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Dapsone

    DEA Class; Rx

    Common Brand Names; Aczone

    • Antileprosy Agents, 
    • Acne Agents, Topical

    Synthetic sulfone chemically similar to sulfonamides
    Has antiinfective and immunosuppressive properties
    Agent of choice for all forms of leprosy; used for PCP prophylaxis; used in combination with pyrimethamine for prevention of toxoplasmosis in AIDS patients; used for various dermatologic disorders and topically for acne.

    Indicated for the treatment of dermatitis herpetiformis.

    For the treatment leprosy (Hansen’s disease).
    For the treatment of acne vulgaris.
    For the treatment of actinomycotic mycetoma.
    For the treatment of granuloma annulare.
    For the treatment of chronic immune thrombocytopenic purpura (ITP).
    For the treatment of Pneumocystis pneumonia (PCP).
    For primary toxoplasmosis prophylaxis in HIV-infected patients, specifically prevention of toxoplasmic encephalitis (TE) due to Toxoplasmosis gondii.

    Hypersensitivity to drug or component

    • Hemolysis
    • Methemoglobinemia
    • Reactional states (ie, abrupt changes in clinical activity occurring during any leprosy treatment; classified as reversal of erythema nodosum leprosum reactions)
    • Insomnia
    • Headache
    • Exfoliative dermatitis
    • Photosensitivity
    • Nausea
    • Vomiting
    • Anemia
    • Leukopenia
    • Agranulocytosis
    • Hepatitis
    • Cholestatic jaundice
    • Peripheral neuropathy (usually in nonleprosy patients)
    • Blurred vision
    • Tinnitus
    • SLE

    May cause blood dyscrasias (eg, agranulocytosis); monitor closely

    Peripheral neuropathy may occur

    Toxic epidermal necrolysis and other dermatologic reactions may occur

    Use caution when treating patients with hypersensitivity to sulfonamides

    Bacterial and fungal superinfections may occur from prolonged treatments

    Pregnancy category: C

    Lactation: Enters breast milk; not recommended (AAP Committee states “compatible with nursing

    Adults

    Leprosy, up to 100 mg/day PO; dermatitis herpetiformis, up to 300 mg/day PO; relapsing polychondritis, up to 200 mg/day PO; for acne topical use, 5% gel 2 applications/day topically or 7.5% gel 1 application/day topically.

    Geriatric

    Leprosy, up to 100 mg/day PO; dermatitis herpetiformis, up to 300 mg/day PO; relapsing polychondritis, up to 200 mg/day PO; for acne topical use, 5% gel 2 applications/day topically or 7.5% gel 1 application/day topically.

    Adolescents

    Leprosy, up to 100 mg/day PO; dermatitis herpetiformis, up to 300 mg/day PO; relapsing polychondritis, up to 200 mg/day PO; for acne topical use, 5% gel 2 applications/day topically or 7.5% gel 1 application/day topically.

    Children

    12 years: Maximum oral dosage information not established; for acne topical use, 5% gel 2 applications/day topically or 7.5% gel 1 application/day topically.
    9 to 11 years: Maximum oral dosage information not established; for acne topical use, 7.5% gel 1 application/day topically, safety and efficacy of 5% gel not established.
    1 to 8 years: Maximum oral dosage information not established; safety and efficacy of topical gel not established.

    Infants

    Maximum oral dosage information not established; safety and efficacy of topical gel not established.

    Neonates

    Safety and efficacy not established.

    Dapsone

    tablet

    • 25mg
    • 100mg

    topical gel

    • 5% (30g, 60g, 90g)
    • 7.5% (30g, 60g, 90g)