Adapalene 0.3% Gel (pump) 45gm
It is used to treat pimples (acne).
Drug Class
Anti-acne agent
Pharmacologic Class
Retinoid-like agent; Topical anti-inflammatory
Pregnancy Category
Category C
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 skin cells turn over more normally and by reducing inflammation. It's a stronger version of adapalene than the over-the-counter strength.
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 medication. It is essential to use this medication only as directed.
Application Instructions
Apply this medication only to your skin, as directed. 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. 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 applying the medication, and make sure it is dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
After using the medication, replace the cap to prevent contamination.
Storage and Disposal
Store the medication at room temperature, avoiding freezing temperatures and excessive heat.
Keep the medication in a safe location, out of the reach of children and pets, to prevent accidental ingestion or exposure.
Missed Dose Instructions
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 the same time or use extra 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 medication. It is essential to use this medication only as directed.
Application Instructions
Apply this medication only to your skin, as directed. 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. 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 applying the medication, and make sure it is dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
After using the medication, replace the cap to prevent contamination.
Storage and Disposal
Store the medication at room temperature, avoiding freezing temperatures and excessive heat.
Keep the medication in a safe location, out of the reach of children and pets, to prevent accidental ingestion or exposure.
Missed Dose Instructions
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 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.
- Use a gentle, non-medicated cleanser and moisturizer daily.
- Limit sun exposure, including sunlamps, and use sunscreen (SPF 30 or higher) and protective clothing when outdoors, as adapalene can increase sensitivity to sunlight.
- Avoid waxing on treated skin areas.
- Do not apply to cuts, scrapes, eczematous, or sunburned skin.
- Initial worsening of acne (purging) may occur during the first few weeks of treatment; continue use as directed.
- Be patient; it can take 8-12 weeks to see significant improvement.
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. It normalizes the differentiation of follicular epithelial cells, resulting in decreased microcomedone formation. Adapalene also has anti-inflammatory properties 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:
Negligible (less than 0.25% of the applied dose is absorbed systemically)
Tmax:
Not clinically significant due to minimal systemic absorption
FoodEffect:
Not applicable (topical administration)
Distribution:
Vd:
Not clinically significant due to minimal systemic absorption
ProteinBinding:
Not clinically significant due to minimal systemic absorption
CnssPenetration:
Limited/Negligible
Elimination:
HalfLife:
Not clinically significant due to minimal systemic absorption
Clearance:
Not clinically significant due to minimal systemic absorption
ExcretionRoute:
Primarily biliary excretion (for systemically absorbed drug)
Unchanged:
Not clinically significant
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen after 4-8 weeks of treatment, with further improvement over time.
PeakEffect:
Optimal results may take up to 12 weeks or longer.
DurationOfAction:
Continuous use is required to maintain 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, but many people experience no side effects or only mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
- Skin irritation is a common side effect, which may include burning, dry skin, itching, peeling, redness, and scaling. If your skin irritation is severe, bothers you, or does not improve, contact your doctor.
- Mild warmth or tingling at the application site for a short time after using the medication.
Additional Information
This list does not include all possible side effects. If you have questions or concerns about side effects, contact your doctor. For medical advice 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, 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, but many people experience no side effects or only mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
- Skin irritation is a common side effect, which may include burning, dry skin, itching, peeling, redness, and scaling. If your skin irritation is severe, bothers you, or does not improve, contact your doctor.
- Mild warmth or tingling at the application site for a short time after using the medication.
Additional Information
This list does not include all possible side effects. If you have questions or concerns about side effects, contact your doctor. For medical advice 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 (redness, dryness, scaling, burning, stinging) that does not improve or worsens significantly.
- Allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing).
- Severe sunburn despite sun protection.
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 it is safe to take this medication with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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 it is safe to take this medication with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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 like cold and wind may irritate your skin. Consult with your doctor or pharmacist about ways to safeguard your skin in these conditions.
Precautions and Interactions
Do not wax the affected skin area, as this may 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 containing alpha hydroxy or glycolic acids.
Safety and Administration
Keep in mind that it may take a few months to notice the full effects of this medication. If this medication is accidentally swallowed, contact a doctor or poison control center immediately.
Special Considerations
This medication is not recommended for children under 12 years old without consulting a doctor first.
If you are pregnant, planning to become pregnant, or breastfeeding, discuss the benefits and risks of using this medication 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 like cold and wind may irritate your skin. Consult with your doctor or pharmacist about ways to safeguard your skin in these conditions.
Precautions and Interactions
Do not wax the affected skin area, as this may 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 containing alpha hydroxy or glycolic acids.
Safety and Administration
Keep in mind that it may take a few months to notice the full effects of this medication. If this medication is accidentally swallowed, contact a doctor or poison control center immediately.
Special Considerations
This medication is not recommended for children under 12 years old without consulting a doctor first.
If you are pregnant, planning to become pregnant, or breastfeeding, discuss the benefits and risks of using this medication 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
What to Do:
Topical overdose is unlikely to cause systemic symptoms due to minimal absorption. Discontinue use temporarily until irritation subsides. If accidental ingestion occurs, seek medical attention. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Moderate Interactions
- Other topical preparations with a strong drying or irritating effect (e.g., sulfur, resorcinol, salicylic acid, alpha hydroxy acids, abrasive soaps, medicated cleansers, astringents, or peeling agents) - concurrent use should be avoided or used with caution due to potential for additive irritation.
Monitoring
Baseline Monitoring
Skin condition (erythema, scaling, dryness, burning/stinging)
Rationale: To assess baseline irritation and guide initial patient counseling.
Timing: Before starting treatment
Routine Monitoring
Skin condition (erythema, scaling, dryness, burning/stinging)
Frequency: Weekly for the first 4 weeks, then as needed
Target: Mild to moderate irritation is expected; severe irritation requires intervention.
Action Threshold: Severe or persistent irritation may require temporary discontinuation, reduced frequency, or use of moisturizers.
Acne lesion count (inflammatory and non-inflammatory)
Frequency: Every 4-8 weeks
Target: Reduction in lesion count
Action Threshold: Lack of improvement after 12 weeks may warrant re-evaluation of treatment plan.
Symptom Monitoring
- Skin dryness
- Scaling
- Erythema (redness)
- Burning/stinging sensation
- Pruritus (itching)
- Photosensitivity (increased sensitivity to sunlight)
Special Patient Groups
Pregnancy
Adapalene is Pregnancy Category C. While systemic absorption is minimal, use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Oral retinoids are teratogenic; topical retinoids have much lower systemic exposure but caution is still advised.
Trimester-Specific Risks:
First Trimester:
Potential risk, avoid if possible.
Second Trimester:
Potential risk, avoid if possible.
Third Trimester:
Potential risk, avoid if possible.
Lactation
It is not known whether adapalene is excreted in human milk. Due to minimal systemic absorption, excretion into breast milk is expected to be very low. Use with caution. Avoid applying to areas where the infant may come into direct contact with the medication.
Infant Risk:
Low (L3 - Moderately safe, but monitor infant for adverse effects)
Pediatric Use
Safety and effectiveness in pediatric patients younger than 12 years of age have not been established. For patients 12 years and older, dosing is similar to adults.
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, no overall differences in safety or effectiveness were observed. No specific dose adjustment is needed due to minimal systemic absorption.
Clinical Information
Clinical Pearls
- Adapalene 0.3% is a higher strength than the OTC 0.1% gel and may cause more initial irritation. Advise patients about the potential for increased dryness, redness, and peeling, especially during the first few weeks.
- Emphasize the importance of consistent, once-daily evening application. More frequent application will not speed up results but will increase irritation.
- Instruct patients to use a gentle, non-comedogenic moisturizer and sunscreen daily to help manage dryness and photosensitivity.
- Explain that acne may appear to worsen before it improves (known as 'purging'), which is a normal part of the retinization process. Encourage patients to continue treatment.
- Avoid concomitant use of other potentially irritating topical products (e.g., benzoyl peroxide, salicylic acid) unless directed by a healthcare professional, as this can exacerbate irritation. If used together, apply at different times of the day (e.g., adapalene at night, benzoyl peroxide in the morning).
Alternative Therapies
- Tretinoin (Retin-A, Renova)
- Tazarotene (Tazorac)
- Trifarotene (Aklief)
- Topical Clindamycin
- Topical Erythromycin
- Topical Dapsone
- Azelaic Acid
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe, recalcitrant acne)
Cost & Coverage
Average Cost:
$200 - $400 per 45gm pump
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (prescription strength)
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. 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.