Aczone topical

Name: Aczone topical

Aczone Pharmacokinetics



Absorbed systemically following topical application to skin.1 5

In patients with acne vulgaris skin lesions, plasma concentrations of dapsone are detectable within 2 hours after the first dose of topical dapsone 5% gel.5

After topical application of dapsone 5% gel to acne vulgaris skin lesions on the face, upper back, shoulders, and/or upper chest (up to approximately 22.5% of total body surface area) twice daily for 14 days, mean peak plasma concentrations of the drug were 19.4 ng/mL and the median time to peak concentrations after a dose was 9 hours.5

In a long-term safety study of dapsone 5% gel, there was no evidence that systemic exposure increases over time.1

Systemic exposure (AUC) following a 14-day regimen of dapsone 5% gel is 126 times lower than systemic exposure (AUC) following a single 100-mg dose of oral dapsone.5

Special Populations

Systemic dapsone exposure following topical application of dapsone 5% gel in children 12–15 years of age is similar to that reported in those ≥16 years of age.1


  • Synthetic sulfone1 2 3 5 18 with anti-infective and anti-inflammatory effects.3 5 18

  • For dermatologic use, dapsone is commercially available in an aqueous gel base.1

  • Mechanism of action in the treatment of acne vulgaris not known, but may result from a combination of both anti-inflammatory and anti-infective effects.1 2 3 18

  • Dapsone exerts a variety of anti-inflammatory effects.2 3 18 The drug may inhibit myeloperoxidase- and hydrogen peroxide-based cytotoxic systems in neutrophils or may act as a scavenger of reactive oxygen species, thereby minimizing inflammation associated with generation of these reactive species.18

  • The anti-infective effects of dapsone involve inhibition of folic acid synthesis in susceptible organisms.18

  • In vitro, dapsone has some antibacterial activity against Propionibacterium acnes.18 It is not known whether topical dapsone therapy results in decreased susceptibility of P. acnes to other drugs used to treat acne.1

Advice to Patients

  • Importance of using as directed by the clinician and only for condition prescribed.1

  • Advise patient that topical dapsone is for external use only and should not be used orally or intravaginally; importance of avoiding contact with the mouth and eyes.1

  • Importance of storing at room temperature and protecting the drug from freezing.1

  • Importance of informing clinician of glucose-6-phosphate dehydrogenase (G6PD) deficiency.1

  • Importance of reporting any signs of adverse reactions to a clinician.1

  • Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, especially topical agents applied to the skin (e.g., preparations containing benzoyl peroxide).1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)

Before Using Aczone

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of dapsone topical in children 12 years and older. However, dapsone topical is not recommended for children younger than 12 years.


Although appropriate studies on the relationship of age to the effects of dapsone topical have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of dapsone topical in the elderly.


Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency or
  • Methemoglobinemia—May increase risk for serious side effects.