Aczone

Dapsone is a prescription antibiotic; topical dapsone is sold under the brand name Aczone (manufactured by Allergan) and is used to treat acne.

The oral form of the drug is used to treat leprosy (an infectious disease that causes skin lesions and nerve damage), certain lung and brain infections associated with HIV/AIDS, and skin infections.

The medicine works by reducing swelling and stopping the growth of bacteria.

The Food and Drug Administration (FDA) first approved dapsone in 1955.

Oral dapsone is manufactured by various pharmaceutical companies.

Dapsone Warnings

Before taking oral dapsone, tell your doctor if you have, or have ever had:

• Anemia or another blood disorder
• A glucose-6-phosphate dehydrogenase (G6PD) deficiency
• Liver disease
• Kidney or heart problems
• HIV/AIDS
• Problems with urination
• Lung disease
• Allergies to medications
• Another infection at the same time as the one being treated

Oral dapsone may make your skin more sensitive to sunlight.

Avoid unnecessary or prolonged exposure to the sun, and wear protective clothing and sunscreen while outdoors.

Long-term or repeated use of oral dapsone may cause a second infection. Discuss this risk with your doctor.

Dapsone will only treat bacterial infections. It won't work for the common cold, the flu, or other viral infections.

Oral dapsone should be used with extreme caution in newborn babies. Safety and effectiveness haven't been confirmed in this age group.

Your doctor may want to perform frequent tests to check your body's response to this drug. Keep all appointments with your doctor and laboratory.

Let your healthcare provider know if your symptoms don't improve or worsen while using oral dapsone.

Before using topical Aczone, tell your doctor if you have, or have ever had:

• Anemia or another blood disorder
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency (a genetic disorder)
• Liver disease
• Allergies to other medicines

Aczone should only be used on the skin. Avoid contact with the eyes, mouth, nose, or vagina.

Don't use other skin products or medicines at the same time as Aczone without first checking with your doctor.

If Aczone is used along with benzoyl peroxide, it may cause a temporary yellow or orange discoloration of the skin and facial hair.

Let your doctor know if your symptoms don't improve, or if they worsen, within 12 weeks of starting this medicine.

Aczone shouldn't be used by children under age 12. Safety and effectiveness haven't been confirmed in this age group.

Pregnancy and Dapsone

It's not known whether dapsone may harm an unborn baby.

Talk to your doctor if you become pregnant while using dapsone. You'll have to discuss the risks and benefits of taking the medicine during your pregnancy.

Certain antibiotics, possibly including dapsone, may interfere with oral contraceptives. Talk to your doctor if this is a concern.

Dapsone is found in breast milk and may harm a breastfeeding baby.

Don't breastfeed while using dapsone without first talking to your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Dapsone topical can cause a serious condition called methemoglobinemia, especially if you use certain medicines at the same time, including sulfa drugs, acetaminophen (Tylenol), nitroglycerin or other nitrite heart medications, seizure medicine, and several other drugs. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with dapsone topical.

This list is not complete. Other drugs may interact with dapsone topical, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Aczone, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Aczone. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Aczone (dapsone (topical)).

Review Date: October 4, 2017

No formal drug-drug interaction studies were conducted with Aczone Gel, 7.5%.

Trimethoprim-Sulfamethoxazole

A drug-drug interaction study evaluated the effect of the use of dapsone gel, 5% in combination with double strength (160 mg/800 mg) trimethoprim-sulfamethoxazole (TMP/SMX). During co-administration, systemic levels of TMP and SMX were essentially unchanged, however, levels of dapsone and its metabolites increased in the presence of TMP/SMX. The systemic exposure from Aczone Gel, 7.5% is expected to be about 1% of that from the 100 mg oral dose, even when co-administered with TMP/SMX.

Topical Benzoyl Peroxide

Topical application of dapsone gel followed by benzoyl peroxide in patients with acne vulgaris may result in a temporary local yellow or orange discoloration of the skin and facial hair.

Drug Interactions with Oral Dapsone

Certain concomitant medications (such as rifampin, anticonvulsants, St. John's wort) may increase the formation of dapsone hydroxylamine, a metabolite of dapsone associated with hemolysis. With oral dapsone treatment, folic acid antagonists such as pyrimethamine have been noted to possibly increase the likelihood of hematologic reactions.

Concomitant Use with Drugs that Induce Methemoglobinemia

Concomitant use of Aczone Gel, 7.5% with drugs that induce methemoglobinemia such as sulfonamides, acetaminophen, acetanilide, aniline dyes, benzocaine, chloroquine, dapsone, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, para‐aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, and quinine may increase the risk for developing methemoglobinemia [see Warnings and Precautions (5.1)].

Mechanism of Action

Mechanism of action of dapsone gel in treating acne vulgaris is not known

Sulfone; prevents normal bacterial utilization of para-aminobenzoic acid (PABA) for the synthesis of folic acid by acting as a competitive antagonist of PABA; it is bactericidal and bacteriostatic against Mycobacterium leprae

Absorption

AUC: 415 ± 224 ng•h/mL

Exposure of single 100 mg PO dose is 100 times that of topical 5% BID

Topical Administration

For topical use only; not for oral, ophthalmic, or intravaginal use

Gently cleanse skin and pat dry

Apply pea-size amount in thin layer to acne affected area

Rub gel in gently and completely

Wash hands after application

Aczone (dapsone) is an anti-infective medication.

Aczone is a topical gel used to help treat acne. The mechanism of action of in treating acne is not known. It is not for oral use. Use is contraindicated in persons with a hypersensitivity to dapsone.

Aczone gel may also be used for purposes not listed in this medication guide.

You should not use Aczone if you are allergic to dapsone.

To make sure Aczone gel 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 Aczone will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

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

Aczone gel is not approved for use by anyone younger than 12 years old.

Rinse with water if this medicine gets in your eyes.

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