Adapalene 0.3% Gel 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 0.3% Gel is a topical medication used to treat acne. It works by helping to prevent pimples, blackheads, and whiteheads from forming, and by reducing inflammation.
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 thoroughly with water.
Do not apply the medication to cuts, scrapes, eczema, or damaged skin. Additionally, avoid applying 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.
Preparation and Application
Wash your hands before and after using the medication.
Clean the affected area before application and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
After use, replace the cap to prevent contamination.
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 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 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 thoroughly with water.
Do not apply the medication to cuts, scrapes, eczema, or damaged skin. Additionally, avoid applying 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.
Preparation and Application
Wash your hands before and after using the medication.
Clean the affected area before application and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
After use, replace the cap to prevent contamination.
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 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 a thin layer to clean, dry skin once daily in the evening.
- Avoid contact with eyes, lips, angles of the nose, and mucous membranes.
- Limit sun exposure, including tanning beds, and use sunscreen and protective clothing when outdoors, as adapalene can increase sensitivity to sunlight.
- Avoid waxing on treated skin.
- Do not use on cuts, scrapes, or eczematous skin.
- Initial irritation (redness, dryness, peeling) is common and usually subsides with continued use. If severe, contact your doctor.
- Cosmetics can be used, but avoid those that are irritating or drying.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer of Adapalene 0.3% Gel 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 or adjustments needed 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 does not bind to the cytosolic receptor protein. Adapalene normalizes the differentiation of follicular epithelial cells, resulting in decreased microcomedone formation.
Pharmacokinetics
Absorption:
Bioavailability:
Very low systemic absorption (typically below quantifiable limits)
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:
No
Elimination:
HalfLife:
Not clinically relevant due to minimal systemic absorption
Clearance:
Not clinically relevant due to minimal systemic absorption
ExcretionRoute:
Primarily biliary excretion (animal studies), but systemic levels are negligible.
Unchanged:
Not clinically relevant due to minimal systemic absorption
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically observed after 8 to 12 weeks of treatment.
PeakEffect:
Approximately 3 months of continuous use.
DurationOfAction:
Requires continuous use for maintenance of effect.
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 immediate 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
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, contact your doctor if they bother you or do not go away:
Skin irritation, which is common with this medication, may include:
+ Burning
+ Dry skin
+ Itching
+ Peeling
+ Redness
+ Scaling
Contact your doctor if skin irritation is severe, bothersome, or persistent.
* Mild warmth or tingling at the application site, which is usually temporary
Reporting Side Effects
This is not an exhaustive list of possible side effects. 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.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. Seek immediate 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
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, contact your doctor if they bother you or do not go away:
Skin irritation, which is common with this medication, may include:
+ Burning
+ Dry skin
+ Itching
+ Peeling
+ Redness
+ Scaling
Contact your doctor if skin irritation is severe, bothersome, or persistent.
* Mild warmth or tingling at the application site, which is usually temporary
Reporting Side Effects
This is not an exhaustive list of possible side effects. 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.
Seek Immediate Medical Attention If You Experience:
- Severe skin irritation (excessive redness, dryness, peeling, burning, stinging) that does not improve or worsens.
- Signs of an allergic reaction (e.g., rash, itching/swelling, severe dizziness, trouble breathing).
- Swelling of the face, lips, or tongue.
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 safely with all your other 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 safely with all your other 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 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 products containing 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 products containing 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, and discomfort of the skin. Oral ingestion of the topical gel is unlikely to cause significant systemic toxicity due to low absorption.
What to Do:
If topical overdose occurs, discontinue use temporarily. If accidental ingestion occurs, seek medical attention immediately. Call a poison control center at 1-800-222-1222.
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)
- Concomitant use with other topical retinoids (e.g., tretinoin, tazarotene) due to increased irritation risk.
Monitoring
Baseline Monitoring
Skin assessment (type, severity of acne, presence of irritation)
Rationale: To establish baseline condition and guide treatment plan.
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin irritation (erythema, scaling, dryness, burning, stinging, pruritus)
Frequency: Regularly, especially during the first 4 weeks of treatment
Target: Mild to moderate irritation is expected; severe irritation should prompt re-evaluation.
Action Threshold: Severe or persistent irritation may require temporary discontinuation or reduction in frequency.
Efficacy (reduction in acne lesions)
Frequency: Monthly or every 2-3 months
Target: Gradual improvement in inflammatory and non-inflammatory lesions.
Action Threshold: Lack of improvement after 12 weeks may indicate need for alternative therapy.
Symptom Monitoring
- Erythema (redness)
- Scaling (flaking)
- Dryness
- Burning sensation
- Stinging sensation
- Pruritus (itching)
- Photosensitivity (increased sensitivity to sunlight)
Special Patient Groups
Pregnancy
Adapalene is a retinoid. While systemic absorption is minimal with topical use, oral retinoids are known teratogens. Adapalene was historically classified as Pregnancy Category C. Current guidance recommends avoiding 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 for fetal harm, though systemic absorption is low. Avoid if possible.
Second Trimester:
Potential for fetal harm, though systemic absorption is low. Avoid if possible.
Third Trimester:
Potential for fetal harm, though systemic absorption is low. Avoid if possible.
Lactation
It is not known whether adapalene is excreted in human milk. Due to minimal systemic absorption, it is considered unlikely to pose a significant risk to a nursing infant. However, caution should be exercised, and direct contact with the infant's skin or breast area should be avoided.
Infant Risk:
Low risk due to minimal systemic absorption; however, avoid application to areas that may come into direct contact with the infant.
Pediatric Use
Safety and effectiveness in pediatric patients under the age of 12 years have not been established. Approved for use in patients 12 years of age and older.
Geriatric Use
Clinical studies of Adapalene 0.3% Gel did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. No specific dosage adjustments are recommended based on age due to minimal systemic absorption.
Clinical Information
Clinical Pearls
- Adapalene 0.3% Gel is a stronger formulation than the 0.1% gel and may cause more initial irritation. Patients should be advised about potential dryness, redness, and peeling, especially during the first few weeks of treatment.
- Emphasize the importance of consistent, once-daily evening application for optimal results.
- Sun protection (sunscreen, protective clothing) is crucial due to increased photosensitivity.
- Acne may appear to worsen during the initial weeks of treatment ('purging') before improvement is seen. This is a normal part of the process as the medication works to bring underlying lesions to the surface.
- Advise patients to use a gentle, non-comedogenic cleanser and moisturizer to help manage dryness and irritation.
Alternative Therapies
- Other topical retinoids (e.g., tretinoin, tazarotene)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Topical antimicrobials (e.g., benzoyl peroxide, azelaic acid)
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe, recalcitrant acne)
- Salicylic acid
- Dapsone topical gel
Cost & Coverage
Average Cost:
$200 - $400 per 45gm tube
Generic Available:
Yes
Insurance Coverage:
Often Tier 2 or Tier 3 on most commercial insurance plans. May require prior authorization.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.