Dapsone topical

Indications

Dapsone topical is used for: Acne

Adult Dose

Topical/Cutaneous Acne vulgaris Adult: As 5% gel: Apply a thin layer on the affected area bid. As 7.5% gel: Apply a thin layer on the entire face or other affected areas once daily. Reassess treatment if there is no improvement after 12 weeks.

Child Dose

Topical/Cutaneous Acne Vulgaris <9 years: Safety and efficacy not established >9 years: Apply pea-sized amount in thin layer to the entire face once daily. (7.5% gel); a thin layer can also be applied to other affected areas. If no improvement after 12 weeks, reassess treatment

Renal Dose

Administration

Topical Administration For topical use only; not for oral, ophthalmic, or intravaginal use Gently cleanse skin and pat dry Apply pea-size amount in thin layer to acne affected area Rub gel in gently and completely Wash hands after application

Contra Indications

Hypersensitivity to dapsone. Congenital or idiopathic methaemoglobinaemia.

Precautions

Patient with history of hypersensitivity to sulfonamides. Cases of methemoglobinemia, with resultant hospitalization reported postmarketing in association with 5% gel formulation; patients with glucose-6-phosphate dehydrogenase deficiency or congenital or idiopathic methemoglobinemia are more susceptible to drug-induced methemoglobinemia; avoid use of 5% gel in those patients with congenital or idiopathic methemoglobinemia.

Pregnancy-Lactation

Pregnancy There are no available data on Gel, 5%, use in pregnant women to inform a drug-associated risk for adverse developmental outcomes; in animal reproduction studies, oral doses of dapsone administered to pregnant rats and rabbits during organogenesis that resulted in systemic exposures more than 250 times the systemic exposure at maximum recommended human dose (MRHD) of Gel, 5%, resulted in embryocidal effects; when orally administered to rats from the onset of organogenesis through the end of lactation at systemic exposures approximately 400 times the exposure at the MRHD, dapsone resulted in increased stillbirths and decreased pup weight; systemic absorption in humans following topical application is low relative to oral dapsone administration. Lactation There is no information regarding presence of topical dapsone in breastmilk, effects on breastfed infant, or on milk production; orally administered dapsone appears in human milk and could result in hemolytic anemia and hyperbilirubinemia especially in infants with G6PD deficiency; systemic absorption of dapsone following topical application is minimal relative to oral dapsone administration; however, it is known that dapsone is present in human milk following administration of oral dapsone; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from therapy or from underlying maternal condition.

Interactions

Side Effects

Side effects of Dapsone topical : >10% Dryness (16%) Erythema (13%) 1-10% Burning (1%) Pruritus (1%)

Mode of Action

Mechanism of action of dapsone gel in treating acne vulgaris is not known. However, it may be a result from both of its anti-inflammatory and antimicrobial effects. Dapsone is a sulfone that inhibits the synthesis of dihydrofolic acid by competing with para-aminobenzoic acid for the active site of dihydropteroate synthetase in susceptible organisms.