Differin 0.1% Cream 45gm
It is used to treat pimples (acne).
Drug Class
Anti-acne agent
Pharmacologic Class
Retinoid-like agent, topical
Pregnancy Category
Not available
FDA Approved
May 1996
DEA Schedule
Not Controlled
Overview
What is this medicine?
Adapalene is a topical medication 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
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.
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. If accidental contact occurs, rinse the affected area with water.
Do not apply the medication to cuts, scrapes, eczema, or damaged skin.
Avoid applying the medication 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.
Preparation and Application
Wash your hands before and after using the medication.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Replace the cap after using the medication.
Storage and Disposal
Store the medication at room temperature, avoiding freezing temperatures.
Protect the medication from heat sources.
Keep all medications in a safe and secure location, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
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 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.
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. If accidental contact occurs, rinse the affected area with water.
Do not apply the medication to cuts, scrapes, eczema, or damaged skin.
Avoid applying the medication 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.
Preparation and Application
Wash your hands before and after using the medication.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Replace the cap after using the medication.
Storage and Disposal
Store the medication at room temperature, avoiding freezing temperatures.
Protect the medication from heat sources.
Keep all medications in a safe and secure location, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
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 the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Apply once daily in the evening to clean, dry skin.
- Use a gentle, non-medicated cleanser and moisturizer.
- Avoid applying to eyes, lips, nostrils, or mucous membranes.
- Limit sun exposure, including sunlamps, and use sunscreen and protective clothing when outdoors, as adapalene can increase sensitivity to sunlight.
- Avoid waxing on treated skin areas.
- Be patient; it may take up to 12 weeks to see full results. Acne may worsen initially before improving.
- Do not use if pregnant or planning to become pregnant.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer of Differin 0.1% Cream 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 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 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 (RARΞ² and RARΞ³) but not 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 lipo-oxidation of arachidonic acid and inhibiting the chemotactic and chemokinetic responses of human polymorphonuclear leukocytes.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (generally below quantifiable limits of 0.25 ng/mL) after topical application.
Tmax:
If detectable, typically 2-4 hours.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not applicable due to minimal systemic absorption.
ProteinBinding:
Not applicable due to minimal systemic absorption.
CnssPenetration:
Limited
Elimination:
HalfLife:
Not precisely determined due to minimal systemic absorption; if detected, typically short (e.g., 8-12 hours).
Clearance:
Not precisely determined due to minimal systemic absorption.
ExcretionRoute:
Primarily biliary excretion if absorbed systemically.
Unchanged:
Not applicable due to minimal systemic absorption.
Pharmacodynamics
OnsetOfAction:
Initial improvement may be seen within 4-8 weeks; full therapeutic effect may take up to 12 weeks.
PeakEffect:
Approximately 12 weeks.
DurationOfAction:
Maintained with continued use.
Confidence:
Medium
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 of this medication. This 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.
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 of this medication. This 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.
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 redness, dryness, scaling, burning, or stinging that does not improve or worsens.
- Swelling or blistering of the skin.
- Signs of an allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat).
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, any of 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 health problems you have, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Do not start, stop, or adjust the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of 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 health problems you have, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Do not start, stop, or adjust the dose of any medication without first consulting your doctor.
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 conditions.
Precautions and Interactions
Do not wax the affected skin, 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. However, avoid products containing alpha hydroxy or glycolic acids.
Safety Precautions
Keep in mind that it may take a few months to see the full effects of this medication. If this medication is swallowed, it can cause harm. In the event of accidental ingestion, immediately contact a doctor or poison control center.
Special Considerations
This medication is not recommended for children under 12 years old without consulting a doctor. If you are pregnant, planning to become pregnant, or breastfeeding, discuss the benefits and risks with your doctor.
If you are breastfeeding and apply this medication to your breast or nipple, be sure to 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 conditions.
Precautions and Interactions
Do not wax the affected skin, 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. However, avoid products containing alpha hydroxy or glycolic acids.
Safety Precautions
Keep in mind that it may take a few months to see the full effects of this medication. If this medication is swallowed, it can cause harm. In the event of accidental ingestion, immediately contact a doctor or poison control center.
Special Considerations
This medication is not recommended for children under 12 years old without consulting a doctor. If you are pregnant, planning to become pregnant, or breastfeeding, discuss the benefits and risks with your doctor.
If you are breastfeeding and apply this medication to your breast or nipple, be sure to wash the area thoroughly before feeding your child.
Overdose Information
Overdose Symptoms:
- Excessive redness
- Scaling
- Discomfort
- Burning
- Itching
What to Do:
Topical overdose is unlikely to result in significant systemic symptoms. If excessive application occurs, wash the area thoroughly. Management is symptomatic and supportive for local irritation. If accidental ingestion occurs, contact a poison control center immediately (e.g., 1-800-222-1222 in the US).
Drug Interactions
Moderate Interactions
- Concomitant use with other potentially irritating topical products (e.g., medicated or abrasive soaps and cleansers, soaps and cosmetics with strong drying effect, products with high concentrations of alcohol, astringents, spices or lime, permanent wave solutions, hair removers or waxes, products containing alpha hydroxy acids, salicylic acid, sulfur, or resorcinol) should be approached with caution due to potential for increased irritation.
Monitoring
Baseline Monitoring
Skin assessment (erythema, scaling, dryness, burning/stinging)
Rationale: To establish baseline skin condition and identify potential for irritation.
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin irritation (erythema, scaling, dryness, burning/stinging)
Frequency: Regularly during initial weeks of therapy, then as needed.
Target: Mild to moderate irritation is common and expected; severe irritation is not.
Action Threshold: If severe irritation occurs, reduce frequency of application or temporarily discontinue use until irritation subsides. Consult healthcare provider if persistent or severe.
Therapeutic response (reduction in acne lesions)
Frequency: Monthly or as clinically indicated.
Target: Gradual improvement in acne lesions.
Action Threshold: If no improvement after 12 weeks, re-evaluate diagnosis or treatment plan.
Symptom Monitoring
- Redness
- Scaling
- Dryness
- Burning
- Stinging
- Itching
- Peeling
- Discomfort
Special Patient Groups
Pregnancy
Adapalene is a retinoid. Although systemic absorption is minimal after topical application, retinoids are known teratogens. Therefore, use of adapalene is generally not recommended during pregnancy. If a patient becomes pregnant while using adapalene, treatment should be discontinued.
Trimester-Specific Risks:
First Trimester:
Theoretical risk of teratogenicity; avoid use.
Second Trimester:
Theoretical risk; avoid use.
Third Trimester:
Theoretical risk; avoid use.
Lactation
It is not known whether adapalene is excreted in human milk. Due to minimal systemic absorption, risk to the infant is considered low. However, caution should be exercised. Avoid applying adapalene to the chest area to prevent direct infant exposure.
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 use in children younger than 12 years of age.
Geriatric Use
Clinical studies of adapalene did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, given the minimal systemic absorption, no specific dose adjustments or precautions are generally needed for geriatric patients.
Clinical Information
Clinical Pearls
- Adapalene can cause initial worsening of acne (purging) during the first few weeks of treatment. This is normal and usually subsides with continued use.
- Consistency is key; apply daily as directed, even if skin appears to be improving.
- Always use a broad-spectrum sunscreen with an SPF of 30 or higher daily, as adapalene increases sun sensitivity.
- Avoid using harsh or irritating skin products (e.g., abrasive cleansers, toners with alcohol) concurrently with adapalene, as this can exacerbate irritation.
- A pea-sized amount is usually sufficient for the entire face.
- Moisturizer can be applied before or after adapalene to help mitigate dryness, but ensure skin is dry before applying adapalene.
Alternative Therapies
- 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 acne)
- Hormonal therapies (e.g., Spironolactone, oral contraceptives for females)
Cost & Coverage
Average Cost:
Varies widely, typically $50-$150 for generic, higher for brand. per 45gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for generic adapalene); Tier 3 or higher (for brand Differin)
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 overdose, including the medication taken, the amount, and the time it occurred.