INDICATIONS AND USAGE
ACZONE® (dapsone) Gel 7.5% is indicated for the topical treatment of acne
vulgaris in patients aged 12 years and older.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Cases of methemoglobinemia with resultant hospitalization have been reported post marketing 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 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-gray cyanosis seen in, eg, buccal mucous membranes, lips, and nail beds.
Advise patients to discontinue ACZONE® Gel 7.5% 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% if signs and symptoms suggestive of hemolytic anemia occur. Avoid use
of ACZONE® Gel 7.5% in patients who are taking oral dapsone or antimalarial medications because of
the potential for hemolytic reactions. Combination of ACZONE® Gel 7.5% 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.
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.
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 full
1. Collier CN, Harper JC, Cafardi JA, et al. The prevalence of acne in adults
20 years and older [published correction appears in J Am Acad Dermatol. 2008;58(5):874].
J Am Acad Dermatol. 2008;58(1):56-59.
2. Holzmann R, Shakery K. Postadolescent acne in females.
Skin Pharmacol Physiol. 2014;27(suppl 1):3-8.
3. Dréno B. Treatment of adult female acne: a new challenge.
J Eur Acad Dermatol Venereol. 2015;29(suppl 5):4‑19.
4. Khunger N. Kumar C. A clinico-epidemiological study of adult acne:
is it different from adolescent acne? Indian J Dermatol Venereol Leprol.
5. Kaur S, Verma P Sangwan A, Dayal S,
Jain VK. Etiopathogenesis and therapeutic approach to adult onset acne. Indian J Dermatol.
6. Goulden V, Clark SM, Cunlifle WJ. Post-adolescent acne: a review of
clinical features. Br J Dermatol. 1997;136(1):66-70.
7. McCarty M. Evaluation and management of refractory acne vulgaris in adolescent
and adult men. Dermatol Clin. 2016;34(2):203-206.
8. Kim BY, Choi JW, Park K, Youn SW Sebum, acne, skin elasticity, and gender
difference—which is the major influencing factor for facial pores? Skin Res Technol.
9. Data on file, Allergan, January 10, 2014; Defining Acne Treatment: Final Report.
10. Dréno B, Layton A, Zouboulis CC, et al. Adult female acne: a new paradigm.
J Eur Acad Dermatol Venereol. 2013;27(9):1063-1070.
11. Kamangar F, Shinkai K. Acne in the adult female patient: a practical
approach. Int J Dermatol. 2012;51(10):1162-1174.
12. Data on file, Allergan, November 14, 2016; Acne Patient Insights Research.
13. Data on file, Allergan, October 2015; Teen Boy Acne Conversation Tool Report.