Tretinoin 0.01% Gel 45gm
It is used to treat pimples (acne).
Drug Class
Antiacne Agent; Keratolytic
Pharmacologic Class
Retinoid
Pregnancy Category
Category D
FDA Approved
Apr 1971
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tretinoin is a topical medication, a form of Vitamin A, used to treat acne and reduce the appearance of fine wrinkles and rough skin caused by sun damage. It works by helping the skin renew itself more quickly and by unclogging pores.
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, following these steps:
1. Wash your hands before and after use.
2. Gently wash the affected skin area 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 regular application schedule. Do not apply a double dose or 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 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, following these steps:
1. Wash your hands before and after use.
2. Gently wash the affected skin area 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 regular application schedule. Do not apply a double dose or extra doses to make up for the missed one.
Lifestyle & Tips
- Apply only a pea-sized amount to the entire affected area, not just individual spots.
- Apply once daily, preferably at bedtime, to clean, dry skin.
- Avoid contact with eyes, mouth, angles of the nose, and mucous membranes.
- Sun protection is CRITICAL: 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.
- Avoid waxing on treated areas as it can cause severe irritation or skin tearing.
- Do not use other topical products that may cause irritation (e.g., abrasive soaps, astringents, products with high alcohol content, or other acne medications like benzoyl peroxide or salicylic acid, unless directed by your doctor). If using other topical acne treatments, apply them at a different time of day.
- Initial worsening of acne (purging) is common during the first few weeks of treatment; continue use as directed.
- Be patient; it may take 6-12 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 pea-sized amount to the affected area once daily at bedtime.
Condition-Specific Dosing:
acne vulgaris:
Apply a thin layer to the entire affected area (not just individual lesions) once daily at bedtime.
photoaging:
Apply a thin layer to the entire affected area once daily at bedtime.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (safety and efficacy not established in children younger than 12 years)
Adolescent:
Apply a pea-sized amount to the affected area once daily at bedtime (typically for ages 12 and older).
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed due to minimal systemic absorption.
Moderate:
No specific adjustment needed due to minimal systemic absorption.
Severe:
No specific adjustment needed due to minimal systemic absorption.
Dialysis:
No specific adjustment needed due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment needed due to minimal systemic absorption.
Moderate:
No specific adjustment needed due to minimal systemic absorption.
Severe:
No specific adjustment needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Tretinoin is a retinoid that binds to specific retinoic acid receptors (RARs) in the nucleus, including RAR-alpha, RAR-beta, and RAR-gamma. This binding modulates gene expression, leading to altered cellular differentiation, proliferation, and inflammation. In acne, it reduces follicular occlusion by decreasing cohesion of follicular epithelial cells and stimulating mitotic activity and increased turnover of follicular epithelial cells. This promotes extrusion of comedones and prevents formation of new ones. It also has anti-inflammatory effects. In photoaging, it affects collagen synthesis and epidermal thickness.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (<2%) from topical application.
Tmax:
Not well-defined for topical application due to minimal systemic absorption; peak plasma concentrations are very low.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not clinically significant for topical application.
ProteinBinding:
Highly protein bound (>95%) if systemically absorbed.
CnssPenetration:
Limited (not clinically significant for topical application).
Elimination:
HalfLife:
Not clinically significant for topical application due to minimal systemic absorption (systemic half-life is approximately 0.7 hours if absorbed).
Clearance:
Not clinically significant for topical application.
ExcretionRoute:
Primarily renal and biliary excretion if systemically absorbed.
Unchanged:
Very little unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen after 2-3 weeks, but optimal results may take 6-12 weeks.
PeakEffect:
Optimal therapeutic effect usually observed after 6-12 weeks of continuous use.
DurationOfAction:
Effects persist as long as treatment is continued; relapse may occur upon discontinuation.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
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 is 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 if they bother you or persist, contact your doctor for guidance:
Feeling of warmth
Burning or stinging
Change in skin color
Skin reactions, such as:
+ 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, don't hesitate to reach out to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
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 is 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 if they bother you or persist, contact your doctor for guidance:
Feeling of warmth
Burning or stinging
Change in skin color
Skin reactions, such as:
+ 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, don't hesitate to reach out to 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, burning, stinging, or peeling that is intolerable or persistent.
- Blistering or crusting of the skin.
- Swelling of the treated area.
- Signs of an allergic reaction (e.g., 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. Describe the symptoms you experienced with the allergy.
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.
Pregnancy, as this is a crucial factor in determining the safety of this medication for you.
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 existing health problems
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. Describe the symptoms you experienced with the allergy.
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.
Pregnancy, as this is a crucial factor in determining the safety of this medication for you.
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 existing health problems
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
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, discuss this with your doctor, as some products contain fish protein.
You may not notice the full effects of this medication for several weeks. To minimize the risk of severe side effects, it is crucial to follow your doctor's instructions regarding dosage and frequency of use. Do not exceed the recommended dose, and do not use the medication more often or for a longer period than prescribed.
When applying this medication, avoid using it on sunburned skin, cuts, scrapes, eczema, or damaged skin. Instead, 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 recommended to avoid direct sunlight, sunlamps, and tanning beds. When going outside, use sunscreen and lip balm with a Sun Protection Factor (SPF) of 15 or higher, and wear protective clothing and eyewear. 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, be cautious when handling limes, as contact with the peels may cause irritation. Using other skin products in conjunction with this medication may increase the risk of irritation, so it is essential to discuss any other skin products or medications with your doctor before use. This includes soaps and other cleansers.
If you experience dry skin while using this medication, you may use a moisturizer. However, consult your doctor or pharmacist to determine the most suitable type of moisturizer for your skin. You can use makeup unless your doctor has advised against it; if you do use makeup, ensure the area to be treated is clean before applying the medication.
In case of accidental ingestion, this medication can be harmful. If you swallow this medication, immediately contact a doctor or 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, discuss the potential risks to your baby with your doctor.
You may not notice the full effects of this medication for several weeks. To minimize the risk of severe side effects, it is crucial to follow your doctor's instructions regarding dosage and frequency of use. Do not exceed the recommended dose, and do not use the medication more often or for a longer period than prescribed.
When applying this medication, avoid using it on sunburned skin, cuts, scrapes, eczema, or damaged skin. Instead, 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 recommended to avoid direct sunlight, sunlamps, and tanning beds. When going outside, use sunscreen and lip balm with a Sun Protection Factor (SPF) of 15 or higher, and wear protective clothing and eyewear. 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, be cautious when handling limes, as contact with the peels may cause irritation. Using other skin products in conjunction with this medication may increase the risk of irritation, so it is essential to discuss any other skin products or medications with your doctor before use. This includes soaps and other cleansers.
If you experience dry skin while using this medication, you may use a moisturizer. However, consult your doctor or pharmacist to determine the most suitable type of moisturizer for your skin. You can use makeup unless your doctor has advised against it; if you do use makeup, ensure the area to be treated is clean before applying the medication.
In case of accidental ingestion, this medication can be harmful. If you swallow this medication, immediately contact a doctor or 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, discuss the potential risks to your baby with your doctor.
Overdose Information
Overdose Symptoms:
- Excessive redness, peeling, and discomfort of the skin (topical overdose).
- Systemic overdose is highly unlikely with topical application due to minimal absorption, but theoretical symptoms could include headache, nausea, vomiting, and severe irritation of mucous membranes if ingested.
What to Do:
For topical overdose, discontinue use temporarily and allow skin to recover. For accidental ingestion, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222).
Drug Interactions
Moderate Interactions
- Topical products containing sulfur, resorcinol, salicylic acid, or benzoyl peroxide (may cause excessive irritation if used concurrently or immediately after tretinoin; use with caution or at different times of day).
- Astringents, abrasive soaps, medicated cleansers, or peeling agents (may increase irritation).
Minor Interactions
- Cosmetics or soaps with strong drying effects (may exacerbate dryness/irritation).
- Products containing alcohol, spices, or lime (may cause stinging/burning).
Monitoring
Baseline Monitoring
Skin assessment (type, condition, presence of lesions, irritation)
Rationale: To establish baseline skin health and identify potential sensitivities or contraindications.
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin irritation (erythema, scaling, dryness, burning, stinging)
Frequency: Daily/Weekly during initial weeks, then as needed.
Target: Mild to moderate irritation is common and expected; severe irritation warrants dose adjustment or temporary discontinuation.
Action Threshold: Severe or persistent irritation: reduce frequency of application, temporarily discontinue, or consult prescriber.
Therapeutic response (reduction in acne lesions, improvement in skin texture)
Frequency: Monthly or every 2-3 months.
Target: Gradual improvement over weeks to months.
Action Threshold: No improvement after 12 weeks: re-evaluate diagnosis or treatment plan.
Symptom Monitoring
- Excessive dryness or peeling of skin
- Severe redness or inflammation
- Burning or stinging sensation that is intolerable
- Swelling or blistering
- Increased sensitivity to sunlight
Special Patient Groups
Pregnancy
Tretinoin is classified as Pregnancy Category D. While systemic absorption from topical application is minimal, retinoids are known teratogens. Use is generally contraindicated during pregnancy. Women of childbearing potential should use effective contraception during treatment.
Trimester-Specific Risks:
First Trimester:
Highest risk of teratogenicity; contraindicated.
Second Trimester:
Risk remains; contraindicated.
Third Trimester:
Risk remains; contraindicated.
Lactation
Minimal systemic absorption is expected with topical application, making infant exposure unlikely. However, caution is advised. It is generally recommended to avoid applying tretinoin to areas where the infant may come into direct contact with the medication (e.g., breast area). Consult with a healthcare provider.
Infant Risk:
Low risk, but theoretical concern due to retinoid class. Monitor infant for any adverse effects.
Pediatric Use
Safety and efficacy have not been established in children younger than 12 years of age. It is commonly used in adolescents (12 years and older) for acne vulgaris, with similar dosing and precautions as adults.
Geriatric Use
No specific dose adjustments are required. Tretinoin is often used in older adults for photoaging. Geriatric patients may have more fragile skin and may experience increased irritation, requiring careful monitoring and potentially less frequent application.
Clinical Information
Clinical Pearls
- The 'purging' phase (initial worsening of acne) is common and expected during the first few weeks of treatment; patients should be counseled to continue use.
- Consistency is key; daily application is necessary for optimal results.
- A pea-sized amount is sufficient for the entire face; using more will not speed up results and will likely increase irritation.
- Always apply to dry skin, typically 20-30 minutes after washing the face.
- Emphasize strict sun protection due to increased photosensitivity.
- Start with a lower concentration (like 0.01% gel) and gradually increase if tolerated and needed, to minimize irritation.
- Moisturizer can be applied after tretinoin has absorbed to help manage dryness, but avoid heavy, occlusive moisturizers immediately after application.
Alternative Therapies
- Other topical retinoids (e.g., Adapalene, Tazarotene)
- Topical antibiotics (e.g., Clindamycin, Erythromycin)
- Topical benzoyl peroxide
- Topical salicylic acid
- Oral antibiotics (e.g., Doxycycline, Minocycline)
- Oral isotretinoin (for severe, recalcitrant acne)
- Hormonal therapies (e.g., Spironolactone, Oral Contraceptives for hormonal acne)
Cost & Coverage
Average Cost:
Varies widely, typically $30 - $200+ per 45gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 for generic; Tier 3 or higher for brand-name products.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.