Aczone 7.5% Gel (pump) 60gm
It is used to treat pimples (acne).
Drug Class
Acne Agent
Pharmacologic Class
Sulfone; Anti-inflammatory; Antimicrobial
Pregnancy Category
Not available
FDA Approved
Jul 2015
DEA Schedule
Not Controlled
Overview
What is this medicine?
Aczone 7.5% Gel is a topical medication used to treat acne. It contains dapsone, which helps reduce inflammation and kill bacteria that cause acne.
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, eyes, or vagina, as it may cause irritation or burning.
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 secure location, 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 explore 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 resume your regular application schedule. Do not apply two doses at once 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, eyes, or vagina, as it may cause irritation or burning.
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 secure location, 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 explore 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 resume your regular application schedule. Do not apply two doses at once or use extra doses to make up for a missed one.
Lifestyle & Tips
- Apply a thin layer to the entire affected area of the face once daily, after gently washing and drying the 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, as it can cause temporary yellow or orange discoloration of the skin and facial hair. If both are prescribed, apply one in the morning and the other at night, or wash off one before applying the other.
- Sun protection is recommended as with any acne treatment, though dapsone itself is not known to cause photosensitivity.
- This medication is for external use only. Do not swallow.
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 area of the face once daily.
Condition-Specific Dosing:
acne_vulgaris:
Apply a pea-sized amount to the entire affected area of the face once daily, after the skin is gently washed and patted dry.
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 of the face 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 considerations due to minimal systemic absorption.
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 elucidated. However, it is believed to exert its effects through anti-inflammatory properties, including inhibition of neutrophil migration and function, and potentially through antimicrobial activity against Cutibacterium acnes (formerly Propionibacterium acnes) by inhibiting bacterial folate synthesis.
Pharmacokinetics
Absorption:
Bioavailability:
Low systemic absorption (typically <1% to 10% of applied dose)
Tmax:
Systemic Tmax is variable and generally not clinically relevant due to low absorption (e.g., 6-12 hours for detectable levels, if any).
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not clinically relevant for topical application due to minimal systemic absorption.
ProteinBinding:
Systemic dapsone is highly protein bound (70-90%), but this is not clinically relevant for topical application.
CnssPenetration:
Limited (not clinically relevant for topical application).
Elimination:
HalfLife:
Systemic half-life of dapsone is 10-50 hours, but this is not clinically relevant for topical application due to minimal systemic absorption.
Clearance:
Not clinically relevant for topical application.
ExcretionRoute:
Primarily renal (for systemically absorbed drug).
Unchanged:
Minimal (for systemically absorbed drug).
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
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when 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), 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 tired or weak
+ Shortness of breath
Signs of hemolytic anemia, including:
+ Dark urine or lips
+ Dizziness or fainting
+ Confusion
+ Feeling extremely tired or weak
+ 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. Many people experience no side effects or only mild ones. If you notice 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.
While rare, some people may experience severe and potentially life-threatening side effects when 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), 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 tired or weak
+ Shortness of breath
Signs of hemolytic anemia, including:
+ Dark urine or lips
+ Dizziness or fainting
+ Confusion
+ Feeling extremely tired or weak
+ 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. Many people experience no side effects or only mild ones. If you notice 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 (e.g., redness, dryness, peeling, burning, stinging) that does not improve or worsens.
- Unusual yellow or orange discoloration of the skin or facial hair (especially if using benzoyl peroxide).
- Signs of a serious allergic reaction (e.g., rash, itching/swelling, severe dizziness, trouble breathing).
- Signs of methemoglobinemia (rare): bluish or grayish discoloration of the lips, nail beds, or skin; shortness of breath; fatigue; dizziness; headache.
- Signs of hemolytic anemia (rare): unusual tiredness, pale skin, yellowing of the skin or eyes (jaundice), dark urine.
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 prevent potential interactions.
Remember, before starting, stopping, or modifying 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 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 prevent potential interactions.
Remember, before starting, stopping, or modifying 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 of 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 concurrently 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.
A rare but serious blood condition called methemoglobinemia has been associated with this medication, requiring hospitalization in some cases.
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.
In the event that this medication is 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 of this medication 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.
Using benzoyl peroxide concurrently 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.
A rare but serious blood condition called methemoglobinemia has been associated with this medication, requiring hospitalization in some cases.
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.
In the event that this medication is 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 of this medication to you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with topical application due to minimal systemic absorption.
- If significant amount is ingested or applied to large areas of compromised skin, systemic effects such as methemoglobinemia (bluish skin, shortness of breath, fatigue) or hemolytic anemia (pallor, jaundice, dark urine) could theoretically occur.
What to Do:
If accidental ingestion or excessive application occurs, contact a poison control center immediately (Call 1-800-222-1222 in the US) or seek emergency medical attention. Treatment is supportive; methylene blue may be used for severe methemoglobinemia.
Drug Interactions
Moderate Interactions
- Benzoyl Peroxide (concomitant use may cause temporary yellow or orange discoloration of the skin and facial hair)
Monitoring
Baseline Monitoring
G6PD deficiency status (optional)
Rationale: While systemic absorption is minimal, dapsone can cause hemolytic anemia in G6PD deficient individuals. Routine screening is generally not recommended for topical dapsone due to very low risk, but consider in patients with known G6PD deficiency or high-risk populations if extensive application or compromised skin barrier is present.
Timing: Prior to initiation, if clinically indicated.
Routine Monitoring
Local skin irritation (e.g., dryness, erythema, peeling)
Frequency: Daily, during use
Target: Minimal to none
Action Threshold: If severe or persistent, consider reducing frequency or discontinuing use.
Clinical improvement of acne
Frequency: Monthly or as clinically indicated
Target: Reduction in inflammatory and non-inflammatory lesions
Action Threshold: If no improvement after 12 weeks, re-evaluate treatment.
Symptom Monitoring
- Skin irritation (redness, dryness, peeling, oiliness)
- Itching
- Burning/stinging sensation
- Yellow/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)
- Signs of hemolytic anemia (rare, but fatigue, pallor, jaundice, dark urine)
Special Patient Groups
Pregnancy
Topical dapsone is generally considered low risk during pregnancy due to minimal systemic absorption. Systemic dapsone is classified as Category C (older system) or has data suggesting potential risks at higher doses. Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Minimal systemic absorption suggests low risk, but data are limited for topical use.
Second Trimester:
Minimal systemic absorption suggests low risk.
Third Trimester:
Minimal systemic absorption suggests low risk.
Lactation
Dapsone is excreted in breast milk following systemic administration. However, systemic absorption from topical application is minimal, making the amount transferred to breast milk likely negligible. The manufacturer recommends caution when administering to a nursing woman. Consider the developmental and health benefits of breastfeeding, the mother’s clinical need for Aczone, and any potential adverse effects on the breastfed infant from Aczone or from the underlying maternal condition.
Infant Risk:
Low risk due to minimal systemic absorption. Monitor infant for signs of hemolytic anemia (e.g., pallor, jaundice) or methemoglobinemia (e.g., cyanosis), especially if the infant is G6PD deficient.
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 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. Minimal systemic absorption suggests similar safety profile to younger adults.
Clinical Information
Clinical Pearls
- Aczone 7.5% Gel is applied once daily, which may improve patient adherence compared to twice-daily regimens.
- Advise patients to apply a pea-sized amount to the entire affected area, not just individual lesions, for best results.
- Emphasize the importance of avoiding concomitant use of dapsone gel and benzoyl peroxide at the same time to prevent temporary yellow/orange skin discoloration. Suggest applying one in the morning and the other at night, or washing off one before applying the other.
- Patients should be informed that clinical improvement may take several weeks (typically 4-12 weeks) and consistent use is key.
- While the risk of systemic side effects like hemolytic anemia or methemoglobinemia is very low with topical dapsone, patients should be aware of the rare symptoms and seek medical attention if they occur, especially in individuals with G6PD deficiency.
Alternative Therapies
- Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
- Topical antimicrobials (e.g., clindamycin, erythromycin)
- Topical benzoyl peroxide
- Topical azelaic acid
- Oral antibiotics (e.g., doxycycline, minocycline, sarecycline)
- Oral isotretinoin (for severe acne)
- Hormonal therapies (e.g., oral contraceptives, spironolactone for females)
Cost & Coverage
Average Cost:
Varies widely, typically $400-$800+ per 60gm pump
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand name), Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 it's a good idea to check with your pharmacist. 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 medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.