Aczone Gel (Dapsone Gel)

Please read the instructions before using Aczone (dapsone) Gel, 5%. Follow your doctor's prescription exactly. Apply Aczone Gel, 5% twice daily to affected areas. Wash and pat dry your skin before applying the gel. Use a pea-sized amount and spread a thin layer over acne-prone areas. Rub it in gently and completely. The gel may feel gritty, and small particles may be visible. After applying, replace the cap tightly and wash your hands. If your acne does not improve after 12 weeks, consult your doctor about continuing treatment.

What are the ingredients in Aczone Gel, 5%?

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

Common Side Effects of Aczone Gel

• Dryness of the skin being treated
• Itching of the skin being treated

Serious Side Effects

• Mental/mood changes, such as depression or agitation
• Unusual tiredness or weakness
• Dark urine
• Shortness of breath
• Blue or gray appearance of lips, fingernails, or inside of the mouth
• Serious allergic reaction, such as rash or itching/swelling of the face, tongue, or throat

This is not an exhaustive list, and other side effects may occur. If you experience any unusual or severe side effects while taking  Aczone gel,  contact your healthcare provider for medical advice.

Let your healthcare provider know if you have any allergies to dapsone or other medications before using Aczone Gel.

Inform your healthcare provider about your medical history, particularly if you have G6PD deficiency (an enzyme deficiency) or methemoglobinemia (a blood disorder).

Tell your healthcare provider about all medications you use, including Aczone Gel, before any surgery.

Discuss the risks and benefits of using this gel while pregnant with your healthcare provider.

Aczone can pass into breast milk. Consult your healthcare provider before breastfeeding while using this medication.

Aczone Drug Interactions (Dapsone Topical)

Methemoglobin-Inducing Agents Aczone Gel may increase methemoglobin levels, which can reduce oxygen in the blood. Using it with other methemoglobin-inducing drugs can heighten this risk. Examples include:

• Sulfonamides
• Acetaminophen
• Benzocaine
• Nitrates and nitrites
• Phenacetin
• Primaquine

Oral Dapsone and Antimalarial Medications Avoid using Aczone Gel with oral dapsone or antimalarial drugs. This combination may cause hemolytic reactions, especially in people with G6PD deficiency. Enzyme Inducers Certain drugs can increase dapsone hydroxylamine levels, raising the risk of toxicity. These include:

• Rifampin (CYP2C enzyme inducer)
• Anticonvulsants
• St. John's wort

Folic Acid Antagonists When combined with oral dapsone, drugs like pyrimethamine may increase the risk of blood disorders. Always consult a healthcare provider before using Aczone Gel with other medications. This list is not exhaustive, and interactions may vary.

How should I store Aczone Gel, 5%?

Store Aczone Gel, 5% at room temperature 68ºF to 77ºF (20ºC to 25ºC). Protect it from freezing. Keep this gel and all medicines out of the reach of children.

Generic name:	Dapsone Gel, Dapsone Gel
Formulation:	Gel
Strength(s):	5%
Quantities Available:	60, 120