Dapsone 7.5% Gel (pump) 60gm
It is used to treat pimples (acne).
Drug Class
Anti-acne agent
Pharmacologic Class
Sulfone, anti-inflammatory
Pregnancy Category
Category C
FDA Approved
Jul 2015
DEA Schedule
Not Controlled
Overview
What is this medicine?
Dapsone 7.5% Gel is a topical medication used to treat acne. It works by reducing inflammation and potentially by fighting bacteria that contribute to acne.
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, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Do not apply this medication to the vagina.
Before and after using the medication, wash your hands thoroughly.
Clean the affected area before applying the medication, and make 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 place, out of the 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.
Check with your pharmacist for guidance on the best way to dispose of medications. You may also want to explore drug take-back programs 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 make up for a missed dose.
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, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Do not apply this medication to the vagina.
Before and after using the medication, wash your hands thoroughly.
Clean the affected area before applying the medication, and make 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 place, out of the 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.
Check with your pharmacist for guidance on the best way to dispose of medications. You may also want to explore drug take-back programs 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 make up for a missed dose.
Lifestyle & Tips
- Cleanse skin gently before application.
- Apply a thin layer to the entire affected area, not just individual pimples.
- Avoid contact with eyes, lips, and mucous membranes.
- Wash hands thoroughly after application.
- Use sunscreen and protective clothing as dapsone may cause photosensitivity, although this is rare with topical use.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a pea-sized amount of Dapsone 7.5% Gel to the entire affected facial area once daily.
Condition-Specific Dosing:
acneVulgaris:
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 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 understood. However, it is believed to exert its effects through anti-inflammatory properties, including inhibition of neutrophil myeloperoxidase, and potentially through antimicrobial activity against Cutibacterium acnes (formerly Propionibacterium acnes).
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 1% of applied dose)
Tmax:
Systemic peak plasma concentrations (Cmax) are very low, typically around 10.8 ng/mL after 12 weeks of twice-daily application of 7.5% gel.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not clinically relevant for topical administration due to minimal systemic absorption.
ProteinBinding:
Systemic dapsone is highly protein bound (70-90%).
CnssPenetration:
Limited (not clinically relevant for topical administration).
Elimination:
HalfLife:
Systemic dapsone has a half-life of 10-50 hours. Not clinically relevant for topical administration due to minimal systemic absorption.
Clearance:
Not clinically relevant for topical administration.
ExcretionRoute:
Systemic dapsone is primarily excreted renally. Not clinically relevant for topical administration.
Unchanged:
Not clinically relevant for topical administration.
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 4-12 weeks.
PeakEffect:
Peak therapeutic effect may take 12 weeks or longer.
DurationOfAction:
Maintained with continued use.
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 experience any of the following symptoms, contact your doctor or seek medical attention immediately:
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
+ Feeling extremely tired or weak
+ 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. Many people experience no side effects or only mild ones. 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
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact 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 experience any of the following symptoms, contact your doctor or seek medical attention immediately:
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
+ Feeling extremely tired or weak
+ 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. Many people experience no side effects or only mild ones. 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
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact 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, burning, stinging, peeling)
- Allergic reactions (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
- Unusual yellow or orange discoloration of skin or 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 to 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 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 to 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 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 using 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 (glucose-6-phosphate dehydrogenase), 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 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, these side effects have not been reported with this specific form of dapsone. However, it is crucial to 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 to discuss the potential benefits and risks of using this medication to ensure the best outcome for 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 (glucose-6-phosphate dehydrogenase), 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 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, these side effects have not been reported with this specific form of dapsone. However, it is crucial to 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 to discuss the potential benefits and risks of using this medication to ensure the best outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Due to minimal systemic absorption, topical overdose is unlikely to cause systemic symptoms.
- Excessive local application may lead to increased skin irritation.
What to Do:
If swallowed or applied excessively, contact a poison control center (1-800-222-1222) or seek medical attention. For local irritation, discontinue use and apply soothing agents.
Drug Interactions
Moderate Interactions
- Benzoyl peroxide (topical)
Monitoring
Routine Monitoring
Local skin reactions (e.g., dryness, erythema, peeling, oiliness)
Frequency: During treatment, as needed
Target: Minimize discomfort
Action Threshold: If severe irritation occurs, reduce frequency or discontinue use.
Symptom Monitoring
- Skin irritation (redness, dryness, peeling, oiliness)
- Yellow/orange discoloration of skin/hair (if used with benzoyl peroxide)
Special Patient Groups
Pregnancy
Pregnancy Category C. There are no adequate and well-controlled studies of dapsone gel in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential risk, but systemic absorption is minimal.
Second Trimester:
Potential risk, but systemic absorption is minimal.
Third Trimester:
Potential risk, but systemic absorption is minimal.
Lactation
It is not known whether dapsone is excreted in human milk following topical application. Systemic dapsone is excreted in human milk and can cause hemolytic anemia and methemoglobinemia in breastfed infants, especially those with G6PD deficiency. Due to minimal systemic absorption of topical dapsone, the risk to a breastfed infant is considered low. Use with caution.
Infant Risk:
Low risk, but monitor for signs of hemolysis (e.g., pallor, jaundice) in infants, especially those with G6PD deficiency.
Pediatric Use
Safety and effectiveness have been established in pediatric patients 12 years of age and older. Safety and effectiveness in pediatric patients younger than 12 years have not been established.
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. However, due to minimal systemic absorption, age-related differences in pharmacokinetics are unlikely to be clinically significant.
Clinical Information
Clinical Pearls
- Dapsone gel is primarily an anti-inflammatory agent for acne, making it a good option for inflammatory lesions.
- Advise patients that it may take several weeks (up to 12 weeks) to see significant improvement.
- Educate patients about the potential for temporary yellow/orange skin discoloration if used concurrently with benzoyl peroxide, and suggest applying them at different times of the day.
- Emphasize that a 'pea-sized' amount is sufficient for the entire face to avoid excessive application and potential irritation.
Alternative Therapies
- Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- 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:
Varies, typically $400-$600 per 60gm pump
Insurance Coverage:
Tier 2 or 3 (Brand-name prescription)
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 seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.