Indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

If there is no improvement after 12 weeks, treatment with ACZONE Gel, 7.5% should be reassessed.

Cases of methemoglobinemia, with resultant hospitalization, have been reported postmarketing in association with twice daily dapsone gel, 5%, treatment. Patients with glucose-6-phosphate dehydrogenase deficiency or congenital or idiopathic methemoglobinemia are more susceptible to drug induced methemoglobinemia. Avoid use of ACZONE Gel, 7.5% in those patients with congenital or idiopathic methemoglobinemia. Dapsone can cause elevated methemoglobin levels particularly in conjunction with methemoglobin-inducing agents.

Oral dapsone treatment has produced dose-related hemolysis and hemolytic anemia. Individuals with glucose-6- phosphate dehydrogenase (G6PD) deficiency are more prone to hemolysis with the use of certain drugs. G6PD deficiency is most prevalent in populations of African, South Asian, Middle Eastern, and Mediterranean ancestry.

Peripheral neuropathy (motor loss and muscle weakness) has been reported with oral dapsone treatment. No events of peripheral neuropathy were observed in clinical trials with topical dapsone treatment.

Skin reactions (toxic epidermal necrolysis, erythema multiforme, morbilliform and scarlatiniform reactions, bullous and exfoliative dermatitis, erythema nodosum, and urticaria) have been reported with oral dapsone treatment. These types of skin reactions were not observed in clinical trials with topical dapsone treatment.

Topical application of dapsone gel followed by benzoyl peroxide in patients with acne vulgaris may result in a temporary local yellow or orange discoloration of the skin and facial hair.

Concomitant use of ACZONE with medications (such as rifampin, anticonvulsants, St. John’s wort) may increase the formation of dapsone hydroxylamine, a metabolite of dapsone associated with hemolysis. With oral dapsone treatment, folic acid antagonists such as pyrimethamine have been noted to possibly increase the likelihood of hematologic reactions.

Concomitant use of ACZONE Gel, 7.5% with drugs that induce methemoglobinemia such as sulfonamides, acetaminophen, acetanilide, aniline dyes, benzocaine, chloroquine, dapsone, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, para‐aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, and quinine may increase the risk for developing methemoglobinemia.

There are no available data on ACZONE Gel, 7.5%, use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. Animal studies: stillbirths and decreased weight.

There is no information regarding the presence of topical dapsone in breastmilk, the effects on the breastfed infant, or the effects 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.

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• Use in patients under the age of 9. GoToSource 

• Prophylaxis against pneumocystis jiroveci in HIV infected patients. GoToSource

• Granuloma faciale. GoToSource 

• Erythema elevatum diutinum. GoToSource 

• Hidradenitis suppurativa. GoToSource 

• Second-line therapy for cutaneous lupus erythematosus. GoToSource 

• Pustular psoriasis. GoToSource

Peripheral neuropathy. GoToSource

Hemolytic anemia. GoToSource

Methemoglobinemia (blood disorder). GoToSource

Fulminant hepatitis (severe liver function impairment). GoToSource

Acute pancreatitis (inflammation of pancreas). GoToSource

Life-threatening dapsone systemic hypersensitivity syndrome. GoToSource

Lawsuits filed for methemoglobinemia.