Retin-A 0.025% Cream 20gm
It is used to treat pimples (acne).
Drug Class
Retinoid; Anti-acne agent
Pharmacologic Class
Retinoid
Pregnancy Category
Category C
FDA Approved
Apr 1971
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tretinoin cream is a medication derived from Vitamin A that helps your skin renew itself. For acne, it helps to clear clogged pores and prevent new breakouts. For wrinkles and sun-damaged skin, it helps to improve skin texture and reduce the appearance of fine lines and dark spots. It works by speeding up how quickly your skin cells turn over.
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 application.
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 application.
Lifestyle & Tips
- Apply a pea-sized amount to clean, dry skin once daily at bedtime.
- Avoid contact with eyes, mouth, angles of the nose, and mucous membranes.
- Use a gentle, non-medicated cleanser and moisturizer.
- Strictly avoid sun exposure, including tanning beds. Use broad-spectrum sunscreen (SPF 30 or higher) daily, even on cloudy days, and wear protective clothing (hats, long sleeves).
- Expect some redness, dryness, and peeling, especially during the first few weeks. This is normal and often indicates the medication is working. If irritation is severe, contact your doctor.
- Do not use other irritating topical products (e.g., those with benzoyl peroxide, salicylic acid, or harsh soaps) at the same time unless directed by your doctor.
- Be patient; it can take several weeks to months to see full results.
Available Forms & Alternatives
Available Strengths:
- Retin-A 0.025% Gel 15gm
- Retin-A 0.025% Cream 20gm
- Retin-A Micro 0.08% Gel Pump 50gm
- Retin-A 0.05% Cream 20gm
- Retin-A 0.05% Cream 45gm
- Retin-A 0.025% Cream 45gm
- Retin-A 0.1% Cream 20gm
- Retin-A 0.01% Gel 15gm
- Retin-A 0.01% Gel 45gm
- Retin-A Micro 0.04% Gel 45gm
- Retin-A 0.1% Cream 45gm
- Retin-A Micro 0.1% Gel 20gm
- Retin-A 0.025% Gel 45gm
- Retin-A Micro 0.1% Gel 45gm
- Retin-A Micro 0.04% Gel Pump 50gm
- Retin-A Micro 0.1% Gel Pump 50gm
- Retin-A Micro 0.04% Gel 20gm
- Retin-A Micro 0.06% Gel Pump 50gm
Generic Alternatives:
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 response may be seen in 2-3 weeks, but full therapeutic effects may take 6-12 weeks.
Photoaging (fine wrinkles, mottled hyperpigmentation, tactile roughness):
Apply a thin layer to affected areas once daily at bedtime. Clinical improvement usually occurs after 3-4 months of treatment.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 12 years of age.
Adolescent:
For acne vulgaris, apply a thin layer to affected areas once daily at bedtime (typically 12 years and older).
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due0 to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Tretinoin is a metabolite of Vitamin A that binds to specific retinoic acid receptors (RARs) in the nucleus, including RAR-alpha, RAR-beta, and RAR-gamma. This binding modulates gene expression, leading to altered cellular differentiation, proliferation, and intercellular communication. In acne, it decreases the cohesiveness of follicular epithelial cells, leading to increased cell turnover and expulsion of comedones. It also reduces the formation of new comedones. In photoaging, it increases epidermal cell turnover, compacts the stratum corneum, and may stimulate collagen synthesis in the dermis.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (typically <2% of applied dose)
Tmax:
Not applicable for topical systemic effects; local effects are gradual.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not clinically significant due to minimal systemic absorption.
ProteinBinding:
Highly protein bound if systemically absorbed (e.g., to albumin).
CnssPenetration:
Limited/Not clinically significant due to minimal systemic absorption.
Elimination:
HalfLife:
Not clinically significant for topical application due to minimal systemic absorption.
Clearance:
Not clinically significant for topical application.
ExcretionRoute:
If systemically absorbed, metabolites are excreted primarily in urine and feces.
Unchanged:
Minimal unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Acne: 2-3 weeks for initial improvement, 6-12 weeks for full effect. Photoaging: 3-4 months for initial improvement.
PeakEffect:
Acne: 6-12 weeks. Photoaging: 6-12 months of continuous use.
DurationOfAction:
Effects persist as long as treatment is continued; relapse may occur 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, difficulty 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. 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:
- A feeling of warmth
- Burning or stinging sensations
- Changes in skin color
- Skin reactions, including dry skin, redness, swelling, blisters, or peeling
If you develop 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 for 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. 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, difficulty 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. 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:
- A feeling of warmth
- Burning or stinging sensations
- Changes in skin color
- Skin reactions, including dry skin, redness, swelling, blisters, or peeling
If you develop 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 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 blistering, crusting, or swelling of the skin
- Excessive burning or stinging that does not subside
- Significant worsening of skin condition
- 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.
If you have a sunburn, skin sensitivity to light, or any other skin problems.
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 to ensure safe use. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.
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 problems.
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 to ensure safe use. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.
Precautions & Cautions
Important Information About Your Medication
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent any potential interactions with other treatments.
Using Your Medication Correctly
To achieve the full benefits of this medication, it may take several weeks of consistent use. It is crucial to follow your doctor's instructions carefully and not exceed the recommended dosage or frequency of application. Taking more than prescribed or using it for a longer period than recommended can increase the risk of severe side effects.
Skin Precautions
Do not apply this medication to sunburned, cut, scraped, eczematous, or damaged skin, as this can exacerbate skin irritation. To minimize the risk of skin problems, practice good skin care and take measures to protect your skin from the sun. You may be more susceptible to sunburn while using this medication, so it is essential to:
Avoid direct 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 can irritate the 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. When using other skin products, including soaps, be sure to discuss them with your doctor first, as they may increase the risk of skin irritation.
Managing Dry Skin and Using Cosmetics
If this medication causes dry skin, you may use a moisturizer. However, 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 do use makeup, be sure to clean the area to be treated before applying this medication.
Safety Precautions
If this medication is swallowed, it can cause harm. In the event of accidental ingestion, call a doctor or poison control center immediately.
Pregnancy and Breastfeeding
This medication may harm an unborn baby if taken during pregnancy. If you think you may be pregnant or plan to become pregnant while using this medication, contact your doctor right away. If you are breastfeeding, inform your doctor, as you will need to discuss any potential risks to your baby.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent any potential interactions with other treatments.
Using Your Medication Correctly
To achieve the full benefits of this medication, it may take several weeks of consistent use. It is crucial to follow your doctor's instructions carefully and not exceed the recommended dosage or frequency of application. Taking more than prescribed or using it for a longer period than recommended can increase the risk of severe side effects.
Skin Precautions
Do not apply this medication to sunburned, cut, scraped, eczematous, or damaged skin, as this can exacerbate skin irritation. To minimize the risk of skin problems, practice good skin care and take measures to protect your skin from the sun. You may be more susceptible to sunburn while using this medication, so it is essential to:
Avoid direct 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 can irritate the 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. When using other skin products, including soaps, be sure to discuss them with your doctor first, as they may increase the risk of skin irritation.
Managing Dry Skin and Using Cosmetics
If this medication causes dry skin, you may use a moisturizer. However, 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 do use makeup, be sure to clean the area to be treated before applying this medication.
Safety Precautions
If this medication is swallowed, it can cause harm. In the event of accidental ingestion, call a doctor or poison control center immediately.
Pregnancy and Breastfeeding
This medication may harm an unborn baby if taken during pregnancy. If you think you may be pregnant or plan to become pregnant while using this medication, contact your doctor right away. If you are breastfeeding, inform your doctor, as you will need 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 marked redness, peeling, and discomfort.
- Accidental oral ingestion of a large amount could potentially lead to symptoms similar to hypervitaminosis A (e.g., headache, nausea, vomiting, dizziness, dry skin, cheilitis), but this is rare with topical formulations.
What to Do:
For excessive topical application, discontinue use temporarily until irritation subsides. For accidental ingestion, seek medical attention. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Moderate Interactions
- Topical products containing sulfur, resorcinol, salicylic acid, or benzoyl peroxide (may cause excessive irritation if used concurrently or immediately after tretinoin).
- Astringents, abrasive soaps, medicated cleansers, or other drying agents (may exacerbate irritation).
- Products with high concentrations of alcohol, spices, or lime (e.g., certain aftershaves, perfumes).
Minor Interactions
- Photosensitizing agents (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines) - may increase risk of photosensitivity.
Monitoring
Baseline Monitoring
Skin assessment (type, sensitivity, presence of lesions)
Rationale: To establish baseline skin condition and identify potential contraindications or sensitivities.
Timing: Prior to initiation of therapy.
Patient education on proper application and sun protection
Rationale: To ensure correct use and minimize adverse effects.
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin irritation (redness, peeling, dryness, burning, stinging)
Frequency: Weekly for the first few weeks, then monthly or as needed.
Target: Mild to moderate irritation is expected; severe irritation should prompt dose adjustment or temporary discontinuation.
Action Threshold: Severe blistering, crusting, or swelling; persistent severe irritation.
Therapeutic response (reduction in acne 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 months for photoaging, or worsening condition.
Symptom Monitoring
- Excessive dryness
- Peeling or flaking of skin
- Redness (erythema)
- Burning sensation
- Stinging sensation
- Itching
- Blistering
- Crusting
- Swelling
- Increased sensitivity to sunlight
Special Patient Groups
Pregnancy
Tretinoin topical is Pregnancy Category C. While systemic absorption is minimal, there have been rare reports of birth defects associated with topical use. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Oral retinoids (e.g., isotretinoin) are highly teratogenic (Category X) and absolutely contraindicated.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though systemic absorption is low. Avoid if possible.
Second Trimester:
Risk considered lower than first trimester, but still generally advised against.
Third Trimester:
Risk considered lower than first trimester, but still generally advised against.
Lactation
It is not known whether topical tretinoin is excreted in human milk. Due to minimal systemic absorption, the risk to a nursing infant is considered low. However, caution should be exercised. Avoid applying to areas where the infant may come into direct contact with the medication (e.g., breast area).
Infant Risk:
Low risk (L3 - Moderate risk, but often considered lower for topical due to minimal absorption).
Pediatric Use
Safety and effectiveness in pediatric patients under 12 years of age have not been established. It is commonly used in adolescents (12 years and older) for acne vulgaris.
Geriatric Use
No specific dosage adjustments are required. Elderly patients may have more fragile or sensitive skin and may be more prone to irritation, dryness, or peeling. Use with caution and monitor for adverse effects.
Clinical Information
Clinical Pearls
- Start with a lower concentration (e.g., 0.025%) and gradually increase as tolerated to minimize irritation.
- 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.
- Initial worsening of acne ('purging') is common during the first few weeks of treatment as comedones are brought to the surface. This is temporary.
- Consistent daily use is key for efficacy. Skipping applications can prolong the adjustment period.
- Moisturizer is essential to combat dryness, apply it after tretinoin has absorbed or in the morning.
- Sun protection is paramount; tretinoin increases photosensitivity significantly.
- Avoid waxing on treated areas as skin may be more fragile and prone to tearing.
Alternative Therapies
- Adapalene (Differin) - another topical retinoid, often better tolerated.
- Tazarotene (Tazorac) - another topical retinoid, generally more potent and potentially more irritating.
- Benzoyl Peroxide (topical)
- Salicylic Acid (topical)
- Topical antibiotics (e.g., Clindamycin, Erythromycin)
- Oral antibiotics (e.g., Doxycycline, Minocycline)
- Oral isotretinoin (for severe, recalcitrant acne)
- Azelaic Acid
- Chemical peels
- Laser therapy
Cost & Coverage
Average Cost:
$50 - $150 per 20gm tube (0.025% cream)
Generic Available:
Yes
Insurance Coverage:
Tier 2-3 (generic often Tier 1-2)
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 medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.