Aczone 5% Gel 60gm
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 the bacteria that contribute to acne breakouts. It's applied directly to the skin, usually once a day.
How to Use This Medicine
Using Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. Avoid getting it in your mouth, nose, or eyes, as it may cause burning. Do not apply it to the vaginal area.
Before applying the medication, wash your hands thoroughly. Clean the affected area of your skin and make sure it is completely dry. Then, apply a thin layer of the medication to the affected area and gently rub it in.
Storing and Disposing of Your Medication
Store this medication at room temperature, avoiding freezing. Keep all medications in a safe place, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or look into drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not apply two doses at the same time or use extra doses to make up for a missed one.
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. Avoid getting it in your mouth, nose, or eyes, as it may cause burning. Do not apply it to the vaginal area.
Before applying the medication, wash your hands thoroughly. Clean the affected area of your skin and make sure it is completely dry. Then, apply a thin layer of the medication to the affected area and gently rub it in.
Storing and Disposing of Your Medication
Store this medication at room temperature, avoiding freezing. Keep all medications in a safe place, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or look into drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not apply two doses at the same time or use extra doses to make up for a missed one.
Lifestyle & Tips
- Apply a thin layer to clean, dry skin.
- 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 use with benzoyl peroxide at the same time of day, as it can cause temporary yellow/orange skin discoloration. If both are prescribed, use one in the morning and one at night, or as directed by your doctor.
- Sun protection is recommended as with any acne treatment, though dapsone itself is not known to cause significant photosensitivity.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a pea-sized amount of Aczone 5% Gel as a thin layer to the entire affected area once daily.
Condition-Specific Dosing:
acne_vulgaris:
Apply a pea-sized amount to affected areas 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 as a thin layer to the entire affected area once daily.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment is necessary due to minimal systemic absorption.
Moderate:
No dosage adjustment is necessary due to minimal systemic absorption.
Severe:
No dosage adjustment is necessary due to minimal systemic absorption.
Dialysis:
No specific recommendations due to minimal systemic absorption; use with caution if significant systemic exposure is anticipated.
Hepatic Impairment:
Mild:
No dosage adjustment is necessary due to minimal systemic absorption.
Moderate:
No dosage adjustment is necessary due to minimal systemic absorption.
Severe:
No dosage adjustment is necessary due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Dapsone is a sulfone with anti-inflammatory and antimicrobial properties. While the exact mechanism of action for the topical treatment of acne vulgaris is unknown, it is thought to involve both anti-inflammatory effects (e.g., inhibition of neutrophil migration and function, reduction of reactive oxygen species) and antimicrobial activity against Cutibacterium acnes (formerly Propionibacterium acnes) through inhibition of folate synthesis.
Pharmacokinetics
Absorption:
Bioavailability:
Low systemic absorption (typically <1% to 10% of applied dose)
Tmax:
Approximately 12-24 hours (for systemic levels after topical application)
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not well-defined for topical application due to minimal systemic absorption.
ProteinBinding:
Approximately 50% (for systemically absorbed dapsone)
CnssPenetration:
Limited (for systemically absorbed dapsone, minimal for topical)
Elimination:
HalfLife:
Approximately 20-30 hours (for systemically absorbed dapsone, but systemic levels are very low with topical application)
Clearance:
Not well-defined for topical application.
ExcretionRoute:
Renal (primarily as metabolites for systemically absorbed dapsone)
Unchanged:
Minimal (for systemically absorbed dapsone)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 4-12 weeks.
PeakEffect:
Peak therapeutic effect may take 12 weeks or longer.
DurationOfAction:
Maintained with continued daily application.
Safety & Warnings
Side Effects
Urgent 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
+ Abnormal heartbeat
+ Seizures
+ Severe dizziness or fainting
+ Severe headache
+ Excessive sleepiness
+ Feeling extremely 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
+ Yellowing of the 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 unusual symptoms, contact your doctor for advice:
Dry skin
Oily skin
Skin irritation
Redness
* Peeling
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, 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
+ Abnormal heartbeat
+ Seizures
+ Severe dizziness or fainting
+ Severe headache
+ Excessive sleepiness
+ Feeling extremely 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
+ Yellowing of the 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 unusual symptoms, contact your doctor for advice:
Dry skin
Oily skin
Skin irritation
Redness
* Peeling
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, 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 (redness, dryness, peeling, burning)
- Signs of allergic reaction (hives, rash, swelling of face/lips/tongue, difficulty breathing)
- Unusual skin discoloration (especially if using 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 symptoms you experienced as a result of the allergy.
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 existing health problems. Your doctor and pharmacist need this information to ensure safe treatment and minimize potential interactions.
To guarantee your safety, do not start, stop, or modify the dosage of any medication without first consulting your doctor. It is your responsibility to verify that it is safe to take this medication in conjunction with all 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 symptoms you experienced as a result of the allergy.
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 existing health problems. Your doctor and pharmacist need this information to ensure safe treatment and minimize potential interactions.
To guarantee your safety, do not start, stop, or modify the dosage of any medication without first consulting your doctor. It is your responsibility to verify that it is safe to take this medication in conjunction with all 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 glucose-6-phosphate dehydrogenase (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 a blood disorder called methemoglobinemia associated with this medication, which may require hospitalization.
Although 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.
If this medication is accidentally swallowed, it can be harmful. In such cases, 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 glucose-6-phosphate dehydrogenase (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 a blood disorder called methemoglobinemia associated with this medication, which may require hospitalization.
Although 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.
If this medication is accidentally swallowed, it can be harmful. In such cases, 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:
- Unlikely with topical application due to minimal systemic absorption.
- If significant amount is ingested, symptoms could include nausea, vomiting, abdominal pain, headache, dizziness, methemoglobinemia (cyanosis, shortness of breath, fatigue).
What to Do:
Call 911 or Poison Control (1-800-222-1222). Treatment is supportive. Methylene blue may be used for severe methemoglobinemia.
Drug Interactions
Moderate Interactions
- Benzoyl peroxide (concurrent use may cause temporary yellow or orange discoloration of the skin and facial hair)
Monitoring
Baseline Monitoring
G6PD deficiency status (optional, consider if patient is at risk for G6PD deficiency and significant systemic absorption is a concern, though rare with topical use)
Rationale: Dapsone can cause hemolytic anemia in G6PD deficient individuals. While systemic absorption from topical application is minimal, caution is advised.
Timing: Prior to initiation, if clinically indicated.
Routine Monitoring
Clinical assessment of acne lesions
Frequency: Periodically (e.g., every 4-12 weeks)
Target: Reduction in inflammatory and non-inflammatory lesions
Action Threshold: Lack of improvement after 12 weeks may warrant re-evaluation of treatment.
Skin irritation (erythema, dryness, peeling)
Frequency: Daily, by patient self-monitoring
Target: Minimal to mild irritation
Action Threshold: Severe or persistent irritation may require temporary discontinuation or reduced frequency.
Symptom Monitoring
- Skin redness
- Dryness
- Peeling
- Itching
- Burning sensation
- Discoloration of skin/hair (if used with benzoyl peroxide)
- Signs of allergic reaction (rash, hives, swelling)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemic absorption is minimal, but dapsone is known to cross the placenta.
Trimester-Specific Risks:
First Trimester:
Potential risk, but minimal systemic exposure from topical use.
Second Trimester:
Potential risk, but minimal systemic exposure from topical use.
Third Trimester:
Potential risk, but minimal systemic exposure from topical use.
Lactation
L3 (Moderate concern). Dapsone is excreted in breast milk following systemic administration. While systemic absorption from topical application is minimal, caution is advised. Consider the developmental and health benefits of breastfeeding, the mother’s clinical need for Aczone, and any potential adverse effects on the breastfed infant.
Infant Risk:
Low risk due to minimal systemic absorption, but monitor infant for signs of hemolytic anemia (e.g., jaundice, lethargy) especially if infant is G6PD deficient.
Pediatric Use
Safety and effectiveness have been established in pediatric patients 12 years of age and older. Not established for children under 12 years.
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 age-related concerns.
Clinical Information
Clinical Pearls
- Aczone 5% Gel is generally well-tolerated, with common side effects being mild skin irritation.
- It is particularly useful for inflammatory acne and can be a good option for patients who cannot tolerate or prefer to avoid retinoids or oral antibiotics.
- Advise patients to be consistent with daily application for best results, as improvement may take several weeks.
- Emphasize the importance of applying a thin layer to the entire affected area, not just individual lesions.
- The interaction with benzoyl peroxide leading to temporary yellow/orange discoloration is a common patient concern; advise patients to apply these products at different times of the day (e.g., dapsone in the morning, benzoyl peroxide at night) if both are used.
Alternative Therapies
- Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Topical benzoyl peroxide
- Azelaic acid
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe acne)
- Hormonal therapies (e.g., oral contraceptives, spironolactone)
Cost & Coverage
Average Cost:
$300 - $600 per 60gm tube of 5% gel
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (for brand), Tier 1 (for generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 overdose, including the medication taken, the amount, and the time it occurred.