Clinical Pharmacology Details


DAPSONE


View Drug Forms

Indications & Dose:

Treatment of leprosy and dermatitis herpetiformis


DOSE


Adults: 50-100 mg/day for 3-10 years Dermatitis herpetiformis: Adults: Start at 50 mg/day, increase to 300 mg/day, or higher to achieve full control, reduce dosage to minimum level as soon as possible Pneumocystis carinii pneumonia (unlabeled use): Prophylaxis:


Children >1 month: 2 mg/kg/day once daily (maximum dose: 100 mg/day) or 4 mg/kg/doseonce weekly (maximum dose: 200 mg)


Adults: 100 mg/day Treatment: Adults: 100 mg/day in combination with trimethoprim (15-20 mg/kg/day) for 21 days Topical: Acne: Children >12 years and Adults: Apply pea-sized amount (approximately) in a thin layer to affected areas twice daily; reevaluate patient if no improvement after 12 weeks of therapy Dosing in renal impairment: No specific guidelines are available

Contraindications:

Hypersensitivity to dapsone or any component of the formulation 

Side Effects:

Cautions:

Precautions:

Interaction:

Warnings:

Use with caution in patients with severe anemia, G6PD, methemoglobin reductase deficiency or hemoglobin M deficiency; hypersensitivity to other sulfonamides; aplastic anemia, agranulocytosis and other severe blood dyscrasias have resulted in death; monitor carefully; serious dermatologic reactions (including toxic epidermal necrolysis) are rare but potential occurrences; sulfone reactions may also occur as potentially fatal hypersensitivity reactions; these, but not leprosy reactional states, require drug discontinuation. Motor loss and muscle weakness have been reported with use. Prolonged use may result in fungal or bacterial super-infection, including C. c//Wc/7e-associated diarrhea and pseudomembranous colitis. Safety and efficacy of topical dapsone has not been established in children <12 years of age. 

Adverse Effects:

Adverse reactions reported for oral formulation unless otherwise noted. >10%: Hematologic: Hemolysis (dose related; seen in patients with and without G6PD deficiency), hemoglobin decrease (1-2 g/dL; almost all patients), reticulocyte increase (2% to 12%), methemoglobinemia, red cell life span shortened Frequency not always defined. Cardiovascular: Facial edema (topical), tachycardia Central nervous system:  Depression (topical), fever, headache, insomnia, psychosis (oral/topical), suicide attempt (topical), tonic clonic movement (topical), vertigo


Dermatologic:   Bullous  and  exfoliative  dermatitis, erythema nodosum, exfoliative dermatitis, morbilliform and scarlatiniform reactions, phototoxicity, Stevens-Johnson syndrome, toxic epidural necrolysis, urticaria Endocrine  & metabolic: Hypoalbuminemia  (without proteinuria), male infertility Gastrointestinal: Abdominal pain (oral/ topical), nausea, pancreatitis (oral/topical), vomiting (oral/topical) Hematologic: Agranulocytosis, anemia, leukopenia, pure red cell aplasia (case report) Hepatic: Cholestatic jaundice, hepatitis Neuromuscular & skeletal: Drug-induced lupus erythe-matosus,  lower motor neuron toxicity (prolonged therapy),  peripheral  neuropathy  (rare, nonleprosy patients)


Ocular: Blurred vision Otic: Tinnitus Renal: Albuminuria, nephrotic syndrome, renal papillary necrosis Respiratory: Interstitial pneumonitis, pulmonary eosinophilia, sinusitis (topical 2%)


Miscellaneous: Infectious mononucleosis-like syndrome (rash, fever, lymphadenopathy, hepatic dysfunction) 

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: