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brand aczone 7.5% gel pump

In stock Manufacturer ALLERG/ALMIRALL 00023520660
$692.92 / 60 Grams Bottle

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Uses

Acne Vulgaris

Dapsone is used topically for the treatment of acne vulgaris. Topical therapy with the drug is effective against inflammatory acne lesions and, to a lesser extent, noninflammatory acne lesions.

Clinical Experience

Safety and efficacy of topical dapsone 5% gel for the treatment of acne vulgaris were evaluated in 2 randomized, double-blind, vehicle-controlled studies that included patients 12 years of age or older with 20-50 inflammatory and 20-100 noninflammatory acne lesions at baseline. Patients applied topical dapsone gel or vehicle twice daily for up to 12 weeks; efficacy was evaluated in terms of success on the global acne assessment score (no or minimal acne) and the percent reduction in inflammatory, noninflammatory, and total lesions. After 12 weeks, 35 or 42% of patients treated with topical dapsone and 28 or 32% of those treated with placebo had no or minimal acne. There was a 37 or 38% reduction in acne lesions in those treated with topical dapsone compared with a 29 or 32% reduction in those treated with placebo.

Dosage and Administration

Administration

Dapsone is applied topically to the skin as a 5% gel.

Dapsone topical gel is for external use only. The gel should not be used orally or intravaginally and contact with the mouth and eyes should be avoided.

The acne affected area should be gently cleansed and dried prior to application of dapsone 5% gel. A pea-sized amount of the gel should be applied in a thin layer and rubbed in gently and completely.

Dapsone 5% gel is gritty with visible drug substance particles. Hands should be washed after applying the gel.

Dapsone 5% gel should be stored at 20-25°C, but may be exposed to temperatures ranging from 15-30°C. The gel should not be frozen.

Dosage

Acne Vulgaris

For the treatment of acne vulgaris in adults, adolescents, and children 12 years of age or older, a thin layer of dapsone 5% gel should be applied to the cleansed affected area twice daily.

If improvement does not occur after 12 weeks of treatment, use of the drug should be reassessed.

Topical dapsone has been used for up to 12 months in clinical studies.

Cautions

Contraindications

Manufacturer states none known.

Warnings/Precautions

Sensitivity Reactions

Moderate erythema has been reported when topical dapsone 5% gel was evaluated in combined contact sensitization/irritation studies. Pruritus, rash, and contact dermatitis were reported in some patients receiving topical dapsone 5% gel for the treatment of acne vulgaris.

Oral dapsone has been associated with hypersensitivity reactions that include severe dermatologic reactions.(See Dermatologic Reactions under Cautions: Warnings/Precautions.) Hypersensitivity reactions reported with oral dapsone also have included fever, malaise, hepatitis, and hemolysis.

Topical dapsone did not induce phototoxicity or photoallergy in human dermal safety studies.

Hematologic Effects

Oral dapsone has been associated with dose-related hemolysis and hemolytic anemia. Agranulocytosis also has been reported in patients receiving oral dapsone. Individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency are more prone to hemolysis when receiving certain drugs. G6PD deficiency is most prevalent in populations of African, South Asian, Middle Eastern, and Mediterranean ancestry.

There were no reports of clinically relevant hemolysis or hemolytic anemia in clinical studies evaluating topical dapsone 5% gel in individuals with acne vulgaris, including individuals with G6PD deficiency. However, laboratory changes suggestive of mild hemolysis (slight decreases in hemoglobin) occurred in some individuals with G6PD deficiency using the topical gel.

If signs and symptoms suggestive of hemolytic anemia occur, topical dapsone therapy should be discontinued.

Because of the potential for hemolytic reactions, topical dapsone 5% gel should not be used in individuals receiving oral dapsone or antimalarial agents.(See Drug Interactions.)

Concomitant use of topical dapsone 5% gel and co-trimoxazole may increase the risk of hemolysis in patients with G6PD deficiency.(See Drug Interactions: Co-trimoxazole.)

Peripheral Neuropathy

Oral dapsone has been associated with peripheral neuropathy (motor loss and muscle weakness).

Peripheral neuropathy was not reported in clinical studies evaluating topical dapsone 5% gel for the treatment of acne vulgaris.

Dermatologic Reactions

Oral dapsone has been associated with serious skin reactions, including toxic epidermal necrolysis, erythema multiforme, morbilliform and scarlatiniform reactions, bullous and exfoliative dermatitis, erythema nodosum, and urticaria.

Although erythema, pruritus, and rash were reported in clinical studies evaluating topical dapsone 5% gel for the treatment of acne vulgaris, more severe dermatologic reactions were not reported.

Specific Populations

Pregnancy

Category C.

Oral dapsone has been associated with embryocidal effects in rats and rabbits when used in dosages approximately 800 and 500 times, respectively, the systemic exposure (based on AUC) observed in human females receiving the maximum recommended dosage of topical dapsone 5% gel. These effects were probably secondary to maternal toxicity.

Topical dapsone 5% gel should be used during pregnancy only if potential benefits outweigh potential risks to the fetus.

Lactation

Dapsone is distributed into milk following oral administration. Systemic absorption is low following topical application of dapsone 5% gel; however, because of the potential to cause adverse reactions in nursing infants, discontinue nursing or discontinue topical dapsone therapy.

Pediatric Use

Safety and efficacy of topical dapsone 5% gel have not been established in children younger than 12 years of age.

Geriatric Use

There is insufficient experience with topical dapsone 5% gel in geriatric patients 65 years of age or older to determine whether such individuals respond differently than younger individuals.

Common Adverse Effects

Adverse effects reported in 10% or more of patients receiving topical dapsone 5% gel are oiliness/peeling, dryness, and erythema at the application site.

Drug Interactions

Although only small amounts of dapsone are absorbed systemically following topical application to skin, the possibility that drug interactions could occur should be considered. Concomitant use of oral dapsone and certain drugs (e.g., rifampin, anticonvulsants, St. John's wort) may increase the formation of dapsone hydroxylamine, a dapsone metabolite associated with hemolysis. In addition, concomitant use of oral dapsone and folic acid antagonists (e.g., pyrimethamine) may increase the likelihood of adverse hematologic effects.

Antimalarial Agents

Topical dapsone 5% gel should not be used in patients receiving antimalarial agents since the risk of hemolytic reactions may be increased.

Benzoyl Peroxide

In vitro, combinations of topical dapsone 5% gel and topical benzoyl peroxide resulted in an orange discoloration.

Concomitant use of topical dapsone 5% gel and topical benzoyl peroxide in individuals with acne vulgaris may result in temporary local yellow or orange discoloration of the skin and facial hair. This effect usually resolves in 4-57 days.

Co-trimoxazole

Concomitant use of topical dapsone 5% gel and oral co-trimoxazole results in increased systemic exposure to dapsone and dapsone metabolites; the pharmacokinetics of co-trimoxazole are not affected. Possible increased risk of hemolysis in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Dapsone

Topical dapsone 5% gel should not be used in patients receiving oral dapsone since the risk of hemolytic reactions may be increased.

Pharmacokinetics

Absorption

Bioavailability

Dapsone is absorbed systemically following topical application to skin.

In patients with acne vulgaris skin lesions, plasma concentrations of dapsone are detectable within 2 hours after the first dose of topical dapsone 5% gel.

After topical application of dapsone 5% gel to acne vulgaris skin lesions on the face, upper back, shoulders, and/or upper chest (up to approximately 22.5% of total body surface area) twice daily for 14 days, mean peak plasma concentrations of the drug were 19.4 ng/mL and the median time to peak concentrations after a dose was 9 hours.

In a long-term safety study of dapsone 5% gel, there was no evidence that systemic exposure increases over time.

Systemic exposure (AUC) following a 14-day regimen of dapsone 5% gel is 126 times lower than systemic exposure (AUC) following a single 100-mg dose of oral dapsone.

Special Populations

Systemic dapsone exposure following topical application of dapsone 5% gel in children 12-15 years of age is similar to that reported in those 16 years of age or older.

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