Tretinoin 0.025% Gel 15gm
It is used to treat pimples (acne).
Drug Class
Antiacne agent
Pharmacologic Class
Retinoid
Pregnancy Category
Not available
FDA Approved
Apr 1971
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tretinoin gel is a topical medication used to treat acne and sometimes to improve the appearance of skin affected by sun damage. It works by helping the skin renew itself more quickly and by unclogging pores. It's a type of vitamin A.
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 burning. If accidental contact occurs, rinse the affected area thoroughly with water.
Apply the medication at bedtime.
Before and after use, wash your hands thoroughly.
Gently wash the affected skin area with a mild, non-medicated soap and pat it dry. 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.
Important Safety Precautions
This medication is flammable, so avoid using it near open flames or while smoking.
Storage and Disposal
Store all products at room temperature, avoiding freezing.
Missed Dose Instructions
* If you miss a dose, skip it and resume your normal application schedule. Do not apply two doses at once or use 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.
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 burning. If accidental contact occurs, rinse the affected area thoroughly with water.
Apply the medication at bedtime.
Before and after use, wash your hands thoroughly.
Gently wash the affected skin area with a mild, non-medicated soap and pat it dry. 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.
Important Safety Precautions
This medication is flammable, so avoid using it near open flames or while smoking.
Storage and Disposal
Store all products at room temperature, avoiding freezing.
Missed Dose Instructions
* If you miss a dose, skip it and resume your normal application schedule. Do not apply two doses at once or use 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 once daily, preferably in the evening before bedtime, to clean, dry skin.
- Avoid contact with eyes, mouth, angles of the nose, and mucous membranes.
- Use a gentle, non-medicated cleanser and moisturizer. Avoid harsh soaps, astringents, or products containing alcohol.
- Sun protection is crucial: Tretinoin makes your skin more sensitive to the sun. Use a broad-spectrum sunscreen (SPF 30 or higher) daily, wear protective clothing, and avoid prolonged sun exposure, including tanning beds.
- Initial worsening of acne (purging) is common during the first few weeks of treatment; continue use as directed.
- Skin irritation (redness, dryness, peeling, stinging) is common, especially during the first few weeks. This usually subsides with continued use. If severe, contact your doctor.
- Do not use if pregnant or planning to become pregnant without consulting your doctor, despite minimal systemic absorption.
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 pea-sized amount to affected areas once daily at bedtime
Dose Range:
0.025 - 0.1 mg
Condition-Specific Dosing:
Acne Vulgaris:
Apply a thin layer of Tretinoin 0.025% Gel to the entire affected area of the face once daily in the evening, after washing and drying the skin. Avoid eyes, lips, and mucous membranes.
Fine Wrinkles/Hyperpigmentation (off-label):
Apply a thin layer of Tretinoin 0.025% Gel to the entire affected area once daily in the evening.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 12 years of age. For children 12 years and older, dosing is similar to adults.
Adolescent:
Apply a pea-sized amount to affected areas once daily at bedtime (similar to adult dosing).
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 retinoid that binds to specific retinoic acid receptors (RARs) and retinoid X receptors (RXRs) in the nucleus, which then modulate gene expression. In acne, it reduces the cohesiveness of follicular epithelial cells, leading to decreased formation of microcomedones. It also stimulates mitotic activity and increased turnover of follicular epithelial cells, causing extrusion of comedones. Additionally, it has anti-inflammatory properties and can reduce the number of P. acnes bacteria indirectly by reducing the follicular environment conducive to their growth. For photoaging, it influences collagen synthesis and degradation, and epidermal cell proliferation.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (approximately 1-5% of topical dose)
Tmax:
Not well-defined for topical application due to minimal systemic absorption; peak plasma concentrations are very low and variable.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not well-defined due to minimal systemic absorption
ProteinBinding:
Highly protein bound (>95%) if absorbed systemically
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not well-defined for topical application; systemic half-life of absorbed tretinoin is 0.5-2 hours.
Clearance:
Rapid hepatic clearance if absorbed systemically
ExcretionRoute:
Biliary and renal (as metabolites)
Unchanged:
Negligible
Pharmacodynamics
OnsetOfAction:
Several weeks (typically 2-3 weeks for initial improvement, 6-12 weeks for full effect in acne)
PeakEffect:
12-24 weeks for optimal results in acne; longer for photoaging.
DurationOfAction:
Effects persist as long as treatment is continued; relapse 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 go away
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people do not experience side effects or only have mild 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 sensation
- Change in skin color
- Skin reactions, including dry skin, redness, swelling, blisters, or peeling
If you experience any skin reactions, consult your doctor. They may recommend temporarily stopping the medication, adjusting the dosage, or changing the frequency of application.
Reporting Side Effects
This list does not include all possible 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.
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 go away
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people do not experience side effects or only have mild 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 sensation
- Change in skin color
- Skin reactions, including dry skin, redness, swelling, blisters, or peeling
If you experience any skin reactions, consult your doctor. They may recommend temporarily stopping the medication, adjusting the dosage, or changing the frequency of application.
Reporting Side Effects
This list does not include all possible 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 burning, stinging, or itching
- Excessive redness or swelling
- Blistering or crusting of the skin
- Allergic reaction (rash, hives, difficulty 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 many drugs can have this effect. If you are unsure, consult your doctor or pharmacist for guidance.
If you are pregnant, as this medication may have implications for your pregnancy.
Additionally, it is crucial to disclose all your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
* Vitamins
as well as any health problems you are experiencing. This information will help your doctor and pharmacist determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
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 many drugs can have this effect. If you are unsure, consult your doctor or pharmacist for guidance.
If you are pregnant, as this medication may have implications for your pregnancy.
Additionally, it is crucial to disclose all your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
* Vitamins
as well as any health problems you are experiencing. This information will help your doctor and pharmacist determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
Important Warnings and Cautions
Before taking this medication, inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug. If you have a fish allergy, consult your doctor, as some products contain fish protein.
Administration and Usage
It may take several weeks to experience the full effects of this medication. To minimize the risk of severe side effects, adhere to your doctor's instructions regarding dosage, frequency, and duration of use. Do not exceed the recommended dose, and do not use this medication more frequently or for a longer period than prescribed.
Skin Precautions
Avoid applying this medication to sunburned skin, cuts, scrapes, eczema, or damaged skin. Practice good skin care and limit sun exposure to prevent further irritation. You may be more susceptible to sunburn while using this medication, so take necessary precautions:
Avoid direct 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
Be aware that cold and windy weather conditions may irritate your skin; consult your doctor or pharmacist for guidance on protecting your skin
Additionally, avoid contact with lime peels, as they may cause irritation.
Interactions with Other Skin Products
Using other skin products while taking this medication may increase the risk of irritation. Consult your doctor before using any other drugs or products on your skin, including soaps. If you experience dry skin, you may use a moisturizer; however, consult your doctor or pharmacist to determine the best type of moisturizer to use. You may use makeup unless your doctor has advised against it; if you do use makeup, clean the treatment area before applying this medication.
Safety Precautions
If this medication is swallowed, call a doctor or poison control center immediately, as it may cause harm. If you are pregnant or plan to become pregnant, inform your doctor, as this medication may harm the unborn baby. If you are breastfeeding, consult your doctor to discuss any potential risks to your baby.
Before taking this medication, inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug. If you have a fish allergy, consult your doctor, as some products contain fish protein.
Administration and Usage
It may take several weeks to experience the full effects of this medication. To minimize the risk of severe side effects, adhere to your doctor's instructions regarding dosage, frequency, and duration of use. Do not exceed the recommended dose, and do not use this medication more frequently or for a longer period than prescribed.
Skin Precautions
Avoid applying this medication to sunburned skin, cuts, scrapes, eczema, or damaged skin. Practice good skin care and limit sun exposure to prevent further irritation. You may be more susceptible to sunburn while using this medication, so take necessary precautions:
Avoid direct 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
Be aware that cold and windy weather conditions may irritate your skin; consult your doctor or pharmacist for guidance on protecting your skin
Additionally, avoid contact with lime peels, as they may cause irritation.
Interactions with Other Skin Products
Using other skin products while taking this medication may increase the risk of irritation. Consult your doctor before using any other drugs or products on your skin, including soaps. If you experience dry skin, you may use a moisturizer; however, consult your doctor or pharmacist to determine the best type of moisturizer to use. You may use makeup unless your doctor has advised against it; if you do use makeup, clean the treatment area before applying this medication.
Safety Precautions
If this medication is swallowed, call a doctor or poison control center immediately, as it may cause harm. If you are pregnant or plan to become pregnant, inform your doctor, as this medication may harm the unborn baby. If you are breastfeeding, consult your doctor to discuss any potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Excessive redness
- Severe peeling
- Discomfort
What to Do:
Topical overdose is unlikely to cause systemic toxicity. Discontinue use and apply a moisturizer. If accidental ingestion occurs, contact a poison control center (1-800-222-1222) or seek emergency medical attention. Symptoms of systemic overdose (from oral retinoids) include headache, nausea, vomiting, and dizziness.
Drug Interactions
Moderate Interactions
- Topical products containing sulfur, resorcinol, salicylic acid, or benzoyl peroxide (may cause excessive irritation)
- Astringents, abrasive soaps, cleansers, or medicated soaps/cleansers
- Products with high concentrations of alcohol, spices, or lime
- Other topical medications with a strong drying effect
- Photosensitizing agents (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) - increased risk of sunburn
Monitoring
Baseline Monitoring
Skin condition assessment (e.g., severity of acne, presence of irritation)
Rationale: To establish baseline for evaluating treatment response and adverse effects.
Timing: Prior to initiation of therapy
Routine Monitoring
Skin irritation (erythema, scaling, dryness, burning, stinging)
Frequency: Daily, especially during initial weeks of therapy
Target: Mild to moderate irritation is common and expected; severe irritation warrants dose adjustment or temporary discontinuation.
Action Threshold: Severe or persistent irritation; consider reducing frequency of application or temporarily stopping.
Therapeutic response (reduction in lesions, improvement in skin texture)
Frequency: Monthly or every 2-3 months
Target: Gradual improvement over 6-12 weeks
Action Threshold: No improvement after 12 weeks, or worsening of condition.
Symptom Monitoring
- Excessive redness
- Severe peeling
- Intense burning or stinging
- Swelling
- Blistering
- Crusting
- Unusual dryness or itching
Special Patient Groups
Pregnancy
Tretinoin is a retinoid. While systemic absorption from topical application is minimal, there have been rare reports of birth defects associated with topical use. Therefore, it is generally advised to avoid use during pregnancy. If a patient becomes pregnant while using tretinoin, discontinue immediately and consult a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though risk from topical is considered low, it's generally avoided.
Second Trimester:
Risk considered low, but still generally avoided.
Third Trimester:
Risk considered low, but still generally avoided.
Lactation
Minimal systemic absorption is expected with topical application. It is unlikely to cause adverse effects in a breastfed infant. However, caution is advised. Avoid applying to areas where the infant may come into direct contact with the medication (e.g., chest).
Infant Risk:
Low risk
Pediatric Use
Safety and effectiveness in pediatric patients under 12 years of age have not been established. Use in adolescents (12 years and older) is similar to adults.
Geriatric Use
No specific dosage adjustments are required for geriatric patients. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, older patients may have more fragile skin and may be more susceptible to irritation.
Clinical Information
Clinical Pearls
- Patients should be advised that a 'purging' phase (initial worsening of acne) is common during the first few weeks of treatment and is usually temporary.
- Emphasize the critical importance of consistent daily sunscreen use (SPF 30+) and sun avoidance due to increased photosensitivity.
- Start with the lowest concentration (0.025% gel) and gradually increase strength or frequency if tolerated and needed.
- Advise patients to apply to 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 improve efficacy but will increase irritation.
- Tretinoin is inactivated by benzoyl peroxide; if both are used, apply tretinoin at night and benzoyl peroxide in the morning, or use a different retinoid (e.g., adapalene) that is stable with benzoyl peroxide.
Alternative Therapies
- Adapalene (Differin) - another topical retinoid, often better tolerated and more photostable.
- Tazarotene (Tazorac) - another topical retinoid, generally more potent and potentially more irritating.
- Benzoyl peroxide (topical)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Azelaic acid (topical)
- Salicylic acid (topical)
- Oral antibiotics (e.g., doxycycline, minocycline) for moderate to severe acne
- Oral isotretinoin (for severe, recalcitrant acne)
- Hormonal therapies (e.g., oral contraceptives, spironolactone) for hormonal acne
Cost & Coverage
Average Cost:
$50 - $150 per 15gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization for brand, generic usually covered)
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 details. 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 information about what was taken, the amount, and the time it occurred.