17/2017
DAPSONE
dapsone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-299(NDC:69543-151)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DAPSONE (UNII: 8W5C518302) (DAPSONE - UNII:8W5C518302) DAPSONE 100 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
Product Characteristics
Color white (white to off-white) Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code 100;101;NCP
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42291-299-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/17/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204074 05/17/2017
Labeler - AvKARE, Inc. (796560394)

Revised: 1/2018 AvKARE, Inc.

Dapsone Tablets, Usp 25 Mg And 100 Mg  

Rx only

Contraindications  

Hypersensitivity to dapsone and/or its derivatives.

No Title 1572455368 

NDC 47781-333-31
Dapsone Tablet, USP 25 mg
Mfg. for Alvogen, Inc.
1 X 15 Unit-of-Use

25-mg-blister

Rx Only Description  

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, odorless crystalline powder, practically in-soluble in water and insoluble in fixed and vegetable oils.

Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use.

Chemical Structure

Inactive Ingredients: Colloidal silicone dioxide, magnesium stearate, microcrystalline cellulose and corn starch.



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