Differin 0.3% Gel 45gm
It is used to treat pimples (acne).
Drug Class
Anti-acne agent
Pharmacologic Class
Topical retinoid; synthetic naphthoic acid derivative
Pregnancy Category
Not available (FDA has moved away from letter categories; generally considered Category C under old system, but topical absorption is minimal. Avoid in pregnancy is generally recommended.)
FDA Approved
May 2007
DEA Schedule
Not Controlled
Overview
What is this medicine?
Adapalene is a topical medication, similar to vitamin A, that helps treat acne by affecting how skin cells grow and by reducing inflammation. It helps to unclog pores and prevent new acne from forming.
How to Use This Medicine
Using Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions and the information provided with your prescription. This medication is for topical use only, meaning it should be applied directly to your skin. Avoid getting it in your mouth, nose, or eyes, as it may cause burning. If accidental contact occurs, rinse the affected area thoroughly with water.
Applying the Medication
Do not apply this medication to cuts, scrapes, eczema, damaged skin, or sunburned skin. Before using, wash your hands and clean the affected area, making sure it is dry. Apply a thin layer of the medication to the affected skin and gently rub it in. Replace the cap after use.
Timing of Application
Some products are designed to be used at bedtime, while others can be used at any time. Consult with your pharmacist to determine the best application schedule for your specific product.
Storage and Disposal
Store your medication at room temperature, avoiding freezing temperatures and excessive heat. Keep all medications in a secure location, out of the reach of children and pets.
Missing a Dose
If you forget to apply a dose, do so 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 application.
To use this medication safely and effectively, follow your doctor's instructions and the information provided with your prescription. This medication is for topical use only, meaning it should be applied directly to your skin. Avoid getting it in your mouth, nose, or eyes, as it may cause burning. If accidental contact occurs, rinse the affected area thoroughly with water.
Applying the Medication
Do not apply this medication to cuts, scrapes, eczema, damaged skin, or sunburned skin. Before using, wash your hands and clean the affected area, making sure it is dry. Apply a thin layer of the medication to the affected skin and gently rub it in. Replace the cap after use.
Timing of Application
Some products are designed to be used at bedtime, while others can be used at any time. Consult with your pharmacist to determine the best application schedule for your specific product.
Storage and Disposal
Store your medication at room temperature, avoiding freezing temperatures and excessive heat. Keep all medications in a secure location, out of the reach of children and pets.
Missing a Dose
If you forget to apply a dose, do so 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 application.
Lifestyle & Tips
- Apply a thin layer to clean, dry skin once daily in the evening.
- Avoid contact with eyes, lips, angles of the nose, and mucous membranes.
- Do not apply to cuts, scrapes, eczematous, or sunburned skin.
- Use a gentle, non-medicated cleanser and moisturizer daily.
- Sun sensitivity is increased; use sunscreen (SPF 30 or higher) daily and wear protective clothing when outdoors.
- Avoid excessive exposure to sunlight, sunlamps, and tanning beds.
- Initial worsening of acne (purging) may occur during the first few weeks of treatment; continue use as directed.
- Results may take 8-12 weeks to become noticeable; full benefits may take longer.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer of Differin 0.3% Gel to affected areas of the face and/or trunk once daily in the evening, after washing gently with a non-medicated cleanser and drying.
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 thin layer to affected areas of the face and/or trunk once daily in the evening.
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
Adapalene is a retinoid-like compound that modulates cellular differentiation, keratinization, and inflammatory processes. It binds to specific retinoic acid nuclear receptors (RAR-beta and RAR-gamma) but does not bind to the cytosolic receptor protein. It normalizes the differentiation of follicular epithelial cells, resulting in decreased microcomedone formation. Adapalene also has anti-inflammatory properties by inhibiting the chemotactic and chemokinetic responses of human polymorphonuclear leukocytes and by inhibiting the metabolism of arachidonic acid to inflammatory mediators.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (typically <0.25% of applied dose)
Tmax:
Not applicable for systemic Tmax due to minimal absorption; local skin concentration peaks within hours.
FoodEffect:
Not applicable (topical administration)
Distribution:
Vd:
Not applicable (minimal systemic distribution)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
Limited (due to minimal systemic absorption)
Elimination:
HalfLife:
Not precisely quantifiable due to minimal systemic absorption; elimination from skin is slow.
Clearance:
Not precisely quantifiable due to minimal systemic absorption.
ExcretionRoute:
Primarily biliary excretion (if systemically absorbed).
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 8-12 weeks.
PeakEffect:
Maximum therapeutic effect may take several months (e.g., 3 months or more).
DurationOfAction:
Sustained with continued use.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help 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, or swelling of the mouth, face, lips, tongue, or throat.
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. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or do not go away:
- Skin irritation is a common side effect, which may include burning, dry skin, itching, peeling, redness, and scaling. If you experience severe skin irritation or if it bothers you and does not go away, contact your doctor.
- Mild warmth or tingling at the application site for a short period is also possible.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, contact your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help 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, or swelling of the mouth, face, lips, tongue, or throat.
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. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or do not go away:
- Skin irritation is a common side effect, which may include burning, dry skin, itching, peeling, redness, and scaling. If you experience severe skin irritation or if it bothers you and does not go away, contact your doctor.
- Mild warmth or tingling at the application site for a short period is also possible.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, contact your doctor for medical advice. 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 burning, stinging, or itching that does not subside
- Excessive redness, dryness, or peeling that is intolerable
- Significant swelling or blistering of the skin
- Signs of an allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat - 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 as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor identify potential interactions between this medication and other substances.
Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is crucial to:
Discuss all your medications and health problems with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other treatments.
* Avoid starting, stopping, or changing the dose of any medication without first consulting your doctor. This precaution will help prevent potential interactions and adverse effects.
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor identify potential interactions between this medication and other substances.
Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is crucial to:
Discuss all your medications and health problems with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other treatments.
* Avoid starting, stopping, or changing the dose of any medication without first consulting your doctor. This precaution will help prevent potential interactions and adverse effects.
Precautions & Cautions
Important Information About Your Medication
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Potential Skin Effects
When you start using this medication, your skin may appear to worsen before it improves. You may also be more susceptible to sunburn, so it is crucial to avoid exposure to the sun, sunlamps, and tanning beds. To protect your skin, use sunscreen and wear protective clothing and eyewear when going outside.
Additionally, certain weather conditions, such as cold and wind, may irritate your skin. Consult with your doctor or pharmacist for guidance on how to protect your skin in these situations.
Precautions and Interactions
Do not wax the affected skin area, as this may cause irritation. Be cautious when using 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.
If you experience dry or irritated skin, you can use moisturizers, but avoid products containing alpha hydroxy or glycolic acids.
Safety Precautions
If this medication is swallowed, it can cause harm. If ingestion occurs, immediately call a doctor or poison control center.
Special Considerations
This medication is not recommended for children under 12 years old without consulting a doctor first.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of using this medication to you and your baby.
If you are breastfeeding and apply this medication to your breast or nipple, wash the area thoroughly before feeding your child.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Potential Skin Effects
When you start using this medication, your skin may appear to worsen before it improves. You may also be more susceptible to sunburn, so it is crucial to avoid exposure to the sun, sunlamps, and tanning beds. To protect your skin, use sunscreen and wear protective clothing and eyewear when going outside.
Additionally, certain weather conditions, such as cold and wind, may irritate your skin. Consult with your doctor or pharmacist for guidance on how to protect your skin in these situations.
Precautions and Interactions
Do not wax the affected skin area, as this may cause irritation. Be cautious when using 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.
If you experience dry or irritated skin, you can use moisturizers, but avoid products containing alpha hydroxy or glycolic acids.
Safety Precautions
If this medication is swallowed, it can cause harm. If ingestion occurs, immediately call a doctor or poison control center.
Special Considerations
This medication is not recommended for children under 12 years old without consulting a doctor first.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of using this medication to you and your baby.
If you are breastfeeding and apply this medication to your breast or nipple, wash the area thoroughly before feeding your child.
Overdose Information
Overdose Symptoms:
- Excessive redness, peeling, and discomfort (if applied topically in excess). Systemic toxicity is unlikely due to minimal absorption.
What to Do:
Discontinue use temporarily. Apply moisturizers. If accidental ingestion occurs, seek medical attention. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Contraindicated Interactions
- None
Major Interactions
- None
Moderate Interactions
- Other topical retinoids (e.g., tretinoin, tazarotene) - concurrent use may increase irritation and should be avoided.
- Products containing alpha hydroxy acids (AHAs), glycolic acid, salicylic acid, or benzoyl peroxide - concurrent use may increase irritation; use with caution and consider applying at different times of day.
Minor Interactions
- Astringents, abrasive soaps and cleansers, strong drying agents, or other irritating topical products - concurrent use may increase irritation.
Monitoring
Baseline Monitoring
Skin assessment for acne severity and type
Rationale: To establish baseline and guide treatment plan.
Timing: Prior to initiation of therapy
Patient education on proper application and potential side effects (e.g., dryness, redness, peeling)
Rationale: To ensure patient understanding and adherence, and manage expectations.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical assessment of acne improvement
Frequency: Every 4-8 weeks initially, then as needed
Target: Reduction in inflammatory and non-inflammatory lesions
Action Threshold: Lack of improvement after 12 weeks, or significant irritation requiring dose adjustment/discontinuation.
Monitoring for local skin irritation (erythema, scaling, dryness, burning, stinging)
Frequency: Daily by patient, periodically by clinician
Target: Mild to moderate irritation is common and expected; severe irritation should be addressed.
Action Threshold: Severe or persistent irritation may require temporary discontinuation, reduced frequency, or use of moisturizers.
Symptom Monitoring
- Increased redness or erythema
- Scaling or peeling of skin
- Dryness
- Burning or stinging sensation
- Itching
- Swelling
- Acne flare-up (initial worsening is possible)
Special Patient Groups
Pregnancy
Adapalene is generally not recommended for use during pregnancy. Although systemic absorption is minimal, retinoids are known teratogens. If a patient becomes pregnant while using adapalene, treatment should be discontinued.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though risk is considered very low with topical application due to minimal systemic absorption.
Second Trimester:
Potential for teratogenicity, though risk is considered very low with topical application due to minimal systemic absorption.
Third Trimester:
Potential for teratogenicity, though risk is considered very low with topical application due to minimal systemic absorption.
Lactation
Limited data exist on the presence of adapalene in human milk, its effects on the breastfed infant, or its effects on milk production. Due to minimal systemic absorption, it is considered unlikely to cause adverse effects in a breastfed infant. However, caution should be exercised. Avoid applying to areas that may come into direct contact with the infant's skin or mouth.
Infant Risk:
Low risk (L3)
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
Clinical studies of Differin 0.3% Gel did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, no specific dose adjustments or precautions are generally needed for geriatric patients due to minimal systemic absorption.
Clinical Information
Clinical Pearls
- A 'pea-sized' amount is usually sufficient for the entire face.
- Apply to clean, dry skin, not wet skin, to minimize irritation.
- Patients should be advised that an initial worsening of acne (purging) may occur during the first few weeks of treatment, which is normal and usually resolves with continued use.
- Emphasize the importance of consistent daily use and patience, as full therapeutic effects may take several months.
- Strict adherence to sunscreen use is crucial due to increased photosensitivity.
- For patients experiencing significant irritation, consider reducing application frequency (e.g., every other day) until tolerance improves, then gradually increase to daily.
- Differin 0.3% Gel is a higher strength prescription product compared to the 0.1% gel (available OTC and prescription); it may cause more irritation.
Alternative Therapies
- Other topical retinoids (e.g., tretinoin, tazarotene)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Topical benzoyl peroxide
- Topical azelaic acid
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe, recalcitrant acne)
- Hormonal therapies (e.g., oral contraceptives, spironolactone for females)
Cost & Coverage
Average Cost:
$200 - $400+ per 45gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization or step therapy)
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 this 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 emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.