Tretinoin 0.05% Cream 20gm
It is used to treat pimples (acne).
Drug Class
Anti-acne agent; Antipsoriatic
Pharmacologic Class
Retinoid
Pregnancy Category
Category C
FDA Approved
Apr 1971
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tretinoin is a medication derived from vitamin A that helps your skin renew itself more quickly. It's commonly used to treat acne by helping to unclog pores and reduce inflammation, and also to improve the appearance of fine wrinkles and rough skin caused by sun damage.
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 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 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 two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Apply to clean, dry skin, usually 20-30 minutes after washing your face.
- Use only a pea-sized amount for the entire face.
- Apply at bedtime, as sunlight can reduce its effectiveness and increase irritation.
- Strictly avoid sun exposure and use a broad-spectrum sunscreen (SPF 30 or higher) daily, even on cloudy days, as tretinoin increases sun sensitivity.
- Wear protective clothing and hats when outdoors.
- Avoid using harsh or abrasive skin products, strong soaps, astringents, or products containing alcohol, menthol, or lime, as these can increase irritation.
- Moisturize regularly to combat dryness, but apply moisturizer at a different time of day than tretinoin (e.g., in the morning).
- Be patient; it can take 6-12 weeks to see significant improvement, and skin may initially worsen (purging).
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 of Tretinoin 0.05% Cream to the affected areas once daily at bedtime, after washing and drying the skin.
Condition-Specific Dosing:
acne_vulgaris:
Apply once daily at bedtime.
photodamage:
Apply once daily at bedtime.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (safety and efficacy not established in children under 12 years of age)
Adolescent:
Apply a thin layer once daily at bedtime for acne vulgaris (typically 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 retinoid that acts by modifying abnormal follicular keratinization, reducing the cohesiveness of follicular epithelial cells, and increasing epithelial cell turnover. This leads to the extrusion of comedones and inhibition of new comedone formation. It also has anti-inflammatory effects and promotes dermal collagen synthesis, which contributes to its efficacy in photodamage.
Pharmacokinetics
Absorption:
Bioavailability:
<5% (systemic absorption after topical application)
Tmax:
Not well-defined for systemic levels after topical application; local effects are primary.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not clinically relevant for topical application.
ProteinBinding:
Highly protein bound (>95%) if systemically absorbed, but systemic absorption is minimal.
CnssPenetration:
Limited/Not clinically relevant for topical application.
Elimination:
HalfLife:
Not clinically relevant for topical application due to minimal systemic absorption.
Clearance:
Not clinically relevant for topical application.
ExcretionRoute:
Biliary and renal (for systemically absorbed drug).
Unchanged:
Not clinically relevant for topical application.
Pharmacodynamics
OnsetOfAction:
Initial improvement may be seen in 2-3 weeks; significant improvement typically takes 6-12 weeks.
PeakEffect:
6-12 weeks for acne; several months for photodamage.
DurationOfAction:
Effects are sustained with continued use; regression occurs upon discontinuation.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice 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.
- A severe skin reaction that bothers you or does not resolve on its own.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people experience none or only mild symptoms. If any of the following side effects or any other symptoms bother you or persist, consult your doctor or seek medical help:
- A feeling of warmth
- Burning or stinging sensations
- Changes in skin color
- Skin reactions, including dry skin, redness, swelling, blisters, and peeling
If you experience any skin reactions, discuss them with 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. If you have questions or concerns about side effects, contact your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice 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.
- A severe skin reaction that bothers you or does not resolve on its own.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people experience none or only mild symptoms. If any of the following side effects or any other symptoms bother you or persist, consult your doctor or seek medical help:
- A feeling of warmth
- Burning or stinging sensations
- Changes in skin color
- Skin reactions, including dry skin, redness, swelling, blisters, and peeling
If you experience any skin reactions, discuss them with 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. If you have questions or concerns about side effects, contact your doctor for advice. 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 symptoms (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.
Medications that may increase your skin's sensitivity to light, as several drugs can cause this interaction. If you are unsure, consult your doctor or pharmacist for guidance.
Pregnancy, as this medication may have implications for your condition.
This is not an exhaustive list of all potential interactions with this medication. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss your health problems with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other treatments.
* Never start, stop, or modify the dosage of any medication without first consulting your doctor to avoid potential interactions or adverse effects.
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.
Medications that may increase your skin's sensitivity to light, as several drugs can cause this interaction. If you are unsure, consult your doctor or pharmacist for guidance.
Pregnancy, as this medication may have implications for your condition.
This is not an exhaustive list of all potential interactions with this medication. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss your health problems with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other treatments.
* Never start, stop, or modify the dosage of any medication without first consulting your doctor to avoid potential interactions or adverse effects.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Please note that it may take several weeks to experience the full effects of this drug.
To minimize the risk of severe side effects, it is crucial to follow your doctor's instructions carefully. Do not exceed the recommended dosage, and do not use this medication more frequently or for a longer period than prescribed. Adhering to your doctor's instructions will help reduce the chance of adverse reactions.
When applying this medication, avoid using it on sunburned skin, cuts, scrapes, eczema, or damaged skin, as this may exacerbate skin irritation. To maintain healthy skin and minimize the risk of further irritation, practice good skin care habits and limit your exposure to the sun. You may be more susceptible to sunburn while using this medication, so it is essential to take precautions. Avoid direct sunlight, sunlamps, and tanning beds, and use a broad-spectrum sunscreen with a Sun Protection Factor (SPF) of 15 or higher when outdoors. Additionally, wear protective clothing and eyewear to shield your skin from the sun. Certain weather conditions, such as cold and wind, may also irritate your skin; consult your doctor or pharmacist for guidance on how to protect your skin in these situations.
Be aware that contact with lime peels may cause adverse reactions, so it is best to avoid them while using this medication. Using other skin products in conjunction with this medication may increase the risk of irritation, so it is essential to discuss this with your doctor before using any other skin products, including soaps. If you experience dry skin as a result of using this medication, you may use a moisturizer; however, consult your doctor or pharmacist to determine the most suitable type of moisturizer for your skin.
You may use makeup while taking this medication, unless your doctor has advised against it. If you do use makeup, ensure that you clean the area to be treated before applying this medication.
In the event that this medication is swallowed, it may cause harm, so it is crucial to seek medical attention immediately. If you suspect that you or someone else has ingested this medication, contact a doctor or a poison control center right away.
If you are pregnant or plan to become pregnant while taking this medication, it is essential to inform your doctor, as this medication may harm the unborn baby. If you suspect that you may be pregnant, contact your doctor promptly.
If you are breastfeeding, inform your doctor, as you will need to discuss any potential risks to your baby. Your doctor will help you weigh the benefits and risks of using this medication while breastfeeding.
To minimize the risk of severe side effects, it is crucial to follow your doctor's instructions carefully. Do not exceed the recommended dosage, and do not use this medication more frequently or for a longer period than prescribed. Adhering to your doctor's instructions will help reduce the chance of adverse reactions.
When applying this medication, avoid using it on sunburned skin, cuts, scrapes, eczema, or damaged skin, as this may exacerbate skin irritation. To maintain healthy skin and minimize the risk of further irritation, practice good skin care habits and limit your exposure to the sun. You may be more susceptible to sunburn while using this medication, so it is essential to take precautions. Avoid direct sunlight, sunlamps, and tanning beds, and use a broad-spectrum sunscreen with a Sun Protection Factor (SPF) of 15 or higher when outdoors. Additionally, wear protective clothing and eyewear to shield your skin from the sun. Certain weather conditions, such as cold and wind, may also irritate your skin; consult your doctor or pharmacist for guidance on how to protect your skin in these situations.
Be aware that contact with lime peels may cause adverse reactions, so it is best to avoid them while using this medication. Using other skin products in conjunction with this medication may increase the risk of irritation, so it is essential to discuss this with your doctor before using any other skin products, including soaps. If you experience dry skin as a result of using this medication, you may use a moisturizer; however, consult your doctor or pharmacist to determine the most suitable type of moisturizer for your skin.
You may use makeup while taking this medication, unless your doctor has advised against it. If you do use makeup, ensure that you clean the area to be treated before applying this medication.
In the event that this medication is swallowed, it may cause harm, so it is crucial to seek medical attention immediately. If you suspect that you or someone else has ingested this medication, contact a doctor or a poison control center right away.
If you are pregnant or plan to become pregnant while taking this medication, it is essential to inform your doctor, as this medication may harm the unborn baby. If you suspect that you may be pregnant, contact your doctor promptly.
If you are breastfeeding, inform your doctor, as you will need to discuss any potential risks to your baby. Your doctor will help you weigh the benefits and risks of using this medication while breastfeeding.
Overdose Information
Overdose Symptoms:
- Topical overdose is unlikely to cause systemic toxicity due to minimal absorption.
- Excessive application may lead to severe local irritation, redness, peeling, and discomfort.
What to Do:
If excessive application occurs, wash the area with mild soap and water. Discontinue use temporarily until irritation subsides. If severe irritation persists, consult a healthcare professional. For accidental ingestion, call a poison control center (1-800-222-1222) or seek medical attention.
Drug Interactions
Moderate Interactions
- Topical products containing sulfur, resorcinol, or salicylic acid (may cause excessive irritation if used concurrently or immediately after tretinoin).
- Astringents, abrasive soaps, cleansers, or cosmetics with a strong drying effect (may exacerbate irritation).
- Products containing alcohol, spices, or lime (may cause stinging or burning).
Minor Interactions
- Photosensitizing agents (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines) - may increase risk of sunburn.
Monitoring
Baseline Monitoring
Skin assessment (type, sensitivity, existing lesions, photodamage)
Rationale: To establish baseline skin condition and identify potential contraindications or areas of increased sensitivity.
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin irritation (erythema, scaling, dryness, burning, stinging)
Frequency: Daily during initial weeks, then as needed.
Target: Mild to moderate irritation is expected; severe irritation requires 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, improvement in skin texture/pigmentation)
Frequency: Monthly for first 3-6 months, then periodically.
Target: Gradual improvement over weeks to months.
Action Threshold: If no improvement after 12 weeks, re-evaluate diagnosis or treatment plan.
Symptom Monitoring
- Excessive redness
- Severe dryness or peeling
- Burning or stinging sensation
- Itching
- Blistering
- Crusting
- Swelling
Special Patient Groups
Pregnancy
Tretinoin is Pregnancy Category C. While systemic absorption from topical application is minimal, oral retinoids are highly teratogenic. Due to the potential for absorption and the known risks of retinoids, topical tretinoin is generally advised to be avoided during pregnancy or used with extreme caution only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential risk of teratogenicity, though systemic absorption is minimal. Avoid if possible.
Second Trimester:
Potential risk, though less critical than first trimester. Avoid if possible.
Third Trimester:
Potential risk. Avoid if possible.
Lactation
Use with caution. It is not known whether topical tretinoin is excreted in human milk. Due to minimal systemic absorption, infant exposure is expected to be very low. However, avoid applying to areas that may come into direct contact with the infant during breastfeeding.
Infant Risk:
Low risk, but caution advised. Monitor infant for any adverse effects.
Pediatric Use
Safety and efficacy have not been established in children under 12 years of age. Use in adolescents (12 years and older) for acne vulgaris is common, but generally with lower concentrations initially.
Geriatric Use
No specific dose adjustments are necessary. However, older patients may have more sensitive or fragile skin and may experience increased irritation. Use with caution and monitor for adverse skin reactions.
Clinical Information
Clinical Pearls
- The 'retinization' period (initial irritation, redness, peeling) is common and usually subsides within 2-4 weeks as the skin adapts. Starting with a lower concentration and gradually increasing frequency can help mitigate this.
- Apply to completely dry skin (20-30 minutes after washing) to minimize irritation.
- A 'purging' phase, where acne may temporarily worsen, is common during the first few weeks of treatment as tretinoin brings underlying lesions to the surface.
- Consistent and rigorous sun protection (sunscreen SPF 30+, protective clothing) is paramount due to increased photosensitivity.
- Tretinoin is inactivated by benzoyl peroxide; if both are used, apply tretinoin at night and benzoyl peroxide in the morning, or use a combination product designed for co-administration.
- Results for acne typically take 6-12 weeks; for photodamage, it can take several months to a year for optimal results.
Alternative Therapies
- Adapalene (Differin) - another retinoid, often better tolerated.
- Tazarotene (Tazorac) - another retinoid, generally stronger.
- Benzoyl Peroxide (topical)
- Salicylic Acid (topical)
- Azelaic Acid (topical)
- Topical Antibiotics (e.g., Clindamycin, Erythromycin)
- Oral Antibiotics (e.g., Doxycycline, Minocycline)
- Oral Isotretinoin (for severe, recalcitrant acne)
- Chemical peels
- Laser therapy
Cost & Coverage
Average Cost:
$50 - $200+ per 20gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (varies by insurance plan)
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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.