Retin-A 0.025% Gel 45gm
It is used to treat pimples (acne).
Drug Class
Antiacne agent; Antipsoriatic; Keratolytic
Pharmacologic Class
Retinoid
Pregnancy Category
Category C
FDA Approved
Apr 1971
DEA Schedule
Not Controlled
Overview
What is this medicine?
Retin-A 0.025% Gel is a medication used on the skin to treat acne. It works by helping the skin renew itself more quickly and by preventing pores from becoming clogged. It can also help reduce fine wrinkles and rough skin.
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 applying the medication. You may need to wait 20 to 30 minutes after washing before applying the medication; consult with your pharmacist for specific guidance.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Safety Precautions
This medication is flammable, so avoid using it near an open flame or while smoking.
Storage and Disposal
Store all products at room temperature, away from freezing temperatures.
Missed Dose Instructions
* If you miss a dose, skip it and resume your normal 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 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 applying the medication. You may need to wait 20 to 30 minutes after washing before applying the medication; consult with your pharmacist for specific guidance.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Safety Precautions
This medication is flammable, so avoid using it near an open flame or while smoking.
Storage and Disposal
Store all products at room temperature, away from freezing temperatures.
Missed Dose Instructions
* If you miss a dose, skip it and resume your normal application schedule. Do not apply a double dose or extra doses to make up for the missed dose.
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.
- Wash hands thoroughly after application.
- Sun protection is crucial: use sunscreen (SPF 30 or higher), wear protective clothing, and avoid excessive sun exposure, including sunlamps and tanning beds, as skin will be more sensitive to sunburn.
- Avoid waxing for hair removal on treated areas.
- Do not use if pregnant or planning to become pregnant without consulting a doctor.
- Initial worsening of acne (a 'purge') is common and usually resolves within a few weeks.
- Moisturize regularly to combat dryness and irritation.
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 of Retin-A 0.025% Gel to the affected areas once daily at bedtime.
Condition-Specific Dosing:
Acne Vulgaris:
Apply once daily at bedtime, covering the entire affected area lightly. Therapeutic effects may be seen after 2-3 weeks, but more than 6 weeks may be required before definite benefits are observed. If irritation is severe, frequency of application may be reduced or temporarily discontinued.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and efficacy in children under 12 years of age have not been established. Use in adolescents (12 years and older) for acne is similar to adult dosing.
Adolescent:
Apply a thin layer of Retin-A 0.025% Gel to the affected areas once daily at bedtime.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended for topical application due to minimal systemic absorption.
Moderate:
No specific dose adjustment recommended for topical application due to minimal systemic absorption.
Severe:
No specific dose adjustment recommended for topical application due to minimal systemic absorption.
Dialysis:
No specific considerations for topical application due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended for topical application due to minimal systemic absorption.
Moderate:
No specific dose adjustment recommended for topical application due to minimal systemic absorption.
Severe:
No specific dose adjustment recommended for topical application due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Tretinoin is a retinoid that binds to specific retinoic acid receptors (RARs) located in the nucleus of target cells. It modulates cell differentiation, proliferation, and intercellular communication. In acne, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells, leading to the expulsion of comedones. It also reduces the cohesiveness of follicular epithelial cells, preventing microcomedone formation. Additionally, it has anti-inflammatory effects.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (approximately 1-2% of topically applied dose)
Tmax:
Not applicable for topical systemic effects; peak plasma concentrations are negligible.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not applicable for topical formulation due to minimal systemic absorption.
ProteinBinding:
Highly protein bound (>95%) if systemically absorbed, primarily to albumin.
CnssPenetration:
Limited
Elimination:
HalfLife:
Not clinically relevant for topical application due to minimal systemic absorption; systemic half-life of absorbed tretinoin is approximately 0.7 hours.
Clearance:
Not clinically relevant for topical application.
ExcretionRoute:
Biliary and renal excretion if systemically absorbed.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically observed within 2-3 weeks, but optimal results may take 6-12 weeks.
PeakEffect:
6-12 weeks
DurationOfAction:
Effects persist as long as treatment is continued; relapse may occur upon discontinuation.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
- A severe skin reaction that bothers you or does not go away.
Other Possible Side Effects
Like all medications, this drug can cause side effects. 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:
- A feeling of warmth
- Burning or stinging sensations
- Changes in skin color
- Skin reactions, including dry skin, redness, swelling, blisters, and 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 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.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
- A severe skin reaction that bothers you or does not go away.
Other Possible Side Effects
Like all medications, this drug can cause side effects. 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:
- A feeling of warmth
- Burning or stinging sensations
- Changes in skin color
- Skin reactions, including dry skin, redness, swelling, blisters, and 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 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 redness, swelling, blistering, or crusting of the skin
- Excessive burning or stinging that does not subside
- Allergic reaction symptoms (rash, itching, 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, sensitive skin, or any other skin conditions.
If you are taking any medications that may increase your skin's sensitivity to light. There are numerous medications 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, sensitive skin, or any other skin conditions.
If you are taking any medications that may increase your skin's sensitivity to light. There are numerous medications 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
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, adhere strictly to your doctor's instructions regarding dosage and frequency of use. Do not exceed the recommended amount or use it for a longer period than prescribed.
Avoid applying this medication to 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. When outdoors, use sunscreen and lip balm with a Sun Protection Factor (SPF) of 15 or higher, wear protective clothing, and use eyewear that shields your eyes from the sun.
Be aware that certain weather conditions, such as cold and wind, may irritate your skin. Consult your doctor or pharmacist for guidance on how to protect 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 first, discuss the suitable type with your doctor or pharmacist. Makeup can be used unless your doctor has advised against it; however, ensure the area is clean before applying this medication.
In case of accidental ingestion, this medication can be harmful. If swallowed, immediately contact a doctor or a 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, adhere strictly to your doctor's instructions regarding dosage and frequency of use. Do not exceed the recommended amount or use it for a longer period than prescribed.
Avoid applying this medication to 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. When outdoors, use sunscreen and lip balm with a Sun Protection Factor (SPF) of 15 or higher, wear protective clothing, and use eyewear that shields your eyes from the sun.
Be aware that certain weather conditions, such as cold and wind, may irritate your skin. Consult your doctor or pharmacist for guidance on how to protect 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 first, discuss the suitable type with your doctor or pharmacist. Makeup can be used unless your doctor has advised against it; however, ensure the area is clean before applying this medication.
In case of accidental ingestion, this medication can be harmful. If swallowed, immediately contact a doctor or a 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:
- Excessive redness
- Peeling
- Discomfort
What to Do:
Topical overdose is unlikely to cause significant systemic effects. Discontinue use temporarily and allow skin to recover. If severe irritation occurs, contact a healthcare provider. For accidental ingestion, call a poison control center (1-800-222-1222) or seek immediate medical attention.
Drug Interactions
Moderate Interactions
- Topical products containing sulfur, resorcinol, or salicylic acid (may cause excessive irritation)
- Abrasive soaps and cleansers
- Medicated soaps or cosmetics with strong drying effect
- Products with high concentrations of alcohol, astringents, spices, or lime
- Other topical acne preparations (e.g., benzoyl peroxide, clindamycin, erythromycin) - use with caution due to potential for increased irritation; consider alternating application times.
Minor Interactions
- Photosensitizing agents (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines) - increased risk of photosensitivity.
Monitoring
Routine Monitoring
Skin irritation (erythema, scaling, dryness, stinging, burning)
Frequency: Daily, especially during initial weeks of therapy
Target: Mild to moderate irritation is expected; severe irritation warrants dose reduction or temporary discontinuation.
Action Threshold: Severe or persistent irritation; contact healthcare provider.
Acne lesion count
Frequency: Monthly or as clinically indicated
Target: Reduction in inflammatory and non-inflammatory lesions.
Action Threshold: No improvement after 8-12 weeks or worsening of condition.
Symptom Monitoring
- Excessive redness
- Swelling
- Blistering
- Crusting
- Severe burning or stinging
- Increased sensitivity to sunlight
Special Patient Groups
Pregnancy
Category C. While systemic absorption of topical tretinoin is minimal, there have been rare reports of birth defects associated with topical use. Oral tretinoin (isotretinoin) is a known teratogen (Category X). Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Women of childbearing potential should be advised to use effective contraception.
Trimester-Specific Risks:
First Trimester:
Potential risk, especially during organogenesis. Avoid if possible.
Second Trimester:
Potential risk, though less critical than first trimester. Avoid if possible.
Third Trimester:
Potential risk. Avoid if possible.
Lactation
L3 (Moderately Safe). It is not known whether tretinoin is excreted in human milk following topical application. Due to minimal systemic absorption, significant transfer to breast milk is unlikely. However, caution should be exercised. Avoid applying to areas where the infant may come into direct contact with the medication.
Infant Risk:
Low risk due to minimal systemic absorption, but potential for irritation if infant comes into direct contact with treated skin.
Pediatric Use
Safety and efficacy in children under 12 years of age have not been established. Use in adolescents (12 years and older) for acne is generally considered safe and effective, with similar considerations as adults.
Geriatric Use
No specific dose adjustments or precautions are generally necessary for geriatric patients. However, older skin may be more sensitive and prone to dryness or irritation, so careful monitoring and possibly less frequent application may be warranted.
Clinical Information
Clinical Pearls
- Tretinoin can cause a 'retinoid flare' or initial worsening of acne during the first few weeks of treatment. This is normal and usually subsides.
- Always apply to completely dry skin (wait 20-30 minutes after washing face) to minimize irritation.
- A pea-sized amount is usually sufficient for the entire face.
- Consistent use is key for optimal results; effects are not immediate.
- Emphasize strict sun protection due to increased photosensitivity.
- Start with a lower concentration (like 0.025%) and gradually increase frequency or concentration if tolerated, to minimize irritation.
- Can be used in combination with other acne treatments (e.g., topical antibiotics, benzoyl peroxide), but apply at different times of day to reduce irritation.
Alternative Therapies
- Adapalene (Differin)
- Tazarotene (Tazorac)
- Benzoyl Peroxide
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Azelaic acid
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe, recalcitrant acne)
- Hormonal therapies (e.g., oral contraceptives, spironolactone for hormonal acne)
Cost & Coverage
Average Cost:
Varies widely, typically $100-$500+ per 45gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 (Generic)
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 occurred.