Dapsone

Dapsone Gel, 5%, is indicated for the topical treatment of acne vulgaris. Dapsone Gel is indicated for the topical treatment of acne vulgaris ( 1 ).

• For topical use only
• Not for oral, ophthalmic, or intravaginal use
• After the skin is gently washed and patted dry, apply approximately a pea-sized amount of dapsone gel, 5%, in a thin layer to the acne affected areas twice daily
• Rub in dapsone gel, 5%, gently and completely
• Dapsone gel, 5%, is gritty with visible drug substance particles
• Wash hands after application of dapsone gel, 5%
• If there is no improvement after 12 weeks, treatment with dapsone gel, 5%, should be reassessed
• Apply twice daily
• Apply approximately a pea-sized amount of dapsone gel, 5%, in a thin layer to the acne affected area
• If there is no improvement after 12 weeks, treatment with dapsone gel, 5% should be reassessed
• For topical use only
• Not for oral, ophthalmic, or intravaginal use

Gel, 5%. Each gram of dapsone gel contains 50 mg of dapsone in a white to pale yellow gel. Gel, 5% ( 3 ).

• Safety and efficacy was evaluated in 1169 children aged 12 to 17 years old treated with dapsone gel, 5%, in the clinical trials
• The adverse event rate for dapsone gel, 5%, was similar to the vehicle control group
• Safety and efficacy was not studied
• In pediatric patients less than 12 years of age, therefore dapsone gel, 5%, is not recommended for use in this age group

Clinical trials of dapsone gel, 5%, did not include sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects.

• Advise the patient to read the FDA-approved patient labeling (Patient Information)
• Hematological Effects Inform patients that methemoglobinemia can occur with topical dapsone treatment
• Advise patients to seek immediate medical attention if they develop cyanosis [see Warnings and Precautions ]
• Inform patients who have G6PD deficiency that hemolytic anemia may occur with topical dapsone treatment
• Advise patients to seek medical attention if they develop signs and symptoms suggestive of hemolytic anemia [see Warnings and Precautions ] . …

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Trimethoprim/sulfamethoxazole (TMP/SMX) increases the level of dapsone and its metabolites ( 7.1 ). Topical benzoyl peroxide used at the same time as dapsone gel may result in temporary local yellow or orange skin discoloration ( 7.2 ). 7.1 Trimethoprim-Sulfamethoxazole A drug-drug interaction study evaluated the effect of the use of dapsone gel, 5%, in combination with double strength (160 mg/800 mg) trimethoprim-sulfamethoxazole (TMP/SMX). During co-administration, systemic levels of TMP and SMX were essentially unchanged. However, levels of dapsone and its metabolites increased in the presence of TMP/SMX. …

Methemoglobinemia: Cases of methemoglobinemia have been reported. Discontinue dapsone gel if signs of methemoglobinemia occur ( 5.1 ). Hematologic Effects: Some subjects with G6PD deficiency using dapsone gel developed laboratory changes suggestive of hemolysis. ( 5.2 ) ( 8.6 ). 5.1 Methemoglobinemia Cases of methemoglobinemia, with resultant hospitalization, have been reported postmarketing in association with 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 dapsone gel, 5% in those patients with congenital or idiopathic methemoglobinemia. …

Most common adverse reactions (incidence ≥ 10%) are oiliness/peeling, dryness and erythema at the application site ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …

8.1 Pregnancy Risk Summary There are no available data on dapsone 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 the maximum recommended human dose (MRHD) of dapsone gel, 5%, resulted in embryocidal …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.