Aczone topical

Name: Aczone topical

Aczone Dosage and Administration

Administration

Topical Administration

Administer topically to the skin as a 5% gel.1

For external use only.1 Do not use orally or intravaginally; avoid contact with the mouth and eyes.1

Gently cleanse and dry the acne-affected area prior to application.1 Apply a pea-sized amount of dapsone 5% gel in a thin layer; rub in gently and completely.1

The gel is gritty with visible drug substance particles.1 Wash hands after applying the gel.1

Dosage

Pediatric Patients

Acne Vulgaris Topical

Children ≥12 years of age: Apply a thin layer of dapsone 5% gel to cleansed affected area twice daily.1

Reassess use of the drug if improvement does not occur after 12 weeks of treatment.1

Has been used for up to 12 months in clinical studies.3

Adults

Acne Vulgaris Topical

Apply a thin layer of dapsone 5% gel to the cleansed affected area twice daily.1

Reassess use of the drug if improvement does not occur after 12 weeks of treatment.1

Has been used for up to 12 months in clinical studies.3

Interactions for Aczone

Although only small amounts of dapsone are absorbed systemically following topical application to skin, the possibility that drug interactions could occur should be considered.1 Concomitant use of oral dapsone and certain drugs (e.g., rifampin, anticonvulsants, St. John’s wort) may increase the formation of dapsone hydroxylamine, a dapsone metabolite associated with hemolysis.1 In addition, concomitant use of oral dapsone and folic acid antagonists (e.g., pyrimethamine) may increase the likelihood of adverse hematologic effects.1

Specific Drugs

Drug

Interaction

Comments

Antimalarial agents

Increased risk of hemolytic reactions if topical dapsone used concomitantly with antimalarial agents1

Do not use topical dapsone in patients receiving antimalarial agents1

Benzoyl peroxide

In vitro, combinations of topical dapsone 5% gel and topical benzoyl peroxide resulted in an orange discoloration17

Concomitant use of topical dapsone 5% gel and topical benzoyl peroxide in individuals with acne vulgaris may result in temporary local yellow or orange discoloration of the skin and facial hair;1 usually resolves in 4–57 days1

Co-trimoxazole

Concomitant use of topical dapsone 5% gel and oral co-trimoxazole results in increased systemic exposure to dapsone and dapsone metabolites; pharmacokinetics of co-trimoxazole not affected1 5

Possible increased risk of hemolysis in patients with G6PD deficiency1

Dapsone, oral

Increased risk of hemolytic reactions if oral and topical dapsone used concomitantly1

Do not use topical dapsone in patients receiving oral dapsone1

Stability

Storage

Topical

Gel

20–25°C (may be exposed to 15–30°C).1 Do not freeze.1

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Dapsone

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Gel

5%

Aczone

Allergan

Commonly used brand name(s)

In the U.S.

  • Aczone

Available Dosage Forms:

  • Gel/Jelly

Therapeutic Class: Antiacne

Chemical Class: Sulfone

Aczone Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known
  • Bluish-colored lips, fingernails, or palms
  • dark urine
  • difficult breathing
  • dizziness or lightheadedness
  • fever
  • headache
  • pale skin
  • rapid heart rate
  • sore throat
  • unusual bleeding or bruising
  • unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Dryness, redness, oiliness, or peeling at the application site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

(web3)