Aczone

Aczone is a prescription medication used to treat acne. Aczone belongs to a group of drugs called anti-infectives. These work by stopping the growth of bacteria.

Aczone comes in topical gel form and is typically applied to the skin in a thin layer twice a day.

Common side effects of Aczone include oiliness, peeling, dryness, and redness of the skin at the application site.

Aczone is a prescription medication used to treat acne in people 12 years of age and older.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Allergan, Inc.

Serious side effects have been reported with Aczone. See the "Drug Precautions" section.

Common side effects include:

• skin oiliness
• peeling of the skin
• dry skin
• redness of the skin at the application site

This is not a complete list of Aczone side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• trimethoprim-sulfamethoxazole
• topical benzoyl peroxide

This is not a complete list of Aczone drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Aczone including the following:

• Methemoglobinemia. Cases of methemoglobinemia requiring hospitalization have been reported with use of Aczone.People with glucose‐6‐phosphate dehydrogenase deficiency or congenital or idiopathic methemoglobinemia are more susceptible to this.

Do not take Aczone if you are allergic to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Aczone, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Aczone, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Aczone or to any of its ingredients
• have glucose‐6‐phosphate dehydrogenase deficiency
• have congenital methemoglobinemia
• have idiopathic methemoglobinemia
• are breastfeeding
• are pregnant or planning to become pregnant

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Aczone falls into category C. There are no well-controlled studies that have been done in pregnant women. Aczone should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

It is not known if Aczone crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Aczone.

Take Aczone exactly as prescribed.

Aczone comes in topical gel form.

After the skin is gently washed and patted dry, apply and rub in Aczone gently and completely. Aczone is gritty with visible drug substance particles.

Wash hands after application of Aczone.

If you miss a dose, apply the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and apply your next dose at the regular time. Do not apply two doses of Aczone at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose of Aczone for the treatment of acne is to apply approximately a pea-sized amount of Aczone in a thin layer to the affected areas twice daily.

If you apply too much Aczone, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Store Aczone gel at controlled room temperature, 20°-25°C (68°-77°F), excursions permitted to 15°-30ºC (59°-86ºF).

Protect from freezing.