DAPSONE

DAPSONE- dapsone gel
Pacific Pharma, Inc.

1 INDICATIONS AND USAGE

Dapsone 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 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.

3 DOSAGE FORMS AND STRENGTHS

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

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

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.

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 dapsone 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 prevalent in populations of African, South Asian, Middle Eastern, and Mediterranean ancestry.

Some subjects with G6PD deficiency using dapsone gel developed laboratory changes suggestive of hemolysis. There was no evidence of clinically relevant hemolysis or anemia in patients treated with dapsone gel, 5%, including patients who were G6PD deficient.

Discontinue dapsone gel, 5%, if signs and symptoms suggestive of hemolytic anemia occur. Avoid use of dapsone gel, 5% in patients who are taking oral dapsone or antimalarial medications because of the potential for hemolytic reactions. Combination of dapsone 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 dapsone 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 dapsone 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 subjects treated with dapsone gel, 5%, during clinical trials included but were not limited to the following:

  • Nervous system/Psychiatric – Suicide attempt, tonic clonic movements.
  • Gastrointestinal – Abdominal pain, severe vomiting, pancreatitis.
  • Other – Severe pharyngitis

In the clinical trials, a total of 12 out of 4032 subjects were reported to have depression (3 of 1660 treated with vehicle and 9 of 2372 treated with dapsone gel, 5%). Psychosis was reported in 2 of 2372 subjects treated with dapsone gel, 5%, and in 0 of 1660 subjects treated with vehicle.

Combined contact sensitization/irritation studies with dapsone gel, 5%, in 253 healthy subjects resulted in at least 3 subjects with moderate erythema. Dapsone gel, 5%, did not induce phototoxicity or photoallergy in human dermal safety studies.

Dapsone gel, 5%, was evaluated for 12 weeks in four controlled trials for local cutaneous events in 1819 subjects. The most common events reported from these studies include oiliness/peeling, dryness, and erythema. These data are shown by severity in Table 1 below.

Table 1 – Application Site Adverse Reactions by Maximum Severity
Dapsone(N=1819) Vehicle(N=1660)
Application Site Event Mild Moderate Severe Mild Moderate Severe
Erythema 9% 5% <1% 9% 6% <1%
Dryness 14% 3% <1% 14% 4% <1%
Oiliness/Peeling 13% 6% <1% 15% 6% <1%

The adverse reactions occurring in at least 1% of subjects in either arm in the four vehicle controlled trials are presented in Table 2.

Table 2 – Adverse Reactions Occurring in at Least 1% of Subjects
DapsoneN=1819 VehicleN=1660
Application Site Reaction NOS 18% 20%
Application Site Dryness 16% 17%
Application Site Erythema 13% 14%
Application Site Burning 1% 2%
Application Site Pruritus 1% 1%
Pyrexia 1% 1%
Nasopharyngitis 5% 6%
Upper Respiratory Tract Inf. NOS 3% 3%
Sinusitis NOS 2% 1%
Influenza 1% 1%
Pharyngitis 2% 2%
Cough 2% 2%
Joint Sprain 1% 1%
Headache NOS 4% 4%

NOS = Not otherwise specified

One subject treated with dapsone gel in the clinical trials had facial swelling which led to discontinuation of medication.

In addition, 486 subjects were evaluated in a 12 month safety trial. The adverse event profile in this trial was consistent with that observed in the vehicle-controlled trials.

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