Aczone 5% Gel 90gm
It is used to treat pimples (acne).
Drug Class
Anti-acne agent
Pharmacologic Class
Sulfone; Anti-inflammatory; Antimicrobial
Pregnancy Category
Category C
FDA Approved
Jul 2005
DEA Schedule
Not Controlled
Overview
What is this medicine?
Aczone 5% Gel is a topical medication used to treat acne. It works by reducing inflammation and fighting bacteria on the skin that contribute to acne breakouts.
How to Use This Medicine
Using Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication only as directed.
Application Instructions
Apply this medication topically, directly to the affected skin area. Do not ingest or take by mouth.
Avoid applying the medication to your mouth, nose, or eyes, as it may cause irritation or burning.
Do not apply the medication to the vaginal area.
Before and after applying the medication, wash your hands thoroughly.
Clean the affected skin area before application and ensure it is completely dry.
Apply a thin layer of the medication to the affected area and gently rub it in.
Storage and Disposal
Store the medication at room temperature, avoiding freezing temperatures.
Keep all medications in a secure location, out of reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
If you have questions about disposing of your medication, consult your pharmacist, who may be aware of local drug take-back programs.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If the missed dose is close to the time for your next scheduled dose, skip the missed dose and resume your regular application schedule.
* Do not apply extra doses or double doses to make up for a missed dose.
To use this medication safely and effectively, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication only as directed.
Application Instructions
Apply this medication topically, directly to the affected skin area. Do not ingest or take by mouth.
Avoid applying the medication to your mouth, nose, or eyes, as it may cause irritation or burning.
Do not apply the medication to the vaginal area.
Before and after applying the medication, wash your hands thoroughly.
Clean the affected skin area before application and ensure it is completely dry.
Apply a thin layer of the medication to the affected area and gently rub it in.
Storage and Disposal
Store the medication at room temperature, avoiding freezing temperatures.
Keep all medications in a secure location, out of reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
If you have questions about disposing of your medication, consult your pharmacist, who may be aware of local drug take-back programs.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If the missed dose is close to the time for your next scheduled dose, skip the missed dose and resume your regular application schedule.
* Do not apply extra doses or double doses to make up for a missed dose.
Lifestyle & Tips
- Apply a thin layer to clean, dry skin once daily.
- Wash hands thoroughly after applying the gel.
- Avoid contact with eyes, lips, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not apply to open wounds or irritated skin.
- Sun protection is recommended as some acne treatments can increase sun sensitivity, though dapsone itself is not a primary photosensitizer.
- If using benzoyl peroxide, apply it at a different time of day (e.g., dapsone in the morning, benzoyl peroxide at night) to minimize temporary skin discoloration.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a pea-sized amount of Aczone 5% Gel to the entire affected area once daily.
Condition-Specific Dosing:
acneVulgaris:
Apply a pea-sized amount to the entire affected area once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 12 years of age.
Adolescent:
For patients 12 years of age and older: Apply a pea-sized amount to the entire affected area once daily.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Dialysis:
No specific recommendations due to minimal systemic absorption. Use with caution if extensive skin breakdown is present.
Hepatic Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
The exact mechanism of action of dapsone in treating acne vulgaris is not fully understood. It is believed to exert its effects through both anti-inflammatory and antimicrobial properties. Dapsone is a sulfone that inhibits bacterial folate synthesis (dihydropteroate synthase), thereby inhibiting bacterial growth (e.g., P. acnes). Its anti-inflammatory effects may involve inhibition of neutrophil migration and function, and modulation of reactive oxygen species.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 1-2% of the topically applied dose is systemically absorbed.
Tmax:
Systemic Tmax is typically 15 hours (range 4-100 hours) after topical application.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not precisely quantified for topical application due to minimal systemic absorption. Systemic dapsone has a large volume of distribution.
ProteinBinding:
Approximately 70-90% (systemic dapsone).
CnssPenetration:
Limited (for topical application due to minimal systemic absorption).
Elimination:
HalfLife:
Systemic half-life of dapsone is 10-50 hours (after oral administration). For topical application, systemic exposure is minimal, and elimination is primarily through hepatic metabolism and renal excretion of metabolites.
Clearance:
Not precisely quantified for topical application.
ExcretionRoute:
Mainly renal excretion of metabolites; some biliary excretion.
Unchanged:
Less than 20% of systemically absorbed dapsone is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 4-12 weeks.
PeakEffect:
Peak therapeutic effect may take 12 weeks or longer.
DurationOfAction:
Continuous application is required for sustained effect.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of pancreatitis (pancreas problem), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Signs of methemoglobinemia, a rare but potentially life-threatening condition, such as:
+ Blue or gray discoloration of the lips, nails, or skin
+ Irregular heartbeat
+ Seizures
+ Severe dizziness or fainting
+ Severe headache
+ Excessive sleepiness
+ Feeling tired or weak
+ Shortness of breath
Signs of hemolytic anemia, such as:
+ Dark urine or lips
+ Dizziness or fainting
+ Confusion
+ Extreme fatigue or weakness
+ Pale skin
+ Shortness of breath
+ Yellow skin or eyes
Back pain
Fever
Thoughts of self-harm or suicide
Severe sore throat
Trouble controlling body movements
Stomach pain
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dry skin
Oily skin
Skin irritation
Redness
* Peeling
This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of pancreatitis (pancreas problem), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Signs of methemoglobinemia, a rare but potentially life-threatening condition, such as:
+ Blue or gray discoloration of the lips, nails, or skin
+ Irregular heartbeat
+ Seizures
+ Severe dizziness or fainting
+ Severe headache
+ Excessive sleepiness
+ Feeling tired or weak
+ Shortness of breath
Signs of hemolytic anemia, such as:
+ Dark urine or lips
+ Dizziness or fainting
+ Confusion
+ Extreme fatigue or weakness
+ Pale skin
+ Shortness of breath
+ Yellow skin or eyes
Back pain
Fever
Thoughts of self-harm or suicide
Severe sore throat
Trouble controlling body movements
Stomach pain
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dry skin
Oily skin
Skin irritation
Redness
* Peeling
This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe skin irritation (e.g., excessive redness, dryness, peeling, burning, stinging)
- Signs of an allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
- Unusual yellow or orange discoloration of the skin or facial hair (especially if used with benzoyl peroxide)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have been diagnosed with methemoglobinemia, a condition characterized by an abnormal amount of methemoglobin in the blood.
* If you are currently taking oral dapsone or medications to treat malaria, as these may interact with this drug.
This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. Your doctor and pharmacist need this information to ensure safe treatment and minimize potential interactions.
Remember, before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm it is safe to do so in conjunction with your other medications and health conditions.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have been diagnosed with methemoglobinemia, a condition characterized by an abnormal amount of methemoglobin in the blood.
* If you are currently taking oral dapsone or medications to treat malaria, as these may interact with this drug.
This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. Your doctor and pharmacist need this information to ensure safe treatment and minimize potential interactions.
Remember, before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm it is safe to do so in conjunction with your other medications and health conditions.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
When using this drug, be cautious with other skin products, as they may increase the risk of irritation. Before using any other medications or products on your skin, including soaps, consult with your doctor to ensure safe use.
Using benzoyl peroxide simultaneously with this medication may cause temporary yellow or orange discoloration of the skin or facial hair.
If you have a deficiency of the enzyme G6PD, use this medication with caution, as it may increase the risk of anemia. Individuals of African, South Asian, Middle Eastern, and Mediterranean descent are more likely to have low G6PD levels.
There is a risk of methemoglobinemia, a blood disorder, associated with this medication. Although rare, this condition may require hospitalization.
While rare, oral forms of dapsone have been linked to nerve problems, such as loss of muscle control and muscle weakness, as well as severe skin reactions like toxic epidermal necrolysis. However, these side effects have not been reported with this specific form of dapsone. Discuss any concerns with your doctor.
In case of accidental ingestion, this medication can be harmful. If swallowed, immediately contact a doctor or a poison control center.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby.
When using this drug, be cautious with other skin products, as they may increase the risk of irritation. Before using any other medications or products on your skin, including soaps, consult with your doctor to ensure safe use.
Using benzoyl peroxide simultaneously with this medication may cause temporary yellow or orange discoloration of the skin or facial hair.
If you have a deficiency of the enzyme G6PD, use this medication with caution, as it may increase the risk of anemia. Individuals of African, South Asian, Middle Eastern, and Mediterranean descent are more likely to have low G6PD levels.
There is a risk of methemoglobinemia, a blood disorder, associated with this medication. Although rare, this condition may require hospitalization.
While rare, oral forms of dapsone have been linked to nerve problems, such as loss of muscle control and muscle weakness, as well as severe skin reactions like toxic epidermal necrolysis. However, these side effects have not been reported with this specific form of dapsone. Discuss any concerns with your doctor.
In case of accidental ingestion, this medication can be harmful. If swallowed, immediately contact a doctor or a poison control center.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Topical overdose is unlikely to cause systemic effects due to minimal absorption. However, if large amounts are ingested or applied to compromised skin, systemic effects could theoretically occur, similar to oral dapsone overdose:
- Cyanosis (bluish discoloration of skin/lips due to methemoglobinemia)
- Headache
- Dizziness
- Nausea
- Vomiting
- Fatigue
- Shortness of breath
- Hemolytic anemia (especially in G6PD deficient individuals)
What to Do:
If accidental ingestion or excessive application leading to systemic symptoms occurs, seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment may involve supportive care, oxygen, and methylene blue for methemoglobinemia if severe.
Drug Interactions
Moderate Interactions
- Benzoyl peroxide (concurrent use with dapsone gel may result in temporary yellow or orange discoloration of the skin and facial hair)
Monitoring
Routine Monitoring
Skin irritation (e.g., redness, dryness, peeling)
Frequency: Regularly during treatment
Target: Minimal to no irritation
Action Threshold: If severe irritation occurs, reduce frequency or discontinue use and consult a healthcare provider.
Symptom Monitoring
- Redness
- Dryness
- Peeling
- Erythema
- Oily skin
- Pruritus
- Burning sensation
- Discoloration of skin/hair (with benzoyl peroxide)
Special Patient Groups
Pregnancy
Dapsone topical is Pregnancy Category C. While systemic absorption is minimal, dapsone has been shown to be teratogenic in animal studies at high oral doses. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential risk based on animal data, but human data for topical dapsone is limited. Minimal systemic absorption reduces concern.
Second Trimester:
Minimal systemic absorption reduces concern.
Third Trimester:
Minimal systemic absorption reduces concern. Theoretical risk of hemolytic anemia in G6PD deficient neonates if significant systemic exposure occurs, but highly unlikely with topical use.
Lactation
Dapsone is excreted in human milk following oral administration. While systemic absorption from topical application is minimal, caution should be exercised when administering Aczone Gel to a nursing woman. The potential for hemolytic anemia in a G6PD deficient infant should be considered. The L3 (Moderate risk) rating suggests weighing benefits vs. risks.
Infant Risk:
Low risk for most infants due to minimal maternal systemic absorption. Theoretical risk of hemolytic anemia in G6PD deficient infants if significant exposure occurs.
Pediatric Use
Safety and effectiveness in pediatric patients under 12 years of age have not been established. Approved for use in patients 12 years of age and older.
Geriatric Use
No specific dosage adjustments are recommended for geriatric patients. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Minimal systemic absorption suggests no increased risk in this population.
Clinical Information
Clinical Pearls
- Aczone 5% Gel is typically well-tolerated, with common side effects being mild skin irritation (dryness, redness, peeling).
- The yellow/orange discoloration interaction with benzoyl peroxide is temporary and can be avoided by applying products at different times of the day (e.g., dapsone in the morning, benzoyl peroxide at night).
- Unlike oral dapsone, G6PD deficiency screening is generally not required for topical dapsone 5% gel due to very low systemic absorption.
- Consistent, once-daily application is key for optimal results, which may take several weeks to become apparent.
- This formulation is less irritating than some other topical acne treatments, making it a good option for patients with sensitive skin.
Alternative Therapies
- Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Benzoyl peroxide
- Azelaic acid
- Salicylic acid
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin
- Hormonal therapies (e.g., oral contraceptives, spironolactone)
Cost & Coverage
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (preferred or non-preferred brand/generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.