Aczone (dapsone)

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Dapsone is applied topically to the skin as a 5% gel.

Dapsone topical gel is for external use only. The gel should not be used orally or intravaginally and contact with the mouth and eyes should be avoided.

The acne affected area should be gently cleansed and dried prior to application of dapsone 5% gel. A pea-sized amount of the gel should be applied in a thin layer and rubbed in gently and completely.

Dapsone 5% gel is gritty with visible drug substance particles. Hands should be washed after applying the gel.

Dapsone 5% gel should be stored at 20-25degreesC, but may be exposed to temperatures ranging from 15-30degreesC. The gel should not be frozen.

Although only small amounts of dapsone are absorbed systemically following topical application to skin, the possibility that drug interactions could occur should be considered. Concomitant use of oral dapsone and certain drugs (e.g., rifampin, anticonvulsants, St. John's wort) may increase the formation of dapsone hydroxylamine, a dapsone metabolite associated with hemolysis. In addition, concomitant use of oral dapsone and folic acid antagonists (e.g., pyrimethamine) may increase the likelihood of adverse hematologic effects.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Manufacturer states none known.

• Hemolytic anemia from pyruvate kinase and g6PD deficiencies
• Methemoglobinemia

• Glucose-6-phosphate dehydrogenase (g6Pd) deficiency

There are no moderate contraindications for this drug.

Adverse effects reported in 10% or more of patients receiving topical dapsone 5% gel are oiliness/peeling, dryness, and erythema at the application site.

Rare or Very Rare

• Depression
• Drug-induced psychosis
• Hemolysis
• Methemoglobinemia
• Pancreatitis
• Pharyngitis
• Severe vomiting
• Suicidal
• Tonic clonic seizure

More Frequent

• Abnormal desquamation
• Dry skin
• Erythema
• Oily skin
• Pruritus of skin

Less Frequent

• Fever
• Sinusitis
• Skin irritation

Rare or Very Rare

• Acute abdominal pain
• Cough
• Facial edema
• Headache disorder
• Skin rash

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Safety and efficacy of topical dapsone 5% gel have not been established in children younger than 12 years of age.

Category C. (See Users Guide)

Oral dapsone has been associated with embryocidal effects in rats and rabbits when used in dosages approximately 800 and 500 times, respectively, the systemic exposure (based on AUC) observed in human females receiving the maximum recommended dosage of topical dapsone 5% gel. These effects were probably secondary to maternal toxicity.

Topical dapsone 5% gel should be used during pregnancy only if potential benefits outweigh potential risks to the fetus.

Dapsone is distributed into milk following oral administration. Systemic absorption is low following topical application of dapsone 5% gel; however, because of the potential to cause adverse reactions in nursing infants, discontinue nursing or discontinue topical dapsone therapy.

There is insufficient experience with topical dapsone 5% gel in geriatric patients 65 years of age or older to determine whether such individuals respond differently than younger individuals.