Dapsone (Topical Gel)

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

Dapsone has both anti-infammatory and antimicrobial properties. A combination of these activities may account for its efcacy in acne. Anti-infammatory efects include inhibition of neutrophil myeloperoxidase and eosinophil peroxidase activity, suppression of hypochlorous acid production, scavenging of reactive oxygen species, suppression of neutrophil activity, and inhibition of chemoattractant-induced signal transduction. Antimicrobial activity, similar to that of sulfones and sulfonamides, is by inhibition of bacterial dihydropteroate synthase in the folic acid metabolic pathway. This mechanism is efective against microorganisms synthesizing their own folic acid. In vitro susceptibility testing has demonstrated some activity for Dapsone against Propionibacterium species, including Propionibacterium acnes (P. acnes).

After the skin is gently washed and patted dry, apply approximately a pea-sized amount of Dapsone in a thin layer to the entire face once daily. In addition, a thin layer may be applied to other afected areas once daily. Rub in Dapsone, gently and completely. If there is no improvement after 12 weeks, treatment with Dapsone should be reassessed. Not for oral, ophthalmic or intravaginal use.

Trimethoprim/ sulfamethoxazole (TMP/ SMX) increases the systemic level of Dapsone and its metabolites.

Topical benzoyl peroxide used at the same time as Dapsone may result in temporary local yellow or orange skin discoloration.

Those who are hypersensitive to Dapsone.

Most common (incidence ≥ 0.9%) effects are application site dryness and pruritus.

Pregnancy Category C. There are no adequate and well controlled studies in pregnant women. Dapsone should be used during pregnancy only if the potential beneft justifes the potential risk to the fetus.

Although systemic absorption of Dapsone following topical application of Dapsone is minimal relative to oral Dapsone administration, it is known that Dapsone is excreted in human milk. Because of the potential for oral Dapsone to cause adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue Dapsone, taking into account the importance of the drug to the mother.

Methemoglobinemia: Cases of methemoglobinemia have been reported. Discontinue Dapsone if signs of methemoglobinemia occur.

Hemolysis: Some patients with Glucose-6-Phosphate Dehydrogenase (G6PD) defciency using topical Dapsone developed laboratory changes suggestive of hemolysis.

Acne treatment preparations

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

Geriatric Use: Clinical trials of Dapsone did not include sufcient numbers of subjects aged 65 years and over to determine whether they respond diferently from younger subjects.

Store in a cool & dry place. Keep out of reach of children. Do not freeze.