INDICATIONS AND USAGE
ACZONE® (dapsone) Gel, 7.5% is indicated for the topical treatment of acne
vulgaris in patients 12 years of age and older.
ACZONE® (dapsone) Gel, 5% is indicated for
the topical treatment of acne vulgaris.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
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% or 5% in those patients with congenital or idiopathic methemoglobinemia.
Signs and symptoms of methemoglobinemia may be delayed some hours after exposure. Initial signs and symptoms of
methemoglobinemia are characterized by a slate grey cyanosis seen in e.g., buccal mucous membranes, lips, and nail beds.
Advise patients to discontinue ACZONE® Gel, 7.5% or 5% and seek immediate medical attention in the event of cyanosis.
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.
In clinical trials, there was no evidence of clinically relevant hemolysis or hemolytic anemia in subjects treated with topical
dapsone. Some subjects with G6PD deficiency using dapsone gel, 5%, twice daily developed laboratory changes suggestive of hemolysis.
Discontinue ACZONE® Gel, 7.5% or 5%, if signs and symptoms suggestive of hemolytic anemia occur. Avoid use
of ACZONE® Gel, 7.5% or 5% in patients who are taking oral dapsone or antimalarial medications because of
the potential for hemolytic reactions. Combination of ACZONE® Gel, 7.5% or 5%, with trimethoprim/sulfamethoxazole
(TMP/SMX) may increase the likelihood of hemolysis in patients with G6PD deficiency.
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.
With the exception of urticaria, these types of skin reactions were not observed in clinical trials with topical dapsone treatment.
The most common adverse reactions of ACZONE® Gel, 7.5% are dryness and pruritus at the application site.
The most common adverse reactions of ACZONE® Gel, 5% (incidence ≥ 10%) are
oiliness/peeling, dryness, and erythema at the application site.
Methemoglobinemia has been identified during postmarketing use of topical dapsone.
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.
Please see ACZONE® Gel 7.5% full
Please see ACZONE® Gel 5% full
1. ACZONE® Gel 7.5% Prescribing Information.
2. Data on file, Allergan, 2016; NDA Summary of Clinical Efficacy and Safety.
3. Data on file, Allergan, 2016; Integrated Summary of Effectiveness Analysis Plan.
4. Acne vulgaris pivotal trials. National Institutes of Health
Web site: http://www.clinicaltrials.gov. Accessed April 2016.
5. Draelos ZD, Carter E, Maloney JM, et al; for United States/Canada Dapsone
Gel Study Group. Two randomized studies demonstrate the efficacy and safety of dapsone gel, 5%
for the treatment of acne vulgaris. J Am Acad Dermatol. 2007;56(3):439.e1-439.e10.
6. Data on file, Allergan, April 2015; Summary of Demographic Information:
Studies 225678-006 and Studies 225678-007 Combined.
7. Data on file, Allergan, 2016; Study Photos.