Tretinoin 0.025% Cream 45gm
It is used to treat pimples (acne).
Drug Class
Antiacne agent; Keratolytic; Retinoid
Pharmacologic Class
Retinoid
Pregnancy Category
Category C
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 reduce the appearance of fine wrinkles and rough skin. It works by helping the 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.
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 use, wash your hands thoroughly.
Gently wash the affected skin 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.
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 regular application schedule. Do not apply two doses at the same time 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 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 use, wash your hands thoroughly.
Gently wash the affected skin 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.
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 regular application schedule. Do not apply two doses at the same time or use extra doses to make up for the missed one.
Lifestyle & Tips
- Apply to clean, dry skin, usually once daily at bedtime.
- Use only a pea-sized amount for the entire face.
- Avoid applying to eyes, mouth, angles of the nose, or mucous membranes.
- Strictly avoid sun exposure and use broad-spectrum sunscreen (SPF 30+) daily, even on cloudy days. Wear protective clothing and hats.
- Avoid harsh skin products (e.g., abrasive soaps, astringents, alcohol-containing products) while using tretinoin.
- Moisturize regularly to combat dryness and irritation.
- Be patient; it can take weeks to months to see full results, and skin may worsen initially.
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 0.025% Cream to the affected areas once daily at bedtime.
Condition-Specific Dosing:
Acne Vulgaris:
Apply once daily at bedtime.
Photodamage/Wrinkles:
Apply once daily at bedtime.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (generally not recommended for children under 12 years)
Adolescent:
Apply a thin layer to affected areas once daily at bedtime (typically for ages 12 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 binds to specific retinoic acid receptors (RARs) and retinoid X receptors (RXRs) in the nucleus of target cells. 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. In photodamaged skin, it influences cellular differentiation and proliferation, promoting epidermal hyperplasia, compaction of the stratum corneum, and increased collagen synthesis in the papillary dermis.
Pharmacokinetics
Absorption:
Bioavailability:
Very low systemic bioavailability (approximately 1-5% of applied dose)
Tmax:
Not well-defined for topical application due to minimal systemic absorption.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not clinically relevant for topical application.
ProteinBinding:
Highly protein bound (primarily to albumin) if systemically absorbed.
CnssPenetration:
Limited (minimal systemic absorption).
Elimination:
HalfLife:
Not clinically relevant for topical application due to minimal systemic absorption (systemic half-life of absorbed tretinoin is approximately 0.5-2 hours).
Clearance:
Not clinically relevant for topical application.
ExcretionRoute:
If systemically absorbed, primarily renal and biliary excretion.
Unchanged:
Minimal unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Acne: 2-3 weeks for initial improvement, 6-12 weeks for full therapeutic effect. Photodamage: Several months (e.g., 3-6 months) for noticeable improvement.
PeakEffect:
Acne: 6-12 weeks. Photodamage: 6-12 months.
DurationOfAction:
Effects persist with continued use; regression occurs upon discontinuation.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
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 is bothersome or persistent
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
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. 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, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
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 is bothersome or persistent
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
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. 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, 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
- Blistering
- Crusting
- Swelling of the treated skin
- Severe itching or rash (signs of allergic reaction)
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, sensitive skin, or any other skin conditions that may be relevant.
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, as this may affect your treatment.
Additionally, it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This includes any health problems you may have, as they can interact with this medication. To ensure your safety, do not start, stop, or change the dose 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, sensitive skin, or any other skin conditions that may be relevant.
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, as this may affect your treatment.
Additionally, it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This includes any health problems you may have, as they can interact with this medication. To ensure your safety, do not start, stop, or change the dose 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. 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 regarding dosage and frequency of use. Do not exceed the recommended dose, and do not use this medication more often or for a longer period than prescribed.
When applying this medication, avoid using it on sunburned skin, cuts, scrapes, eczema, or damaged skin. Instead, practice good skin care and take precautions to protect your skin from the sun, as this medication may increase your susceptibility to sunburn. To reduce this risk, avoid exposure to direct sunlight, sunlamps, and tanning beds. When going outside, use a broad-spectrum sunscreen and lip balm with a Sun Protection Factor (SPF) of 15 or higher. Additionally, wear protective clothing and eyewear to shield your skin from the sun.
Be aware that certain weather conditions, such as cold and wind, may irritate your skin. If you have concerns about protecting your skin, consult with your doctor or pharmacist for guidance.
It is also important to avoid contact with lime peels while using this medication. If you plan to use other skin products, consult with your doctor first, as they may increase the risk of irritation. This includes soaps and other topical agents.
If this medication causes dry skin, you may use a moisturizer. However, consult with your doctor or pharmacist to determine the most suitable type of moisturizer for your skin.
You can use makeup while taking this medication, unless your doctor has advised against it. If you do plan to use makeup, ensure that you clean the area to be treated before applying this drug.
In case of accidental ingestion, this medication can be harmful. If you or someone else swallows this drug, immediately contact a doctor or a poison control center.
If you are pregnant or plan to become pregnant, inform your doctor, as this medication may harm the unborn baby. If you suspect you may be pregnant or are planning to conceive while taking this medication, contact your doctor right away.
If you are breastfeeding, inform your doctor, as they will need to discuss potential risks to your baby.
To minimize the risk of severe side effects, it is crucial to follow your doctor's instructions regarding dosage and frequency of use. Do not exceed the recommended dose, and do not use this medication more often or for a longer period than prescribed.
When applying this medication, avoid using it on sunburned skin, cuts, scrapes, eczema, or damaged skin. Instead, practice good skin care and take precautions to protect your skin from the sun, as this medication may increase your susceptibility to sunburn. To reduce this risk, avoid exposure to direct sunlight, sunlamps, and tanning beds. When going outside, use a broad-spectrum sunscreen and lip balm with a Sun Protection Factor (SPF) of 15 or higher. Additionally, wear protective clothing and eyewear to shield your skin from the sun.
Be aware that certain weather conditions, such as cold and wind, may irritate your skin. If you have concerns about protecting your skin, consult with your doctor or pharmacist for guidance.
It is also important to avoid contact with lime peels while using this medication. If you plan to use other skin products, consult with your doctor first, as they may increase the risk of irritation. This includes soaps and other topical agents.
If this medication causes dry skin, you may use a moisturizer. However, consult with your doctor or pharmacist to determine the most suitable type of moisturizer for your skin.
You can use makeup while taking this medication, unless your doctor has advised against it. If you do plan to use makeup, ensure that you clean the area to be treated before applying this drug.
In case of accidental ingestion, this medication can be harmful. If you or someone else swallows this drug, immediately contact a doctor or a poison control center.
If you are pregnant or plan to become pregnant, inform your doctor, as this medication may harm the unborn baby. If you suspect you may be pregnant or are planning to conceive while taking this medication, contact your doctor right away.
If you are breastfeeding, inform your doctor, as they will need to discuss potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Severe redness
- Excessive peeling
- Discomfort
- Swelling
What to Do:
Topical overdose is unlikely to cause systemic toxicity. Wash the area thoroughly with soap and water. Discontinue use temporarily until irritation subsides. For severe reactions, seek medical attention. Call 1-800-222-1222 for poison control.
Drug Interactions
Moderate Interactions
- Other topical preparations with strong drying or irritating effects (e.g., sulfur, resorcinol, benzoyl peroxide, salicylic acid) - concurrent use may increase irritation.
- Products containing alcohol, astringents, spices, or lime - may cause excessive drying or irritation.
- Photosensitizing agents (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) - may increase risk of photosensitivity.
Minor Interactions
- Medicated or abrasive soaps and cleansers
- Cosmetics with strong drying effect
- Permanent wave solutions
- Electrolysis
- Hair depilatories or waxes
Monitoring
Baseline Monitoring
Skin condition assessment (e.g., severity of acne, photodamage)
Rationale: To establish a baseline for evaluating therapeutic response and adverse effects.
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin irritation (redness, scaling, dryness, burning, stinging)
Frequency: Daily during initial weeks, then as needed.
Target: Mild to moderate irritation is expected; severe irritation warrants dose adjustment or temporary discontinuation.
Action Threshold: Severe or persistent irritation: reduce frequency, use lower concentration, or temporarily discontinue.
Therapeutic response (e.g., reduction in lesions, improvement in skin texture)
Frequency: Monthly for first 3-6 months, then every 3-6 months.
Target: Gradual improvement over weeks to months.
Action Threshold: Lack of improvement after 12 weeks for acne or 6-12 months for photodamage: re-evaluate treatment plan.
Symptom Monitoring
- Redness
- Scaling
- Dryness
- Itching
- Burning
- Stinging
- Peeling
- Crusting
- Blistering
- Swelling
Special Patient Groups
Pregnancy
Pregnancy Category C. While systemic absorption is minimal with topical application, tretinoin is a retinoid, and oral retinoids are highly teratogenic. Use during pregnancy should be avoided unless the potential benefit justifies the potential risk to the fetus. Discuss risks with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Potential risk, especially during organogenesis, though systemic absorption is low.
Second Trimester:
Potential risk, though systemic absorption is low.
Third Trimester:
Potential risk, though systemic absorption is low.
Lactation
Use with caution. It is not known whether tretinoin is excreted in human milk following topical application. Due to minimal systemic absorption, the risk to a nursing infant is considered low, but caution is advised. Avoid applying to areas where the infant may come into direct contact with the medication.
Infant Risk:
Low (L3 - Moderately Safe)
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 generally similar to adults, but skin sensitivity should be monitored.
Geriatric Use
No specific dose adjustments are required. However, geriatric patients may have more fragile or sensitive skin and may experience increased irritation. Consider starting with a lower concentration or less frequent application.
Clinical Information
Clinical Pearls
- Start low, go slow: Begin with a lower concentration (e.g., 0.025%) and/or apply every other night to minimize irritation, gradually increasing frequency as tolerated.
- Apply to completely dry skin (20-30 minutes after washing) to reduce irritation.
- A 'pea-sized' amount is sufficient for the entire face; using more will not speed up results and will increase irritation.
- Expect an initial 'purging' phase (worsening of acne) during the first few weeks; this is normal and indicates the medication is working.
- Consistent daily use of broad-spectrum sunscreen (SPF 30+) is crucial due to increased photosensitivity.
- Combine with a gentle, non-comedogenic moisturizer to counteract dryness and peeling.
Alternative Therapies
- Other topical retinoids (e.g., adapalene, tazarotene)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Benzoyl peroxide
- Salicylic acid
- Azelaic acid
- Oral antibiotics (for moderate to severe acne)
- Oral isotretinoin (for severe, recalcitrant acne)
- Chemical peels
- Laser therapy
Cost & Coverage
Average Cost:
$30 - $150+ per 45gm tube (generic vs. brand)
Generic Available:
Yes
Insurance Coverage:
Tier 2-3 (generic often preferred, brand may require prior authorization)
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.