HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ACZONE ® Gel, 5% safely and effectively. See full prescribing information for ACZONE ® Gel, 5%.
ACZONE ® (dapsone) Gel, 5%, for topical use only
Initial U.S. Approval: 1955
RECENT MAJOR CHANGES
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Warnings and Precautions, Methemoglobinemia (5.1) |
7/2015 |
INDICATIONS AND USAGE
ACZONE® Gel is indicated for the topical treatment of acne vulgaris ( 1).
DOSAGE AND ADMINISTRATION
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Apply twice daily (2).
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Apply approximately a pea-sized amount of ACZONE® Gel, 5%, in a thin layer to the acne affected area (2).
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If there is no improvement after 12 weeks, treatment with ACZONE® Gel, 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, 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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Hematologic Effects: Some subjects with G6PD deficiency using ACZONE® Gel developed laboratory changes suggestive of hemolysis. (5.2)(8.6).
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥ 10%) are oiliness/peeling, dryness and erythema at the application site (6).
To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-433-8871 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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Trimethoprim/sulfamethoxazole (TMP/SMX) increases the level of dapsone and its metabolites (7.1).
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Topical benzoyl peroxide used at the same time as ACZONE® may result in temporary local yellow or orange skin discoloration (7.2).
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 7/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
ACZONE® Gel, 5%, is indicated for the topical treatment of acne vulgaris.
2 DOSAGE AND ADMINISTRATION
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 ACZONE® Gel, 5%, in a thin layer to the acne affected areas twice daily. Rub in ACZONE® Gel, 5%, gently and completely. ACZONE® Gel, 5%, is gritty with visible drug substance particles. Wash hands after application of ACZONE® Gel, 5%.
If there is no improvement after 12 weeks, treatment with ACZONE® Gel, 5%, should be reassessed.
3 DOSAGE FORMS AND STRENGTHS
Gel, 5%. Each gram of ACZONE® gel contains 50 mg of dapsone in a white to pale yellow gel.
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Methemoglobinemia
Cases of methemoglobinemia, with resultant hospitalization, have been reported postmarketing in association with ACZONE® 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, 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, 5% and seek immediate medical attention in the event of cyanosis.
Dapsone can cause elevated methemoglobin levels particularly in conjunction with methemoglobin‐inducing agents.
5.2 Hematologic Effects
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 preva lent in populations of African, South Asian, Middle Eastern, and Mediterranean ancestry.
Some subjects with G6PD deficiency using ACZONE® Gel developed laboratory changes suggestive of hemolysis. There was no evidence of clinically relevant hemolysis or anemia in patients treated with ACZONE® Gel, 5%, including patients who were G6PD deficient.
Discontinue ACZONE® Gel, 5%, if signs and symptoms suggestive of hemolytic anemia occur. Avoid use of ACZONE® Gel, 5% in patients who are taking oral dapsone or antimalarial medications because of the potential for hemolytic reactions. Combination of ACZONE® Gel, 5%, with trimethoprim/sulfamethoxazole (TMP/SMX) may increase the likelihood of hemolysis in patients with G6PD deficiency.
5.3 Peripheral Neuropathy
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 ACZONE® Gel, 5% treatment.
5.4 Skin
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 ACZONE® Gel, 5% treatment.
6 ADVERSE REACTIONS
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.
Serious adverse reactions reported in patients treated with ACZONE® Gel, 5%, during clinical trials included but were not limited to the following:
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Nervous system/Psychiatric – Suicide attempt, tonic clonic movements.
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Gastrointestinal – Abdominal pain, severe vomiting, pancreatitis.
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Other – Severe pharyngitis
In the clinical trials, a total of 12 out of 4032 patients were reported to have depression (3 of 1660 treated with vehicle and 9 of 2372 treated with ACZONE® Gel, 5%). Psychosis was reported in 2 of 2372 patients treated with ACZONE® Gel, 5%, and in 0 of 1660 patients treated with vehicle.
Combined contact sensitization/irritation studies with ACZONE® Gel, 5%, in 253 healthy subjects resulted in at least 3 subjects with moderate erythema. ACZONE® Gel, 5%, did not induce phototoxicity or photoallergy in human dermal safety studies.
ACZONE® Gel, 5%, was eva luated for 12 weeks in four controlled studies for local cutaneous events in 1819 patients. The most common events reported from these studies include oiliness/peeling, dryness, and erythema. These data are shown by severity in Table 1 below.
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