Adapalene 0.1% Cream 45gm
It is used to treat pimples (acne).
Drug Class
Anti-acne agent
Pharmacologic Class
Retinoid, topical
Pregnancy Category
Category C (older classification, refer to Special Populations for updated info)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Adapalene is a topical medication used to treat acne. It belongs to a class of drugs called retinoids. It works by helping to normalize skin cell growth and reduce inflammation, which helps to 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 prescription. This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. Avoid getting the medication 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
Before applying the medication, wash your hands and clean the affected area of your skin. Make sure the area is dry before applying a thin layer of the medication and gently rubbing it in. Replace the cap on the medication after use.
Important Application Instructions
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.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from heat sources and freezing temperatures. Keep all medications in a safe and 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 extra doses or double 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 prescription. This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. Avoid getting the medication 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
Before applying the medication, wash your hands and clean the affected area of your skin. Make sure the area is dry before applying a thin layer of the medication and gently rubbing it in. Replace the cap on the medication after use.
Important Application Instructions
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.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from heat sources and freezing temperatures. Keep all medications in a safe and 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 extra doses or double doses to make up for a missed dose.
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.
- Use a gentle, non-medicated cleanser and moisturizer daily.
- Sun sensitivity may increase; use sunscreen (SPF 30 or higher) and wear protective clothing when outdoors.
- Avoid excessive sun exposure, sunlamps, and tanning beds.
- Do not apply to cuts, scrapes, eczematous, or sunburned skin.
- Initial worsening of acne (purging) may occur during the first few weeks of treatment; this is normal and usually resolves with continued use.
- Be patient; it may take 8-12 weeks to see significant improvement.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer of Adapalene 0.1% Cream to affected areas of the face and/or trunk once daily in the evening.
Condition-Specific Dosing:
acne_vulgaris:
Apply a thin layer to affected areas 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 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 not to the cytosolic receptor protein. It normalizes the differentiation of follicular epithelial cells, resulting in decreased microcomedone formation.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal (<0.25% of applied dose systemically absorbed)
Tmax:
Not well-defined for topical application; peak plasma concentrations are very low (e.g., 0.25 ng/mL after chronic application)
FoodEffect:
Not applicable (topical administration)
Distribution:
Vd:
Not clinically relevant due to minimal systemic absorption
ProteinBinding:
Not clinically relevant due to minimal systemic absorption
CnssPenetration:
Limited (not clinically relevant)
Elimination:
HalfLife:
Not clinically relevant due to minimal systemic absorption (reported as 17 hours for systemically absorbed drug)
Clearance:
Not clinically relevant due to minimal systemic absorption
ExcretionRoute:
Primarily biliary excretion (for systemically absorbed drug)
Unchanged:
Not clinically relevant due to minimal systemic absorption
Pharmacodynamics
OnsetOfAction:
Initial improvement may be seen within 1-4 weeks; full therapeutic effect typically takes 8-12 weeks.
PeakEffect:
8-12 weeks of continuous use.
DurationOfAction:
Requires continuous application for sustained effect.
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 significantly.
- Swelling, blistering, or crusting of the skin (rare, indicates severe irritation or allergic reaction).
- Signs of an allergic reaction (e.g., rash, itching/swelling, severe dizziness, trouble breathing) - 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, 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.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or exacerbate certain health problems.
To ensure safe use, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Existing health problems
Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. Never start, stop, or adjust the dosage 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.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or exacerbate certain health problems.
To ensure safe use, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Existing health problems
Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. Never start, stop, or adjust the dosage 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 safeguard your skin in these conditions.
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. However, avoid products containing alpha hydroxy or glycolic acids, as they may interact with this medication.
Safety and Administration
It may take a few months to notice the full effects of this medication. If you accidentally swallow this medication, call your doctor or a poison control center immediately, as it can cause harm.
Special Considerations
Do not administer this medication to children under 12 years old without consulting your 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, be sure to wash the area 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 safeguard your skin in these conditions.
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. However, avoid products containing alpha hydroxy or glycolic acids, as they may interact with this medication.
Safety and Administration
It may take a few months to notice the full effects of this medication. If you accidentally swallow this medication, call your doctor or a poison control center immediately, as it can cause harm.
Special Considerations
Do not administer this medication to children under 12 years old without consulting your 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, be sure to wash the area before feeding your child.
Overdose Information
Overdose Symptoms:
- Topical overdose is unlikely to cause systemic toxicity due to minimal absorption.
- Excessive application may result in marked redness, peeling, or discomfort.
What to Do:
If excessive application occurs, discontinue use temporarily. If accidental ingestion occurs, seek medical attention or call a poison control center (e.g., 1-800-222-1222). Systemic toxicity from topical overdose is highly unlikely.
Drug Interactions
Moderate Interactions
- Other topical retinoids (e.g., tretinoin, tazarotene) - increased irritation
- Products with strong drying or irritating effects (e.g., abrasive cleansers, astringents, medicated soaps, strong drying agents, products with high concentrations of alcohol, sulfur, resorcinol, or salicylic acid) - increased irritation
Monitoring
Baseline Monitoring
Skin assessment (acne severity, skin type)
Rationale: To establish baseline for treatment efficacy and tolerability.
Timing: Prior to initiation of therapy
Routine Monitoring
Skin irritation (erythema, scaling, dryness, burning/stinging)
Frequency: Regularly, especially during the first 4 weeks of treatment
Target: Mild to moderate irritation is common; severe irritation warrants dose modification or temporary discontinuation.
Action Threshold: Severe or persistent irritation: reduce frequency of application, temporarily discontinue, or switch to a lower strength if available.
Therapeutic response (reduction in acne lesions)
Frequency: Monthly or as clinically indicated
Target: Gradual improvement over 8-12 weeks
Action Threshold: Lack of improvement after 12 weeks may warrant re-evaluation of treatment plan.
Symptom Monitoring
- Increased redness
- Excessive dryness
- Peeling or flaking of skin
- Burning sensation
- Stinging sensation
- Itching
- Swelling
- Blistering or crusting (rare, severe irritation)
Special Patient Groups
Pregnancy
Adapalene is classified as Pregnancy Category C (older system). While systemic absorption is minimal, it is generally recommended to avoid use during pregnancy unless the potential benefit justifies the potential risk to the fetus. Consult with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Potential risk cannot be ruled out. Use only if clearly needed.
Second Trimester:
Potential risk cannot be ruled out. Use only if clearly needed.
Third Trimester:
Potential risk cannot be ruled out. Use only if clearly needed.
Lactation
Minimal systemic absorption suggests low risk to the breastfed infant. However, caution is advised. Avoid applying to areas that may come into direct contact with the infant's skin or mouth during breastfeeding.
Infant Risk:
Low risk due to minimal systemic absorption, but direct exposure should be avoided.
Pediatric Use
Safety and effectiveness in pediatric patients younger than 12 years of age have not been established. Approved for use in patients 12 years of age and older.
Geriatric Use
No specific dosage adjustments are 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. However, due to minimal systemic absorption, age-related differences in pharmacokinetics are not expected to be clinically significant.
Clinical Information
Clinical Pearls
- Adapalene is a first-line topical retinoid for acne treatment.
- Apply a pea-sized amount to the entire affected area, not just individual lesions.
- It is normal to experience some dryness, redness, and peeling, especially during the first few weeks of treatment. This usually subsides with continued use.
- Emphasize consistent daily use for optimal results, even if acne appears to worsen initially.
- Always use a broad-spectrum sunscreen (SPF 30+) daily, as adapalene can increase sun sensitivity.
- Avoid waxing on treated areas as skin may be more fragile and prone to irritation or tearing.
Alternative Therapies
- Other topical retinoids (e.g., tretinoin, tazarotene)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Benzoyl peroxide
- Salicylic acid
- Azelaic acid
- Oral antibiotics (for moderate to severe acne)
- Oral isotretinoin (for severe, recalcitrant acne)
Cost & Coverage
Average Cost:
Varies widely by pharmacy and formulation (generic cream 45gm typically $30-$100+ without insurance) per 45gm tube
Generic Available:
Yes
Insurance Coverage:
Often covered by most prescription drug plans, typically as a Tier 2 or Tier 3 medication. OTC versions may not be covered.
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 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.