Tretinoin 0.1% Cream 20gm
It is used to treat pimples (acne).
Drug Class
Retinoid; Anti-acne; Anti-wrinkle
Pharmacologic Class
Retinoid
Pregnancy Category
Category C
FDA Approved
May 1971
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tretinoin is a medicine related to vitamin A that is applied to the skin. It helps treat acne by clearing clogged pores and preventing new breakouts. It also helps improve the appearance of fine wrinkles, dark spots, and rough skin caused by sun damage by speeding up skin cell turnover.
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.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not ingest it.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation. If accidental contact occurs, rinse the affected area thoroughly with water.
Apply the medication at bedtime.
Before and after application, wash your hands thoroughly.
Gently wash the affected skin area with a mild, non-medicated soap and pat it dry before applying the medication. 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 area and gently rub it in.
Storage and Disposal
Store this medication at room temperature, avoiding freezing.
Keep all medications in a secure location, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, skip it and resume your regular 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.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not ingest it.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation. If accidental contact occurs, rinse the affected area thoroughly with water.
Apply the medication at bedtime.
Before and after application, wash your hands thoroughly.
Gently wash the affected skin area with a mild, non-medicated soap and pat it dry before applying the medication. 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 area and gently rub it in.
Storage and Disposal
Store this medication at room temperature, avoiding freezing.
Keep all medications in a secure location, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, skip it and resume your regular 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, usually once daily at bedtime.
- Use only a pea-sized amount for the entire face.
- Avoid contact with eyes, mouth, angles of the nose, and mucous membranes.
- Use a gentle, non-medicated cleanser and moisturizer.
- Strictly avoid sun exposure, including tanning beds. Use broad-spectrum sunscreen (SPF 30 or higher) daily and wear protective clothing (hats, long sleeves) when outdoors, even on cloudy days.
- Initial worsening of acne (purging) is common and usually resolves within a few weeks.
- Skin may become red, dry, and peel, especially during the first few weeks. This is normal and usually subsides with continued use. If severe, contact your doctor.
- Avoid waxing on treated areas as skin may be more fragile.
- Do not use other irritating topical products (e.g., those with benzoyl peroxide, salicylic acid, or high alcohol content) at the same time unless directed by your doctor.
Available Forms & Alternatives
Available Strengths:
- Tretinoin 0.025% Cream 45gm
- Tretinoin Micro 0.1% Gel 20gm
- Tretinoin Micro 0.1% Gel 45gm
- Tretinoin Micro 0.1% Gel Pump 50gm
- Tretinoin Micro 0.04% Gel Pump 50gm
- Tretinoin Micro 0.04% Gel 45gm
- Tretinoin Micro 0.04% Gel 20gm
- Tretinoin 10mg Capsules
- Tretinoin 0.01% Gel 45gm
- Tretinoin 0.1% Cream 45gm
- Tretinoin 0.05% Cream 45gm
- Tretinoin 0.05% Gel 45gm
- Tretinoin 0.025% Gel 45gm
- Tretinoin 0.01% Gel 15gm
- Tretinoin 0.025% Gel 15gm
- Tretinoin 0.05% Cream 20gm
- Tretinoin 0.025% Cream 20gm
- Tretinoin 0.1% Cream 20gm
- Tretinoin 0.08% Gel Pump 50gm
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected areas once daily at bedtime
Condition-Specific Dosing:
acne vulgaris:
Apply a thin layer to affected areas once daily at bedtime, after washing and drying the skin. A pea-sized amount is usually sufficient for the entire face.
photodamage:
Apply a thin layer to affected areas once daily at bedtime, after washing and drying the skin. A pea-sized amount is usually sufficient for the entire face.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (safety and efficacy not established in children under 12 years for acne, or under 18 years for photodamage)
Adolescent:
Apply a thin layer to affected areas once daily at bedtime (for acne, generally 12 years 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) located in the nucleus, including RAR-alpha, RAR-beta, and RAR-gamma. This binding modulates gene expression, leading to altered cellular differentiation, proliferation, and inflammation. In acne, it reduces follicular keratinization, promoting the expulsion of comedones and inhibiting the formation of new ones. It also has anti-inflammatory effects. In photodamage, it influences epidermal cell turnover, collagen synthesis, and dermal matrix components.
Pharmacokinetics
Absorption:
Bioavailability:
<5% (systemic absorption after topical application)
Tmax:
Not clinically relevant for topical application (systemic absorption is minimal)
FoodEffect:
Not applicable for topical application
Distribution:
Vd:
Not clinically relevant for topical application
ProteinBinding:
Highly protein bound if systemically absorbed (e.g., to albumin)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not clinically relevant for topical application (systemic half-life of absorbed drug is short, ~0.7-1.5 hours)
Clearance:
Not clinically relevant for topical application
ExcretionRoute:
If systemically absorbed, primarily renal and biliary excretion
Unchanged:
Not available (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
2-3 weeks (initial improvement), 6-12 weeks (maximal therapeutic effect)
PeakEffect:
6-12 weeks
DurationOfAction:
Effects persist as long as treatment is continued; regression occurs upon discontinuation.
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
+ 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. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or do not go away:
Feeling of warmth
Burning or stinging
Change in skin color
Skin reactions, such as:
+ Dry skin
+ Redness
+ Swelling
+ Blisters
+ Peeling
If you experience any skin reactions, consult your doctor, as they may recommend temporarily stopping the medication, adjusting the dosage, or changing the frequency of use.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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, 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
+ 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. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or do not go away:
Feeling of warmth
Burning or stinging
Change in skin color
Skin reactions, such as:
+ Dry skin
+ Redness
+ Swelling
+ Blisters
+ Peeling
If you experience any skin reactions, consult your doctor, as they may recommend temporarily stopping the medication, adjusting the dosage, or changing the frequency of use.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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 burning, stinging, or itching that does not subside
- Excessive redness, swelling, blistering, or crusting of the skin
- Allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat - seek immediate medical attention)
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.
Skin conditions, including sunburn, sensitivity to light, or other skin problems.
Any medications you are taking that may increase your skin's sensitivity to light. There are numerous medications that can cause this interaction, so consult your doctor or pharmacist if you are unsure.
If you are pregnant, as this may affect the safety of taking this medication.
This is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to discuss the following with your doctor and pharmacist:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your overall health and any existing medical conditions
To ensure your safety, do not start, stop, or modify the dosage of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication in combination with your other medications and health conditions.
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.
Skin conditions, including sunburn, sensitivity to light, or other skin problems.
Any medications you are taking that may increase your skin's sensitivity to light. There are numerous medications that can cause this interaction, so consult your doctor or pharmacist if you are unsure.
If you are pregnant, as this may affect the safety of taking this medication.
This is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to discuss the following with your doctor and pharmacist:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your overall health and any existing medical conditions
To ensure your safety, do not start, stop, or modify the dosage of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication in combination with your other medications and health conditions.
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 not exceed the recommended dosage or frequency of application. Taking more than prescribed or using it for a longer period than directed can increase the risk of severe side effects.
Skin Precautions
Avoid applying this medication to sunburned skin, cuts, scrapes, eczema, or damaged skin, as this can exacerbate skin irritation. To minimize the risk of skin problems, practice good skin care and take measures to protect your skin from the sun. You may be more susceptible to sunburn while using this medication, so be sure to:
Avoid direct sunlight, sunlamps, and tanning beds
Use sunscreen and lip balm with a Sun Protection Factor (SPF) of 15 or higher when outdoors
Wear protective clothing and eyewear to shield your skin from the sun
Discuss with your doctor or pharmacist how to protect your skin from harsh weather conditions, such as cold and wind
Interactions with Other Products
Be cautious when using other skin products, including soaps, as they may increase the risk of skin irritation. Consult with your doctor before using any other products on your skin. If you experience dry skin due to this medication, you may use a moisturizer, but be sure to discuss the type of moisturizer to use with your doctor or pharmacist. You can use makeup unless your doctor advises against it; however, make sure to clean the area to be treated before applying this medication.
Safety Precautions
If you accidentally swallow this medication, seek medical attention or contact a poison control center immediately, as it can cause harm. Additionally, if you are pregnant or plan to become pregnant, inform your doctor right away, as this medication 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 not exceed the recommended dosage or frequency of application. Taking more than prescribed or using it for a longer period than directed can increase the risk of severe side effects.
Skin Precautions
Avoid applying this medication to sunburned skin, cuts, scrapes, eczema, or damaged skin, as this can exacerbate skin irritation. To minimize the risk of skin problems, practice good skin care and take measures to protect your skin from the sun. You may be more susceptible to sunburn while using this medication, so be sure to:
Avoid direct sunlight, sunlamps, and tanning beds
Use sunscreen and lip balm with a Sun Protection Factor (SPF) of 15 or higher when outdoors
Wear protective clothing and eyewear to shield your skin from the sun
Discuss with your doctor or pharmacist how to protect your skin from harsh weather conditions, such as cold and wind
Interactions with Other Products
Be cautious when using other skin products, including soaps, as they may increase the risk of skin irritation. Consult with your doctor before using any other products on your skin. If you experience dry skin due to this medication, you may use a moisturizer, but be sure to discuss the type of moisturizer to use with your doctor or pharmacist. You can use makeup unless your doctor advises against it; however, make sure to clean the area to be treated before applying this medication.
Safety Precautions
If you accidentally swallow this medication, seek medical attention or contact a poison control center immediately, as it can cause harm. Additionally, if you are pregnant or plan to become pregnant, inform your doctor right away, as this medication 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:
- Topical overdose is unlikely to cause systemic toxicity due to minimal absorption.
- Excessive application may lead to marked redness, peeling, and discomfort.
What to Do:
Discontinue use. Symptomatic treatment for local irritation. If accidental ingestion occurs, contact a poison control center (e.g., 1-800-222-1222) or seek medical attention, though systemic toxicity from topical ingestion is rare.
Drug Interactions
Moderate Interactions
- Other topical preparations with strong drying or irritating effects (e.g., sulfur, resorcinol, salicylic acid, benzoyl peroxide)
- Astringents, medicated soaps/cleansers, abrasive soaps/cleansers, cosmetics with strong drying effect, products with high alcohol content
- Photosensitizing drugs (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) - increased risk of photosensitivity
Monitoring
Baseline Monitoring
Skin assessment (type, condition, severity of acne/photodamage)
Rationale: To establish baseline for efficacy and tolerability assessment.
Timing: Prior to initiation of therapy
Routine Monitoring
Local skin irritation (erythema, scaling, dryness, burning, stinging, pruritus)
Frequency: Regularly during initial weeks of therapy, then as needed
Target: Mild to moderate irritation is expected; severe irritation warrants dose adjustment or temporary discontinuation.
Action Threshold: Severe or persistent irritation: reduce frequency, temporarily discontinue, or switch to lower concentration.
Therapeutic response (reduction in lesions, improvement in skin texture)
Frequency: Monthly for first 3-6 months, then every 3-6 months
Target: Gradual improvement over weeks to months.
Action Threshold: Lack of improvement after 12 weeks may warrant re-evaluation of therapy.
Symptom Monitoring
- Excessive redness
- Severe peeling or flaking
- Intense dryness
- Burning or stinging sensation
- Itching
- Swelling
- Blistering or crusting (rare, severe reaction)
Special Patient Groups
Pregnancy
Tretinoin is Pregnancy Category C. While systemic absorption from topical application is minimal, oral retinoids are highly teratogenic. Therefore, topical tretinoin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Many clinicians advise avoiding use during pregnancy.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though risk from topical is considered low due to minimal absorption. Avoid if possible.
Second Trimester:
Risk considered low due to minimal absorption, but still generally avoided.
Third Trimester:
Risk considered low due to minimal absorption, but still generally avoided.
Lactation
Tretinoin is Pregnancy/Lactation Risk L3 (Moderately Safe). Minimal systemic absorption is expected, making infant exposure via breast milk unlikely to be significant. 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 adverse effects to breastfed infant due to minimal maternal systemic absorption.
Pediatric Use
Safety and efficacy have not been established in children under 12 years of age for acne, or under 18 years of age for photodamage. Use in adolescents (12 years and older for acne) should be under medical supervision.
Geriatric Use
No specific dose adjustments are necessary. However, geriatric patients may have more fragile or sensitive skin, and may experience increased dryness or irritation. Use with caution and monitor for adverse skin reactions.
Clinical Information
Clinical Pearls
- Start with a lower concentration (e.g., 0.025%) and gradually increase as tolerated to minimize irritation.
- Apply to completely dry skin (wait 20-30 minutes after washing) to reduce irritation.
- A 'pea-sized' amount is sufficient for the entire face; more does not mean faster results and increases irritation.
- Initial worsening of acne (purging) is common during the first 2-6 weeks as the skin adjusts and clogged pores are cleared.
- Consistent daily use is key for efficacy; results take time (weeks to months).
- Sun protection is paramount due to increased photosensitivity. Use broad-spectrum SPF 30+ daily.
- Use a gentle, non-comedogenic moisturizer to combat dryness and irritation.
- Avoid concomitant use of other harsh or irritating topical products unless specifically advised by a healthcare professional.
Alternative Therapies
- Adapalene (another topical retinoid, often better tolerated)
- Tazarotene (another topical retinoid)
- Benzoyl peroxide (for acne)
- Salicylic acid (for acne)
- Azelaic acid (for acne and rosacea)
- Topical antibiotics (e.g., clindamycin, erythromycin - for acne)
- Oral antibiotics (e.g., doxycycline, minocycline - for severe acne)
- Oral isotretinoin (for severe, recalcitrant acne)
- Chemical peels (for acne and photodamage)
- Laser therapy (for acne scars, photodamage)
- Alpha hydroxy acids (AHAs) / Beta hydroxy acids (BHAs) (for photodamage)
Cost & Coverage
Average Cost:
Varies widely, typically $30-$200+ per 20gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 for generic, Tier 3 or higher for brand-name formulations
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 your 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.