Retin-A 0.025% Gel 15gm
It is used to treat pimples (acne).
Drug Class
Retinoid; Anti-acne agent
Pharmacologic Class
Retinoic acid receptor agonist; Keratolytic
Pregnancy Category
Category C
FDA Approved
Apr 1971
DEA Schedule
Not Controlled
Overview
What is this medicine?
Retin-A Gel is a medication that contains tretinoin, a form of Vitamin A. It's used on the skin to treat acne by helping to clear up pimples and blackheads. It works by affecting how skin cells grow and shed, which helps to unclog pores and prevent new acne from forming. It can also help improve the appearance of fine wrinkles and rough skin, though this specific concentration is primarily for acne. It's important to use it exactly as prescribed and to protect your skin from the sun while using it.
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, following these steps:
1. Wash your hands before and after use.
2. Gently wash the affected skin with a mild, non-medicated soap and pat it dry.
3. You may need to wait 20 to 30 minutes after washing before applying the medication. Consult with your pharmacist for specific guidance.
4. 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 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, following these steps:
1. Wash your hands before and after use.
2. Gently wash the affected skin with a mild, non-medicated soap and pat it dry.
3. You may need to wait 20 to 30 minutes after washing before applying the medication. Consult with your pharmacist for specific guidance.
4. 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 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 in the evening.
- Avoid applying to eyes, mouth, angles of the nose, or mucous membranes.
- Do not apply to sunburned, eczematous, or broken skin.
- Use a mild, non-medicated cleanser and moisturizer daily.
- Strictly avoid excessive sun exposure, including sunlamps and tanning beds. Use a broad-spectrum sunscreen (SPF 15 or higher) and wear protective clothing when outdoors.
- Initial irritation (redness, peeling, dryness) is common and usually subsides with continued use. Do not stop treatment unless irritation is severe.
- Acne may appear worse during the first few weeks of treatment before improving; this is normal.
- Results typically take 6-12 weeks to become noticeable.
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, usually in the evening, before bedtime.
Condition-Specific Dosing:
acne_vulgaris:
Apply once daily, in the evening, to skin areas where acne lesions appear. Use enough to lightly cover the entire affected area.
photodamage:
Not specifically indicated for photodamage at this concentration, but higher concentrations of tretinoin are used. Consult product-specific labeling for photodamage indications.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and efficacy not established in pediatric patients younger than 12 years of age)
Adolescent:
Apply a thin layer to affected areas once daily, usually in the evening, before bedtime (for patients 12 years 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 metabolite of Vitamin A that binds to specific retinoic acid receptors (RARs) located in the nucleus of target cells. This binding modulates gene expression, leading to altered cellular differentiation, proliferation, and intercellular communication. In acne, tretinoin decreases the cohesion of follicular epithelial cells, leading to a reduction in microcomedone formation. It also stimulates mitotic activity and increases the turnover of follicular epithelial cells, causing extrusion of existing comedones. Additionally, it may enhance the penetration of other topical agents.
Pharmacokinetics
Absorption:
Bioavailability:
<5% (systemic absorption after topical application)
Tmax:
Not well-defined for topical systemic absorption, but peak plasma concentrations are very low and occur within hours if detectable.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not applicable (minimal systemic distribution)
ProteinBinding:
Highly protein bound (>95%) if systemically absorbed, primarily to albumin.
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not well-defined for topical systemic absorption; plasma half-life of systemically absorbed tretinoin is approximately 0.5-2 hours.
Clearance:
Rapid hepatic clearance if systemically absorbed.
ExcretionRoute:
Renal and biliary (if systemically absorbed)
Unchanged:
Minimal (if systemically absorbed)
Pharmacodynamics
OnsetOfAction:
2-3 weeks (initial improvement), 6-12 weeks (maximal therapeutic effect)
PeakEffect:
6-12 weeks
DurationOfAction:
Maintained with continued use; effects reverse 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 when taking this medication. Seek medical attention right away if you experience any of the following symptoms, which may indicate a serious side effect:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ 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. However, many people do not experience any side effects or only have mild ones. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
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, discuss them with your doctor. Your doctor may recommend stopping the medication temporarily, 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, 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 when taking this medication. Seek medical attention right away if you experience any of the following symptoms, which may indicate a serious side effect:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ 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. However, many people do not experience any side effects or only have mild ones. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
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, discuss them with your doctor. Your doctor may recommend stopping the medication temporarily, 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, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe burning, stinging, or itching that does not subside
- Excessive redness, swelling, blistering, or crusting of the skin
- Signs of an allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat)
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. Describe the allergic reaction you experienced, including any symptoms that occurred.
If you have a sunburn, skin sensitivity to light, or any other skin conditions that may be relevant.
If you are currently 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 the safety of taking this medication.
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 (OTC) 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 all your other medications and health conditions. Never start, stop, or modify 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. Describe the allergic reaction you experienced, including any symptoms that occurred.
If you have a sunburn, skin sensitivity to light, or any other skin conditions that may be relevant.
If you are currently 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 the safety of taking this medication.
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 (OTC) 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 all your other medications and health conditions. Never start, stop, or modify the dosage of any medication without first consulting your doctor.
Precautions & Cautions
Important Warnings and Precautions
Before taking this medication, inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug. If you have a fish allergy, consult your doctor, as some products contain fish protein.
Administration and Usage
It may take several weeks to experience the full effects of this medication. To minimize the risk of severe side effects, adhere to your doctor's instructions regarding dosage, frequency, and duration of use. Do not exceed the recommended dose, and do not use this medication more frequently or for a longer period than prescribed.
Skin Precautions
Avoid applying this medication to sunburned skin, cuts, scrapes, eczema, or damaged skin. Practice good skin care and limit sun exposure to prevent further irritation. You may be more susceptible to sunburn while using this medication, so take necessary precautions:
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 guidance on protecting your skin
Additionally, avoid contact with lime peels, as they may cause further irritation.
Interactions with Other Skin Products
Using other skin products while taking this medication may increase the risk of irritation. Consult your doctor before using any other drugs or products on your skin, including soaps. If you experience dry skin, you may use a moisturizer; however, consult your doctor or pharmacist to determine the best type of moisturizer to use. You may use makeup unless your doctor has advised against it; if you do use makeup, clean the treatment area before applying this medication.
Safety Precautions
If this medication is swallowed, call a doctor or poison control center immediately, as it may cause harm. Women who are pregnant or plan to become pregnant should consult their doctor, as this medication may harm the unborn baby. If you are breastfeeding, inform your doctor, as you will need to discuss potential risks to your baby.
Before taking this medication, inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug. If you have a fish allergy, consult your doctor, as some products contain fish protein.
Administration and Usage
It may take several weeks to experience the full effects of this medication. To minimize the risk of severe side effects, adhere to your doctor's instructions regarding dosage, frequency, and duration of use. Do not exceed the recommended dose, and do not use this medication more frequently or for a longer period than prescribed.
Skin Precautions
Avoid applying this medication to sunburned skin, cuts, scrapes, eczema, or damaged skin. Practice good skin care and limit sun exposure to prevent further irritation. You may be more susceptible to sunburn while using this medication, so take necessary precautions:
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 guidance on protecting your skin
Additionally, avoid contact with lime peels, as they may cause further irritation.
Interactions with Other Skin Products
Using other skin products while taking this medication may increase the risk of irritation. Consult your doctor before using any other drugs or products on your skin, including soaps. If you experience dry skin, you may use a moisturizer; however, consult your doctor or pharmacist to determine the best type of moisturizer to use. You may use makeup unless your doctor has advised against it; if you do use makeup, clean the treatment area before applying this medication.
Safety Precautions
If this medication is swallowed, call a doctor or poison control center immediately, as it may cause harm. Women who are pregnant or plan to become pregnant should consult their doctor, as this medication may harm the unborn baby. If you are breastfeeding, inform your doctor, as you will need to discuss potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Severe local irritation (redness, peeling, discomfort)
What to Do:
Topical overdose is unlikely to cause systemic toxicity due to minimal absorption. If excessive application occurs, discontinue use temporarily until irritation subsides. If accidentally ingested, seek medical attention. For general overdose concerns, call 1-800-222-1222 (Poison Control).
Drug Interactions
Moderate Interactions
- Topical products containing sulfur, resorcinol, or salicylic acid (may cause excessive irritation)
- Astringents, medicated soaps or cleansers, abrasive soaps or cleansers, products with strong drying effect (e.g., alcohol-containing products)
- Products containing alpha hydroxy acids (AHAs) or glycolic acid
- Other topical acne preparations (e.g., benzoyl peroxide, clindamycin, erythromycin) - use with caution and consider staggered application times to minimize irritation.
Minor Interactions
- Cosmetics or soaps that are highly irritating or drying
- Photosensitizing agents (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines) - increased risk of sunburn.
Monitoring
Baseline Monitoring
Skin assessment (type, condition, presence of lesions, sensitivity)
Rationale: To establish baseline skin health and identify potential contraindications or areas requiring special care.
Timing: Prior to initiation of therapy
Patient education on proper application and expected side effects
Rationale: To ensure patient adherence and manage expectations regarding initial irritation and delayed onset of action.
Timing: Prior to initiation of therapy
Routine Monitoring
Skin irritation (erythema, peeling, dryness, burning, stinging)
Frequency: Weekly for first few weeks, then as needed
Target: Mild to moderate irritation is expected; severe irritation is not.
Action Threshold: If severe irritation occurs, reduce frequency of application or temporarily discontinue until irritation subsides. Re-evaluate concentration if persistent.
Therapeutic response (reduction in acne lesions)
Frequency: Monthly for first 3-6 months, then every 3-6 months
Target: Gradual improvement over 6-12 weeks.
Action Threshold: If no improvement after 12 weeks, re-evaluate diagnosis and treatment plan.
Sun exposure and use of sun protection
Frequency: Ongoing
Target: Consistent use of sunscreen (SPF 15+) and protective clothing.
Action Threshold: Increased sun sensitivity; advise strict sun avoidance and protection.
Symptom Monitoring
- Excessive redness
- Severe peeling or flaking
- Intense burning or stinging
- Swelling
- Crusting
- Blistering
- Itching
- Dryness
Special Patient Groups
Pregnancy
Tretinoin topical is Pregnancy Category C. While systemic absorption is minimal, oral tretinoin (isotretinoin) is a known teratogen. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Advise women of childbearing potential to use effective contraception during treatment.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though risk with topical use is considered low due to minimal systemic absorption. Avoid if possible.
Second Trimester:
Risk considered low due to minimal systemic absorption.
Third Trimester:
Risk considered low due to minimal systemic absorption.
Lactation
It is not known whether tretinoin is excreted in human milk. Due to minimal systemic absorption, it is generally considered compatible with breastfeeding, 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 efficacy have not been established in pediatric patients younger than 12 years of age. Use in adolescents (12 years and older) is common for acne treatment.
Geriatric Use
No specific dose adjustments are necessary. However, geriatric patients may have more fragile or sensitive skin, potentially leading to increased irritation. Use with caution and monitor for adverse skin reactions.
Clinical Information
Clinical Pearls
- Start with a lower concentration (e.g., 0.025%) and gradually increase as tolerated, if needed, to minimize irritation.
- The 'retinization' period (initial irritation, redness, peeling) is common and typically lasts 2-4 weeks. Patient education is crucial to ensure adherence during this phase.
- 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.
- Consistent daily use is key for efficacy; skipping doses will delay results.
- Emphasize strict sun protection (sunscreen SPF 15+ and protective clothing) as tretinoin increases photosensitivity.
- Avoid concomitant use of other topical irritants or drying agents unless specifically advised by a healthcare professional.
Alternative Therapies
- Adapalene (Differin) - another topical retinoid, often better tolerated
- Tazarotene (Tazorac) - another topical retinoid, more potent
- 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 (topical)
Cost & Coverage
Average Cost:
$50 - $200+ per 15gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (generic often Tier 1)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.