Aczone 7.5% Gel (pump) 90gm
It is used to treat pimples (acne).
Drug Class
Acne vulgaris agent
Pharmacologic Class
Sulfone; Anti-inflammatory; Antimicrobial
Pregnancy Category
Not available
FDA Approved
Sep 2015
DEA Schedule
Not Controlled
Overview
What is this medicine?
Aczone Gel is a topical medication used to treat acne. It works by reducing inflammation and killing some of the bacteria that cause acne, helping to clear up pimples and prevent new ones from forming.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication as directed.
Application Instructions
Apply this medication only to your skin. Do not ingest it or apply it to your mouth, nose, or eyes, as it may cause burning.
Avoid applying this medication to the vaginal area.
Before and after use, wash your hands thoroughly.
Clean the affected area before applying the medication, ensuring it is completely dry.
Gently rub a thin layer of the medication onto the affected skin.
Storage and Disposal
Store this medication at room temperature, avoiding freezing.
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 disposal, consult your pharmacist, who may be aware of drug take-back programs in your area.
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 two doses at once or use extra doses to make up for a missed dose.
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication as directed.
Application Instructions
Apply this medication only to your skin. Do not ingest it or apply it to your mouth, nose, or eyes, as it may cause burning.
Avoid applying this medication to the vaginal area.
Before and after use, wash your hands thoroughly.
Clean the affected area before applying the medication, ensuring it is completely dry.
Gently rub a thin layer of the medication onto the affected skin.
Storage and Disposal
Store this medication at room temperature, avoiding freezing.
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 disposal, consult your pharmacist, who may be aware of drug take-back programs in your area.
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 two doses at once or use extra 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, mouth, and other mucous membranes.
- Do not apply to open wounds or irritated skin.
- If using with benzoyl peroxide, apply at different times of day (e.g., dapsone in morning, benzoyl peroxide at night) to minimize temporary skin/hair discoloration.
- Use sunscreen and protective clothing as dapsone may increase sun sensitivity, although this is more pronounced with oral dapsone.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a pea-sized amount of Aczone 7.5% Gel to the entire affected facial area once daily.
Condition-Specific Dosing:
acne_vulgaris:
Apply a pea-sized amount to the entire affected facial 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 facial area once daily.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment recommended due to minimal systemic absorption.
Moderate:
No adjustment recommended due to minimal systemic absorption.
Severe:
No adjustment recommended due to minimal systemic absorption.
Dialysis:
No specific recommendations due to minimal systemic absorption; consider monitoring for systemic effects if significant skin barrier compromise.
Hepatic Impairment:
Mild:
No adjustment recommended due to minimal systemic absorption.
Moderate:
No adjustment recommended due to minimal systemic absorption.
Severe:
No adjustment recommended due to minimal systemic absorption.
Confidence:
Medium
Pharmacology
Mechanism of Action
The exact mechanism of action of dapsone in treating acne vulgaris is not fully elucidated. It is believed to exert its effects through both anti-inflammatory and antimicrobial properties. Dapsone inhibits neutrophil chemotaxis and reduces the production of reactive oxygen species by neutrophils, thereby decreasing inflammation. It also has bacteriostatic activity against Propionibacterium acnes (now Cutibacterium acnes), although its primary role in acne treatment is thought to be anti-inflammatory.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 1%) after topical application.
Tmax:
Approximately 15 hours (for systemic exposure after topical application, but systemic levels are very low).
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).
Elimination:
HalfLife:
Approximately 21 hours (for systemically absorbed dapsone, but highly variable).
Clearance:
Not well-defined for topical application due to minimal systemic absorption.
ExcretionRoute:
Renal (primarily as metabolites) and biliary (for systemically absorbed dapsone).
Unchanged:
Less than 20% (for systemically absorbed dapsone).
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically observed within 4-12 weeks.
PeakEffect:
Peak efficacy may be seen after 12 weeks of continuous use.
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 a pancreas problem (pancreatitis), including:
+ 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 extremely tired or weak
+ Shortness of breath
Signs of hemolytic anemia, including:
+ 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 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 a pancreas problem (pancreatitis), including:
+ 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 extremely tired or weak
+ Shortness of breath
Signs of hemolytic anemia, including:
+ 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 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 (redness, dryness, peeling, burning) that does not improve or worsens.
- Yellow or orange discoloration of skin or facial hair (especially if used with benzoyl peroxide).
- Rare but serious symptoms like severe headache, unusual tiredness, shortness of breath, or bluish discoloration of lips/nails (signs of methemoglobinemia) - seek immediate medical attention.
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 (OTC) drugs, natural products, and vitamins, to your doctor and pharmacist. This will help ensure that it is safe to take this medication in conjunction with your other treatments and health conditions.
Remember, do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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 (OTC) drugs, natural products, and vitamins, to your doctor and pharmacist. This will help ensure that it is safe to take this medication in conjunction with your other treatments and health conditions.
Remember, do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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.
Combining this medication with benzoyl peroxide may temporarily cause 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 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, seek immediate medical attention by calling a doctor or poison control center.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks to 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.
Combining this medication with benzoyl peroxide may temporarily cause 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 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, seek immediate medical attention by calling a doctor or poison control center.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.
Overdose Information
Overdose Symptoms:
- Topical overdose is unlikely to cause systemic toxicity due to minimal absorption.
- Excessive application may lead to increased local irritation (redness, peeling).
What to Do:
If excessive amount is applied, gently wipe off excess. If accidental ingestion occurs, or if systemic symptoms (e.g., methemoglobinemia) are suspected, contact a poison control center (1-800-222-1222) or seek emergency medical attention immediately.
Drug Interactions
Moderate Interactions
- Benzoyl peroxide (concurrent use with dapsone topical gel may result in temporary yellow or orange discoloration of the skin and facial hair).
Confidence Interactions
Monitoring
Baseline Monitoring
G6PD deficiency status
Rationale: While systemic absorption is minimal, dapsone can cause hemolytic anemia in individuals with G6PD deficiency. Screening is generally not required for topical dapsone due to low systemic exposure, but should be considered if there are concerns about significant systemic absorption (e.g., large surface area application, compromised skin barrier) or if the patient develops signs of hemolytic anemia.
Timing: Prior to initiation if concerns exist, otherwise not routinely required.
Routine Monitoring
Skin irritation (erythema, dryness, peeling)
Frequency: Regularly during treatment, especially during the initial weeks.
Target: Minimal to no irritation.
Action Threshold: If severe irritation occurs, reduce frequency or temporarily discontinue use. Consult healthcare provider.
Acne lesion count and severity
Frequency: Every 4-12 weeks or as clinically indicated.
Target: Reduction in inflammatory and non-inflammatory lesions.
Action Threshold: If no improvement after 12 weeks, reassess treatment plan.
Symptom Monitoring
- Skin redness
- Dryness
- Peeling
- Itching
- Burning sensation
- Yellow or orange discoloration of skin/hair (if used with benzoyl peroxide)
- Signs of methemoglobinemia (rare, but severe headache, fatigue, shortness of breath, bluish skin discoloration, dizziness - seek immediate medical attention if these occur)
Special Patient Groups
Pregnancy
Topical dapsone is generally considered low risk due to minimal systemic absorption. However, human data are limited. Use during pregnancy should only be if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data, theoretical risk low due to minimal absorption.
Second Trimester:
Limited data, theoretical risk low due to minimal absorption.
Third Trimester:
Limited data, theoretical risk low due to minimal absorption. Consider potential for neonatal methemoglobinemia if significant systemic absorption occurs, though highly unlikely with topical use.
Lactation
Dapsone is excreted in human milk after oral administration. While systemic absorption from topical application is minimal, caution should be exercised. The amount transferred to breast milk is expected to be very low. Consider the developmental and health benefits of breastfeeding, the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.
Infant Risk:
Low risk. Monitor for signs of hemolytic anemia (e.g., jaundice, lethargy) in the infant, especially if the infant has G6PD deficiency, though this is highly unlikely with topical maternal use.
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 adjustment is required 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. However, due to minimal systemic absorption, age-related pharmacokinetic changes are unlikely to be clinically significant.
Clinical Information
Clinical Pearls
- Aczone 7.5% Gel is a once-daily formulation, which may improve patient adherence compared to twice-daily regimens.
- Patients should be advised that improvement may not be seen for several weeks, and consistent use is key.
- The temporary yellow/orange discoloration when used with benzoyl peroxide is a known interaction; advise patients to apply these products at different times of the day (e.g., morning/night) to minimize this cosmetic effect.
- While G6PD deficiency screening is not routinely recommended for topical dapsone due to low systemic absorption, it should be considered if the patient develops signs of hemolytic anemia (e.g., pallor, fatigue, jaundice) or if there are other risk factors for increased systemic absorption (e.g., large surface area application, compromised skin barrier).
Alternative Therapies
- Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Topical benzoyl peroxide
- Topical azelaic acid
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe acne)
- Hormonal therapies (e.g., oral contraceptives, spironolactone)
- Chemical peels
- Laser and light therapies
Cost & Coverage
Average Cost:
Varies widely, typically $400-$800+ per 90gm pump
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 or 2 (Generic)
General Drug Facts
If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may have additional patient information leaflets, so it is a good idea to consult with your pharmacist for more information. If you have any questions or concerns about your medication, do not 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.