Aczone topical

Name: Aczone topical

Introduction

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

Uses for Aczone

Acne Vulgaris

Topical treatment of acne vulgaris.1 2 3 4 11

Effective against inflammatory acne lesions and, to a lesser extent, noninflammatory acne lesions.2 3

Cautions for Aczone

Contraindications

  • Manufacturer states none known.1

Warnings/Precautions

Sensitivity Reactions

Moderate erythema has been reported when topical dapsone 5% gel was evaluated in combined contact sensitization/irritation studies.1 Pruritus,2 3 6 rash,3 and contact dermatitis6 were reported in some patients receiving the topical gel for treatment of acne vulgaris.

Oral dapsone has been associated with hypersensitivity reactions that include severe dermatologic reactions.1 7 16 (See Dermatologic Reactions under Cautions.) Hypersensitivity reactions reported with oral dapsone have also included fever, malaise, hepatitis, and hemolysis.10

Topical dapsone did not induce phototoxicity or photoallergy in human dermal safety studies.1

Hematologic Effects

Oral dapsone has been associated with dose-related hemolysis and hemolytic anemia.1 14 Agranulocytosis also reported in patients receiving oral dapsone.1 9 Individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency are more prone to hemolysis when receiving certain drugs.1 G6PD deficiency is most prevalent in populations of African, South Asian, Middle Eastern, and Mediterranean ancestry.1

There were no reports of clinically relevant hemolysis or hemolytic anemia in clinical studies evaluating topical dapsone 5% gel in individuals with acne vulgaris, including individuals with G6PD deficiency.1 2 3 6 However, laboratory changes suggestive of hemolysis (slight decreases in hemoglobin) occurred in some individuals with G6PD deficiency using the topical gel.1 2 6

If signs and symptoms suggestive of hemolytic anemia occur, discontinue topical dapsone therapy.1

Because of the potential for hemolytic reactions, do not use topical dapsone 5% gel in individuals receiving oral dapsone or antimalarial agents.1 (See Specific Drugs under Interactions.)

Concomitant use of topical dapsone 5% gel and co-trimoxazole may increase the risk of hemolysis in patients with G6PD deficiency.1 (See Specific Drugs under Interactions.)

Peripheral Neuropathy

Oral dapsone has been associated with peripheral neuropathy (motor loss and muscle weakness).1

Peripheral neuropathy was not reported in clinical studies evaluating topical dapsone 5% gel for the treatment of acne vulgaris.1

Dermatologic Reactions

Oral dapsone has been associated with serious skin reactions, including toxic epidermal necrolysis, erythema multiforme, morbilliform and scarlatiniform reactions, bullous and exfoliative dermatitis, erythema nodosum, and urticaria.1 7

Although erythema,1 pruritus,2 3 and rash3 were reported in clinical studies evaluating topical dapsone 5% gel for the treatment of acne vulgaris, more severe dermatologic reactions were not reported.1

Specific Populations

Pregnancy

Category C.1

Oral dapsone has been associated with embryocidal effects in rats and rabbits when used in dosages approximately 800 and 500 times, respectively, the systemic exposure (based on AUC) observed in human females receiving the maximum recommended dosage of topical dapsone 5% gel.1 These effects were probably secondary to maternal toxicity.1

Use during pregnancy only if potential benefits outweigh potential risks to the fetus.1

Lactation

Distributed into milk following oral administration.1 Systemic absorption is low following topical application of dapsone 5% gel; however, because of the potential to cause adverse reactions in nursing infants, discontinue nursing or discontinue topical dapsone therapy.1

Pediatric Use

Safety and efficacy not established in children <12 years of age.1

Geriatric Use

Insufficient experience with topical dapsone 5% gel in geriatric patients ≥65 years of age to determine whether such individuals respond differently than younger individuals.1

Common Adverse Effects

Local reactions at the application site (oiliness/peeling, dryness, erythema).1 2

Uses For Aczone

Dapsone topical is used to treat acne. It works by killing the bacteria that cause acne and by keeping the skin pores clean.

This medicine is available only with your doctor's prescription.

Proper Use of Aczone

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may increase the chance for unwanted effects.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

This medicine is for use only on the skin. Do not put it in your eyes, nose, mouth, or vagina. Rinse it off right away if it does get on these areas.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For topical dosage form (gel):
    • For acne:
      • Adults and children 12 years and older—Apply a thin layer on the acne area once a day (7.5% gel) or 2 times per day (5% gel).
      • Children younger than 12 years—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Aczone

It is important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.

Check with your doctor right away if you have bluish-colored lips, fingernails, or palms, dark urine, trouble breathing, dizziness or lightheadedness, a headache, pale skin, unusual bleeding or bruising, or unusual tiredness or weakness. These may be symptoms of a serious blood disorder.

Hemolytic anemia may occur while using this medicine. Tell your doctor right away if you have back, leg, or stomach pain, bleeding gums, chills, dark urine, nosebleeds, nausea or vomiting, or yellow eyes or skin.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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