Dapsone is indicated for the topical treatment of acne vulgaris in patients aged 12 years and above.

Dapsone possesses both anti-inflammatory and antimicrobial effects, and the combination of these actions may explain its effectiveness in treating acne. Its anti-inflammatory activity involves inhibition of neutrophil myeloperoxidase and eosinophil peroxidase, reduction of hypochlorous acid production, scavenging of reactive oxygen species, suppression of neutrophil function, and blocking chemoattractant-mediated signal transduction. Its antimicrobial action, similar to sulfones and sulfonamides, works by inhibiting bacterial dihydropteroate synthase in the folic acid synthesis pathway. This mechanism is particularly effective against organisms that produce their own folic acid. In vitro studies have shown that Dapsone has some activity against Propionibacterium species, including Propionibacterium acnes (P. acnes).

• Apply once daily (7.5% gel) and twice daily (5% gel) after the skin is gently washed and patted dry
• Apply approximately a pea-sized amount of gel in a thin layer to the acne affected area
• Rub the gel gently and completely
• If there is no improvement after 12 weeks, treatment with this gel should be reassessed
• Dapsone gel maybe gritty with visible drug substance particles
• Wash hands after application

Co-administration of Trimethoprim/Sulfamethoxazole (TMP/SMX) can increase the systemic exposure of Dapgel and its metabolites. Concurrent use of topical benzoyl peroxide with Dapgel may cause a temporary yellow or orange discoloration of the skin at the application site.

Individuals who are hypersensitive to Dapsone.

Oiliness, peeling, dryness, and erythema may occur at the application site.

Dapsone is classified as Pregnancy Category C. There are no adequate, well-controlled studies in pregnant women. Dapsone has shown embryocidal effects in rats and rabbits, which were likely secondary to maternal toxicity. Dapsone Gel should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Although systemic absorption of Dapsone from topical gel use is minimal compared to oral administration, it is known that Dapsone is excreted in human breast milk. Due to the potential risk of adverse effects in nursing infants from oral Dapsone exposure, a decision should be made whether to discontinue breastfeeding or discontinue Dapsone Gel, considering the importance of the treatment for the mother.

Methemoglobinemia: Cases of methemoglobinemia have been reported. Dapgel Gel should be discontinued if signs or symptoms of methemoglobinemia develop.

Hematologic effects: Some individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency using Dapgel Gel showed laboratory findings suggestive of hemolysis.

Pediatric Use: Safety and effectiveness of Dapsone have not been established in pediatric patients below 12 years of age.

Geriatric Use: Clinical trials of Dapsone did not include a sufficient number of patients aged 65 years and above to determine whether they respond differently from younger patients.

Acne treatment preparations

Store at a temperature of 30°C or below. Protect from light and moisture. Keep out of reach of children.