Dapsone Topical

What is Dapsone Topical?

• Dapsone Topical (Aczone), is a synthetic derivative of diamino-sulfone with anti-inflammatory and anti-bacterial properties.

Dapsone

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What are the uses of this medicine?

• Dapsone Topical (Aczone), is a prescription medicine used on your skin (topical) to treat acne vulgaris.

How does this medicine work?

• The 5% gel preparation of dapsone, a synthetic derivative of diamino-sulfone with anti-inflammatory and anti-bacterial properties.
• As a structural analog of p-aminobenzoic acid (PABA), dapsone inhibits dihydropteroate synthase (DHPS), an enzyme important in folate synthesis, resulting in a depletion of the folate pool and a reduction in the amount of thymidylate available for DNA synthesis. Although the exact mechanism through which dapsone exerts its anti-inflammatory activity has yet to be fully elucidated, this agent interferes with the activation and oxidative damage of myeloperoxidase in neutrophils and inhibits the integrin-mediated adherence and chemotaxis of neutrophils.
• Dapsone's anti-inflammatory activities may contribute to the effects seen upon topical administration.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• acetaminophen
• anticonvulsant medications such as phenytoin (Dilantin, Phenytek)
• antimalarial medications such as chloroquine (Aralen), primaquine, and quinine (Qualaquin) dapsone (by mouth)
• nitrofurantoin (Furadantin)
• nitroglycerin (Minitran, Nitro-Dur, Nitromist, others)
• phenobarbital
• pyrimethamine (Daraprim)
• rifampin (Rifadin, Rimactane; in Rifamate, in Rifater)
• sulfonamide-containing medications including co-trimoxazole (Bactrim, Septra)

• Tell your doctor what herbal products you are taking, especially St. John's wort.

Is this medicine FDA approved?

• Dapsone was approved for use in the United States in 1979.

How should this medicine be used?

Recommended dosage:

• Apply twice daily.
• Apply approximately a pea-sized amount of dapsone gel, 5%, in a thin layer to the acne affected area.
• If there is no improvement after 12 weeks, treatment with dapsone gel, 5%, should be reassessed.

Administration:

• Use Dapsone Gel, 5% exactly as your doctor tells you.
• Apply Dapsone Gel, 5% twice a day.
• Gently wash and pat dry the areas of your skin where you will apply Dapsone Gel, 5%.
• Apply a pea-sized amount of Dapsone Gel, 5% in a thin layer to the areas of your skin that have acne.
• Rub Dapsone Gel, 5% in gently and completely. It may feel gritty and you may see particles in the gel.
• Make sure to put the cap back on the Dapsone Gel tube. Close it tightly.
• Wash your hands after applying Dapsone Gel, 5%.
• If your acne does not get better after using Dapsone Gel, 5% for 12 weeks, talk to your doctor about continuing treatment.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Gel, 5%

This medicine is available in fallowing brand namesː

• Aczone

What side effects can this medication cause?

The most common side effects of this medicine may include:

• oiliness, peeling, dryness, and redness

Less common, but serious side effects may include:

• methemoglobinemia
• hemolytic anemia

What special precautions should I follow?

• Inform patients that methemoglobinemia can occur with topical dapsone treatment. Advise patients to seek immediate medical attention if they develop cyanosis
• Inform patients who have G6PD deficiency that hemolytic anemia may occur with topical dapsone treatment. Advise patients to seek medical attention if they develop signs and symptoms suggestive of hemolytic anemia
• Advise patients to apply Dapsone Gel, 5%, twice daily to the acne affected area. Do not apply Dapsone Gel, 5% to eyes, mouth, or mucous membranes.
• If you are having surgery, including dental surgery, tell the doctor or dentist that you are using dapsone.
• Tell your doctor if you are using acne medicines that contain benzoyl peroxide. Use of benzoyl peroxide with Dapsone Gel, 5% at the same time may cause your skin or facial hair to temporarily turn yellow or orange at the site of application.
• Dapsone Gel, 5% can pass into your breast milk and may harm your baby. You and your doctor should decide if you will use Dapsone Gel, 5% or breastfeed. You should not do both.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• It is not known if Dapsone Gel, 5 % will harm your unborn baby.

Can this medicine be used in children?

• Dapsone Gel has not been studied in children under 12 years of age.

What are the active and inactive ingredients in this medicine?

• Active ingredient: dapsone, USP
• Inactive ingredients: carbomer homopolymer type C, diethylene glycol monoethyl ether, methylparaben, purified water and sodium hydroxide

Who manufactures and distributes this medicine?

Manufactured for:

• X-GEN Pharmaceuticals, Inc.
• Big Flats, NY
• Manufactured in the USA

What should I know about storage and disposal of this medication?

• Store Dapsone Gel, 5% at room temperature, 68° to 77°F (20° to 25°C).
• Protect Dapsone Gel, 5% from freezing.

• Dailymed label info on Dapsone Topical
• FDA Dapsone Topical

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