HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ACZONE - ® Gel, 7.5% safely and effectively. See full prescribing information for ACZONE - ® Gel, 7.5%. ACZONE - ...
These highlights do not include all the information needed to use ACZONE ® Gel, 7.5% safely and effectively. See full prescribing information for ACZONE ® Gel, 7.5%.
ACZONE ® (dapsone) Gel, 7.5%, for topical use
Initial U.S. Approval: 1955
INDICATIONS AND USAGE
ACZONE® Gel, 7.5%, is a sulfone indicated for the topical treatment of acne vulgaris in patients 12 years of age and older (1).
DOSAGE AND ADMINISTRATION
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Apply once daily (2).
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Apply approximately a pea-sized amount of ACZONE Gel, 7.5%, in a thin layer to the entire face. A thin layer can also be applied to other affected areas (2).
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If there is no improvement after 12 weeks, treatment with ACZONE Gel, 7.5% should be reassessed (2).
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For topical use only. Not for oral, ophthalmic, or intravaginal use (2).
DOSAGE FORMS AND STRENGTHS
Gel, 7.5% (3).
CONTRAINDICATIONS
None (4).
WARNINGS AND PRECAUTIONS
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Methemoglobinemia: Cases of methemoglobinemia have been reported. Discontinue ACZONE Gel if signs of methemoglobinemia occur (5.1).
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Hemolysis: Some patients with Glucose-6-phosphate Dehydrogenase (G6PD) deficiency using topical dapsone developed laboratory changes suggestive of hemolysis (5.1)(8.6).
