Retin-A 0.1% Cream 20gm
It is used to treat pimples (acne).
Drug Class
Antiacne agent; Keratolytic
Pharmacologic Class
Retinoid
Pregnancy Category
C
FDA Approved
Apr 1971
DEA Schedule
Not Controlled
Overview
What is this medicine?
Retin-A 0.1% Cream is a topical medication containing tretinoin, a form of Vitamin A. It works by helping your skin renew itself more quickly, which can clear up acne and improve the appearance of skin texture. It's important to use it exactly as directed and protect your skin from the sun.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication as directed to ensure safe and effective treatment.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. 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.
Apply the medication at bedtime.
Before and after applying the medication, wash your hands thoroughly.
Gently wash the affected skin with a mild, non-medicated soap and pat it dry before application. You may need to wait 20 to 30 minutes after washing before applying the medication; consult with your pharmacist for specific guidance.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Storage and Disposal
Store this medication at room temperature, avoiding freezing.
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, skip it and resume your normal application schedule.
Do not apply a double dose or extra doses to make up for a missed dose.
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication as directed to ensure safe and effective treatment.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. 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.
Apply the medication at bedtime.
Before and after applying the medication, wash your hands thoroughly.
Gently wash the affected skin with a mild, non-medicated soap and pat it dry before application. You may need to wait 20 to 30 minutes after washing before applying the medication; consult with your pharmacist for specific guidance.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Storage and Disposal
Store this medication at room temperature, avoiding freezing.
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, skip it and resume your normal application schedule.
Do not apply a double dose or extra doses to make up for a missed dose.
Lifestyle & Tips
- Apply to clean, dry skin, typically once daily at bedtime.
- Use only a pea-sized amount for the entire face.
- Avoid applying to eyes, lips, nostrils, and mucous membranes.
- Sun protection is crucial: use sunscreen (SPF 30 or higher), wear protective clothing, and limit sun exposure, as tretinoin increases sensitivity to sunlight.
- Avoid waxing on treated areas.
- Use a gentle, non-medicated cleanser and moisturizer.
- Do not use other topical products that may cause irritation (e.g., those with alcohol, astringents, or strong drying agents) unless directed by your doctor.
- Be patient; it may take 6-12 weeks to see significant improvement.
Available Forms & Alternatives
Available Strengths:
- Retin-A 0.025% Gel 15gm
- Retin-A 0.025% Cream 20gm
- Retin-A Micro 0.08% Gel Pump 50gm
- Retin-A 0.05% Cream 20gm
- Retin-A 0.05% Cream 45gm
- Retin-A 0.025% Cream 45gm
- Retin-A 0.1% Cream 20gm
- Retin-A 0.01% Gel 15gm
- Retin-A 0.01% Gel 45gm
- Retin-A Micro 0.04% Gel 45gm
- Retin-A 0.1% Cream 45gm
- Retin-A Micro 0.1% Gel 20gm
- Retin-A 0.025% Gel 45gm
- Retin-A Micro 0.1% Gel 45gm
- Retin-A Micro 0.04% Gel Pump 50gm
- Retin-A Micro 0.1% Gel Pump 50gm
- Retin-A Micro 0.04% Gel 20gm
- Retin-A Micro 0.06% Gel Pump 50gm
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a pea-sized amount to the entire affected area once daily at bedtime.
Condition-Specific Dosing:
Acne Vulgaris:
Apply a thin layer to the affected areas once daily at bedtime, after washing and drying the skin. Avoid eyes, lips, and mucous membranes.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and efficacy not established in children younger than 12 years of age).
Adolescent:
Apply a pea-sized amount to the entire affected area once daily at bedtime (typically for ages 12 and older).
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
Tretinoin is a metabolite of Vitamin A that binds to specific retinoic acid receptors (RARs and RXRs) in the nucleus, modulating gene expression. It reduces the cohesiveness of follicular epithelial cells, leading to decreased microcomedone formation. It also stimulates mitotic activity and increased turnover of follicular epithelial cells, resulting in extrusion of comedones. Additionally, it may enhance the penetration of other topical agents.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 1-5% (systemic absorption after topical application)
Tmax:
Not well-defined for topical application; peak plasma concentrations are very low (ng/mL range) and occur within hours if detectable.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not clinically relevant for topical application due to minimal systemic absorption.
ProteinBinding:
Highly protein bound (>95%) if absorbed systemically.
CnssPenetration:
Limited/Not relevant for topical application.
Elimination:
HalfLife:
Not clinically relevant for topical application; systemic half-life of absorbed tretinoin is approximately 0.7-1.4 hours.
Clearance:
Rapid systemic clearance if absorbed.
ExcretionRoute:
Primarily renal and biliary excretion if absorbed systemically.
Unchanged:
Negligible amount excreted unchanged.
Pharmacodynamics
OnsetOfAction:
Initial improvement may be seen in 2-3 weeks; significant therapeutic effects typically observed after 6-12 weeks of continuous use.
PeakEffect:
12-24 weeks
DurationOfAction:
Effects persist as long as treatment is continued; relapse may occur upon discontinuation.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
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
+ Swelling of the mouth, face, lips, tongue, or throat
Severe skin reactions that are bothersome or persistent
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. 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:
Feeling of warmth
Burning or stinging
Change in skin color
Skin reactions, including:
+ Dry skin
+ Redness
+ Swelling
+ Blisters
+ Peeling
If you develop any skin reactions, consult your doctor, as they may recommend temporarily stopping the medication, adjusting the dosage, or changing the frequency of application.
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.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
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
+ Swelling of the mouth, face, lips, tongue, or throat
Severe skin reactions that are bothersome or persistent
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. 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:
Feeling of warmth
Burning or stinging
Change in skin color
Skin reactions, including:
+ Dry skin
+ Redness
+ Swelling
+ Blisters
+ Peeling
If you develop any skin reactions, consult your doctor, as they may recommend temporarily stopping the medication, adjusting the dosage, or changing the frequency of application.
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.
Seek Immediate Medical Attention If You Experience:
- Severe redness
- Excessive peeling or flaking
- Blistering
- Crusting
- Swelling
- Severe burning or stinging
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.
If you have a sunburn, skin sensitivity to light, or any other skin problems.
If you are taking any medications that may increase your skin's sensitivity to light. There are numerous drugs that can cause this interaction, so consult your doctor or pharmacist if you are unsure.
If you are pregnant or planning to become pregnant.
This is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to discuss all of your:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Health problems
with your doctor and pharmacist to ensure safe use. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this 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.
If you have a sunburn, skin sensitivity to light, or any other skin problems.
If you are taking any medications that may increase your skin's sensitivity to light. There are numerous drugs that can cause this interaction, so consult your doctor or pharmacist if you are unsure.
If you are pregnant or planning to become pregnant.
This is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to discuss all of your:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Health problems
with your doctor and pharmacist to ensure safe use. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this 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. This will help ensure your safety and prevent any potential interactions with other treatments.
Using Your Medication Correctly
To achieve the full benefits of this medication, it may take several weeks of consistent use. It is crucial to follow your doctor's instructions carefully and only use the medication as directed. Do not exceed the recommended dosage, frequency, or duration of treatment, as this may increase the risk of severe side effects.
Skin Precautions
Avoid applying this medication to sunburned skin, cuts, scrapes, eczema, or damaged skin, as this may cause further irritation. To minimize the risk of skin problems, practice good skin care and take steps to protect your skin from the sun. You may be more susceptible to sunburn while using this medication, so be sure to:
Avoid exposure to sunlight, sunlamps, and tanning beds
Use sunscreen and lip balm with an SPF of 15 or higher when outdoors
Wear protective clothing and eyewear to shield your skin from the sun
Take precautions in cold and windy weather, as these conditions may irritate your skin
If you have concerns about protecting your skin, consult with your doctor or pharmacist for guidance.
Interactions with Other Products
Using other skin products in combination with this medication may increase the risk of irritation. Before using any other skin products, including soaps, consult with your doctor to ensure safe use. If you experience dry skin while using this medication, you may use a moisturizer. However, be sure to discuss the type of moisturizer to use with your doctor or pharmacist.
You may use makeup while taking this medication, unless your doctor has advised against it. If you do use makeup, be sure to clean the area to be treated before applying the medication.
Safety Precautions
If you accidentally swallow this medication, call your doctor or a poison control center immediately, as it may cause harm.
Pregnancy and Breastfeeding
If you are pregnant or plan to become pregnant while taking this medication, inform your doctor right away, as it may harm the unborn baby. If you are breastfeeding, consult with your doctor to discuss any potential risks to your baby.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent any potential interactions with other treatments.
Using Your Medication Correctly
To achieve the full benefits of this medication, it may take several weeks of consistent use. It is crucial to follow your doctor's instructions carefully and only use the medication as directed. Do not exceed the recommended dosage, frequency, or duration of treatment, as this may increase the risk of severe side effects.
Skin Precautions
Avoid applying this medication to sunburned skin, cuts, scrapes, eczema, or damaged skin, as this may cause further irritation. To minimize the risk of skin problems, practice good skin care and take steps to protect your skin from the sun. You may be more susceptible to sunburn while using this medication, so be sure to:
Avoid exposure to sunlight, sunlamps, and tanning beds
Use sunscreen and lip balm with an SPF of 15 or higher when outdoors
Wear protective clothing and eyewear to shield your skin from the sun
Take precautions in cold and windy weather, as these conditions may irritate your skin
If you have concerns about protecting your skin, consult with your doctor or pharmacist for guidance.
Interactions with Other Products
Using other skin products in combination with this medication may increase the risk of irritation. Before using any other skin products, including soaps, consult with your doctor to ensure safe use. If you experience dry skin while using this medication, you may use a moisturizer. However, be sure to discuss the type of moisturizer to use with your doctor or pharmacist.
You may use makeup while taking this medication, unless your doctor has advised against it. If you do use makeup, be sure to clean the area to be treated before applying the medication.
Safety Precautions
If you accidentally swallow this medication, call your doctor or a poison control center immediately, as it may cause harm.
Pregnancy and Breastfeeding
If you are pregnant or plan to become pregnant while taking this medication, inform your doctor right away, as it may harm the unborn baby. If you are breastfeeding, consult with your doctor to discuss any potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Excessive redness
- Severe peeling
- Discomfort
- Blistering
What to Do:
Topical overdose is unlikely to cause systemic toxicity due to minimal absorption. If excessive application occurs, discontinue use temporarily. For severe local reactions, symptomatic treatment (e.g., emollients, cool compresses) may be used. If ingested, seek medical attention. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Moderate Interactions
- Topical products containing sulfur, resorcinol, or salicylic acid (may cause excessive irritation)
- Astringents, abrasive soaps/cleansers, medicated soaps/cleansers, strong drying agents (may cause excessive irritation)
- Alcohol-containing products (e.g., toners, aftershaves, perfumes) (may cause excessive irritation)
- Other topical acne medications (use with caution, may increase irritation)
- Photosensitizing agents (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines) (may increase risk of photosensitivity)
Monitoring
Baseline Monitoring
Skin assessment (type, condition, presence of lesions)
Rationale: To establish baseline for evaluating treatment response and potential adverse effects.
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin irritation (erythema, peeling, dryness, stinging, burning)
Frequency: Daily during initial weeks, then as needed.
Target: Mild to moderate irritation is expected; severe irritation warrants dose adjustment or temporary discontinuation.
Action Threshold: If severe irritation, blistering, crusting, or swelling occurs, discontinue use and consult physician.
Therapeutic response (reduction in acne lesions)
Frequency: Monthly or every 2-3 months.
Target: Gradual improvement in acne lesions.
Action Threshold: If no improvement after 12 weeks, re-evaluate diagnosis or treatment plan.
Symptom Monitoring
- Redness
- Peeling
- Dryness
- Stinging
- Burning
- Itching
- Blistering (severe)
- Crusting (severe)
- Swelling (severe)
Special Patient Groups
Pregnancy
Category C. While systemic absorption is minimal, topical tretinoin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Oral retinoids are highly teratogenic (Category X). Discuss risks and benefits with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though systemic absorption is low. Avoid if possible.
Second Trimester:
Lower risk than first trimester, but still use with caution.
Third Trimester:
Lower risk than first trimester, but still use with caution.
Lactation
L3 (Moderately safe). It is not known whether tretinoin is excreted in human milk. Due to minimal systemic absorption, significant transfer to breast milk is unlikely. Use with caution; consider applying after feeding and avoiding application to areas where the infant may come into contact with the medication.
Infant Risk:
Low risk due to minimal systemic absorption, but potential for irritation if infant comes into direct contact with treated skin.
Pediatric Use
Safety and efficacy have not been established in children younger than 12 years of age. Use in adolescents (12 years and older) is common and generally follows adult dosing guidelines.
Geriatric Use
No specific dose adjustments are necessary. Older patients may have more sensitive or fragile skin and may experience increased irritation. Use with caution and monitor for adverse reactions.
Clinical Information
Clinical Pearls
- Start with a lower concentration (e.g., 0.025%) if skin is sensitive, and gradually increase as tolerated.
- Apply to completely dry skin (wait 20-30 minutes after washing) to minimize irritation.
- A 'pea-sized' amount is sufficient for the entire face; using more will not speed up results and will increase irritation.
- Expect an initial 'purging' phase where acne may worsen before it improves; this is normal and usually resolves within the first few weeks.
- Consistent daily use is key for optimal results.
- Moisturize regularly with a non-comedogenic, fragrance-free moisturizer to combat dryness.
- Strict sun protection (sunscreen SPF 30+, hats, sun avoidance) is mandatory due to increased photosensitivity.
Alternative Therapies
- Adapalene (Differin) - another topical retinoid, often better tolerated.
- Tazarotene (Tazorac) - another topical retinoid, generally more potent and irritating.
- Benzoyl Peroxide - topical antibacterial and keratolytic.
- Topical antibiotics (e.g., clindamycin, erythromycin) - often used in combination with retinoids.
- Oral antibiotics (e.g., doxycycline, minocycline) - for moderate to severe acne.
- Oral isotretinoin (Accutane) - for severe, recalcitrant nodular acne (highly effective but with significant side effects and strict monitoring requirements).
- Azelaic acid - for acne and rosacea.
- Salicylic acid - topical exfoliant.
Cost & Coverage
Average Cost:
$50 - $200 per 20gm tube (0.1% cream)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand); Tier 1 (Generic)
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 overdose, including the medication taken, the amount, and the time it occurred.