Aczone

Name: Aczone

Dapsone Side Effects

Common Side Effects of Dapsone

Tell your doctor if any of the following side effects of oral dapsone become severe or don't go away:

  • Upset stomach
  • Vomiting
  • Headache
  • Mild nausea
  • Ringing in the ears
  • Trouble sleeping
  • Blurred vision

Tell your doctor if any of the following side effects of topical Aczone become severe or don't go away:

  • Dryness, peeling, redness, or oiliness of the skin

Serious Side Effects of Dapsone

Tell your doctor right away if you experience any of the following serious side effects of oral dapsone:

  • Sore throat
  • Fever
  • Yellowing of the skin or eyes
  • Unusual bruising
  • A severe allergic reaction (may include hives, rash, itching, chest tightness, or swelling of the face, lips, tongue, or throat)
  • Unusual behavior or personality changes
  • Bloody stools
  • Loss of appetite
  • Weight loss
  • Unusual fatigue
  • Chest pain
  • Changes in skin color
  • Dark-colored urine
  • Pale-colored stools
  • Muscle weakness
  • Numbness, tingling, or burning sensation in the arms, hands, legs, or feet
  • Severe diarrhea
  • Severe rash
  • Severe stomach pains or cramps

Tell your doctor right away if you experience any of the following serious side effects of topical dapsone:

  • Dark-colored urine
  • Mental or mood changes
  • Suicidal thoughts
  • Numbness, tingling, or burning sensation in the hands or feet
  • Red, swollen, blistered, or severely peeling skin
  • Severe stomach pain or vomiting
  • Sudden back pain
  • Unusual weakness or fatigue
  • Yellow or pale skin
  • Signs of infection (may include fever, chills, or sore throat)
  • Signs of a severe allergic reaction (anaphylaxis), such as rash, hives, difficulty breathing, tightness in the chest, or swelling of the mouth, face, lips, or tongue

Dapsone Interactions

Before taking oral dapsone, tell your doctor about all prescription, non-prescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking, especially:

  • Aminobenzoic acid
  • Bactrim, Cotrim, and Septra (trimethoprim)
  • Benemid (probenecid)
  • Daraprim (pyrimethamine)
  • Lamprene (clofazimine)
  • Potaba (aminobenzoate potassium)
  • Rifadin (rifampin)
  • Videx (didanosine)
  • Vitamins

Before using topical Aczone, tell your doctor about all prescription, non-prescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking, especially:

  • Antimalarial medicines such as Aralen (chloroquine) or oral dapsone
  • Bactrim (trimethoprim and sulfamethoxazole)
  • Other topical medicines

Dapsone and Other Interactions

Oral dapsone may cause blurred vision.

Don't drive or perform activities that require alertness until you know how the drug affects you.

Dapsone and Alcohol

Alcohol may worsen certain side effects of oral dapsone.

Talk to your doctor about how much alcohol is safe to consume while taking this medicine.

Why is this medication prescribed?

Dapsone topical is used to treat acne. Dapsone is in a class of medications called sulfone antibiotics. It works by slowing or stopping the growth of bacteria and to decrease inflammation.

What are some other side effects of Aczone?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dry skin.
  • Oily skin.
  • Skin irritation.
  • Redness.
  • Peeling.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Dosage Forms and Strengths

Gel, 7.5%. Each gram of Aczone Gel, 7.5% contains 75 mg of dapsone in an off-white to yellow gel with suspended particles.

Warnings and Precautions

Hematological Effects

Methemoglobinemia

Cases of methemoglobinemia, with resultant hospitalization, have been reported postmarketing in association with twice daily dapsone gel, 5%, treatment. Patients with glucose-6-phosphate dehydrogenase deficiency or congenital or idiopathic methemoglobinemia are more susceptible to drug-induced methemoglobinemia. Avoid use of Aczone Gel, 7.5% in those patients with congenital or idiopathic methemoglobinemia.

Signs and symptoms of methemoglobinemia may be delayed some hours after exposure. Initial signs and symptoms of methemoglobinemia are characterized by a slate grey cyanosis seen in e.g., buccal mucous membranes, lips, and nail beds. Advise patients to discontinue Aczone Gel, 7.5% and seek immediate medical attention in the event of cyanosis.

Dapsone can cause elevated methemoglobin levels particularly in conjunction with methemoglobin-inducing agents [see Drug Interactions (7.4)].

Hemolysis

Oral dapsone treatment has produced dose-related hemolysis and hemolytic anemia. Individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency are more prone to hemolysis with the use of certain drugs. G6PD deficiency is most prevalent in populations of African, South Asian, Middle Eastern, and Mediterranean ancestry.

In clinical trials, there was no evidence of clinically relevant hemolysis or hemolytic anemia in subjects treated with topical dapsone. Some subjects with G6PD deficiency using dapsone gel, 5 %, twice daily developed laboratory changes suggestive of hemolysis [see Use in Specific Populations (8.6)].

Discontinue Aczone Gel, 7.5%, if signs and symptoms suggestive of hemolytic anemia occur. Avoid use of Aczone Gel, 7.5% in patients who are taking oral dapsone or antimalarial medications because of the potential for hemolytic reactions. Combination of Aczone Gel, 7.5%, with trimethoprim/sulfamethoxazole (TMP/SMX) may increase the likelihood of hemolysis in patients with G6PD deficiency [see Drug Interactions (7.1)].

Peripheral Neuropathy

Peripheral neuropathy (motor loss and muscle weakness) has been reported with oral dapsone treatment. No events of peripheral neuropathy were observed in clinical trials with topical dapsone treatment.

Skin Reactions

Skin reactions (toxic epidermal necrolysis, erythema multiforme, morbilliform and scarlatiniform reactions, bullous and exfoliative dermatitis, erythema nodosum, and urticaria) have been reported with oral dapsone treatment. These types of skin reactions were not observed in clinical trials with topical dapsone treatment.

Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Hematological Effects

  • Inform patients that methemoglobinemia can occur with topical dapsone treatment. Advise patients to seek immediate medical attention if they develop cyanosis [see Warnings and Precautions (5.1)].
  • 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 [see Warnings and Precautions (5.1)].

Important Administration Instructions

  • Advise patients to apply Aczone Gel, 7.5%, once daily to the entire face [see Dosage and Administration (2)].
  • Aczone Gel, 7.5% is for topical use only.
  • Do not apply Aczone Gel, 7.5% to eyes, mouth, or mucous membranes.

Manufactured for: Allergan, Inc. Irvine CA 92612, U.S.A.
By: DPT Laboratories, Ltd. San Antonio, TX 78215 U.S.A.

© 2016 Allergan. All rights reserved.
Irvine, CA 92612, U.S.A.
All trademarks are the property of their respective owners.
Patented. See: www.allergan.com/products/patent_notices
Made in the U.S.A.

72780US10

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This Patient Information has been approved by the U.S. Food and Drug Administration.

Issued: 02/2016

Patient Information
Aczone® (AK-zōn) (dapsone) Gel, 7.5%
Important: For use on skin only (topical use). Do not use Aczone Gel, 7.5% in your mouth, eyes, or vagina.
What is Aczone Gel, 7.5%?
Aczone Gel, 7.5%, is a prescription medicine used on the skin (topical) to treat acne in people 12 years and older.
Aczone Gel, 7.5%, has not been studied in children under 12 years of age.
Before you use Aczone Gel, 7.5%, tell your doctor about all of your medical conditions, including if you:
  • have a glucose-6-phosphate dehydrogenase deficiency (G6PD)
  • have higher than normal levels of methemoglobin in your blood (methemoglobinemia)
  • are pregnant or plan to become pregnant. It is not known if Aczone Gel, 7.5% will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. Aczone Gel, 7.5% can pass into your breast milk and may harm your baby. You and your doctor should decide if you will use Aczone Gel, 7.5%, or breastfeed. You should not do both.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially, tell your doctor if you are using acne medicines that contain benzoyl peroxide. Use of benzoyl peroxide with Aczone Gel, 7.5% at the same time may cause your skin or facial hair to temporarily turn yellow or orange at the site of application.
How do I use Aczone Gel, 7.5%?
  • Use Aczone Gel, 7.5% exactly as your doctor tells you to use it.
  • Apply Aczone Gel, 7.5% one time a day.
  • Gently wash and pat dry the areas of your skin where you will apply Aczone Gel, 7.5%.
  • Apply a pea-sized amount of Aczone Gel, 7.5% in a thin layer to the entire face. A thin layer may also be applied to other affected areas as instructed by your doctor.
  • Rub Aczone Gel, 7.5% in gently and completely.
  • Wash your hands after applying Aczone Gel, 7.5%..
  • If your acne does not get better after using Aczone Gel, 7.5% for 12 weeks, talk to your doctor about continuing treatment.
What are the possible side effects of Aczone Gel, 7.5%?
Aczone Gel, 7.5% may cause serious side effects, including:
  • Decrease of oxygen in your blood caused by a certain type of abnormal red blood cell (methemoglobinemia). Stop using Aczone Gel, 7.5% and get medical help right away if your lips, nail beds, or the inside of your mouth turns grey or blue.
  • Breakdown of red blood cells (hemolytic anemia). Some people with G6PD deficiency using Aczone Gel, 7.5% may develop mild hemolytic anemia. Stop using Aczone Gel, 7.5% and tell your doctor right away if you get any of the following signs and symptoms:
  • back pain
  • dark brown urine
  • shortness of breath
  • fever
  • tiredness or weakness
  • yellow or pale skin
The most common side effects of Aczone Gel, 7.5% include dryness and itching of the skin being treated.
These are not all of the possible side effects of Aczone Gel, 7.5%. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Aczone Gel, 7.5%?
  • Store Aczone Gel, 7.5%, at room temperature 68ºF to 77ºF (20ºC to 25ºC).
  • Protect Aczone Gel, 7.5% from freezing.
Keep Aczone Gel, 7.5% and all medicines out of the reach of children.
General information about the safe and effective use of Aczone Gel, 7.5%.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Aczone Gel, 7.5% for a condition for which it was not prescribed. Do not give Aczone Gel, 7.5% to other people, even if they have the same symptoms you have. It may harm them. You can ask your doctor or pharmacist for information about Aczone Gel, 7.5% that is written for health professionals.
What are the ingredients in Aczone Gel, 7.5%?
Active ingredient: dapsone
Inactive ingredients: diethylene glycol monoethyl ether, methylparaben, acrylamide/sodium acryloyldimethyl taurate copolymer, isohexadecane, polysorbate 80, and purified water.

Manufactured for: Allergan, Inc. Irvine CA 92612, U.S.A.
By: DPT Laboratories, Ltd. San Antonio, TX 78215 U.S.A.
© 2016 Allergan.All rights reserved.
Irvine, CA 92612, U.S.A.
All trademarks are the property of their respective owners.
Patented. See: www.allergan.com/products/patent_notices
Made in the U.S.A.



For more information, call 1-800-433-8871

72780US10

Principal Display Panel - Carton Label

NDC 0023-5206-60

Aczone®
(dapsone) Gel, 7.5%

FOR TOPICAL USE ONLY

ALLERGAN®

Rx only

60 g

Aczone (DAPSONE) GEL, 7.5% 
dapsone gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0023-5206
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
dapsone (dapsone) dapsone 75 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
diethylene glycol monoethyl ether  
methylparaben  
isohexadecane  
polysorbate 80  
water  
Packaging
# Item Code Package Description
1 NDC:0023-5206-30 1 BOTTLE, PUMP in 1 CARTON
1 30 g in 1 BOTTLE, PUMP
2 NDC:0023-5206-60 1 BOTTLE, PUMP in 1 CARTON
2 60 g in 1 BOTTLE, PUMP
3 NDC:0023-5206-90 1 BOTTLE, PUMP in 1 CARTON
3 90 g in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207154 02/26/2016
Labeler - Allergan, Inc. (144796497)
Establishment
Name Address ID/FEI Operations
DPT Laboratories, Ltd. 832224526 MANUFACTURE(0023-5206)
Revised: 03/2016   Allergan, Inc.

Dosing & Uses

Dosage Forms & Strengths

topical gel

  • 5% (30g, 60g, or 90g tubes)
  • 7.5% (30g, 60g, or 90g pump)

Acne Vulgaris

Apply thin layer to the entire face BID (5% gel) or qDay (7.5% gel); a thin layer can also be applied to other affected areas

If no improvement after 12 weeks, reassess treatment

Dosage Forms & Strengths

topical gel

  • 5% (30g, 60g, or 90g tubes)
  • 7.5% (30g, 60g, or 90g pump)

Acne Vulgaris

<12 years: Safety and efficacy not established

≥12 years: Apply thin layer to the entire face BID (5% gel) or qDay (7.5% gel); a thin layer can also be applied to other affected areas

If no improvement after 12 weeks, reassess treatment

Patient Handout

Print without Office InfoPrint with Office Info

How should I use Aczone gel?

Use Aczone gel exactly as directed by your doctor. 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. Aczone gel 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 Aczone gel. Gently pat dry with a clean towel. Also wash your hands after applying this medicine.

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

Using benzoyl peroxide acne medication at the same time as Aczone 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.

For Healthcare Professionals

Applies to dapsone topical: topical gel

General

The most commonly reported side effects were application site reaction not otherwise specified, application site dryness, application site erythema, and oiliness/peeling.[Ref]

Hematologic

Frequency not reported: Agranulocytosis, hemolytic anemia
Postmarketing reports: Methemoglobinemia[Ref]

Dermatologic

Frequency not reported: Toxic epidermal necrolysis, erythema multiforme, morbilliform and scarlatiniform reactions, bullous and exfoliative dermatitis, erythema nodosum, urticaria[Ref]

Local

Very common (10% or more): Application site reaction not otherwise specified (18%), application site dryness (16%), application site erythema (13%), oiliness/peeling (up to 13%)
Common (1% to 10%): Application site pruritus[Ref]

Respiratory

Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection not otherwise specified, sinusitis not otherwise specified, influenza, pharyngitis, cough[Ref]

Other

Common (1% to 10%): Pyrexia
Very rare (less than 0.01%): Facial swelling[Ref]

Musculoskeletal

Common (1% to 10%): Joint sprain[Ref]

Nervous system

Common (1% to 10%): Headache not otherwise specified
Frequency not reported: Tonic clonic movements, peripheral neuropathy (motor loss and muscle weakness)[Ref]

Psychiatric

Very rare (less than 0.01%): Depression, psychosis
Frequency not reported: Suicide attempt[Ref]

Gastrointestinal

Frequency not reported: Abdominal pain, severe vomiting, pancreatitis[Ref]

Some side effects of Aczone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Dapsone topical Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Yes Comments: The effects in the nursing infant are unknown.

Administrative Information

LactMed Record Number

695

Last Revision Date

20170411

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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