Dapsone (Monograph)
Drug class:
- Antimycobacterial Agents
Introduction
Antimycobacterial; antiprotozoal; sulfone.116
Uses for Dapsone
Leprosy
Treatment of leprosy (Hansen's disease) in conjunction with other anti-infectives.105 116 216 217 218
WHO and US National Hansen's Disease Program (NHDP) recommend multidrug therapy (MDT) for treatment of all forms of leprosy, including multibacillary leprosy and paucibacillary leprosy.216 217 218
MDT regimens can rapidly kill Mycobacterium leprae, render patient noninfectious after only a few days of treatment, delay or prevent emergence of resistant M. leprae, and reduce risk of relapse after treatment discontinuance.105 216 MDT regimens do not enhance rate of clearance of dead bacilli from the body;217 such clearance may take years216 and depends largely on individual's immune response, which may be defective in leprosy patients.217 Reactive episodes reported in leprosy patients receiving treatment appear to be due to destruction of M. leprae and immune responses to released bacterial antigens.216 217 (See Leprosy Reactional States under Cautions.)
For treatment of multibacillary leprosy (i.e., ≥6 lesions or skin smear positive) in adults, WHO recommends a 12-month MDT regimen of dapsone (once daily), rifampin (once monthly), and clofazimine (once daily and once monthly).217 218 For treatment of paucibacillary leprosy (i.e., 1–5 lesions) in adults, WHO recommends a 6-month MDT regimen of dapsone (once daily) and rifampin (once monthly).217 218
For US patients, NHDP recommends more prolonged treatment.216 NHDP recommends that adults with multibacillary leprosy (i.e., those who are skin smear positive and/or have biopsy indicating more advanced disease) receive a 24-month MDT regimen of dapsone (once daily), rifampin (once daily), and clofazimine (once daily), and that adults with paucibacillary leprosy (i.e., those who are skin smear negative without evidence of more advanced disease on biopsy) receive a 12-month MDT regimen of dapsone (once daily) and rifampin (once daily).216 Clofazimine (no longer commercially available in US) may be obtained from NHDP under an investigational new drug (IND) protocol for treatment of leprosy.216
Treatment of leprosy is complicated and should be undertaken in consultation with a specialist familiar with the disease.105 116 In the US, clinicians should contact NHDP at 800-642-2477 on weekdays from 9:00 a.m. to 5:30 p.m. Eastern Standard Time or via email at nhdped@hrsa.gov for assistance with diagnosis or treatment of leprosy or assistance obtaining clofazimine for treatment of leprosy.216
Dermatitis Herpetiformis
Treatment of dermatitis herpetiformis.116 211
Gluten-free diet recommended for all patients with dermatitis herpetiformis; strict adherence to such a diet can result in slow resolution of skin lesions (may take months to years) and improvement in GI symptoms.211 Dapsone, used as an adjunct to gluten-free diet,211 usually results in prompt decrease in pruritus and resolution of skin lesions in responsive patients.116 211 Dapsone has no effect on GI component of dermatitis herpetiformis.116 211
Some patients who adhere to strict gluten-free diet may be able to decrease dapsone dosage or discontinue the drug after several months when skin manifestations have responded; may then reinitiate dapsone for brief periods as needed to control flares.211
Pneumocystis jirovecii Pneumonia
Alternative for treatment and prevention of Pneumocystis jirovecii (formerly Pneumocystis carinii) pneumonia† [off-label] (PCP) in adults, adolescents, or children.110 134 153 154 155 156 161 174 176 Designated an orphan drug by FDA for treatment and prevention of PCP.185
Co-trimoxazole is drug of choice for treatment of mild, moderate, or severe PCP in adults, adolescents, and children, including HIV-infected individuals.134 155 156
Dapsone in conjunction with trimethoprim is one of several alternatives recommended by CDC, NIH, and IDSA for treatment of mild to moderate PCP† [off-label] in HIV-infected adults and adolescents when co-trimoxazole cannot be used.155 Although efficacy and safety data limited regarding use for treatment of PCP in children,156 some clinicians also recommend dapsone in conjunction with trimethoprim as an alternative for treatment of mild to moderate PCP in children† [off-label].134 Not included in CDC, NIH, IDSA, and AAP recommendations for treatment of severe PCP.134 155 156
Recommended by CDC, NIH, and IDSA as alternative for prevention of initial episode of PCP (primary prophylaxis)† [off-label] in HIV-infected adults and adolescents who cannot tolerate drug of choice (co-trimoxazole);155 used alone or in conjunction with pyrimethamine (and leucovorin) for primary PCP prophylaxis in HIV-infected adults and adolescents.155
Recommended by CDC, NIH, and IDSA as alternative for long-term suppressive or chronic maintenance therapy (secondary prophylaxis) of PCP† [off-label] in HIV-infected adults and adolescents who cannot tolerate drug of choice (co-trimoxazole);155 used alone or in conjunction with pyrimethamine (and leucovorin) for secondary PCP prophylaxis in HIV-infected adults and adolescents.155
Recommended by CDC, NIH, IDSA, and AAP as alternative for primary and secondary PCP prophylaxis in HIV-infected children and infants ≥1 month of age† who cannot tolerate drug of choice (co-trimoxazole);156 used alone for primary and secondary PCP prophylaxis in HIV-infected pediatric patients.156
Toxoplasmosis
Alternative for primary prophylaxis to prevent initial episode of toxoplasmosis caused by Toxoplasma gondii † in HIV-infected adults, adolescents, and children.134 155 156 Designated an orphan drug by FDA for toxoplasmosis prophylaxis in severely immunocompromised individuals with CD4+ T-cell counts <100/mm3.185
Recommended by CDC, NIH, and IDSA as preferred alternative for prevention of initial episodes of toxoplasmosis (primary prophylaxis)† in HIV-infected adults and adolescents who cannot tolerate drug of choice (co-trimoxazole);155 used in conjunction with pyrimethamine (and leucovorin) for primary toxoplasmosis prophylaxis in HIV-infected adults and adolescents.155
Recommended by CDC, NIH, IDSA, and AAP as preferred alternative for primary toxoplasmosis prophylaxis† in HIV-infected children and infants ≥1 month of age who cannot tolerate drug of choice (co-trimoxazole);156 used in conjunction with pyrimethamine (and leucovorin) for primary toxoplasmosis prophylaxis in HIV-infected pediatric patients.156
Not included in CDC, NIH, IDSA, and AAP recommendations for treatment of toxoplasmosis or chronic maintenance therapy to prevent relapse of toxoplasmosis (secondary prophylaxis) in HIV-infected adults, adolescents, and children.155 156
Dapsone Dosage and Administration
Administration
Oral Administration
Administer orally.116
For those unable to swallow tablets whole, the tablets have been crushed and dissolved in strawberry syrup; bioavailability of such preparations not evaluated to date.a
Dosage
Pediatric Patients
Leprosy
Multibacillary Leprosy
OralChildren 10–14 years of age: WHO recommends 50 mg once daily in conjunction with oral rifampin (450 mg once monthly) and oral clofazimine (50 mg once every other day and 150 mg once monthly) given for 12 months.217
Children <10 years of age: WHO recommends appropriately adjusted dosage based on weight217 218 (e.g., dapsone 2 mg/kg once daily in conjunction with rifampin [10 mg/kg once monthly] and clofazimine [1 mg/kg once every other day] given for 12 months).218
US children: NHDP recommends 1 mg/kg once daily in conjunction with oral rifampin (10–20 mg/kg [up to 600 mg] once daily) and oral clofazimine (1 mg/kg once daily or 2 mg/kg once every other day) given for 24 months.216
Paucibacillary Leprosy
OralChildren 10–14 years of age: WHO recommends 50 mg once daily in conjunction with oral rifampin (450 mg once monthly) given for 6 months.217
Children <10 years of age: WHO recommends appropriately adjusted dosage based on weight217 218 (e.g., dapsone 2 mg/kg once daily in conjunction with rifampin [10 mg/kg once monthly] given for 6 months).218
US children: NHDP recommends 1 mg/kg once daily in conjunction with oral rifampin (10–20 mg/kg [up to 600 mg] once daily) given for 12 months.216
Dermatitis Herpetiformis
Oral
Individually titrate dosage to find daily dosage that most effectively controls pruritus and lesions; daily dosage should then be reduced to a minimum maintenance dosage as soon as possible.116
Manufacturer states dosage in children should be based on usual adult dosage using correspondingly smaller doses.116 (See Adult Dosage under Dosage and Administration).
Pneumocystis jirovecii Pneumonia (PCP)†
Treatment of Mild to Moderate PCP†
OralChildren: 2 mg/kg (up to 100 mg) once daily for 21 days in conjunction with oral trimethoprim (5 mg/kg 3 times daily for 21 days).134 156
Adolescents ≥13 years of age: 100 mg once daily for 21 days in conjunction with oral trimethoprim (5 mg/kg 3 times daily for 21 days).134 155
Prevention of Initial Episode (Primary Prophylaxis) of PCP†
OralChildren ≥1 month of age: 2 mg/kg (up to 100 mg) once daily or 4 mg/kg (up to 200 mg) once weekly.134 156
Adolescents ≥13 years of age: 100 mg once daily or 50 mg twice daily.134 155 Alternatively, 50 mg once daily in conjunction with oral pyrimethamine (50 mg once weekly) and oral leucovorin (25 mg once weekly).155 Alternatively, 200 mg once weekly in conjunction with oral pyrimethamine (75 mg once weekly) and oral leucovorin (25 mg once weekly).155
Infants born to HIV-infected mothers: Initiate primary PCP prophylaxis at 4–6 weeks of age and continue until infant found to be non-HIV-infected or presumptively non-HIV-infected.156
HIV-infected infants <1 year of age: Initiate primary PCP prophylaxis regardless of CD4+ T-cell count or CD4+ percentage;156 at minimum, continue throughout first year of life.156
HIV-infected children 1 to <6 years of age: Initiate primary PCP prophylaxis if CD4+ T-cell count <500/mm3 or CD4+ percentage <15%.156
HIV-infected children 6–12 years of age: Initiate primary PCP prophylaxis if CD4+ T-cell count <200/mm3 or CD4+ percentage <15%.156
Consider discontinuing primary PCP prophylaxis in HIV-infected children 1 to <6 years of age who have received ≥6 months of antiretroviral therapy and have CD4+ T-cell counts that have remained ≥500/mm3 or CD4+ percentages that have remained ≥15% for >3 months.156 Assess CD4+ T-cell count and CD4+ percentage every 3 months; reinitiate if indicated based on age-specific thresholds.156
Consider discontinuing primary PCP prophylaxis in HIV-infected children 6–12 years of age who have received ≥6 months of antiretroviral therapy and have CD4+ T-cell counts that have remained ≥200/mm3 or CD4+ percentages that have remained ≥15% for >3 months.156 Assess CD4+ T-cell count and CD4+ percentage every 3 months; reinitiate if indicated based on age-specific thresholds.156
Criteria for initiating or discontinuing primary PCP prophylaxis† in HIV-infected adolescents are the same as those recommended for adults.155 (See Adult Dosage under Dosage and Administration.)
Prevention of Recurrence (Secondary Prophylaxis) of PCP†
OralChildren ≥1 month of age: 2 mg/kg (up to 100 mg) once daily or 4 mg/kg (up to 200 mg) once weekly.134 156
Adolescents ≥13 years of age: 100 mg once daily or 50 mg twice daily.134 155 Alternatively, 50 mg once daily in conjunction with oral pyrimethamine (50 mg once weekly) and oral leucovorin (25 mg once weekly).155 Alternatively, 200 mg once weekly in conjunction with oral pyrimethamine (75 mg once weekly) and oral leucovorin (25 mg once weekly).155
Initiate secondary PCP prophylaxis in all HIV-infected infants and children with a history of PCP.156
Consider discontinuing secondary PCP prophylaxis in HIV-infected children 1 to <6 years of age who have received ≥6 months of antiretroviral therapy and have CD4+ T-cell counts that have remained ≥500/mm3 or CD4+ percentages that have remained ≥15% for >3 months.156 Assess CD4+ T-cell count and CD4+ percentage every 3 months; reinitiate if indicated based on age-specific thresholds.156
Consider discontinuing secondary PCP prophylaxis in HIV-infected children 6–12 years of age who have received ≥6 months of antiretroviral therapy and have CD4+ T-cell counts that have remained ≥200/mm3 or CD4+ percentages that have remained ≥15% for >3 months.156 Assess CD4+ T-cell count and CD4+ percentage every 3 months; reinitiate if indicated based on age-specific thresholds.156
Criteria for initiating or discontinuing secondary PCP prophylaxis in HIV-infected adolescents are the same as those recommended for adults.155 (See Adult Dosage under Dosage and Administration.)
Toxoplasmosis†
Prevention of Initial Episode (Primary Prophylaxis) of Toxoplasmosis†
OralChildren ≥1 month of age: 2 mg/kg or 15 mg/m2 (up to 25 mg) once daily in conjunction with oral pyrimethamine (1 mg/kg [up to 25 mg] once daily) and oral leucovorin (5 mg once every 3 days).156
Adolescents: 50 mg once daily in conjunction with oral pyrimethamine (50 mg once weekly) and oral leucovorin (25 mg once weekly).155 Alternatively, 200 mg once weekly in conjunction with oral pyrimethamine (75 mg once weekly) and oral leucovorin (25 mg once weekly).155
HIV-infected children seropositive for T. gondii: Initiate primary toxoplasmosis prophylaxis in those <6 years of age if CD4+ T-cell percentage <15% and in those ≥6 years of age if CD4+ T-cell count <100/mm3.156
Consider discontinuing primary toxoplasmosis prophylaxis in HIV-infected children 1 to <6 years of age who have received ≥6 months of antiretroviral therapy and have CD4+ T-cell percentages that have remained ≥15% for >3 months.156 Reinitiate if CD4+ T-cell percentage decreases to <15%.156
Consider discontinuing primary toxoplasmosis prophylaxis in HIV-infected children ≥6 years of age who have received ≥6 months of antiretroviral therapy and have CD4+ T-cell counts that have remained >200/mm3 for >3 months.156 Reinitiate if CD4+ T-cell count decreases to <100–200/mm3.156
Criteria for initiating or discontinuing primary toxoplasmosis prophylaxis in HIV-infected adolescents are the same as those recommended for adults.155 (See Adult Dosage under Dosage and Administration.)
Adults
Leprosy
Multibacillary Leprosy
OralWHO recommends 100 mg once daily in conjunction with oral rifampin (600 mg once monthly) and oral clofazimine (50 mg once daily and 300 mg once monthly) given for 12 months.217 218
US adults: NHDP recommends 100 mg once daily in conjunction with oral rifampin (600 mg once daily) and oral clofazimine (50 mg once daily) given for 24 months.216
Paucibacillary Leprosy
OralWHO recommends 100 mg once daily in conjunction with oral rifampin (600 mg once monthly) given for 6 months.217 218
US adults: NHDP recommends 100 mg once daily in conjunction with oral rifampin (600 mg once daily) given for 12 months.216
Dermatitis Herpetiformis
Oral
Individually titrate dosage to find daily dosage that most effectively controls pruritus and lesions; daily dosage should then be reduced to a minimum maintenance dosage as soon as possible.116
Manufacturer recommends 50 mg daily initially;116 if full control not achieved within the range of 50–300 mg daily, higher dosage may be tried.116
Some clinicians state that dosages of 25–100 mg daily usually control symptoms.211
Occasional new lesions (3 or 4 per week) may occur during maintenance therapy and generally are not an indication to alter maintenance dosage.a Maintenance dosage often can be reduced or the drug discontinued after several months in patients who adhere to a gluten-free diet.211 Manufacturer states that average time for dosage reduction is 8 months (range 4 months to 2.5 years) and average time before discontinuance is 29 months (range 6 months to 9 years).116
Pneumocystis jirovecii Pneumonia (PCP)†
Treatment of Mild to Moderate PCP†
Oral100 mg once daily in conjunction with oral trimethoprim (5 mg/kg 3 times daily) for 21 days.134 155
Prevention of Initial Episode (Primary Prophylaxis) of PCP†
Oral100 mg once daily or 50 mg twice daily.134 155
Alternatively, 50 mg once daily in conjunction with oral pyrimethamine (50 mg once weekly) and oral leucovorin (25 mg once weekly).134 155
Alternatively, 200 mg once weekly in conjunction with oral pyrimethamine (75 mg once weekly) and oral leucovorin (25 mg once weekly).134 155
Initiate primary PCP prophylaxis in HIV-infected adults with CD4+ T-cell counts <200/mm3 or a history of oropharyngeal candidiasis.155 Also consider primary PCP prophylaxis if CD4+ T-cell percentage <14% or there is a history of an AIDS-defining illness.155 Also consider in those with CD4+ T-cell counts >200/mm3 but <250/mm3 if frequent monitoring (e.g., every 3 months) not possible.155
Discontinue primary PCP prophylaxis in HIV-infected adults responding to antiretroviral therapy who have CD4+ T-cell counts that have remained >200/mm3 for >3 months.155
Reinitiate primary PCP prophylaxis if CD4+ T-cell count decreases to <200/mm3.155
Prevention of Recurrence (Secondary Prophylaxis) of PCP†
Oral100 mg once daily or 50 mg twice daily.134 155
Alternatively, 50 mg once daily in conjunction with oral pyrimethamine (50 mg once weekly) and oral leucovorin (25 mg once weekly).134 155
Alternatively, 200 mg once weekly in conjunction with oral pyrimethamine (75 mg once weekly) and oral leucovorin (25 mg once weekly).134 155
Initiate secondary PCP prophylaxis in all HIV-infected adults with a history of PCP.155
Consider discontinuing secondary PCP prophylaxis in HIV-infected adults who have responded to antiretroviral therapy and have CD4+ T-cell counts that have remained >200/mm3 for >3 months.155 Reinitiate secondary PCP prophylaxis if CD4+ T-cell count decreases to <200/mm3 or PCP recurs when CD4+ T-cell count >200/mm3.155
Consider continuing secondary prophylaxis for life (regardless of CD4+ T-cell count) if PCP occurred or recurred when CD4+ T-cell count >200/mm3.155
Toxoplasmosis†
Prevention of Initial Episode (Primary Prophylaxis) of Toxoplasmosis†
Oral50 mg once daily in conjunction with oral pyrimethamine (50 mg once weekly) and oral leucovorin (25 mg once weekly).155
Alternatively, 200 mg once weekly in conjunction with oral pyrimethamine (75 mg once weekly) and oral leucovorin (25 mg once weekly).155
Initiate primary toxoplasmosis prophylaxis in all HIV-infected adults seropositive for Toxoplasma IgG antibody who have CD4+ T-cell counts <100/mm3.155
Discontinue primary toxoplasmosis prophylaxis in HIV-infected adults responding to antiretroviral therapy who have CD4+ T-cell counts that have remained >200/mm3 for >3 months.155
Reinitiate primary toxoplasmosis prophylaxis if CD4+ T-cell count decreases to <100–200/mm3.155
Prescribing Limits
Pediatric Patients
Leprosy
Multibacillary or Paucibacillary Leprosy
OralMaximum 100 mg once daily.105
Pneumocystis jirovecii Pneumonia (PCP)†
Prevention of Initial Episode (Primary Prophylaxis) of PCP† or Prevention of Recurrence (Secondary Prophylaxis) of PCP†
OralChildren ≥1 month of age: Maximum 100 mg once daily134 156 or maximum 200 mg once weekly.134 156
Toxoplasmosis†
Prevention of Initial Episode (Primary Prophylaxis) of Toxoplasmosis†
OralChildren ≥1 month of age: Maximum 25 mg once daily.156
Special Populations
No special population dosage recommendation at this time.a
Cautions for Dapsone
Contraindications
-
Hypersensitivity to dapsone or dapsone derivatives.116
Warnings/Precautions
Warnings
Hematologic Effects
Agranulocytosis, aplastic anemia, and other blood dyscrasias reported; fatalities have occurred.116
Patients with severe anemia should be treated for anemia before dapsone is initiated; monitor hemoglobin.116
Hemolysis and Heinz body formation may be exaggerated in individuals with glucose-6-dehydrogenase (G-6-PD) deficiency, methemoglobin reductase deficiency, or hemoglobin M.116 Use with caution in such patients.116 Some clinicians recommend screening for G-6-PD deficiency prior to initiating dapsone, especially in HIV-infected individuals.160 161 162 164
Use with caution in patients who are exposed to other drugs or agents that are capable of inducing hemolysis (see Interactions) and in patients with conditions associated with hemolysis (e.g., certain infections, diabetic ketosis).116 Hemolysis and methemoglobin may be poorly tolerated by patients with severe cardiopulmonary disease.116
Sensitivity Reactions
Hypersensitivity Reactions
Hypersensitivity to dapsone may rarely result in serious cutaneous reactions (e.g., bullous reactions, exfoliative dermatitis, toxic erythema, erythema multiforme, toxic epidermal necrolysis, morbilliform and scarlatiniform reactions, urticaria, erythema nodosum).116
If new or toxic dermatologic reactions occur, promptly discontinue dapsone and institute appropriate therapy.116
Sulfone Syndrome
A potentially fatal hypersensitivity reaction with symptoms of fever, malaise, jaundice (with hepatic necrosis), exfoliative dermatitis, lymphadenopathy, methemoglobinemia, and hemolytic anemia may occur.a
General Precautions
Dermatologic Reactions
Adverse cutaneous effects may occur, including exfoliative dermatitis, toxic erythema, erythema multiforme, toxic epidermal necrolysis, morbilliform and scarlatiniform eruptions, urticaria, and erythema nodosum.116 a
If new or toxic dermatologic reactions occur, discontinue dapsone and initiate appropriate therapy.116
Rash occurs in about 30–40% of AIDS patients receiving dapsone in conjunction with trimethoprim,161 162 but occurs less frequently in those receiving dapsone monotherapy.162
Nervous System Effects
Peripheral neuropathy with motor loss reported rarely with high dapsone dosage (200–500 mg daily).116 a
If muscle weakness occurs, discontinue dapsone.116 Complete recovery may occur if the drug is withdrawn, but may take many months to several years.116 a
Insomnia, headache, nervousness, vertigo, and psychosis also reported.116
Hepatic Effects
Toxic hepatitis and cholestatic jaundice reported.116 Cholestatic jaundice may be a hypersensitivity reaction and generally appears to be reversible following discontinuance of dapsone.a
Adverse hepatic effects reported shortly after initiation of dapsone therapy and may be manifested by increased serum concentrations of alkaline phosphatase, AST, bilirubin, and LDH.113 Liver function test abnormalities occur more frequently when dapsone is used in conjunction with trimethoprim than when dapsone monotherapy is used.162
Laboratory Monitoring
Monitor hemoglobin, hematocrit, and methemoglobin concentrations periodically, particularly in HIV-infected individuals receiving dapsone in conjunction with trimethoprim.160 161 162 164 (See Specific Drugs under Interactions.)
Perform CBCs frequently.116 When feasible, perform CBCs once weekly during first month of therapy, once monthly for the next 6 months, and once every 6 months thereafter.116 If a substantial reduction in leukocytes, platelets, or hematopoiesis is evident, discontinue dapsone and monitor patient closely.116
When feasible, perform baseline liver function tests and monitor during therapy.116 If any abnormality in liver function is evident, discontinue dapsone until the source of the abnormality is established.116
Leprosy Reactional States
In patients with leprosy, effective treatment with dapsone or other antileprosy agents generally results in abrupt changes in clinical and immune state and many patients have reactive episodes (reactions) that may be mild to severe.105 116 216 Leprosy reactive episodes can occur before, during, or after treatment is completed and apparently result from destruction of M. leprae and immune response to released bacterial antigens.216 217
Reactive episodes are classified into 2 types: reversal reactions (type 1) and erythema nodosum leprosum (ENL) reactions (type 2).116 Other reactions (e.g., neuritis or silent neuropathies, iridocyclitis, orchitis) also can occur independently of reactive episodes.216
Reversal reactions (type 1) usually evidenced by edema and erythema of pre-existing lesions;216 presumably occur because `patient is able to mount an enhanced delayed hypersensitivity response to residual infection leading to swelling of existing skin and nerve lesions.116 Existing lesions become erythematous and edematous and may ulcerate; fever and increased WBC count occur frequently; acute neuritis and loss of nerve function may develop.116 a
ENL reactions (type 2) are recurrent immunologically mediated reactions203 205 206 and usually manifest with fever and painful erythematous nodules; peripheral neuritis, orchitis, lymphadenitis, iridocyclitis, nephritis, periostitis, arthralgia, malaise, albuminuria, epistaxis, or depression may also occur.116 216 ENL reported less frequently with currently recommended MDT regimens that include clofazimine compared with dapsone monotherapy.204 208 These reactions considered to be a manifestation of the disease rather than an adverse reaction to antileprosy regimens.116 206 207 208
Treatment of leprosy reactional states depends on severity of manifestations;105 114 116 129 132 195 207 209 216 severe reactions may require hospitalization.116 132 Antileprosy regimen usually continued despite occurrence of a leprosy reactional state116 129 130 132 216 and, if nerve injury or skin ulceration threatened, corticosteroids are administered.129
Reversal reactions that include neuritis or ulceration always require corticosteroid treatment (e.g., prednisone 1 mg/kg daily);116 216 only short course of corticosteroid treatment may be needed if patient has only minimally active disease and no neuritis, but prolonged treatment (4–6 months) may be required in those with neuritis.216 Mild ENL reactions may require no treatment or only symptomatic measures (e.g., analgesics); corticosteroid treatment generally effective and always indicated in those with acute neuritis to prevent permanent nerve injury.216 Thalidomide and clofazimine also effective for treatment of ENL reactions.114 116 129 130 132 192 195 204 207 216
Early diagnosis and treatment of leprosy reactional states is important since these reactions are associated with considerable morbidity, especially if chronic recurrent ENL occurs.105 195 196 203 204
Therapy for leprosy and leprosy reactional states should be undertaken in consultation with an expert in the treatment of leprosy.203 In the US, clinicians should consult NHDP at 800-642-2477 on weekdays from 9:00 a.m. to 5:30 p.m. Eastern Standard Time or via email at nhdped@hrsa.gov for information on management of leprosy reactional states.116 216 216
Specific Populations
Pregnancy
Category C.116
In patients with leprosy, some clinicians recommend maintaining dapsone treatment during pregnancy.116 In addition, dapsone has been important for management of dermatitis herpetiformis in some pregnant women.116
Infertility has been reported in some males receiving dapsone;116 fertility may be restored following discontinuance of the drug.a
Lactation
Distributed into milk;116 hemolytic reactions can occur in neonates.116 Discontinue nursing or the drug, taking into account the importance of the drug to the woman.116
Pediatric Use
Labeled for treatment of leprosy and for treatment of dermatitis herpetiformis in children.116 Generally considered to have no effect on growth, development, and functional development of children.116
Although data limited regarding efficacy and safety in children, dapsone in conjunction with trimethoprim recommended as alternative for treatment of mild to moderate PCP in children† and dapsone monotherapy recommended as alternative for primary and secondary PCP prophylaxis in HIV-infected children ≥1 month of age† (see Pneumocystis jirovecii Pneumonia under Uses).156 Dapsone in conjunction with pyrimethamine (and leucovorin) recommended as alternative for primary prophylaxis of toxoplasmosis in HIV-infected children ≥1 month of age† (see Toxoplasmosis under Uses).156
Common Adverse Effects
Dose-related hemolytic anemia and methemoglobinemia.116 a
Drug Interactions
Drugs Associated with Adverse Hematologic Effects
Increased risk of adverse hematologic effects if used with folic acid antagonists (e.g., pyrimethamine); monitor more frequently than usual for adverse hematologic effects.116 a
Increased risk of hemolysis in patients with G-6-PD deficiency if used with other drugs or agents capable of inducing hemolysis in these individuals (e.g., nitrite, aniline, phenylhydrazine, naphthalene, niridazole, nitrofurantoin, primaquine); use caution.116 a
Specific Drugs
Drug |
Interaction |
Comments |
---|---|---|
Clofazimine |
Dapsone may interfere with some anti-inflammatory effects of clofazimine in patients with ENL reactions121 122 123 126 |
Higher clofazimine dosage may be needed to control ENL reactions121 122 123 126 |
Didanosine |
Possible decreased GI absorption of dapsone and decreased dapsone efficacy for PCP prophylaxis (greater relapse rate) reported in some HIV-infected patients receiving didanosine159 Studies using buffered didanosine indicate no clinically important effect on dapsone peak concentrations or AUC183 |
Some clinicians suggest that dapsone and buffered didanosine doses be administered at least 2 hours apart159 |
Pyrimethamine |
Additive adverse hematologic effects; increased risk of agranulocytosis116 |
Monitor more frequently than usual for adverse hematologic effects116 |
Rifamycins (rifabutin, rifampin, rifapentine) |
Rifabutin: Decreased dapsone AUC215 Rifampin: May accelerate dapsone metabolism;213 decreased dapsone concentrations reported114 116 Rifapentine: May accelerate dapsone metabolism214 |
Rifampin: Dosage adjustments may be needed;213 dosage adjustments not needed when used with dapsone for treatment of leprosy114 116 Rifapentine: Dosage adjustments may be needed214 |
Trimethoprim |
Increased dapsone concentrations116 161 162 and increased risk of dapsone-associated adverse effects (e.g., methemoglobinemia);162 possible increased trimethoprim concentrations,116 162 but no evidence of increased risk of trimethoprim-associated adverse effects162 |
Monitor periodically for potential toxicity (e.g., methemoglobinemia)160 162 |
Dapsone Pharmacokinetics
Absorption
Bioavailability
Rapidly and almost completely absorbed from GI tract.116 Peak serum concentrations attained within 2–8 hours.116
At least 8 days of daily administration is necessary to attain steady-state concentrations; steady-state serum concentrations average 2.3 mcg/mL (range 0.1–7 mcg/mL) with an oral dosage of 200 mg daily.116
Distribution
Extent
Distributes into most tissues.a
Crosses the placenta.128
Distributed into human milk.116
Plasma Protein Binding
50–90% bound to plasma proteins.128 135 136
Monoacetyldapsone (the major metabolite) is almost completely bound to plasma proteins.128 135 136
Elimination
Metabolism
Metabolized by acetylation in the liver to monoacetyl and diacetyl derivatives.128 a Rate of acetylation is genetically determined.a
Elimination Route
20% of dose excreted in urine as unchanged drug;a 70–85% excreted in urine as water-soluble metabolites;116 a small amount excreted in feces.a
Hemodialysis enhances elimination of dapsone and its monoacetyl derivative.104
Half-life
Average 20–30 hours (range 10–83 hours).116 a Large interindividual variation.116 a
Stability
Storage
Oral
Tablets
20–25°C.116 Protect from light.116
Actions and Spectrum
-
Bacteriostatic and weakly bactericidal against Mycobacterium leprae.116 216 217
-
Antibacterial activity of dapsone is inhibited by p-aminobenzoic acid (PABA).a Therefore, it probably has a mechanism of action similar to that of sulfonamides which involves inhibition of folic acid synthesis in susceptible organisms.a
-
May inhibit alternate pathway of complement activation and interfere with the myeloperoxidase-H2O2-halide-mediated cytotoxic system within neutrophils.126 127
-
Stimulates neutrophil motility and121 126 inhibits spontaneous and induced synthesis of prostaglandin E2 by polymorphonuclear leukocytes obtained from healthy individuals or patients with leprosy.122 123
-
Mechanism of action in treatment of dermatitis herpetiformis unknown.116 Dapsone only suppresses the disease; cutaneous IgA and complement deposition not affected by the drug.a May act as an immunomodulator when used in the treatment of this and other dermatologic diseases.a
-
Active against M. leprae,116 a M. tuberculosis,a and some other mycobacteria.a Has some activity against Pneumocystis jirovecii (formerly Pneumocystis carinii)110 111 112 and Plasmodium.a
-
Resistance to dapsone may occur in M. leprae;116 strains resistant to both dapsone and clofazimine, but susceptible to rifampin, reported rarely.117
Advice to Patients
-
Importance of completing full course of therapy, even if feeling better after a few days.116
-
Importance of discontinuing drug and informing clinician if rash or any sign of adverse reaction (sore throat, fever, pallor, purpura, jaundice, muscle weakness) occurs.116
-
Advise leprosy patients regarding the signs and symptoms of neuritis and the importance of immediately reporting such signs or symptoms to a clinician.105 (See Leprosy Reactional States under Cautions.)
-
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.116
-
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.116
-
Importance of informing patients of other important precautionary information.116 (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes |
Dosage Forms |
Strengths |
Brand Names |
Manufacturer |
---|---|---|---|---|
Oral |
Tablets |
25 mg* |
Dapsone Tablets (scored) |
|
100 mg* |
Dapsone Tablets (scored) |
AHFS DI Essentials™. © Copyright 2024, Selected Revisions April 10, 2024. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.
References
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