Dosing & Uses
Dosage Forms & Strengths
topical gel
- 5% (30g, 60g, 90g)
- 7.5% (30g, 60g, 90g)
Acne Vulgaris
Apply (5% gel) pea-sized amount in thin layer to affected areas BID
Apply (7.5% gel) pea-sized amount in thin layer to the entire face qDay; a thin layer can also be applied once daily to other affected areas
If no improvement after 12 weeks, reassess treatment
Dosage Forms & Strengths
topical gel
- 5% (30g, 60g, 90g)
- 7.5% (30g, 60g, 90g)
Acne Vulgaris
<9 years: Safety and efficacy not established
≥9 years: Apply (7.5% gel) pea-sized amount in thin layer to the entire face qDay; a thin layer can also be applied to other affected areas
≥12 years: Apply (5% gel) pea-sized amount in thin layer to affected areas BID
If no improvement after 12 weeks, reassess treatment
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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)
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
Warnings
Contraindications
None
Cautions
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
Methemoglobinemia
- 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
- 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, eg, buccal mucous membranes, lips, and nail beds; advise patients to discontinue therapy and seek immediate medical attention in event of cyanosis
- This drug can cause elevated methemoglobin levels particularly in conjunction with methemoglobin‐inducing agents
Hematologic effects
- Oral dapsone treatment has produced dose-related hemolysis and hemolytic anemia; patients with glucose-6 phosphate dehydrogenase (G6PD) deficiency are more prone to hemolysis with 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 topical dapsone developed laboratory changes suggestive of hemolysis; there was no evidence of clinically relevant hemolysis or anemia in patients treated with this drug, including patients who were G6PD deficient
- Discontinue therapy if signs and symptoms suggestive of hemolytic anemia occur; avoid use in patients who are taking oral dapsone or antimalarial medications because of potential for hemolytic reactions; combination of this drug, with trimethoprim/sulfamethoxazole (TMP/SMX) may increase likelihood of hemolysis in patients with G6PD deficiency
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.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
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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