Retin-A 0.025% Cream 45gm
It is used to treat pimples (acne).
Drug Class
Retinoid; Anti-acne agent; Anti-wrinkle agent
Pharmacologic Class
Retinoid
Pregnancy Category
Category C
FDA Approved
Apr 1971
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tretinoin is a form of Vitamin A that helps skin cells grow and shed more effectively. It's used to treat acne by preventing clogged pores and to improve the appearance of fine wrinkles and rough skin by promoting healthier skin cell turnover.
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 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 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 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 a thin layer to clean, dry skin, usually once daily at bedtime.
- Avoid applying to eyes, mouth, angles of the nose, or mucous membranes.
- Use a mild, non-medicated cleanser and moisturizer daily.
- Sun protection is crucial: use broad-spectrum sunscreen (SPF 30 or higher) daily, wear protective clothing, and avoid excessive sun exposure, including tanning beds. Tretinoin increases sensitivity to sunlight.
- Initial irritation (redness, dryness, peeling) is common and usually subsides with continued use. If severe, contact your doctor.
- Do not use other topical products that may cause irritation (e.g., benzoyl peroxide, salicylic acid, abrasive soaps) unless directed by your doctor.
- Results take time; be patient and consistent with treatment (weeks for acne, months for wrinkles).
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, after washing and drying the skin. Start with lower concentrations (e.g., 0.025%) and gradually increase as tolerated.
fine wrinkles/mottled hyperpigmentation/tactile roughness:
Apply a thin layer to affected areas once daily at bedtime. Use sunscreen and protective clothing.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (generally not recommended for children under 12 years)
Adolescent:
For acne vulgaris, apply a thin layer to affected areas once daily at bedtime, similar to adult dosing. Use with caution and under medical supervision.
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 metabolite of Vitamin A that binds to specific retinoic acid receptors (RARs) located 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 reduces the cohesion of follicular epithelial cells, leading to decreased formation of microcomedones. It also stimulates mitotic activity and increases the turnover of follicular epithelial cells, promoting the expulsion of existing comedones. For photoaging, it influences collagen synthesis and degradation, promoting new collagen formation and reducing fine wrinkles.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (approximately 1-5% of topical dose)
Tmax:
Not clinically significant for topical application due to minimal systemic absorption
FoodEffect:
Not applicable for topical formulation
Distribution:
Vd:
Not clinically significant for topical application
ProteinBinding:
Highly protein bound if systemically absorbed (primarily to albumin)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not clinically significant for topical application (systemic half-life of absorbed drug is 0.5-2 hours)
Clearance:
Not clinically significant for topical application
ExcretionRoute:
If systemically absorbed, primarily renal and biliary excretion
Unchanged:
Minimal (if systemically absorbed)
Pharmacodynamics
OnsetOfAction:
2-3 weeks for initial improvement in acne; 3-6 months for significant improvement in photoaging
PeakEffect:
6-12 weeks for acne; 6-12 months for photoaging
DurationOfAction:
Effects persist with continued use; regression occurs upon discontinuation
Safety & Warnings
Side Effects
Important Side Effects to Report to Your Doctor Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, seek medical attention 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
+ 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. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
Feeling of warmth
Burning or stinging
Change in skin color
Skin reactions, including:
+ Dry skin
+ Redness
+ Swelling
+ Blisters
+ Peeling
If you develop any skin reactions, consult with your doctor, as 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 about side effects, consult 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, seek medical attention 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
+ 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. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
Feeling of warmth
Burning or stinging
Change in skin color
Skin reactions, including:
+ Dry skin
+ Redness
+ Swelling
+ Blisters
+ Peeling
If you develop any skin reactions, consult with your doctor, as 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 about side effects, consult 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 blistering, crusting, or swelling of the skin
- Excessive burning or stinging that does not subside
- Unusual skin discoloration
- Allergic reaction symptoms (rash, itching, swelling, severe dizziness, trouble breathing)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
Skin conditions, including sunburn, sensitivity to light, or other skin problems.
Medications that may increase your skin's sensitivity to light, as several drugs can cause this interaction. If you are unsure, consult your doctor or pharmacist for guidance.
Additionally, if you are pregnant, notify your doctor.
This is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to discuss the following with your doctor and pharmacist:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your overall health and any existing medical conditions
To ensure your safety, verify that it is acceptable to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
Skin conditions, including sunburn, sensitivity to light, or other skin problems.
Medications that may increase your skin's sensitivity to light, as several drugs can cause this interaction. If you are unsure, consult your doctor or pharmacist for guidance.
Additionally, if you are pregnant, notify your doctor.
This is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to discuss the following with your doctor and pharmacist:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your overall health and any existing medical conditions
To ensure your safety, verify that it is acceptable to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
Important Information About Your Medication
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 an extended period may increase the risk of severe side effects.
Skin Precautions
Avoid applying this medication to sunburned skin, cuts, scrapes, eczema, or damaged skin, as this may 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 may irritate your skin; consult your doctor or pharmacist for advice on how to protect your skin in these conditions
Additional Precautions
Be cautious when handling limes, as the peels may cause skin irritation. Using other skin products while taking this medication may increase the risk of skin irritation, so it is essential to consult your doctor before using any other products on your skin, including soaps.
If you experience dry skin while using this medication, you may use a moisturizer to help alleviate this side effect. However, consult your doctor or pharmacist to determine the best type of moisturizer to use. You may also 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 Warnings
If you accidentally swallow this medication, call a doctor or poison control center immediately, as it may cause harm. Additionally, if you are pregnant or plan to become pregnant, inform your doctor right away, as this medication may harm the unborn baby.
Breastfeeding
If you are breastfeeding, consult your doctor to discuss any potential risks to your baby. Your doctor will help you weigh the benefits and risks of continuing to take this medication while breastfeeding.
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 an extended period may increase the risk of severe side effects.
Skin Precautions
Avoid applying this medication to sunburned skin, cuts, scrapes, eczema, or damaged skin, as this may 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 may irritate your skin; consult your doctor or pharmacist for advice on how to protect your skin in these conditions
Additional Precautions
Be cautious when handling limes, as the peels may cause skin irritation. Using other skin products while taking this medication may increase the risk of skin irritation, so it is essential to consult your doctor before using any other products on your skin, including soaps.
If you experience dry skin while using this medication, you may use a moisturizer to help alleviate this side effect. However, consult your doctor or pharmacist to determine the best type of moisturizer to use. You may also 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 Warnings
If you accidentally swallow this medication, call a doctor or poison control center immediately, as it may cause harm. Additionally, if you are pregnant or plan to become pregnant, inform your doctor right away, as this medication may harm the unborn baby.
Breastfeeding
If you are breastfeeding, consult your doctor to discuss any potential risks to your baby. Your doctor will help you weigh the benefits and risks of continuing to take this medication while breastfeeding.
Overdose Information
Overdose Symptoms:
- Topical overdose is unlikely to cause systemic toxicity due to minimal absorption.
- Local symptoms of excessive application may include severe redness, peeling, discomfort, and irritation.
What to Do:
If excessive application occurs, wash the area thoroughly with mild soap and water. Discontinue use temporarily until irritation subsides. For accidental ingestion, contact a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention. Systemic toxicity from topical overdose is rare but could theoretically involve headache, nausea, or vomiting if a very large amount were ingested.
Drug Interactions
Moderate Interactions
- Other topical preparations containing peeling agents (e.g., benzoyl peroxide, salicylic acid, sulfur, resorcinol) - may cause excessive irritation.
- Topical products with strong drying effects (e.g., astringents, abrasive soaps, medicated cleansers) - may exacerbate irritation.
- Photosensitizing agents (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines) - may increase risk of photosensitivity.
Minor Interactions
- Cosmetics or soaps that are highly irritating or drying.
- Products containing alcohol, spices, or lime.
Monitoring
Baseline Monitoring
Skin assessment (type, condition, presence of lesions)
Rationale: To establish baseline skin health and identify areas for treatment.
Timing: Prior to initiation of therapy
Routine Monitoring
Skin irritation (redness, dryness, peeling, stinging, burning)
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 blistering, crusting, or swelling; persistent or intolerable discomfort
Therapeutic response (reduction in acne lesions, improvement in skin texture/wrinkles)
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 photoaging may indicate need for alternative therapy or re-evaluation.
Symptom Monitoring
- Excessive dryness
- Peeling or flaking of skin
- Redness (erythema)
- Stinging or burning sensation
- Itching
- Swelling
- Blistering or crusting (severe reaction, requires medical attention)
- Increased sensitivity to sunlight
Special Patient Groups
Pregnancy
Category C. While systemic absorption of topical tretinoin is minimal, there are theoretical concerns regarding teratogenicity, especially given the known teratogenic effects of oral retinoids (e.g., isotretinoin). Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Many clinicians advise avoiding use during pregnancy.
Trimester-Specific Risks:
First Trimester:
Highest theoretical risk due to organogenesis. Avoid if possible.
Second Trimester:
Lower theoretical risk compared to first trimester, but still generally advised to avoid.
Third Trimester:
Lower theoretical risk, but still generally advised to avoid.
Lactation
L3 (Moderately Safe). It is unknown whether topical tretinoin is excreted in human milk. Due to minimal systemic absorption, significant transfer to breast milk is unlikely. However, caution should be exercised. Avoid applying to areas where the infant might ingest the medication (e.g., breast area).
Infant Risk:
Low risk, but potential for irritation if direct contact occurs. Theoretical risk of systemic effects is very low due to minimal maternal absorption.
Pediatric Use
Safety and efficacy have not been established in children younger than 12 years for acne. Not recommended for use in very young children. Adolescents (12 years and older) may use it for acne under medical supervision, with careful monitoring for irritation.
Geriatric Use
No specific dose adjustments are required. However, geriatric patients may have more fragile or sensitive skin, which could increase susceptibility to irritation. Use with caution and monitor for adverse skin reactions.
Clinical Information
Clinical Pearls
- Start with the lowest concentration (0.025%) and gradually increase strength as tolerated to minimize irritation.
- Apply a pea-sized amount for the entire face; more is not better and will only increase irritation.
- Apply to completely dry skin (wait 20-30 minutes after washing) to reduce irritation.
- The 'retinization' period (initial irritation, redness, peeling) is normal and typically lasts 2-4 weeks. It often subsides with continued use.
- Consistent daily use is key for efficacy. Skipping applications will delay results.
- Strict sun protection is paramount due to increased photosensitivity.
- Combine with a gentle, non-comedogenic moisturizer to help manage dryness and irritation.
- Avoid waxing on treated areas as skin may be more fragile and prone to tearing.
- Do not expect immediate results; significant improvement takes weeks to months.
Alternative Therapies
- Other topical retinoids (e.g., adapalene, tazarotene)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Topical benzoyl peroxide
- Topical salicylic acid
- Azelaic acid
- Oral antibiotics (for severe acne)
- Oral isotretinoin (for severe, recalcitrant acne)
- Chemical peels
- Laser therapy
Cost & Coverage
Average Cost:
$50 - $150 per 45gm tube of 0.025% cream
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (often requires prior authorization for brand-name or higher concentrations)
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 the medication taken, the amount, and the time it happened.