Aczone

Name: Aczone

Brand names

  • Aczone®

What is dapsone topical?

Dapsone is an anti-infective medication.

Dapsone topical (for the skin) is used to treat acne.

Dapsone topical may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using dapsone topical?

You should not use dapsone topical if you are allergic to it.

To make sure dapsone topical is safe for you, tell your doctor if you have:

  • glucose 6-phosphate dehydrogenase (G6PD) deficiency;

  • a blood disorder called methemoglobinemia (abnormal red blood cells in your blood); or

  • if you have ever had methemoglobinemia in the past.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Dapsone topical can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Dapsone topical is not approved for use by anyone younger than 12 years old.

How should I use dapsone topical?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not take by mouth. Dapsone topical is for use only on the skin. If this medicine gets in your eyes, mouth, or vagina, rinse with water.

Wash the skin before you apply dapsone. Gently pat dry with a clean towel. Also wash your hands after applying this medicine.

Use only a pea-sized amount of dapsone each time you apply this medicine.

Using benzoyl peroxide acne medication at the same time as dapsone topical may cause temporary changes in the color of your skin or facial hair.

Call your doctor if your symptoms do not improve after 12 weeks of treatment.

Store at room temperature away from moisture and heat. Do not freeze. Keep the tube tightly closed when not in use.

What should I avoid while using dapsone topical?

Rinse with water if this medicine gets in your eyes.

Avoid using other medications on the areas you treat with dapsone topical unless your doctor tells you to.

Dapsone topical side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Dapsone topical may cause methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a), a serious condition in which the amount of oxygen in your blood stream becomes dangerously low. Stop using this medicine and call your doctor at once if you notice a blue or gray appearance of your lips, fingernails, or the inside of your mouth.

Call your doctor at once if you have:

  • severe sore throat;

  • unusual thoughts or behavior;

  • a red blood cell disorder--back pain, pale or yellowed skin, dark colored urine, fever, confusion or weakness;

  • pancreas problems--severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate; or

  • severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • dry or peeling skin;

  • oily skin; or

  • redness where the medicine was applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What do I need to tell my doctor BEFORE I take Aczone?

  • If you have an allergy to dapsone or any other part of Aczone (dapsone (topical)).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have methemoglobinemia.
  • If you are taking any of these drugs: Oral dapsone or drugs to treat malaria.
  • If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Aczone with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Aczone Description

Aczone (dapsone) Gel, 7.5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. Aczone Gel, 7.5% is an off-white to yellow gel with suspended particles. Chemically, dapsone has an empirical formula of C12H12N2O2S. It is a white or slightly yellow-white, crystalline powder that has a molecular weight of 248.30. Dapsone's chemical name is 4-[(4-aminobenzene) sulfonyl] aniline and its structural formula is:

Each gram of Aczone Gel, 7.5%, contains 75 mg of dapsone, USP, in a gel of diethylene glycol monoethyl ether, methylparaben, acrylamide/sodium acryloyldimethyl taurate copolymer, isohexadecane, polysorbate 80, and purified water.

How Supplied/Storage and Handling

Aczone Gel is an off-white to yellow gel with suspended particles. It is supplied in an airless pump containing a polypropylene bottle with a high density polyethylene piston.

Aczone (dapsone) Gel, 7.5%, is supplied in the following sizes:

  NDC 0023-5206-30         30 gram pump

  NDC 0023-5206-60         60 gram pump

  NDC 0023-5206-90         90 gram pump

Storage: Store at 20°C-25°C (68°F-77°F), excursions permitted to 15°C-30ºC (59°F-86ºF) [see USP Controlled Room Temperature]. Protect from freezing.

Pregnancy & Lactation

Pregnancy Category: C

There are no adequate and well controlled studies in pregnant women; shown to have an embryocidal effect in rats and rabbits when administered orally in doses of 75 mg/kg/day and 150 mg/kg/day (approximately 800 and 500 times the systemic exposure observed in human females as a result of use of the maximum recommended topical dose, based on AUC comparisons), respectively

Lactation: Although systemic absorption of dapsone following topical application is minimal relative to oral dapsone administration, it is known that dapsone is excreted in human milk

Because of the potential for oral dapsone to cause adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the topical gel, taking into account the importance of the drug to the mother

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next dose. Do not use extra medicine to make up the missed dose.

Dapsone topical Pregnancy Warnings

Animal studies have shown embryocidal effects. There are no adequate and well controlled studies in pregnant women. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. US FDA pregnancy category: C

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