Tretinoin 0.025% Gel 45gm
It is used to treat pimples (acne).
Drug Class
Antiacne agent; Antipsoriatic agent
Pharmacologic Class
Retinoid; Keratolytic
Pregnancy Category
Category C (historical, now risk-based labeling)
FDA Approved
Apr 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 improve the appearance of sun-damaged skin. It works by helping skin cells turn over more quickly and reducing inflammation.
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 ingest it, as it is for topical use only.
Avoid getting this medication in your mouth, nose, or eyes, as it may cause irritation or burning. If accidental contact occurs, rinse the affected area thoroughly with water.
Apply the medication at bedtime, following proper preparation of the skin.
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 the affected area before applying the medication. Consult with your pharmacist for specific guidance on using this medication.
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 temperatures.
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 the 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 ingest it, as it is for topical use only.
Avoid getting this medication in your mouth, nose, or eyes, as it may cause irritation or burning. If accidental contact occurs, rinse the affected area thoroughly with water.
Apply the medication at bedtime, following proper preparation of the skin.
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 the affected area before applying the medication. Consult with your pharmacist for specific guidance on using this medication.
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 temperatures.
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 the missed dose.
Lifestyle & Tips
- Apply only a pea-sized amount to clean, dry skin, usually at bedtime.
- Avoid applying to eyes, mouth, angles of the nose, or mucous membranes.
- Use a gentle, non-medicated cleanser and moisturizer daily.
- Strictly avoid sun exposure, including tanning beds. Use a broad-spectrum sunscreen (SPF 30 or higher) daily, even on cloudy days, and wear protective clothing (hats, long sleeves).
- Expect some initial skin irritation (redness, dryness, peeling) during the first few weeks; this usually subsides.
- Do not use other irritating topical products (e.g., those with benzoyl peroxide, salicylic acid, or harsh soaps) unless directed by your doctor.
- Results take time; typically 6-12 weeks for noticeable improvement.
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, usually at bedtime.
Condition-Specific Dosing:
acne vulgaris:
Apply a thin layer to the entire affected area (not just individual lesions) once daily at bedtime.
photodamage:
Apply a thin layer to the entire affected area once daily at bedtime.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 12 years of age.
Adolescent:
For adolescents 12 years and older, apply a pea-sized amount to affected areas once daily, usually at bedtime.
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 adjustment needed (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).
Confidence:
High
Pharmacology
Mechanism of Action
Tretinoin is a metabolite of Vitamin A that binds to specific retinoic acid receptors (RARs) and retinoid X receptors (RXRs) in the nucleus, which regulate gene expression. In acne, it reduces the cohesiveness of follicular epithelial cells, leading to decreased microcomedone formation. It also stimulates mitotic activity and increased turnover of follicular epithelial cells, causing extrusion of comedones. In photodamaged skin, it affects cellular differentiation and proliferation, promoting epidermal hyperplasia, compaction of the stratum corneum, and increased collagen synthesis in the dermis.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 1-5% (topical application)
Tmax:
Not well-defined for topical, systemic levels 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, systemic half-life is short (0.5-2 hours) if absorbed.
Clearance:
Not well-defined for topical.
ExcretionRoute:
Biliary and renal (if absorbed systemically).
Unchanged:
Not significant for topical application.
Pharmacodynamics
OnsetOfAction:
Weeks to months (typically 2-3 weeks for initial improvement, 6-12 weeks for full effect in acne).
PeakEffect:
12-24 weeks for optimal results.
DurationOfAction:
Effects persist as long as treatment is continued; relapse occurs upon discontinuation.
Confidence:
High
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek medical attention, as they may be signs of a severe and potentially life-threatening 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, 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. 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, including dry skin, redness, swelling, blisters, and peeling
If you develop any skin reactions, consult your doctor. They may advise you to temporarily stop using the drug, adjust the dosage, or change 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, consult your doctor. For medical advice about side effects, 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.
If you experience any of the following symptoms, call your doctor immediately or seek medical attention, as they may be signs of a severe and potentially life-threatening 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, 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. 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, including dry skin, redness, swelling, blisters, and peeling
If you develop any skin reactions, consult your doctor. They may advise you to temporarily stop using the drug, adjust the dosage, or change 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, consult your doctor. For medical advice about side effects, 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 symptoms (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.
If you have a sunburn, skin sensitivity to light, or any other skin conditions.
If you are taking any medications that may increase your skin's sensitivity to light. There are numerous drugs that can cause this interaction, so consult your doctor or pharmacist if you are unsure.
If you are pregnant or planning to become pregnant.
This is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to discuss all of your:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Health problems
with your doctor and pharmacist. They will help determine whether it is safe 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.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have a sunburn, skin sensitivity to light, or any other skin conditions.
If you are taking any medications that may increase your skin's sensitivity to light. There are numerous drugs that can cause this interaction, so consult your doctor or pharmacist if you are unsure.
If you are pregnant or planning to become pregnant.
This is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to discuss all of your:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Health problems
with your doctor and pharmacist. They will help determine whether it is safe 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.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you have a fish allergy, consult your doctor before using this product, as some formulations may contain fish protein.
You may not notice the full effects of this medication for several weeks. To minimize the risk of severe side effects, it is crucial to follow your doctor's instructions regarding dosage and usage. Do not exceed the recommended dose, and do not use the medication more frequently or for a longer duration than prescribed.
Avoid applying this medication to sunburned skin, cuts, scrapes, eczema, or damaged skin. Instead, practice good skin care and protect your skin from the sun. You may be more susceptible to sunburn while using this medication, so take precautions to avoid sun exposure, sunlamps, and tanning beds. When outdoors, use sunscreen and lip balm with a Sun Protection Factor (SPF) of 15 or higher, and wear protective clothing and eyewear.
Certain weather conditions, such as cold and wind, may irritate your skin. Consult your doctor or pharmacist for guidance on protecting your skin in these conditions. Additionally, avoid contact with lime peels, as they may cause irritation.
Using other skin products in conjunction with this medication may increase the risk of irritation. Before using any other skin products, including soaps, consult your doctor to ensure safe use. If this medication causes dry skin, you may use a moisturizer, but be sure to discuss the suitable type with your doctor or pharmacist. You can use makeup unless your doctor has advised against it; however, clean the treatment area before applying the medication.
In case of accidental ingestion, this medication can be harmful. If you swallow this medication, immediately contact a doctor or poison control center. Furthermore, 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.
You may not notice the full effects of this medication for several weeks. To minimize the risk of severe side effects, it is crucial to follow your doctor's instructions regarding dosage and usage. Do not exceed the recommended dose, and do not use the medication more frequently or for a longer duration than prescribed.
Avoid applying this medication to sunburned skin, cuts, scrapes, eczema, or damaged skin. Instead, practice good skin care and protect your skin from the sun. You may be more susceptible to sunburn while using this medication, so take precautions to avoid sun exposure, sunlamps, and tanning beds. When outdoors, use sunscreen and lip balm with a Sun Protection Factor (SPF) of 15 or higher, and wear protective clothing and eyewear.
Certain weather conditions, such as cold and wind, may irritate your skin. Consult your doctor or pharmacist for guidance on protecting your skin in these conditions. Additionally, avoid contact with lime peels, as they may cause irritation.
Using other skin products in conjunction with this medication may increase the risk of irritation. Before using any other skin products, including soaps, consult your doctor to ensure safe use. If this medication causes dry skin, you may use a moisturizer, but be sure to discuss the suitable type with your doctor or pharmacist. You can use makeup unless your doctor has advised against it; however, clean the treatment area before applying the medication.
In case of accidental ingestion, this medication can be harmful. If you swallow this medication, immediately contact a doctor or poison control center. Furthermore, 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:
- 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 thoroughly with water. For systemic overdose (extremely rare with topical use), management is supportive. Call 1-800-222-1222 (Poison Control Center) for advice if accidental ingestion or significant systemic exposure is suspected.
Drug Interactions
Moderate Interactions
- Topical products containing sulfur, resorcinol, or salicylic acid (may increase irritation).
- Astringents, medicated cleansers, abrasive soaps, or drying agents (may increase irritation).
- Products containing alcohol, spices, or lime (may increase irritation).
Minor Interactions
- Photosensitizing agents (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines) - theoretical increased risk of photosensitivity.
Monitoring
Baseline Monitoring
Skin condition assessment (e.g., acne severity, photodamage)
Rationale: To establish baseline and monitor treatment efficacy and adverse effects.
Timing: Prior to initiation of therapy.
Patient education on proper application and potential side effects
Rationale: To ensure adherence and manage expectations regarding irritation and photosensitivity.
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin irritation (redness, peeling, dryness, burning, stinging)
Frequency: Weekly for first few weeks, then as needed.
Target: Minimal to mild irritation, tolerable.
Action Threshold: Severe or persistent irritation; consider reducing frequency or temporarily discontinuing.
Acne lesion count/photodamage improvement
Frequency: Monthly or every 2-3 months.
Target: Gradual reduction in lesions/improvement in skin texture.
Action Threshold: No improvement after 12 weeks, or worsening of condition.
Sun exposure habits and use of sunscreen
Frequency: At each follow-up visit.
Target: Consistent use of broad-spectrum sunscreen (SPF 30+) and protective clothing.
Action Threshold: Lack of adherence to sun protection recommendations.
Symptom Monitoring
- Excessive dryness
- Peeling
- Redness
- Burning
- Stinging
- Itching
- Photosensitivity (sunburn)
Special Patient Groups
Pregnancy
Use is generally not recommended during pregnancy due to theoretical risk of teratogenicity, although systemic absorption from topical application is minimal. The FDA has moved away from letter categories, but historically it was Category C. Oral retinoids are highly teratogenic.
Trimester-Specific Risks:
First Trimester:
Theoretical risk of teratogenicity, especially during organogenesis. Avoid use.
Second Trimester:
Avoid use due to theoretical risk.
Third Trimester:
Avoid use due to theoretical risk.
Lactation
Use with caution. While systemic absorption is minimal, it is unknown if tretinoin is excreted in human milk. The potential for infant exposure is low, but benefits of treatment for the mother should be weighed against potential risks to the infant. Avoid applying to areas where the infant may come into direct contact with the medication.
Infant Risk:
Low (L3 - Moderately safe, but caution advised).
Pediatric Use
Safety and effectiveness in pediatric patients younger than 12 years of age have not been established. Use in adolescents 12 years and older is generally considered safe and effective for acne.
Geriatric Use
No specific dosage adjustments are required. Elderly patients may have more fragile skin and may experience increased irritation; careful monitoring and potentially less frequent application may be warranted.
Clinical Information
Clinical Pearls
- The 'peeling' or 'purging' phase (initial worsening of acne and irritation) is common and usually subsides within 2-4 weeks. Patients should be counseled on this to encourage adherence.
- Start with a lower concentration (e.g., 0.025%) and gradually increase frequency or concentration if tolerated, to minimize irritation.
- Apply to completely dry skin (wait 20-30 minutes after washing) to reduce irritation.
- Consistent and diligent use of sunscreen 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 if available.
- Moisturizers are essential to manage dryness and irritation, especially non-comedogenic and fragrance-free options.
Alternative Therapies
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Topical benzoyl peroxide
- Topical azelaic acid
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe, recalcitrant acne)
- Hormonal therapies (e.g., oral contraceptives, spironolactone for hormonal acne)
- Chemical peels, laser therapy (for photodamage)
Cost & Coverage
Average Cost:
$50 - $200+ per 45gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1-3 (generic often Tier 1-2, brand Tier 2-3 or non-preferred)
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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.