Tretinoin Micro 0.1% Gel 20gm
It is used to treat pimples (acne).
Drug Class
Antiacne Agent
Pharmacologic Class
Retinoid
Pregnancy Category
Category C
FDA Approved
Aug 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tretinoin Micro 0.1% Gel is a topical medication used to treat acne. It works by helping the skin renew itself more quickly and by preventing pores from becoming clogged. The 'micro' formulation helps to slowly release the medication, which can reduce irritation compared to other forms of tretinoin.
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 interactions with other activities.
Before and after applying the medication, wash your hands thoroughly to prevent cross-contamination.
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 normal application schedule. Do not apply two doses at once or use 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 interactions with other activities.
Before and after applying the medication, wash your hands thoroughly to prevent cross-contamination.
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 normal application schedule. Do not apply two doses at once or use 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 once daily in the evening, before bedtime, to clean, dry skin.
- Avoid contact with eyes, mouth, angles of the nose, and mucous membranes.
- Use a gentle, non-medicated cleanser and moisturizer.
- Strictly avoid sun exposure, including tanning beds. Use broad-spectrum sunscreen (SPF 30 or higher) daily and wear protective clothing (hats, long sleeves) when outdoors, even on cloudy days.
- Initial worsening of acne (purging) is common during the first few weeks of treatment; continue use as directed.
- Do not use if pregnant or planning to become pregnant without consulting a doctor.
- Avoid waxing on treated areas as skin may be more fragile.
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 of Tretinoin Micro 0.1% Gel to the affected areas of the face once daily, in the evening, before bedtime.
Condition-Specific Dosing:
acne_vulgaris:
Apply a thin layer to the entire affected area once daily at bedtime.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 12 years of age.
Adolescent:
For patients 12 years of age and older: Apply a pea-sized amount to the affected areas once daily, in the evening, before 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 metabolite of Vitamin A that binds to specific retinoic acid receptors (RARs) located in the nucleus. These receptor-ligand complexes bind to DNA and modulate gene expression. Tretinoin normalizes the differentiation of follicular epithelial cells, leading to decreased cohesiveness of follicular epithelial cells and reduced formation of microcomedones. It also reduces sebum production and has anti-inflammatory effects.
Pharmacokinetics
Absorption:
Bioavailability:
< 2% (systemic absorption after topical application)
Tmax:
Not well-defined for topical application due to minimal systemic absorption; if absorbed, plasma concentrations peak within 1-2 hours.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not well-defined for topical application due to minimal systemic absorption.
ProteinBinding:
Highly protein bound (>95%) if systemically absorbed.
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
0.5-2 hours (systemic, if absorbed)
Clearance:
Not well-defined for topical application.
ExcretionRoute:
Biliary and renal (if systemically absorbed)
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Initial improvement typically seen within 2-3 weeks, but full therapeutic effects may take 6-12 weeks.
PeakEffect:
6-12 weeks
DurationOfAction:
Effects persist with continued use; 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 medical attention, as they may be signs of a severe and potentially life-threatening 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, 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:
- Feeling of warmth
- Burning or stinging
- Change in skin color
- Skin reactions, including dry skin, redness, swelling, blisters, and peeling
If you develop any skin reactions, consult your doctor. They may advise you to temporarily stop using the drug, adjust the dosage, or change 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 for medical advice. 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 medical attention, as they may be signs of a severe and potentially life-threatening 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, 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:
- Feeling of warmth
- Burning or stinging
- Change in skin color
- Skin reactions, including dry skin, redness, swelling, blisters, and peeling
If you develop any skin reactions, consult your doctor. They may advise you to temporarily stop using the drug, adjust the dosage, or change 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 for medical advice. 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) - 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 sunburned, sensitive, or problematic skin, as this may affect your treatment.
If you are currently taking any medications that could 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 impact your treatment plan.
Additionally, it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This includes any health problems you may have, as they can interact with this medication. To ensure your safety, do not 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. Be sure to describe the symptoms you experienced.
If you have sunburned, sensitive, or problematic skin, as this may affect your treatment.
If you are currently taking any medications that could 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 impact your treatment plan.
Additionally, it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This includes any health problems you may have, as they can interact with this medication. To ensure your safety, do not start, stop, or modify 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.
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 application. Do not exceed the recommended dose, and do not use this medication more frequently or for a longer duration than prescribed.
Avoid applying this medication to 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 crucial to avoid direct sunlight, sunlamps, and tanning beds. When outdoors, 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 their 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 topical products, including soaps. If this medication causes dry skin, 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 while taking this medication, unless your doctor has advised against it. Before applying this medication, clean the treatment area thoroughly. If you accidentally ingest this medication, 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 suspect you may be pregnant while taking this medication, contact your doctor promptly. 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 application. Do not exceed the recommended dose, and do not use this medication more frequently or for a longer duration than prescribed.
Avoid applying this medication to 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 crucial to avoid direct sunlight, sunlamps, and tanning beds. When outdoors, 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 their 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 topical products, including soaps. If this medication causes dry skin, 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 while taking this medication, unless your doctor has advised against it. Before applying this medication, clean the treatment area thoroughly. If you accidentally ingest this medication, 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 suspect you may be pregnant while taking this medication, contact your doctor promptly. 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 systemic toxicity due to minimal absorption. If excessive application occurs, discontinue use temporarily until irritation subsides. If accidentally ingested, seek medical attention or call a poison control center (e.g., 1-800-222-1222).
Drug Interactions
Moderate Interactions
- Topical preparations containing sulfur, resorcinol, or salicylic acid (may cause excessive irritation)
- Astringents, abrasive soaps, cleansers, or cosmetics with strong drying effects (may cause excessive irritation)
- Products containing alcohol, spices, or lime (may cause excessive irritation)
- Other topical acne medications (use with caution due to potential for cumulative irritation)
- Photosensitizing agents (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines) - increased risk of photosensitivity
Monitoring
Baseline Monitoring
Skin condition and acne severity
Rationale: To establish baseline for assessing treatment efficacy and adverse effects.
Timing: Prior to initiation of therapy
Routine Monitoring
Skin irritation (erythema, scaling, dryness, burning, stinging, pruritus)
Frequency: Regularly during treatment, especially during the first few weeks
Target: Mild to moderate irritation is expected; severe irritation warrants dose adjustment or temporary discontinuation.
Action Threshold: Severe or persistent irritation: reduce frequency of application, temporarily discontinue, or switch to lower strength.
Therapeutic response (reduction in acne lesions)
Frequency: Monthly or as clinically indicated
Target: Gradual improvement over 6-12 weeks
Action Threshold: Lack of improvement after 12 weeks may warrant re-evaluation of treatment plan.
Symptom Monitoring
- Redness
- Scaling
- Dryness
- Burning sensation
- Stinging sensation
- Itching
- Peeling
- Photosensitivity (sunburn-like reaction)
Special Patient Groups
Pregnancy
Tretinoin is Pregnancy Category C. While systemic absorption from topical application is minimal, oral retinoids are known teratogens. Use during pregnancy should be avoided unless the potential benefit justifies the potential risk to the fetus. Women of childbearing potential should be advised to use effective contraception during treatment.
Trimester-Specific Risks:
First Trimester:
Theoretical risk of teratogenicity due to known effects of oral retinoids, despite minimal topical absorption.
Second Trimester:
Theoretical risk, though less critical than first trimester for organogenesis.
Third Trimester:
Theoretical risk, but less concern for major malformations.
Lactation
It is not known whether tretinoin is excreted in human milk. Due to the potential for adverse reactions in nursing infants from retinoids, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Minimal systemic absorption suggests low risk, but caution is advised.
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 effectiveness in pediatric patients under 12 years of age have not been established. Use in adolescents (12 years and older) is common and generally well-tolerated.
Geriatric Use
No specific dosage adjustments are recommended for geriatric patients. However, older patients may have more fragile or sensitive skin and may experience increased irritation. Use with caution and monitor for adverse effects.
Clinical Information
Clinical Pearls
- The 'micro' formulation uses microsphere technology to slowly release tretinoin, which can help reduce irritation compared to conventional tretinoin formulations, making it more tolerable for sensitive skin.
- Patients should be educated that initial worsening of acne (purging) is a common and expected part of the treatment process, typically resolving within the first few weeks.
- Strict sun protection is paramount due to increased photosensitivity. This includes daily sunscreen use (SPF 30+), protective clothing, and avoidance of peak sun hours.
- A 'less is more' approach is crucial; applying more than a pea-sized amount does not increase efficacy but significantly increases irritation.
- Advise patients to use a gentle, non-comedogenic moisturizer to help manage dryness and irritation, applying it after the tretinoin has fully absorbed (e.g., 20-30 minutes later).
Alternative Therapies
- Benzoyl peroxide (topical)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe, recalcitrant acne)
- Azelaic acid
- Salicylic acid
Cost & Coverage
Average Cost:
$50 - $200 per 20gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (varies by insurance plan)
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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.