Differin 0.3% Gel (pump) 45gm
It is used to treat pimples (acne).
Drug Class
Anti-acne agent
Pharmacologic Class
Retinoid, topical
Pregnancy Category
Not available
FDA Approved
Aug 2007
DEA Schedule
Not Controlled
Overview
What is this medicine?
Adapalene is a topical medication, similar to vitamin A, used to treat acne. It works by helping skin cells turn over more normally and by reducing inflammation, which helps prevent pimples, blackheads, and whiteheads 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 medication. It is essential to use this medication only on your skin, as directed.
Application Instructions
Do not take this medication by mouth. Apply it only to your skin, avoiding the mouth, nose, and eyes, as it may cause burning.
If you accidentally get the medication in your mouth, nose, or eyes, rinse the area thoroughly with water.
Avoid applying the medication to cuts, scrapes, eczema, or damaged skin. Additionally, do not apply it to sunburned skin.
Some products are designed for use at bedtime, while others can be used at any time. Consult with your pharmacist to determine the best application schedule for your specific product.
Before and after applying the medication, wash your hands thoroughly.
Clean the affected area before application and ensure it is completely dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
After use, replace the cap on the medication container.
Storage and Disposal
Store the medication at room temperature, avoiding freezing temperatures.
Protect the medication from heat sources.
Keep all medications in a safe location, out of the reach of children and pets.
Missing a 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 scheduled dose, skip the missed dose and resume your regular application 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 safely and effectively, follow your doctor's instructions and the information provided with your medication. It is essential to use this medication only on your skin, as directed.
Application Instructions
Do not take this medication by mouth. Apply it only to your skin, avoiding the mouth, nose, and eyes, as it may cause burning.
If you accidentally get the medication in your mouth, nose, or eyes, rinse the area thoroughly with water.
Avoid applying the medication to cuts, scrapes, eczema, or damaged skin. Additionally, do not apply it to sunburned skin.
Some products are designed for use at bedtime, while others can be used at any time. Consult with your pharmacist to determine the best application schedule for your specific product.
Before and after applying the medication, wash your hands thoroughly.
Clean the affected area before application and ensure it is completely dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
After use, replace the cap on the medication container.
Storage and Disposal
Store the medication at room temperature, avoiding freezing temperatures.
Protect the medication from heat sources.
Keep all medications in a safe location, out of the reach of children and pets.
Missing a 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 scheduled dose, skip the missed dose and resume your regular application schedule.
Do not apply two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Apply to clean, dry skin once daily in the evening.
- Use a pea-sized amount for the entire face, avoiding eyes, lips, and mucous membranes.
- Do not apply to cuts, scrapes, or sunburned skin.
- Sun sensitivity: Use sunscreen daily (SPF 30 or higher) and wear protective clothing when outdoors, as adapalene can increase sensitivity to sunlight.
- Avoid excessive sun exposure, including tanning beds and sunlamps.
- Use a gentle, non-comedogenic moisturizer to help with dryness and irritation.
- Initial worsening of acne (purging) is common during the first few weeks; continue treatment as directed.
- Patience is key; it may take 8-12 weeks to see significant improvement.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected areas of the face and/or trunk once daily in the evening, after washing gently with a non-medicated cleanser.
Condition-Specific Dosing:
acne_vulgaris:
Apply a thin layer to affected areas of the face and/or trunk once daily in the evening.
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 (minimal systemic absorption).
Moderate:
No adjustment needed (minimal systemic absorption).
Severe:
No adjustment needed (minimal systemic absorption).
Dialysis:
No specific considerations (minimal systemic absorption).
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption).
Moderate:
No adjustment needed (minimal systemic absorption).
Severe:
No adjustment needed (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. Adapalene normalizes the differentiation of follicular epithelial cells, resulting in decreased microcomedone formation. It 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:
Very low systemic absorption (<0.25 ng/mL plasma concentration) after topical application.
Tmax:
Not clinically relevant due to minimal systemic absorption; plasma concentrations are generally below quantifiable limits.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not clinically relevant due to minimal systemic absorption.
ProteinBinding:
>99% (if systemically absorbed, primarily to plasma proteins)
CnssPenetration:
Limited/Not applicable (minimal systemic absorption).
Elimination:
HalfLife:
Not clinically relevant due to minimal systemic absorption.
Clearance:
Not clinically relevant due to minimal systemic absorption.
ExcretionRoute:
Primarily biliary excretion if systemically absorbed.
Unchanged:
Not applicable (minimal systemic absorption).
Pharmacodynamics
OnsetOfAction:
Initial improvement may be seen within 1-4 weeks, but full therapeutic effect typically requires 8-12 weeks of consistent use.
PeakEffect:
8-12 weeks
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. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious allergic reaction:
- Rash
- Hives
- Itching
- Red, swollen, blistered, or peeling skin, with or without fever
- Wheezing
- Tightness in the chest or throat
- Difficulty breathing, swallowing, or talking
- Unusual hoarseness
- Swelling of the mouth, face, lips, tongue, or throat
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild side effects. If you are bothered by any of the following side effects or if they do not go away, contact your doctor for advice:
- Skin irritation is a common side effect, which may include burning, dry skin, itching, peeling, redness, and scaling. If your skin irritation is severe, bothers you, or persists, inform your doctor.
- Mild warmth or tingling at the application site, which is usually temporary.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice 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. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious allergic reaction:
- Rash
- Hives
- Itching
- Red, swollen, blistered, or peeling skin, with or without fever
- Wheezing
- Tightness in the chest or throat
- Difficulty breathing, swallowing, or talking
- Unusual hoarseness
- Swelling of the mouth, face, lips, tongue, or throat
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild side effects. If you are bothered by any of the following side effects or if they do not go away, contact your doctor for advice:
- Skin irritation is a common side effect, which may include burning, dry skin, itching, peeling, redness, and scaling. If your skin irritation is severe, bothers you, or persists, inform your doctor.
- Mild warmth or tingling at the application site, which is usually temporary.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice 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 redness, dryness, scaling, burning, or stinging that does not improve or worsens significantly.
- Swelling or blistering of the skin.
- Allergic reaction symptoms (e.g., rash, itching/swelling, severe dizziness, trouble breathing).
Before Using This Medicine
Before taking this medication, it is essential to inform your doctor about the following:
Any allergies you have, including allergies to this drug, any of its components, or other substances, such as foods or other medications. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions, as this drug may affect or be affected by other drugs or health problems.
All medications you are currently taking, including prescription and over-the-counter (OTC) medications, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
All your health problems, as certain conditions may be affected by this medication or may affect how the medication works.
* Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so.
Any allergies you have, including allergies to this drug, any of its components, or other substances, such as foods or other medications. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions, as this drug may affect or be affected by other drugs or health problems.
All medications you are currently taking, including prescription and over-the-counter (OTC) medications, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
All your health problems, as certain conditions may be affected by this medication or may affect how the medication works.
* Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so.
Precautions & Cautions
Important Information About Your Medication
It is crucial that you inform all of 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. Additionally, you may be more susceptible to sunburn. To minimize this risk, avoid exposure to the sun, sunlamps, and tanning beds. Use a broad-spectrum sunscreen with a high SPF and wear protective clothing and eyewear when going outside.
Certain weather conditions, such as cold and wind, can irritate your skin. Consult with your doctor or pharmacist for guidance on how to protect your skin in these conditions.
Precautions and Interactions
Do not wax the affected skin area, as this can cause further 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. However, avoid products that contain alpha hydroxy or glycolic acids, as they may interact with this medication.
Safety Precautions
If this medication is swallowed, it can cause harm. If ingestion occurs, immediately contact a doctor or poison control center.
Pediatric Use
This medication should not be given to children under 12 years old without first consulting with a doctor.
Pregnancy and Breastfeeding
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 crucial that you inform all of 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. Additionally, you may be more susceptible to sunburn. To minimize this risk, avoid exposure to the sun, sunlamps, and tanning beds. Use a broad-spectrum sunscreen with a high SPF and wear protective clothing and eyewear when going outside.
Certain weather conditions, such as cold and wind, can irritate your skin. Consult with your doctor or pharmacist for guidance on how to protect your skin in these conditions.
Precautions and Interactions
Do not wax the affected skin area, as this can cause further 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. However, avoid products that contain alpha hydroxy or glycolic acids, as they may interact with this medication.
Safety Precautions
If this medication is swallowed, it can cause harm. If ingestion occurs, immediately contact a doctor or poison control center.
Pediatric Use
This medication should not be given to children under 12 years old without first consulting with a doctor.
Pregnancy and Breastfeeding
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
- Discomfort
What to Do:
Topical overdose is unlikely to cause systemic symptoms due to minimal absorption. Discontinue use and apply a moisturizer. If accidental ingestion occurs, seek medical attention. Call 1-800-222-1222 for poison control.
Drug Interactions
Moderate Interactions
- Concomitant use with other potentially irritating topical products (e.g., medicated or abrasive soaps and cleansers, soaps and cosmetics with a strong drying effect, products with high concentrations of alcohol, astringents, or lime, other topical retinoids, or products containing alpha hydroxy acids or salicylic acid) should be avoided due to potential for increased irritation.
Monitoring
Routine Monitoring
Skin irritation (erythema, scaling, dryness, burning/stinging)
Frequency: Daily, especially during the first few weeks of treatment.
Target: Mild to moderate irritation is common and expected. Severe irritation should prompt temporary discontinuation or reduction in frequency.
Action Threshold: If severe irritation occurs, reduce frequency of application or temporarily discontinue use until irritation subsides. Consult healthcare provider if irritation persists or worsens.
Therapeutic response (reduction in acne lesions)
Frequency: Monthly, or as clinically indicated.
Target: Gradual reduction in inflammatory and non-inflammatory lesions.
Action Threshold: If no improvement after 12 weeks, reassess treatment plan.
Symptom Monitoring
- Redness
- Scaling
- Dryness
- Burning sensation
- Stinging sensation
- Itching
- Acne flare-up (initial worsening)
Special Patient Groups
Pregnancy
Adapalene is generally not recommended during pregnancy. While systemic absorption is minimal, there are limited data on human pregnancy outcomes. Animal studies have shown developmental toxicity at high oral doses. The decision to use should be made after careful consideration of the potential risks and benefits, but generally, it is advised to avoid.
Trimester-Specific Risks:
First Trimester:
Risk cannot be ruled out. Avoid if possible.
Second Trimester:
Risk cannot be ruled out. Avoid if possible.
Third Trimester:
Risk cannot be ruled out. Avoid if possible.
Lactation
Minimal systemic absorption is expected after topical application, making infant exposure unlikely. However, caution should be exercised. Avoid applying to areas where the infant may come into direct contact with the medication, especially the breast area.
Infant Risk:
Low risk, but caution advised.
Pediatric Use
Safety and effectiveness have been established in pediatric patients 12 years of age and older. Not recommended for children under 12 years of age.
Geriatric Use
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. No specific dose adjustments are recommended for geriatric patients, as systemic absorption is minimal.
Clinical Information
Clinical Pearls
- Adapalene 0.3% is a stronger formulation than 0.1% and may cause more initial irritation. Patients should be counseled on this.
- Emphasize the importance of consistent, once-daily application for optimal results.
- Stress the critical need for daily sunscreen use due to increased photosensitivity.
- Advise patients that an initial 'purging' phase (worsening of acne) is common and temporary, usually lasting a few weeks.
- Recommend using a gentle, non-comedogenic cleanser and moisturizer to help manage dryness and irritation.
- Results are not immediate; full benefits typically take 2-3 months of continuous use.
Alternative Therapies
- Tretinoin (Retin-A, Renova, Altreno)
- Tazarotene (Tazorac, Arazlo)
- Topical Benzoyl Peroxide
- Topical Clindamycin/Erythromycin (often combined with BP)
- Topical Dapsone
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe, recalcitrant acne)
Cost & Coverage
Average Cost:
Varies widely, typically $150-$300+ per 45gm pump
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (brand), Tier 1 (generic)
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 taken, the amount, and the time it occurred.