Adapalene 0.1% Gel 45gm
It is used to treat pimples (acne).
Drug Class
Anti-acne agent
Pharmacologic Class
Retinoid; Retinoic acid receptor (RAR) modulator
Pregnancy Category
Not available (old Category C)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Adapalene gel is a topical medication used to treat acne. It belongs to a class of drugs called retinoids. It works by affecting cell growth and reducing inflammation in the skin, 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 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.
Application Instructions
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.
Some products are designed for use at bedtime, while others can be used at any time. If you are unsure about the best time to use your medication, consult with your pharmacist.
Storage and Disposal
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.
Missed Dose
If you miss a dose, apply it 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 one.
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.
Application Instructions
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.
Some products are designed for use at bedtime, while others can be used at any time. If you are unsure about the best time to use your medication, consult with your pharmacist.
Storage and Disposal
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.
Missed Dose
If you miss a dose, apply it 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 one.
Lifestyle & Tips
- Apply a thin layer to clean, dry skin once daily in the evening.
- Avoid contact with eyes, lips, nostrils, and mucous membranes.
- Use a gentle, non-medicated cleanser and moisturizer.
- Sun sensitivity: Adapalene can make your skin more sensitive to the sun. Use a broad-spectrum sunscreen with an SPF of 15 or higher daily, and wear protective clothing when outdoors.
- Avoid excessive sun exposure, including sunlamps and tanning beds.
- Do not apply to cuts, scrapes, or eczematous skin.
- Be patient: It may take 8-12 weeks to see significant improvement, and acne may initially worsen (purging) before it gets better.
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:
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 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 (RARΞ² and RARΞ³) but does not bind to the cytosolic receptor protein. Adapalene decreases microcomedone formation and has anti-inflammatory effects 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 (plasma concentrations generally below the limit of quantification of 0.25 ng/mL).
Tmax:
Not clinically relevant due to minimal systemic absorption.
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 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 (for systemically absorbed drug, which is negligible).
Unchanged:
Not applicable (minimal systemic absorption).
Pharmacodynamics
OnsetOfAction:
Initial improvement typically seen within 4-8 weeks; full therapeutic effect may take up to 12 weeks.
PeakEffect:
Approximately 8-12 weeks.
DurationOfAction:
Requires continuous use for maintenance of effect.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, some individuals may experience severe and potentially life-threatening side effects while taking this medication. If you exhibit any of the following symptoms, contact your doctor or seek medical help right away, as they may be indicative of a serious adverse reaction:
- 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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Other Potential Side Effects
As with all medications, side effects can occur. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not resolve, contact your doctor for advice:
- Skin irritation is a common side effect of this medication, which may include burning sensations, dry skin, itching, peeling, redness, and scaling. If the skin irritation is severe, bothersome, or persistent, consult your doctor.
- Mild warmth or tingling at the application site, typically temporary.
Reporting Side Effects
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. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor is available to provide medical advice regarding side effects.
Although rare, some individuals may experience severe and potentially life-threatening side effects while taking this medication. If you exhibit any of the following symptoms, contact your doctor or seek medical help right away, as they may be indicative of a serious adverse reaction:
- 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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Other Potential Side Effects
As with all medications, side effects can occur. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not resolve, contact your doctor for advice:
- Skin irritation is a common side effect of this medication, which may include burning sensations, dry skin, itching, peeling, redness, and scaling. If the skin irritation is severe, bothersome, or persistent, consult your doctor.
- Mild warmth or tingling at the application site, typically temporary.
Reporting Side Effects
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. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor is available to provide medical advice regarding side effects.
Seek Immediate Medical Attention If You Experience:
- Severe skin irritation (excessive redness, dryness, scaling, burning, or itching)
- Swelling of the face or lips (signs of allergic reaction)
- Blistering or crusting of the skin
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 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 it is safe to take this medication with all your current medications and health conditions. 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.
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 it is safe to take this medication with all your current medications and health conditions. 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 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. 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 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 using products that contain alpha hydroxy or glycolic acids.
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, plan to become pregnant, or are 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 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. 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 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 using products that contain alpha hydroxy or glycolic acids.
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, plan to become pregnant, or are 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. Discontinue use and apply a moisturizer. If severe irritation occurs, seek medical advice. For accidental ingestion, call a poison control center (1-800-222-1222) or emergency services.
Drug Interactions
Moderate Interactions
- Concomitant use of other potentially irritating topical products (e.g., medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, products with high concentrations of alcohol, astringents, or perfumed products).
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 irritation becomes severe or persistent, reduce frequency of application or temporarily discontinue use. Consult healthcare provider if symptoms persist.
Clinical response to acne treatment
Frequency: Monthly or as clinically indicated.
Target: Reduction in inflammatory and non-inflammatory lesions.
Action Threshold: If no improvement after 12 weeks, re-evaluate treatment plan.
Symptom Monitoring
- Skin redness
- Scaling
- Dryness
- Burning sensation
- Stinging sensation
- Itching
- Acne flare-up (initial worsening)
Special Patient Groups
Pregnancy
Adapalene should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. While systemic absorption is minimal, retinoids are generally considered teratogenic. Consult with a healthcare provider to discuss risks and alternative treatments.
Trimester-Specific Risks:
First Trimester:
Potential risk of teratogenicity, though systemic absorption is low. Avoid if possible.
Second Trimester:
Potential risk, but generally lower than first trimester. Avoid if possible.
Third Trimester:
Potential risk, but generally lower than first trimester. Avoid if possible.
Lactation
It is not known whether adapalene is excreted in human milk. Due to minimal systemic absorption, it is considered low risk. However, caution should be exercised. If used, avoid applying to areas that may come into direct contact with the infant's skin or mouth.
Infant Risk:
Low risk due to minimal systemic absorption, but direct contact should be avoided.
Pediatric Use
Safety and effectiveness have been established in pediatric patients 12 years of age and older. Not recommended for use in children under 12 years of age.
Geriatric Use
No specific dosage adjustments or precautions are necessary 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.
Clinical Information
Clinical Pearls
- The 'purging' phase: Patients may experience an initial worsening of acne (increased breakouts, redness, dryness) during the first few weeks of treatment. This is normal and usually subsides as the skin adjusts.
- Consistency is key: Emphasize daily, consistent application for optimal results, as it takes time to see improvement.
- Sun protection is crucial: Advise patients about increased photosensitivity and the importance of daily sunscreen use.
- Moisturize: Encourage the use of a gentle, non-comedogenic moisturizer to help manage dryness and irritation.
- Avoid harsh products: Advise against using other irritating topical products (e.g., strong astringents, abrasive cleansers, other retinoids) concurrently.
- Small amount, thin layer: A pea-sized amount is usually sufficient for the entire face.
Alternative Therapies
- Topical retinoids (e.g., Tretinoin, Tazarotene)
- Topical antibiotics (e.g., Clindamycin, Erythromycin)
- Topical benzoyl peroxide
- Topical salicylic acid
- Oral antibiotics (e.g., Doxycycline, Minocycline)
- Oral isotretinoin (for severe, recalcitrant acne)
- Azelaic acid
Cost & Coverage
Average Cost:
Varies widely, typically $30-$100+ per 45gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 (brand)
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 taken, the amount, and the time it happened.