Dapsone (Systemic)

Use dapsone as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• To gain the most benefit, do not miss doses.
• Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
• Take with or without food.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Diaminodiphenylsulfone

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Generic: 25 mg, 100 mg

Competitive antagonist of para-aminobenzoic acid (PABA) and prevents normal bacterial utilization of PABA for the synthesis of folic acid

Absorption

Rapid and almost complete

Distribution

Vd: 1.5 L/kg (Zuidema 1986)

Metabolism

Hepatic (acetylation and hydroxylation); forms multiple metabolites (Zuidema 1986)

Excretion

Urine (~85% as metabolites)

Time to Peak

4 to 8 hours

Half-Life Elimination

Children: 15.1 hours (Mirochnick 1993); Adults: 28 hours (range: 10 to 50 hours)

Protein Binding

Dapsone: 70% to 90%; Metabolite: ~99% (Zuidema 1986)

Treatment of leprosy (due to susceptible strains of Mycobacterium leprae) and dermatitis herpetiformis

Hypersensitivity to dapsone or any component of the formulation

Dermatitis herpetiformis: Infants, Children, and Adolescents: Oral: 0.5 to 2 mg/kg/day in 1 to 2 divided doses; maximum initial daily dose in adults: 50 mg/day; once lesions controlled, the dose may be decreased as tolerated for chronic therapy; usual range: 0.125 to 0.5 mg/kg/day (Ermacora 1986; Kliegman 2011)

Leprosy: Children and Adolescents: Oral:

Tuberculoid (paucibacillary):

National Hansen's Disease Program: 1 to 2 mg/kg daily (maximum daily dose: 100 mg/day) in combination with rifampin for 12 months (NHDP [HRSA 2016]; Red Book [AAP] 2015).

World Health Organization (WHO 2012):

<10 years: 2 mg/kg daily in combination with rifampin for 6 months.

≥10 years to ≤14 years: 50 mg daily in combination with rifampin for 6 months.

>14 years: Refer to adult dosing.

Lepromatous (multibacillary):

National Hansen's Disease Program: 1 mg/kg daily (maximum daily dose: 100 mg/day) in combination with rifampin and clofazimine for 24 months (NHDP [HRSA 2016]; Red Book [AAP] 2015).

World Health Organization (WHO 2012):

<10 years: 2 mg/kg daily in combination with rifampin and clofazimine for 12 months.

≥10 years to ≤14 years: 50 mg daily in combination with rifampin and clofazimine for 12 months.

>14 years: Refer to adult dosing.

Immune thrombocytopenia (off-label use): Children ≥3 years and Adolescents: Oral: 1 to 2 mg/kg/day (Damodar 2005, Meeker 2003).

Pneumocystis pneumonia (PCP) in HIV-exposed/-positive patients (off-label use): Oral:

Prophylaxis (primary or secondary; alternative to preferred therapy):

Infants and Children: 2 mg/kg/day once daily (maximum dose: 100 mg daily) or 4 mg/kg/dose once weekly (maximum dose: 200 mg) (HHS [OI pediatric] 2015)

Adolescents: Refer to adult dosing.

Treatment (mild to moderate disease; alternative to preferred therapy):

Infants and Children: 2 mg/kg/day once daily (maximum dose: 100 mg daily) in combination with trimethoprim for 21 days (HHS [OI pediatric] 2015)

Adolescents: Refer to adult dosing.

Toxoplasma gondii encephalitis in HIV-exposed/-positive patients (alternative to preferred therapy) (off-label use): Primary prophylaxis: Oral:

Infants and Children: 2 mg/kg/dose or 15 mg/m2/dose once daily (maximum daily dose: 25 mg/day), in combination with pyrimethamine and leucovorin (HHS [OI pediatric] 2015)

Adolescents (mild to moderate disease): Refer to adult dosing.

Oral: Administer with meals if GI upset occurs.