Dapsone 5% Gel 90gm
It is used to treat pimples (acne).
Drug Class
Anti-acne agent
Pharmacologic Class
Sulfone; Anti-inflammatory; Antibacterial
Pregnancy Category
Not available
FDA Approved
Jul 2005
DEA Schedule
Not Controlled
Overview
What is this medicine?
Dapsone gel is a medication applied to the skin to treat acne. It works by reducing inflammation and fighting the bacteria that cause acne. It's important to use it regularly as directed by your doctor to see the best results.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication only as directed.
Apply this medication to your skin only, avoiding the mouth, nose, and eyes, as it may cause burning.
Do not apply this medication to the vagina.
Before and after use, wash your hands thoroughly.
Clean the affected area before applying the medication, making sure it is completely dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Storage and Disposal
To store this medication properly:
Keep it at room temperature and do not freeze.
Store all medications in a safe location, out of the reach of children and pets.
Dispose of unused or expired medications responsibly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
Check with your pharmacist for guidance on the best way to dispose of medications, as there may be drug take-back programs available in your area.
Missed Dose
If you miss a dose:
Apply the missed dose as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not apply two doses at the same time or use extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication only as directed.
Apply this medication to your skin only, avoiding the mouth, nose, and eyes, as it may cause burning.
Do not apply this medication to the vagina.
Before and after use, wash your hands thoroughly.
Clean the affected area before applying the medication, making sure it is completely dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Storage and Disposal
To store this medication properly:
Keep it at room temperature and do not freeze.
Store all medications in a safe location, out of the reach of children and pets.
Dispose of unused or expired medications responsibly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
Check with your pharmacist for guidance on the best way to dispose of medications, as there may be drug take-back programs available in your area.
Missed Dose
If you miss a dose:
Apply the missed dose as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not apply two doses at the same time or use extra doses.
Lifestyle & Tips
- Apply to clean, dry skin.
- Wash hands thoroughly after applying the gel.
- Avoid contact with eyes, mouth, and other mucous membranes.
- Allow the gel to dry completely before applying other topical products or makeup.
- If using benzoyl peroxide, apply it at a different time of day (e.g., dapsone in the morning, benzoyl peroxide at night) to avoid temporary skin discoloration.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a pea-sized amount of gel to the affected areas of the face and/or trunk once or twice daily.
Condition-Specific Dosing:
acne vulgaris:
Apply a pea-sized amount to affected areas once or twice daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and effectiveness not established in pediatric patients younger than 12 years of age)
Adolescent:
Apply a pea-sized amount of gel to the affected areas of the face and/or trunk once or twice daily (for patients 12 years of age and older).
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment typically required due to minimal systemic absorption.
Moderate:
No dosage adjustment typically required due to minimal systemic absorption.
Severe:
No dosage adjustment typically required due to minimal systemic absorption.
Dialysis:
No specific recommendations due to minimal systemic absorption; consult specialist if significant systemic absorption is suspected.
Hepatic Impairment:
Mild:
No dosage adjustment typically required due to minimal systemic absorption.
Moderate:
No dosage adjustment typically required due to minimal systemic absorption.
Severe:
No dosage adjustment typically required 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 both anti-inflammatory and antimicrobial effects. Dapsone inhibits neutrophil chemotaxis and lysosomal enzyme release, thereby reducing inflammation. It also has bacteriostatic activity against Cutibacterium acnes (formerly Propionibacterium acnes) by inhibiting bacterial folate synthesis.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic bioavailability (topical application)
Tmax:
Not clinically relevant for topical application (systemic Tmax for oral dapsone is 4-8 hours)
FoodEffect:
Not applicable for topical formulation
Distribution:
Vd:
Not clinically relevant for topical application (systemic Vd for oral dapsone is 0.9-1.7 L/kg)
ProteinBinding:
Not clinically relevant for topical application (systemic protein binding for oral dapsone is 50-90%)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not clinically relevant for topical application (systemic half-life for oral dapsone is 10-50 hours)
Clearance:
Not clinically relevant for topical application
ExcretionRoute:
Not clinically relevant for topical application (systemic excretion primarily renal)
Unchanged:
Not clinically relevant for topical application
Pharmacodynamics
OnsetOfAction:
Several weeks (clinical improvement typically seen after 12 weeks)
PeakEffect:
Not precisely defined for topical acne treatment, gradual improvement over weeks to months
DurationOfAction:
Maintained with continued use
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 immediately or seek emergency 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 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 immediately or seek emergency 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 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 (e.g., excessive redness, dryness, peeling, burning)
- Signs of an allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
- Unusual or persistent yellow/orange skin discoloration (especially if not using 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 discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing treatments and health conditions.
Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor to ensure your safety.
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 discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing treatments and health conditions.
Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor to ensure your safety.
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 ingested, symptoms could include cyanosis (bluish skin/lips), headache, fatigue, shortness of breath, dizziness, nausea, vomiting (signs of methemoglobinemia or hemolytic anemia).
What to Do:
Call 1-800-222-1222 (Poison Control Center) immediately or seek emergency medical attention.
Drug Interactions
Moderate Interactions
- Benzoyl peroxide (concomitant use may cause temporary yellow or orange discoloration of the skin and facial hair at the application site)
Monitoring
Symptom Monitoring
- Application site reactions (e.g., dryness, erythema, peeling, oiliness)
- Temporary yellow or orange skin discoloration (if used with benzoyl peroxide)
- Signs of allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
Special Patient Groups
Pregnancy
Available data from published observational studies and case reports on dapsone use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Insufficient data to establish risk.
Second Trimester:
Insufficient data to establish risk.
Third Trimester:
Insufficient data to establish risk.
Lactation
There are no data on the presence of dapsone in human milk, the effects on the breastfed infant, or the effects on milk production following topical administration of dapsone to women. Due to the potential for serious adverse reactions in breastfed infants from systemically absorbed dapsone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Unknown; potential for risk due to systemic absorption of dapsone in infants (e.g., hemolytic anemia, methemoglobinemia) if significant amounts are transferred via milk, though topical absorption is minimal.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients younger than 12 years of age. Approved for use in adolescents 12 years and older.
Geriatric Use
No specific dosage adjustments are needed. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Generally considered safe for use in the elderly with minimal systemic absorption.
Clinical Information
Clinical Pearls
- Dapsone gel is primarily an anti-inflammatory agent for acne, making it particularly useful for inflammatory lesions.
- Patients should be advised that it may take 12 weeks or longer to see significant improvement in their acne.
- To avoid temporary yellow/orange skin discoloration, advise patients to apply dapsone gel and benzoyl peroxide at different times of the day (e.g., dapsone in the morning, benzoyl peroxide at night).
- Minimal systemic absorption means the risks associated with oral dapsone (e.g., methemoglobinemia, hemolytic anemia, especially in G6PD deficient patients) are generally not a concern with topical use, and routine blood monitoring is not required.
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 (for severe acne)
Cost & Coverage
Average Cost:
$300 - $600+ per 90gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (varies by plan)
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 medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.