dapsone topical (Rx)

Brand and Other Names:Aczone
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

topical gel

  • 7.5% (30g, 60g, or 90g pump)

Acne Vulgaris

Apply pea-sized amount in thin layer to the entire face qDay (7.5% gel); a thin layer can also be applied to other affected areas

If no improvement after 12 weeks, reassess treatment

Dosage Forms & Strengths

topical gel

  • 7.5% (30g, 60g, or 90g pump)

Acne Vulgaris

<9 years: Safety and efficacy not established

≥9 years: Apply pea-sized amount in thin layer to the entire face qDay (7.5% gel); a thin layer can also be applied to other affected areas

If no improvement after 12 weeks, reassess treatment

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Interactions

Interaction Checker

and dapsone topical

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Dryness (16%)

            Erythema (13%)

            1-10%

            Burning (1%)

            Pruritus (1%)

            Postmarketing reports

            Methemoglobinemia

            Rash, including erythematous rash

            Swelling of face, including lip and eye swelling

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            Warnings

            Contraindications

            None

            Cautions

            Cases of methemoglobinemia, with resultant hospitalization reported postmarketing in association with 5% gel formulation; patients with glucose-6-phosphate dehydrogenase deficiency or congenital or idiopathic methemoglobinemia are more susceptible to drug-induced methemoglobinemia; avoid use of 5% gel in those patients with congenital or idiopathic methemoglobinemia

            No events of peripheral neuropathy observed with topical dapsone; peripheral neuropathy reported with oral dapsone

            Serious skin reactions have not been observed with topical application, but are associated with oral therapy and include toxic epidermal necrolysis, erythema multiforme, morbilliform and scarlatiniform reactions, bullous and exfoliative dermatitis, erythema nodosum, and urticaria

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            Pregnancy & Lactation

            Pregnancy

            There are no available data on Gel, 5%, use in pregnant women to inform a drug-associated risk for adverse developmental outcomes; in animal reproduction studies, oral doses of dapsone administered to pregnant rats and rabbits during organogenesis that resulted in systemic exposures more than 250 times the systemic exposure at maximum recommended human dose (MRHD) of Gel, 5%, resulted in embryocidal effects; when orally administered to rats from the onset of organogenesis through the end of lactation at systemic exposures approximately 400 times the exposure at the MRHD, dapsone resulted in increased stillbirths and decreased pup weight; systemic absorption in humans following topical application is low relative to oral dapsone administration

            Lactation

            There is no information regarding presence of topical dapsone in breastmilk, effects on breastfed infant, or on milk production; orally administered dapsone appears in human milk and could result in hemolytic anemia and hyperbilirubinemia especially in infants with G6PD deficiency; systemic absorption of dapsone following topical application is minimal relative to oral dapsone administration; however, it is known that dapsone is present in human milk following administration of oral dapsone; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from therapy or from underlying maternal condition

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Mechanism of action of dapsone gel in treating acne vulgaris is not known

            Sulfone; prevents normal bacterial utilization of para-aminobenzoic acid (PABA) for the synthesis of folic acid by acting as a competitive antagonist of PABA; it is bactericidal and bacteriostatic against Mycobacterium leprae

            Absorption

            AUC: 415 ± 224 ng•h/mL

            Exposure of single 100 mg PO dose is 100 times that of topical 5% BID

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            Administration

            Topical Administration

            For topical use only; not for oral, ophthalmic, or intravaginal use

            Gently cleanse skin and pat dry

            Apply pea-size amount in thin layer to acne affected area

            Rub gel in gently and completely

            Wash hands after application

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.