Dapsone 7.5% Gel (pump) 90gm
It is used to treat pimples (acne).
Drug Class
Anti-acne agent
Pharmacologic Class
Sulfone, anti-inflammatory, antimicrobial
Pregnancy Category
Category C
FDA Approved
Sep 2015
DEA Schedule
Not Controlled
Overview
What is this medicine?
Dapsone gel is a topical medication used to treat acne. It works by reducing inflammation and fighting bacteria on the skin. You apply a small amount to your face once a day.
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 as directed.
Application Instructions
Apply this medication only to your skin. 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 applying the medication, wash your hands thoroughly.
Clean the affected area before application 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
Store this medication at room temperature, avoiding freezing.
Keep all medications in a safe location, 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. If you have questions about disposal, consult your pharmacist, who can also inform you about potential drug take-back programs in your area.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If the missed dose is close to the time for your next dose, skip the missed dose and continue with 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 as directed.
Application Instructions
Apply this medication only to your skin. 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 applying the medication, wash your hands thoroughly.
Clean the affected area before application 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
Store this medication at room temperature, avoiding freezing.
Keep all medications in a safe location, 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. If you have questions about disposal, consult your pharmacist, who can also inform you about potential drug take-back programs in your area.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If the missed dose is close to the time for your next dose, skip the missed dose and continue with 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.
- Avoid contact with eyes, mouth, and other mucous membranes.
- Wash hands thoroughly after applying the gel.
- Use sunscreen and protective clothing, as dapsone may increase sensitivity to sunlight (though not a primary concern for topical dapsone, good practice for acne patients).
- Be patient, as it may take several weeks to see improvement.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a pea-sized amount of gel to the entire affected area of the face once daily
Condition-Specific Dosing:
Acne Vulgaris:
Apply a pea-sized amount of gel to the entire affected area of the face once daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 12 years of age
Adolescent:
Apply a pea-sized amount of gel to the entire affected area of the face once daily (12 years and older)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed (minimal systemic absorption)
Dialysis:
No adjustment needed (minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed (minimal systemic absorption)
Pharmacology
Mechanism of Action
The exact mechanism of action of dapsone in treating acne vulgaris is unknown. However, dapsone is a sulfone with anti-inflammatory and antimicrobial properties. It is thought to exert its effects by inhibiting neutrophil chemotaxis and function, thereby reducing inflammation. It may also have some antibacterial activity against Cutibacterium acnes (formerly Propionibacterium acnes).
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (approximately 1% of applied dose)
Tmax:
Not applicable for topical, systemic Tmax is variable (up to 12 hours) if absorbed
FoodEffect:
Not applicable for topical formulation
Distribution:
Vd:
Not available for topical application; for oral dapsone, Vd is 1.5 L/kg
ProteinBinding:
Approximately 50-90% (for systemic dapsone)
CnssPenetration:
Limited (for topical application)
Elimination:
HalfLife:
Approximately 10-24 hours (systemic, after topical application)
Clearance:
Not available for topical application
ExcretionRoute:
Renal (primarily as metabolites)
Unchanged:
Less than 20% (systemic, after topical application)
Pharmacodynamics
OnsetOfAction:
Weeks to months (clinical improvement typically seen within 12 weeks)
PeakEffect:
Not precisely defined, continuous use for sustained effect
DurationOfAction:
Maintained with continued application
Confidence:
Medium
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
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 medical attention right away:
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 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 symptoms that bother you or do not go away, contact your doctor:
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 medical attention right away:
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 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 symptoms that bother you or do not go away, contact your doctor:
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 (burning, stinging, redness, peeling) that does not improve or worsens.
- Unusual yellow or orange discoloration of skin or facial hair (if using benzoyl peroxide concurrently).
- Signs of a serious allergic reaction (rash, itching/swelling, severe dizziness, trouble breathing) - seek immediate medical attention.
- Signs of methemoglobinemia (rare, but includes bluish skin/lips/nails, shortness of breath, fatigue, headache, dizziness) - 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 symptoms you experienced.
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, 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 start, stop, or adjust the dosage of any medication without first consulting your doctor to avoid potential interactions or complications.
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.
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, 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 start, stop, or adjust the dosage of any medication without first consulting your doctor to avoid potential interactions or complications.
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.
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 drug, 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 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.
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 drug, 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 of this medication to you and your baby.
Overdose Information
Overdose Symptoms:
- Not expected with topical use due to minimal systemic absorption. In case of accidental ingestion or excessive application over large areas, systemic symptoms could theoretically occur, such as: nausea, vomiting, abdominal pain, headache, dizziness, fatigue, cyanosis (bluish discoloration of skin/lips/nails), shortness of breath, hemolytic anemia (pallor, jaundice, dark urine).
What to Do:
In case of suspected overdose or accidental ingestion, contact a poison control center immediately (Call 1-800-222-1222 in the US). Treatment would be supportive and symptomatic, potentially including activated charcoal for ingestion, and methylene blue for severe methemoglobinemia.
Drug Interactions
Moderate Interactions
- Benzoyl Peroxide (topical)
Monitoring
Baseline Monitoring
Glucose-6-phosphate dehydrogenase (G6PD) deficiency status
Rationale: Patients with G6PD deficiency may be at increased risk for hemolytic anemia with systemic dapsone. While systemic absorption from topical dapsone is minimal, caution is advised, especially with extensive use or compromised skin barrier.
Timing: Prior to initiation, if patient is at risk (e.g., African American, Mediterranean, or South Asian descent).
Routine Monitoring
Clinical response to acne treatment
Frequency: Regularly (e.g., at follow-up visits)
Target: Reduction in inflammatory and non-inflammatory lesions
Action Threshold: Lack of improvement after 12 weeks may warrant re-evaluation of treatment.
Local skin reactions (e.g., dryness, erythema, peeling)
Frequency: Daily, patient self-monitoring
Target: Minimal to no irritation
Action Threshold: Severe or persistent irritation may require temporary discontinuation or reduced frequency.
Symptom Monitoring
- Skin irritation (redness, dryness, peeling, itching)
- Yellow or orange discoloration of skin/hair (if used with benzoyl peroxide)
- Signs of systemic toxicity (rare, but include fatigue, pallor, shortness of breath, dark urine - suggestive of methemoglobinemia or hemolysis, especially in G6PD deficient individuals)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Minimal systemic absorption is expected with topical use, but dapsone is a Category C drug.
Trimester-Specific Risks:
First Trimester:
Limited data, but systemic dapsone has been associated with potential risks. Minimal absorption from topical use reduces concern.
Second Trimester:
Limited data, minimal absorption from topical use reduces concern.
Third Trimester:
Limited data, minimal absorption from topical use reduces concern. Systemic dapsone near term could theoretically increase risk of neonatal hyperbilirubinemia or hemolytic anemia, especially in G6PD deficient infants.
Lactation
Dapsone is excreted in human milk following oral administration. It is unknown whether topical dapsone results in sufficient systemic absorption to produce detectable quantities in breast milk. Caution should be exercised when dapsone gel is administered to a nursing woman. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for dapsone gel and any potential adverse effects on the breastfed infant from dapsone gel or from the underlying maternal condition.
Infant Risk:
L3 (Moderate risk). Potential for hemolytic anemia in G6PD deficient infants. Monitor breastfed infants for signs of hemolysis (e.g., jaundice, pallor) or methemoglobinemia (e.g., cyanosis).
Pediatric Use
Safety and effectiveness in pediatric patients under 12 years of age have not been established. Use in adolescents 12 years and older is consistent with adult dosing.
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. Minimal systemic absorption suggests no specific age-related concerns.
Clinical Information
Clinical Pearls
- Dapsone gel is primarily used for inflammatory acne due to its anti-inflammatory properties.
- Patients should be advised that it may take 12 weeks or longer to see significant improvement.
- Advise patients about the potential for temporary yellow/orange skin discoloration if used concurrently with benzoyl peroxide, and suggest applying them at different times of day (e.g., dapsone in the morning, benzoyl peroxide at night) or avoiding concomitant use.
- While systemic side effects like methemoglobinemia and hemolytic anemia are rare with topical dapsone due to minimal absorption, clinicians should be aware of these risks, especially in G6PD deficient individuals or with extensive application.
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:
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 issues persist or worsen, it is 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 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 emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.