Adapalene 0.1% Gel 15gm
It is used to treat pimples (acne).
Drug Class
Anti-acne agent
Pharmacologic Class
Retinoid, topical
Pregnancy Category
Category D (older classification); generally considered contraindicated due to retinoid class
FDA Approved
May 1996
DEA Schedule
Not Controlled
Overview
What is this medicine?
Adapalene gel is a topical medication, similar to vitamin A, used to treat acne. It works by helping your skin cells turn over more normally and reducing inflammation, which helps to prevent pimples and blackheads 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
Before applying the medication, wash your hands and clean the affected area of skin. Make sure the skin is dry before applying a thin layer of the medication and gently rubbing it in. Replace the cap after use.
Important Application Guidelines
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 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 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
Before applying the medication, wash your hands and clean the affected area of skin. Make sure the skin is dry before applying a thin layer of the medication and gently rubbing it in. Replace the cap after use.
Important Application Guidelines
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 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 to clean, dry skin once daily in the evening.
- Use a pea-sized amount for the entire face.
- Avoid contact with eyes, lips, angles of the nose, and mucous membranes.
- Limit sun exposure and use sunscreen (SPF 30 or higher) daily, as adapalene can increase sun sensitivity.
- Avoid waxing on treated areas.
- Use a gentle, non-comedogenic moisturizer and cleanser to help manage dryness and irritation.
- Do not apply to cuts, scrapes, or eczematous skin.
Available Forms & 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:
acneVulgaris:
Apply a thin layer to affected areas once daily in the evening.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and efficacy 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 (RARΞ² and RARΞ³) but does not bind to the cytosolic receptor protein. Adapalene normalizes the differentiation of follicular epithelial cells resulting in decreased microcomedone formation.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (<0.25 ng/mL plasma concentrations)
Tmax:
Not well-defined due to minimal systemic absorption; typically below quantifiable limits.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not extensively studied due to minimal systemic absorption.
ProteinBinding:
Not extensively studied due to minimal systemic absorption.
CnssPenetration:
Limited/Not applicable (minimal systemic absorption).
Elimination:
HalfLife:
Not well-defined due to minimal systemic levels; estimated to be 10-12 hours for detectable levels.
Clearance:
Not well-defined due to minimal systemic levels.
ExcretionRoute:
Primarily via biliary excretion.
Unchanged:
Not quantifiable in urine.
Pharmacodynamics
OnsetOfAction:
Several weeks (typically 8-12 weeks for noticeable improvement)
PeakEffect:
Up to 3 months
DurationOfAction:
Maintained with continued use.
Safety & Warnings
Side Effects
Important Side Effects to Report to Your Doctor Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. Seek medical attention right away 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
Trouble 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. However, many people do not experience any side effects or only have mild ones. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
Skin irritation, which is common with this medication, may include:
+ Burning
+ Dry skin
+ Itching
+ Peeling
+ Redness
+ Scaling
Seek medical attention if skin irritation is severe, bothersome, or persistent.
* Mild warmth or tingling at the application site, which is usually temporary
Additional Information
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. 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.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. Seek medical attention right away 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
Trouble 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. However, many people do not experience any side effects or only have mild ones. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
Skin irritation, which is common with this medication, may include:
+ Burning
+ Dry skin
+ Itching
+ Peeling
+ Redness
+ Scaling
Seek medical attention if skin irritation is severe, bothersome, or persistent.
* Mild warmth or tingling at the application site, which is usually temporary
Additional Information
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. 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 or persistent skin irritation (redness, dryness, peeling, burning, stinging)
- Swelling of the face or lips
- Blistering or crusting of the skin
- Signs of an allergic reaction (e.g., rash, itching, hives, difficulty breathing)
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 and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never 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, 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 and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
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, 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 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 accidentally swallowed, call a doctor or poison control center immediately, as it can cause harm.
Pediatric Use
This medication is not recommended for children under 12 years old without consulting a doctor first.
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, 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 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 accidentally swallowed, call a doctor or poison control center immediately, as it can cause harm.
Pediatric Use
This medication is not recommended for children under 12 years old without consulting a doctor first.
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 lead to significant systemic effects due to minimal absorption. Discontinue use temporarily until irritation subsides. If severe symptoms occur or if accidental ingestion happens, seek medical attention or call a poison control center (1-800-222-1222).
Drug Interactions
Moderate Interactions
- Concomitant use with other potentially irritating topical products (e.g., abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, products with high concentrations of alcohol, astringents, spices or lime, other retinoids, alpha hydroxy acids, salicylic acid, sulfur, resorcinol, benzoyl peroxide) should be approached with caution due to potential for additive irritation.
Monitoring
Baseline Monitoring
Skin assessment (type, severity of acne, presence of irritation)
Rationale: To establish baseline for treatment effectiveness and adverse effects.
Timing: Prior to initiation of therapy.
Routine Monitoring
Local skin irritation (erythema, scaling, dryness, burning, stinging)
Frequency: Regularly during treatment, especially during the first few weeks.
Target: Minimal to mild irritation.
Action Threshold: Moderate to severe irritation may require temporary discontinuation or reduction in frequency of application.
Acne lesion count and overall improvement
Frequency: Monthly or as clinically indicated.
Target: Reduction in inflammatory and non-inflammatory lesions.
Action Threshold: Lack of improvement after 8-12 weeks may warrant re-evaluation of treatment plan.
Symptom Monitoring
- Severe redness
- Excessive dryness or peeling
- Intense burning or stinging
- Swelling
- Blistering
- Crusting
- Itching (signs of allergic reaction)
Special Patient Groups
Pregnancy
Adapalene is generally considered contraindicated during pregnancy. While systemic absorption is minimal, retinoids are known teratogens. The decision to use during pregnancy should be made only if the potential benefit justifies the potential risk to the fetus, and typically, alternative treatments are preferred.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though systemic absorption is low.
Second Trimester:
Potential for teratogenicity, though systemic absorption is low.
Third Trimester:
Potential for teratogenicity, though systemic absorption is low.
Lactation
Considered low risk due to minimal systemic absorption. However, caution is advised. Avoid applying to areas where the infant may come into direct contact with the medication, especially the breast area.
Infant Risk:
Low risk of infant exposure via breast milk due to minimal maternal systemic absorption.
Pediatric Use
Safety and effectiveness in pediatric patients younger than 12 years of age have not been established. For adolescents 12 years and older, dosing is the same as adults.
Geriatric Use
No specific dose adjustments are needed 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, given the topical application and minimal systemic absorption, age-related systemic pharmacokinetic differences are not expected to be clinically significant.
Clinical Information
Clinical Pearls
- Patients may experience a temporary worsening of acne (purging) during the first few weeks of treatment. This is normal and usually resolves with continued use.
- Consistency is key; results are not immediate and typically require 8-12 weeks of continuous use.
- Emphasize the importance of daily sunscreen use due to increased photosensitivity.
- Advise patients to use a gentle, non-comedogenic moisturizer to counteract dryness and irritation.
- A 'less is more' approach is often best; applying more than a thin layer does not increase efficacy but can increase irritation.
Alternative Therapies
- Other topical retinoids (e.g., tretinoin, tazarotene)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Benzoyl peroxide
- Salicylic acid
- Azelaic acid
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe, recalcitrant acne)
Cost & Coverage
Generic Available:
Yes
Insurance Coverage:
Often Tier 1 or Tier 2 for generic formulations; Tier 3 or higher for brand.
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 for more information. 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 details about the overdose, including the medication taken, the amount, and the time it occurred.