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Dapsone (Topical)

Medically reviewed by Drugs.com. Last updated on May 19, 2020.

Pronunciation

(DAP sone)

Index Terms

  • Diaminodiphenylsulfone
  • Diaphenylsulfone

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Gel, External:

Aczone: 5% (60 g, 90 g) [contains methylparaben]

Aczone: 7.5% (60 g, 90 g) [contains methylparaben, polysorbate 80]

Generic: 5% (60 g, 90 g); 7.5% (60 g, 90 g)

Brand Names: U.S.

  • Aczone

Pharmacologic Category

  • Topical Skin Product, Acne

Absorption

~1% of the absorption of 100 mg tablet

Use: Labeled Indications

Acne vulgaris: Topical treatment of acne vulgaris in patients ≥9 years of age (7.5% gel) or patients ≥12 years of age (5% gel).

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]).

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Canadian labeling: Hypersensitivity to dapsone or any component of the formulation or container.

Dosing: Adult

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

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Acne vulgaris:

Gel 7.5%: Children ≥9 years and Adolescents: Topical: Apply a pea-sized amount of gel to entire face once daily; may also apply a thin layer to other affected areas of the body once daily; reevaluate patient if no improvement after 12 weeks of therapy.

Gel 5%: Children ≥12 years and Adolescents: Topical: Apply a pea-sized amount of gel to the acne-affected areas twice daily; reevaluate patient if no improvement after 12 weeks of therapy.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Administration

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

Storage

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.

Drug Interactions

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

Local Anesthetics: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. 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. 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

Trimethoprim: May enhance the adverse/toxic effect of Dapsone (Topical). More specifically, trimethoprim may increase the risk for hemolysis Monitor therapy

Adverse Reactions

1% to 10%:

Respiratory: Sinusitis (2%)

Frequency not defined:

Central nervous system: Attempted suicide, tonic-clonic movements

Gastrointestinal: Abdominal pain, pancreatitis, severe vomiting

Respiratory: Pharyngitis

<1%, postmarketing, and/or case reports: Application site rash, depression, erythema, erythematous rash, facial edema, lip edema, methemoglobinemia, periorbital swelling, psychosis, skin rash

Warnings/Precautions

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 of dapsone 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 been reported 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 dapsone 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.

Monitoring Parameters

For patients at risk of anemia, monitor CBC and reticulocyte counts at baseline and routinely thereafter.

Pregnancy Considerations

The amount of topical dapsone available systemically is minimal compared to oral administration.

Topical products are recommended as initial therapy for the treatment of acne vulgaris in pregnant females; however, information specific to dapsone is lacking (Kong 2013). Agents other than topical dapsone are preferred (Chien 2016).

Patient Education

What is this drug used for?

• It is used to treat pimples (acne).

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Skin irritation

• Dry skin

• itching

• Redness

• Peeling

• Oily skin

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Pancreatitis like severe abdominal pain, severe back pain, severe nausea, or vomiting

• Methemoglobinemia like 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

• Hemolytic anemia like severe loss of strength and energy, dark urine, or yellow skin or eyes

• Thoughts of suicide

• Severe sore throat

• Back pain

• Abdominal pain

• Severe nausea

• Severe vomiting

• Abnormal movements

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.