Tretinoin 0.025% Cream 20gm
It is used to treat pimples (acne).
Drug Class
Anti-acne agent; Anti-wrinkle agent
Pharmacologic Class
Retinoid
Pregnancy Category
Category C
FDA Approved
May 1971
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tretinoin is a topical medication, a form of Vitamin A, used to treat acne and reduce the appearance of fine wrinkles and dark spots. It works by helping your skin renew itself more quickly and by unclogging pores.
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 the missed one.
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 the missed one.
Lifestyle & Tips
- Apply only a pea-sized amount to the entire affected area, not just individual spots.
- Apply to clean, dry skin, usually at bedtime.
- Avoid contact with eyes, mouth, angles of the nose, and mucous membranes.
- Use a gentle, non-comedogenic moisturizer daily to help with dryness and irritation.
- Strictly avoid sun exposure, including tanning beds. Use a broad-spectrum sunscreen (SPF 30 or higher) daily and wear protective clothing, as tretinoin increases sun sensitivity.
- Do not use if pregnant or planning to become pregnant without consulting your doctor.
- Be patient; it can take weeks to months to see results, and skin may initially worsen before improving (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 to affected areas once daily at bedtime
Condition-Specific Dosing:
Acne Vulgaris:
Apply a thin layer to affected areas once daily at bedtime. Initial frequency may be every other night if irritation occurs, gradually increasing to nightly as tolerated.
Fine Wrinkles/Hyperpigmentation:
Apply a thin layer to affected areas 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)
Adolescent:
Apply a thin layer to affected areas once daily at bedtime (typically for ages 12 and older for acne)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed (minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Tretinoin is a metabolite of Vitamin A that binds to specific retinoic acid receptors (RARs) located in the nucleus, primarily RAR-alpha, RAR-beta, and RAR-gamma. This binding modulates gene expression, leading to altered cellular differentiation, proliferation, and keratinization. In acne, it reduces follicular occlusion by decreasing cohesion of follicular epithelial cells and stimulating mitotic activity, leading to extrusion of comedones. It also suppresses sebaceous gland activity and has anti-inflammatory effects. For photoaging, it promotes collagen synthesis, reduces epidermal melanin, and improves skin texture.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (approximately 1-2% of topically applied dose)
Tmax:
Not applicable for topical systemic effects; local effects are gradual
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable (minimal systemic distribution)
ProteinBinding:
Highly protein bound if systemically absorbed (primarily to albumin)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not applicable (minimal systemic absorption); if absorbed, plasma half-life is approximately 0.7 hours
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
If systemically absorbed, primarily renal and biliary excretion
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
2-3 weeks for initial improvement; full therapeutic effect may take 6-12 weeks for acne, and several months for photoaging
PeakEffect:
12-24 weeks for acne; 6-12 months for photoaging
DurationOfAction:
Effects persist as long as treatment is continued; relapse may occur upon discontinuation
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 medical attention right away if you experience any of the following symptoms, which may indicate a serious side effect:
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
A severe skin reaction that bothers you or does not go away
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 about side effects, contact your doctor for medical advice. 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 medical attention right away if you experience any of the following symptoms, which may indicate a serious side effect:
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
A severe skin reaction that bothers you or does not go away
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 about side effects, contact your doctor for medical 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 redness, burning, stinging, or peeling that is intolerable or does not improve with reduced frequency.
- Swelling or blistering of the skin.
- Allergic reaction symptoms (rash, itching/swelling, severe dizziness, trouble breathing).
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 have this effect. If you are unsure, consult your doctor or pharmacist for guidance.
Additionally, if you are pregnant, notify your doctor.
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, verify that it is acceptable to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage 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.
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 have this effect. If you are unsure, consult your doctor or pharmacist for guidance.
Additionally, if you are pregnant, notify your doctor.
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, verify that it is acceptable to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
Important Information About Your Medication
Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. It may take several weeks to experience the full effects of this drug.
Using Your Medication Safely
Follow your doctor's instructions carefully and do not exceed the recommended dosage or frequency of application. Using more than prescribed or for a longer period than recommended may increase the risk of severe side effects.
Skin Precautions
Avoid applying this medication to sunburned skin, cuts, scrapes, eczema, or damaged skin. Practice good skin care and protect your skin from the sun, as you may be more susceptible to sunburn. To minimize this risk:
Avoid exposure to 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
Be aware that cold and windy weather conditions may irritate your skin; consult your doctor or pharmacist for guidance on protecting your skin in these conditions
Interactions with Other Products
Avoid contact with lime peels, as they may interact with this medication. Be cautious when using other skin products, as they may increase the risk of irritation. Consult your doctor before using any other medications or products on your skin, including soaps.
Managing Dry Skin and Using Cosmetics
If this medication causes dry skin, you may use a moisturizer. Consult your doctor or pharmacist to determine the best type of moisturizer to use. You can use makeup unless your doctor has advised against it. If you plan to use makeup, clean the treatment area before applying this medication.
Safety Precautions
If you accidentally swallow this medication, call a doctor or 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 your doctor to discuss any potential risks to your baby.
Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. It may take several weeks to experience the full effects of this drug.
Using Your Medication Safely
Follow your doctor's instructions carefully and do not exceed the recommended dosage or frequency of application. Using more than prescribed or for a longer period than recommended may increase the risk of severe side effects.
Skin Precautions
Avoid applying this medication to sunburned skin, cuts, scrapes, eczema, or damaged skin. Practice good skin care and protect your skin from the sun, as you may be more susceptible to sunburn. To minimize this risk:
Avoid exposure to 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
Be aware that cold and windy weather conditions may irritate your skin; consult your doctor or pharmacist for guidance on protecting your skin in these conditions
Interactions with Other Products
Avoid contact with lime peels, as they may interact with this medication. Be cautious when using other skin products, as they may increase the risk of irritation. Consult your doctor before using any other medications or products on your skin, including soaps.
Managing Dry Skin and Using Cosmetics
If this medication causes dry skin, you may use a moisturizer. Consult your doctor or pharmacist to determine the best type of moisturizer to use. You can use makeup unless your doctor has advised against it. If you plan to use makeup, clean the treatment area before applying this medication.
Safety Precautions
If you accidentally swallow this medication, call a doctor or 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 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 severe local irritation (redness, peeling, discomfort).
What to Do:
If excessive topical application occurs, wash the area with mild soap and water. If accidental ingestion occurs, contact a poison control center immediately (Call 1-800-222-1222). Management is supportive.
Drug Interactions
Moderate Interactions
- Topical products containing sulfur, resorcinol, salicylic acid, or benzoyl peroxide (may cause excessive irritation; use with caution or at different times of day)
- Astringents, medicated soaps/cleansers, abrasive soaps/cleansers, strong drying agents, products with high alcohol content (may cause excessive irritation)
- Products containing alpha hydroxy acids (AHAs) or beta hydroxy acids (BHAs) (increased irritation)
Minor Interactions
- Photosensitizing agents (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines) - theoretical increased risk of photosensitivity, though minimal for topical tretinoin.
Monitoring
Baseline Monitoring
Skin assessment (type, sensitivity, existing lesions)
Rationale: To establish baseline skin condition and identify potential contraindications or areas of increased sensitivity.
Timing: Prior to initiation of therapy
Patient education on proper application and expected side effects
Rationale: To ensure patient compliance and manage expectations regarding initial irritation and delayed onset of action.
Timing: Prior to initiation of therapy
Routine Monitoring
Skin irritation (redness, peeling, dryness, burning, stinging)
Frequency: Daily, especially during the first few weeks of therapy
Target: Mild to moderate irritation is expected; severe irritation should prompt dose adjustment or temporary discontinuation.
Action Threshold: Severe or persistent irritation: reduce frequency of application, use lower concentration, or temporarily discontinue. Consult healthcare provider.
Therapeutic response (reduction in lesions, improvement in skin texture)
Frequency: Monthly or every 2-3 months
Target: Gradual improvement over weeks to months.
Action Threshold: No improvement after 12 weeks for acne or 6-12 months for photoaging: re-evaluate diagnosis or treatment plan.
Symptom Monitoring
- Skin redness (erythema)
- Skin peeling (desquamation)
- Dryness
- Burning sensation
- Stinging sensation
- Itching
- Photosensitivity (sunburn)
Special Patient Groups
Pregnancy
Category C. While systemic absorption is minimal with topical application, oral retinoids are highly teratogenic. Tretinoin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Women of childbearing potential should be advised to use effective contraception during treatment.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though risk with topical application is considered low due to minimal systemic absorption. Avoid if possible.
Second Trimester:
Risk considered low due to minimal systemic absorption, but caution advised.
Third Trimester:
Risk considered low due to minimal systemic absorption, but caution advised.
Lactation
L3 (Moderately Safe). It is not known whether tretinoin is excreted in human milk following topical application. Due to minimal systemic absorption, significant transfer to breast milk is unlikely. However, caution should be exercised, and the drug should not be applied to the breast area to prevent infant exposure.
Infant Risk:
Low risk of adverse effects to the infant due to minimal systemic absorption, but direct contact with the infant's skin should be avoided.
Pediatric Use
Safety and effectiveness in pediatric patients under the age of 12 years have not been established. Use in adolescents (12 years and older) for acne is common, with similar considerations as adults.
Geriatric Use
No specific dosage adjustments are required. Elderly patients may have more fragile or sensitive skin and may experience increased irritation. Use with caution and monitor for skin reactions.
Clinical Information
Clinical Pearls
- Start with a lower concentration (e.g., 0.025%) and/or less frequent application (e.g., every other night) to minimize irritation, especially for sensitive skin.
- The 'purging' phase (initial worsening of acne) is common and usually resolves within the first few weeks of treatment. Patient education is crucial to ensure adherence during this period.
- Always apply to completely dry skin (wait 20-30 minutes after washing face) to reduce irritation.
- A pea-sized amount is sufficient for the entire face. More is not better and will only increase irritation.
- Consistent use of a broad-spectrum sunscreen (SPF 30+) daily is non-negotiable due to increased photosensitivity.
- Combine with a gentle, non-comedogenic moisturizer to combat dryness and peeling.
- Avoid waxing on treated areas as skin may be more fragile and prone to tearing.
Alternative Therapies
- Other topical retinoids (e.g., Adapalene, Tazarotene)
- Topical antibiotics (e.g., Clindamycin, Erythromycin)
- Topical benzoyl peroxide
- Topical azelaic acid
- Oral antibiotics (for moderate to severe acne)
- Oral isotretinoin (for severe, recalcitrant acne)
- Chemical peels, laser therapy (for photoaging)
Cost & Coverage
Average Cost:
$50 - $150 per 20gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic); Tier 3 or Non-Formulary (brand)
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.