Tretinoin 0.01% Gel 15gm
It is used to treat pimples (acne).
Drug Class
Antiacne Agent; Keratolytic
Pharmacologic Class
Retinoid
Pregnancy Category
Category C
FDA Approved
May 1971
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tretinoin is a medication applied to the skin to treat acne. It works by helping your skin cells turn over more quickly, which helps to unclog pores and reduce acne breakouts. It can also help to reduce inflammation.
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 ingest it or apply it to your mouth, nose, or eyes, as it may cause burning.
If you accidentally get the medication in your mouth, nose, or eyes, rinse the area thoroughly with water.
Apply the medication at bedtime to minimize potential irritation.
Before and after applying the medication, wash your hands thoroughly to prevent the spread of infection.
Gently wash the affected skin area 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 the affected area before applying the medication. Consult with your pharmacist for specific guidance on using this medication.
Apply a thin layer of the medication to the affected skin area and gently rub it in.
Important Safety Precautions
This medication is flammable, so avoid using it near open flames or while smoking.
Storage and Disposal
Store all products at room temperature, avoiding freezing temperatures.
Missed Dose Instructions
If you miss a dose, skip it and resume your regular 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 ingest it or apply it to your mouth, nose, or eyes, as it may cause burning.
If you accidentally get the medication in your mouth, nose, or eyes, rinse the area thoroughly with water.
Apply the medication at bedtime to minimize potential irritation.
Before and after applying the medication, wash your hands thoroughly to prevent the spread of infection.
Gently wash the affected skin area 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 the affected area before applying the medication. Consult with your pharmacist for specific guidance on using this medication.
Apply a thin layer of the medication to the affected skin area and gently rub it in.
Important Safety Precautions
This medication is flammable, so avoid using it near open flames or while smoking.
Storage and Disposal
Store all products at room temperature, avoiding freezing temperatures.
Missed Dose Instructions
If you miss a dose, skip it and resume your regular application schedule. Do not apply a double dose or extra doses to make up for the missed dose.
Lifestyle & Tips
- Apply only a pea-sized amount to the entire affected area, not just individual pimples.
- Apply to clean, dry skin, usually at bedtime.
- Avoid contact with eyes, mouth, angles of the nose, and mucous membranes.
- Sun sensitivity is significantly increased; use broad-spectrum sunscreen (SPF 30 or higher) daily and wear protective clothing when outdoors. Avoid excessive sun exposure and tanning beds.
- Initial worsening of acne (purging) is common during the first few weeks of treatment; continue use as directed.
- Skin dryness, redness, and peeling are common side effects, especially during the first few weeks. Use a non-comedogenic moisturizer to help manage dryness.
- Avoid using other irritating topical products (e.g., harsh soaps, astringents, other acne treatments like benzoyl peroxide or salicylic acid) unless directed by your doctor, as this can increase irritation.
- Be patient; it can take 8-12 weeks to see significant improvement.
Available Forms & Alternatives
Available Strengths:
- Tretinoin 0.025% Cream 45gm
- Tretinoin Micro 0.1% Gel 20gm
- Tretinoin Micro 0.1% Gel 45gm
- Tretinoin Micro 0.1% Gel Pump 50gm
- Tretinoin Micro 0.04% Gel Pump 50gm
- Tretinoin Micro 0.04% Gel 45gm
- Tretinoin Micro 0.04% Gel 20gm
- Tretinoin 10mg Capsules
- Tretinoin 0.01% Gel 45gm
- Tretinoin 0.1% Cream 45gm
- Tretinoin 0.05% Cream 45gm
- Tretinoin 0.05% Gel 45gm
- Tretinoin 0.025% Gel 45gm
- Tretinoin 0.01% Gel 15gm
- Tretinoin 0.025% Gel 15gm
- Tretinoin 0.05% Cream 20gm
- Tretinoin 0.025% Cream 20gm
- Tretinoin 0.1% Cream 20gm
- Tretinoin 0.08% Gel Pump 50gm
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer of Tretinoin 0.01% Gel to the affected areas once daily at bedtime, after washing the face with a mild soap and drying thoroughly.
Condition-Specific Dosing:
acne vulgaris:
Apply once daily at bedtime.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 12 years.
Adolescent:
For adolescents 12 years and older, apply a thin layer to affected areas once daily at bedtime.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption).
Moderate:
No adjustment needed (minimal systemic absorption).
Severe:
No adjustment needed (minimal systemic absorption).
Dialysis:
No specific considerations (minimal systemic absorption).
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption).
Moderate:
No adjustment needed (minimal systemic absorption).
Severe:
No adjustment needed (minimal systemic absorption).
Pharmacology
Mechanism of Action
Tretinoin is a retinoid that binds to specific retinoic acid receptors (RARs) located in the nucleus of target cells (RAR-alpha, RAR-beta, and RAR-gamma). This binding modulates gene expression, leading to altered cellular differentiation, proliferation, and intercellular adhesion. In acne, tretinoin reduces the cohesion of follicular epithelial cells, leading to increased shedding and expulsion of comedones. It also increases epidermal cell turnover, promoting the replacement of existing comedones with new, less comedogenic cells. Additionally, tretinoin has anti-inflammatory properties.
Pharmacokinetics
Absorption:
Bioavailability:
< 5% (systemic absorption after topical application)
Tmax:
Not well-defined for topical application; systemic levels, if detectable, peak within hours.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not well-quantified for topical application due to minimal systemic absorption.
ProteinBinding:
Highly protein bound (>95%) if systemically absorbed.
CnssPenetration:
Limited (minimal systemic absorption).
Elimination:
HalfLife:
Not well-defined for topical application; systemic half-life is approximately 0.7 hours if absorbed.
Clearance:
Rapid if systemically absorbed.
ExcretionRoute:
Primarily renal and biliary if systemically absorbed.
Unchanged:
Negligible
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically observed after 2-3 weeks, but optimal results may take 8-12 weeks.
PeakEffect:
Optimal therapeutic effect usually seen after 8-12 weeks of continuous use.
DurationOfAction:
Effects persist as long as treatment is continued; cessation may lead to recurrence of acne.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Severe skin reactions that are bothersome or persistent
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. 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 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, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Severe skin reactions that are bothersome or persistent
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. 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 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, 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 or swelling
- Blistering or crusting of the skin
- Allergic reaction symptoms (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat - seek immediate medical attention)
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 conditions.
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. This will help ensure your safety while taking this medication. 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.
If you have a sunburn, skin sensitivity to light, or any other skin conditions.
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. This will help ensure your safety while taking this medication. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you have a fish allergy, consult your doctor before using this product, as some formulations may contain fish protein.
Please note that it may take several weeks to experience the full effects of this medication. To minimize the risk of severe side effects, adhere strictly to your doctor's instructions regarding dosage and frequency of application. Do not exceed the recommended amount or use it more frequently or for a longer duration than prescribed.
When applying this medication, avoid using it on sunburned skin, cuts, scrapes, eczema, or damaged skin. Instead, practice good skin care and limit your sun exposure. You may be more susceptible to sunburn while using this medication, so take precautions to protect your skin. Avoid direct sunlight, sunlamps, and tanning beds, and use a broad-spectrum sunscreen and lip balm with an SPF of 15 or higher when outdoors. Wear protective clothing and eyewear to shield your skin from the sun. Additionally, 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 situations.
Be cautious when handling limes, as the peels may cause irritation. Using other skin products concurrently with this medication may increase the risk of irritation, so consult your doctor before using any other products, including soaps. If you experience dry skin, you may use a moisturizer, but consult your doctor or pharmacist to determine the best type to use. You can use makeup unless your doctor has advised against it; however, ensure the area is clean before applying this medication.
In case of accidental ingestion, seek immediate medical attention or contact a poison control center. If you are pregnant or plan to become pregnant, inform your doctor, as this medication may harm the unborn baby. If you are breastfeeding, consult your doctor to discuss any potential risks to your baby.
Please note that it may take several weeks to experience the full effects of this medication. To minimize the risk of severe side effects, adhere strictly to your doctor's instructions regarding dosage and frequency of application. Do not exceed the recommended amount or use it more frequently or for a longer duration than prescribed.
When applying this medication, avoid using it on sunburned skin, cuts, scrapes, eczema, or damaged skin. Instead, practice good skin care and limit your sun exposure. You may be more susceptible to sunburn while using this medication, so take precautions to protect your skin. Avoid direct sunlight, sunlamps, and tanning beds, and use a broad-spectrum sunscreen and lip balm with an SPF of 15 or higher when outdoors. Wear protective clothing and eyewear to shield your skin from the sun. Additionally, 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 situations.
Be cautious when handling limes, as the peels may cause irritation. Using other skin products concurrently with this medication may increase the risk of irritation, so consult your doctor before using any other products, including soaps. If you experience dry skin, you may use a moisturizer, but consult your doctor or pharmacist to determine the best type to use. You can use makeup unless your doctor has advised against it; however, ensure the area is clean before applying this medication.
In case of accidental ingestion, seek immediate medical attention or contact a poison control center. If you are pregnant or plan to become pregnant, inform your doctor, as this medication may harm the unborn baby. If you are breastfeeding, consult your doctor to discuss any potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Excessive redness, peeling, and discomfort if too much is applied topically.
- Systemic toxicity from topical overdose is highly unlikely due to minimal absorption, but theoretical symptoms could include headache, nausea, vomiting, and hypervitaminosis A symptoms if massive amounts were ingested or absorbed.
What to Do:
For topical overdose, wash the area with mild soap and water. For accidental ingestion, contact a poison control center immediately (Call 1-800-222-1222 in the US). Management is supportive.
Drug Interactions
Moderate Interactions
- Topical products containing sulfur, resorcinol, salicylic acid, or benzoyl peroxide (may increase irritation)
- Abrasive soaps, cleansers, or cosmetics with strong drying effects
- Products containing alcohol, astringents, spices, or lime (may cause stinging or drying)
- Medications with known photosensitizing effects (e.g., tetracyclines, fluoroquinolones, thiazide diuretics) - theoretical increased risk of photosensitivity
Minor Interactions
- Wax epilation (may cause skin tearing or irritation on treated skin)
- Other topical preparations that may cause irritation or dryness
Monitoring
Baseline Monitoring
Skin assessment (type, severity of acne, presence of irritation)
Rationale: To establish baseline condition and guide treatment plan.
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin irritation (erythema, scaling, dryness, burning, stinging)
Frequency: Regularly, especially during the first few weeks of treatment.
Target: Minimal to mild irritation; severe irritation warrants dose adjustment or temporary discontinuation.
Action Threshold: If severe irritation occurs, reduce frequency of application or temporarily discontinue until irritation subsides. Consult healthcare provider.
Therapeutic response (reduction in acne lesions)
Frequency: Monthly or as clinically indicated.
Target: Gradual improvement in acne lesions over 8-12 weeks.
Action Threshold: If no improvement after 12 weeks, re-evaluate diagnosis or treatment plan.
Symptom Monitoring
- Excessive redness
- Severe peeling or flaking
- Intense burning or stinging
- Swelling of the treated area
- Crusting or blistering
Special Patient Groups
Pregnancy
Tretinoin topical is Pregnancy Category C. While systemic absorption is minimal, oral retinoids are highly teratogenic. Use during pregnancy should be avoided unless the potential benefit justifies the potential risk to the fetus. Discuss risks and benefits with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though risk from topical application is considered low due to minimal systemic absorption. Avoid if possible.
Second Trimester:
Risk considered low due to minimal systemic absorption, but caution advised.
Third Trimester:
Risk considered low due to minimal systemic absorption, but caution advised.
Lactation
Tretinoin is considered L3 (moderately safe) during lactation. Systemic absorption is minimal, making infant exposure unlikely. However, caution is advised. Avoid applying to areas where the infant may come into direct contact with the medication (e.g., breast area).
Infant Risk:
Low risk of adverse effects to the breastfed infant due to minimal systemic absorption and low levels in breast milk, if any.
Pediatric Use
Approved for use in adolescents 12 years and older for acne vulgaris. Safety and efficacy in children younger than 12 years have not been established. Children's skin may be more sensitive to the irritating effects of tretinoin.
Geriatric Use
No specific dose adjustments are necessary. However, geriatric 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 skin reactions.
Clinical Information
Clinical Pearls
- Start with a lower concentration (like 0.01% gel) and gradually increase as tolerated to minimize irritation.
- Apply to completely dry skin (wait 20-30 minutes after washing) to reduce irritation.
- Use a non-comedogenic moisturizer and gentle cleanser to support the skin barrier.
- Consistency is key; results are not immediate and require continuous use for several weeks to months.
- Educate patients about the 'retinization' period (initial worsening of acne and irritation) and encourage them to persevere.
- Emphasize strict sun protection due to increased photosensitivity.
Alternative Therapies
- Adapalene (another topical retinoid, often better tolerated)
- Tazarotene (another topical retinoid, stronger)
- Benzoyl peroxide (topical antibacterial/keratolytic)
- Salicylic acid (topical keratolytic)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe, recalcitrant acne)
- Azelaic acid (topical anti-inflammatory/antibacterial)
Cost & Coverage
Average Cost:
Varies widely, typically $50 - $200+ per 15gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization for brand, generic may be preferred)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.