Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Aczone: 5% (30 g [DSC], 60 g, 90 g) [contains methylparaben]
Aczone: 7.5% (60 g, 90 g) [contains methylparaben, polysorbate 80]
Generic: 5% (60 g, 90 g)
Brand Names: U.S.
- Topical Skin Product, Acne
~1% of the absorption of 100 mg tablet
Use: Labeled Indications
Acne vulgaris: Topical treatment of acne vulgaris
Guideline recommendations: American Academy of Dermatology (AAD) acne guidelines recommend dapsone 5% topical gel for inflammatory acne, particularly in adult females with acne (AAD [Zaenglein 2016]).
There are no contraindications listed in the manufacturer's labeling.
Canadian labeling: Hypersensitivity to dapsone or any component of the formulation or container.
Acne vulgaris: Topical: Note: Reevaluate patient if no improvement after 12 weeks of therapy
Gel 5%: Apply pea-sized amount in a thin layer to affected areas twice daily
Gel 7.5%: Apply pea-sized amount in a thin layer to entire face once daily; may also apply a thin layer to other affected areas of the body once daily
Refer to adult dosing.
Acne vulgaris: Children ≥12 years and Adolescents: Topical: Refer to adult dosing.
Dosing: Renal Impairment
There are no dosage adjustments provided in the manufacturer’s labeling.
Dosing: Hepatic Impairment
There are no dosage adjustments provided in the manufacturer’s labeling.
Topical: Clean and dry skin before applying. Rub in gently and completely. Wash hands after applying. Gel may be gritty. For external use only; avoid applying to inside nose, mouth, eyes, vagina, and mucous membranes
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Do not freeze.
Antimalarial Agents: May enhance the adverse/toxic effect of Dapsone (Topical). Specifically, the risk of hemolytic reactions may be increased. Management: Closely monitor for signs/symptoms of hemolytic reactions with concomitant use of topical dapsone and antimalarial agents. Patients with glucose-6-phosphate dehydrogenase deficiency may be at particularly high risk for adverse hematologic effects. Consider therapy modification
Benzoyl Peroxide: May enhance the adverse/toxic effect of Dapsone (Topical). Specifically, the use of these agents in combination may cause skin and facial hair to temporarily turn a tan or yellow/orange color. Monitor therapy
Methemoglobinemia Associated Agents: Dapsone (Topical) may enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Monitor therapy
Nitric Oxide: May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Management: Monitor patients for signs of methemoglobinemia (e.g., hypoxia, cyanosis) when nitric oxide is used in combination with other agents associated with development of methemoglobinemia. Avoid lidocaine/prilocaine. Monitor therapy
Prilocaine: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Prilocaine. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Management: Monitor patients for signs of methemoglobinemia (e.g., hypoxia, cyanosis) when prilocaine is used in combination with other agents associated with development of methemoglobinemia. Avoid lidocaine/prilocaine in infants receiving such agents. Monitor therapy
Sodium Nitrite: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Sodium Nitrite. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Monitor therapy
Tetracaine (Topical): May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Monitor therapy
Trimethoprim: May enhance the adverse/toxic effect of Dapsone (Topical). More specifically, trimethoprim may increase the risk for hemolysis Monitor therapy
Frequency not always defined.
Central nervous system: Suicidal tendencies, tonic-clonic movements
Gastrointestinal: Abdominal pain, pancreatitis, severe vomiting
Respiratory: Sinusitis (2%), pharyngitis
<1% (Limited to important or life-threatening): Depression, erythema, facial edema, methemoglobinemia (Swartzentruber 2015), psychosis
Concerns related to adverse effects:
• Dermatologic: Localized discoloration (yellow or orange) of the skin or facial hair may occur if benzoyl peroxide is used subsequent to dapsone gel; typically resolves in ~1 to 8 weeks. Skin reactions (eg, bullous and exfoliative dermatitis, erythema multiforme, erythema nodosum, morbilliform and scarlatiniform reactions, toxic epidermal necrolysis, urticaria) have been reported with oral dapsone; similar events were not observed during clinical trials with topical dapsone.
• Hematologic effects: Changes suggestive of hemolysis have been observed in some patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency and using twice-daily dapsone 5% gel; discontinue use with signs/symptoms of hemolytic anemia. Do not use concomitantly with oral dapsone or other antimalarial agents due to increased risk of hemolytic reactions.
• Methemoglobinemia: Cases of methemoglobinemia, resulting in hospitalization, have occurred with twice-daily dapsone 5% gel. Patients with glucose-6-phosphate dehydrogenase deficiency or congenital or idiopathic methemoglobinemia are at increased risk; avoid use in patients with congenital or idiopathic methemoglobinemia. Dapsone may increase methemoglobin levels, especially in combination with methemoglobin-inducing agents. Signs and symptoms of methemoglobinemia (eg, slate grey cyanosis in buccal mucous membranes, lips, and nail beds) may be delayed hours after exposure; discontinue treatment promptly and seek immediate medical attention in the event of cyanosis.
• Peripheral neuropathy: Has been reported with oral dapsone; similar events were not observed during clinical trials with topical dapsone.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
For patients at risk of anemia, monitor CBC and reticulocyte counts at baseline and routinely thereafter.
Pregnancy Risk Factor
Adverse events were observed in some animal reproduction studies. The amount of dapsone available systemically is less following topical application than with oral administration. If treatment for acne is deemed necessary during pregnancy, topical agents are currently recommended; information specific to dapsone is lacking (Gollnick 2003; Kong 2013; Meredith 2013).
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience skin irritation, dry skin, redness, peeling, or oily skin. Have patient report immediately to prescriber signs of pancreatitis (severe abdominal pain, severe back pain, severe nausea, or vomiting), signs of methemoglobinemia (blue or gray color of the lips, nails, or skin; abnormal heartbeat; seizures; severe dizziness or passing out; severe headache; fatigue; loss of strength and energy; or shortness of breath), shortness of breath, loss of strength and energy, suicidal ideation, severe pharyngitis, dark urine, back pain, jaundice, abdominal pain, severe nausea, severe vomiting, or abnormal movements (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
More about dapsone topical
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- Drug class: topical acne agents
Other brands: Aczone