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

            All Interactions Sort By:
             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (14)

              • artemether

                artemether, dapsone topical. unspecified interaction mechanism. Avoid or Use Alternate Drug. Avoid coadministration of dapsone topical with oral dapsone or antimalarial medications because of the potential for hemolytic reactions.

              • artemether/lumefantrine

                artemether/lumefantrine, dapsone topical. unspecified interaction mechanism. Avoid or Use Alternate Drug. Avoid coadministration of dapsone topical with oral dapsone or antimalarial medications because of the potential for hemolytic reactions.

              • artesunate

                artesunate, dapsone topical. unspecified interaction mechanism. Avoid or Use Alternate Drug. Avoid coadministration of dapsone topical with oral dapsone or antimalarial medications because of the potential for hemolytic reactions.

              • atovaquone

                atovaquone, dapsone topical. unspecified interaction mechanism. Avoid or Use Alternate Drug. Avoid coadministration of dapsone topical with oral dapsone or antimalarial medications because of the potential for hemolytic reactions.

              • chloroquine

                chloroquine, dapsone topical. unspecified interaction mechanism. Avoid or Use Alternate Drug. Avoid coadministration of dapsone topical with oral dapsone or antimalarial medications because of the potential for hemolytic reactions.

              • dapsone

                dapsone, dapsone topical. unspecified interaction mechanism. Avoid or Use Alternate Drug. Avoid coadministration of dapsone topical with oral dapsone or antimalarial medications because of the potential for hemolytic reactions.

              • hydroxychloroquine sulfate

                hydroxychloroquine sulfate, dapsone topical. unspecified interaction mechanism. Avoid or Use Alternate Drug. Avoid coadministration of dapsone topical with oral dapsone or antimalarial medications because of the potential for hemolytic reactions.

              • mefloquine

                mefloquine, dapsone topical. unspecified interaction mechanism. Avoid or Use Alternate Drug. Avoid coadministration of dapsone topical with oral dapsone or antimalarial medications because of the potential for hemolytic reactions.

              • primaquine

                primaquine, dapsone topical. unspecified interaction mechanism. Avoid or Use Alternate Drug. Avoid coadministration of dapsone topical with oral dapsone or antimalarial medications because of the potential for hemolytic reactions.

              • proguanil

                proguanil, dapsone topical. unspecified interaction mechanism. Avoid or Use Alternate Drug. Avoid coadministration of dapsone topical with oral dapsone or antimalarial medications because of the potential for hemolytic reactions.

              • pyrimethamine

                pyrimethamine, dapsone topical. unspecified interaction mechanism. Avoid or Use Alternate Drug. Avoid coadministration of dapsone topical with oral dapsone or antimalarial medications because of the potential for hemolytic reactions.

              • quinidine

                quinidine, dapsone topical. unspecified interaction mechanism. Avoid or Use Alternate Drug. Avoid coadministration of dapsone topical with oral dapsone or antimalarial medications because of the potential for hemolytic reactions.

              • quinine

                quinine, dapsone topical. unspecified interaction mechanism. Avoid or Use Alternate Drug. Avoid coadministration of dapsone topical with oral dapsone or antimalarial medications because of the potential for hemolytic reactions.

              • tafenoquine

                tafenoquine, dapsone topical. unspecified interaction mechanism. Avoid or Use Alternate Drug. Avoid coadministration of dapsone topical with oral dapsone or antimalarial medications because of the potential for hemolytic reactions.

              Monitor Closely (21)

              • acetaminophen

                acetaminophen increases toxicity of dapsone topical by altering metabolism. Modify Therapy/Monitor Closely. May induce methemoglobinemia .

              • aminosalicylic acid

                aminosalicylic acid increases toxicity of dapsone topical by altering metabolism. Modify Therapy/Monitor Closely. May induce methemoglobinemia.

              • amyl nitrite

                amyl nitrite increases toxicity of dapsone topical by altering metabolism. Modify Therapy/Monitor Closely. May induce methemoglobinemia.

              • benzocaine

                benzocaine increases toxicity of dapsone topical by altering metabolism. Modify Therapy/Monitor Closely. May induce methemoglobinemia .

              • benzoyl peroxide

                benzoyl peroxide, dapsone topical. unspecified interaction mechanism. Use Caution/Monitor. Coadministration may cause temporary local yellow or orange discoloration of the skin and facial hair.

              • isosorbide dinitrate

                isosorbide dinitrate increases toxicity of dapsone topical by altering metabolism. Modify Therapy/Monitor Closely. May induce methemoglobinemia.

              • isosorbide mononitrate

                isosorbide mononitrate increases toxicity of dapsone topical by altering metabolism. Modify Therapy/Monitor Closely. May induce methemoglobinemia.

              • nitrofurantoin

                nitrofurantoin increases toxicity of dapsone topical by altering metabolism. Modify Therapy/Monitor Closely. May induce methemoglobinemia.

              • nitroglycerin IV

                nitroglycerin IV increases toxicity of dapsone topical by altering metabolism. Modify Therapy/Monitor Closely. May induce methemoglobinemia.

              • nitroglycerin PO

                nitroglycerin PO increases toxicity of dapsone topical by altering metabolism. Modify Therapy/Monitor Closely. May induce methemoglobinemia.

              • nitroglycerin rectal

                nitroglycerin rectal increases toxicity of dapsone topical by altering metabolism. Modify Therapy/Monitor Closely. May induce methemoglobinemia.

              • nitroglycerin transdermal

                nitroglycerin transdermal increases toxicity of dapsone topical by altering metabolism. Modify Therapy/Monitor Closely. May induce methemoglobinemia.

              • nitroglycerin translingual

                nitroglycerin translingual increases toxicity of dapsone topical by altering metabolism. Modify Therapy/Monitor Closely. May induce methemoglobinemia.

              • nitroprusside sodium

                nitroprusside sodium increases toxicity of dapsone topical by altering metabolism. Modify Therapy/Monitor Closely. May induce methemoglobinemia.

              • phenobarbital

                phenobarbital increases toxicity of dapsone topical by altering metabolism. Modify Therapy/Monitor Closely. May induce methemoglobinemia.

              • phenytoin

                phenytoin increases toxicity of dapsone topical by altering metabolism. Modify Therapy/Monitor Closely. May induce methemoglobinemia.

              • sodium thiosulfate & sodium nitrite

                sodium thiosulfate & sodium nitrite increases toxicity of dapsone topical by altering metabolism. Modify Therapy/Monitor Closely. May induce methemoglobinemia.

              • sulfadiazine

                sulfadiazine increases toxicity of dapsone topical by decreasing metabolism. Modify Therapy/Monitor Closely. May induce methemoglobinemia .

              • sulfamethoxazole

                sulfamethoxazole increases toxicity of dapsone topical by decreasing metabolism. Modify Therapy/Monitor Closely. Coadministration increases systemic exposure of dapsone and its metabolites (N-acetyl-dapsone, dapsone hydroxylamine). May induce methemoglobinemia.

              • sulfisoxazole

                sulfisoxazole increases toxicity of dapsone topical by decreasing metabolism. Modify Therapy/Monitor Closely. May induce methemoglobinemia .

              • trimethoprim

                trimethoprim increases toxicity of dapsone topical by decreasing metabolism. Modify Therapy/Monitor Closely. Coadministration increases systemic exposure of dapsone and its metabolites (N-acetyl-dapsone, dapsone hydroxylamine). May induce methemoglobinemia.

              Minor (0)

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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

                No images available for this drug.
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                Patient Handout

                A Patient Handout is not currently available for this monograph.
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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.
                OR Other Restrictions
                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.