Tretinoin Micro 0.1% Gel 45gm
It is used to treat pimples (acne).
Drug Class
Antiacne agent, topical
Pharmacologic Class
Retinoid
Pregnancy Category
Category C
FDA Approved
Jan 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tretinoin Micro 0.1% Gel is a topical medication used to treat acne. It's a form of Vitamin A that helps your skin renew itself and prevents pores from getting clogged. The 'micro' formulation means it's designed to release the medicine slowly, which can help reduce irritation.
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 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 mild, non-medicated soap and pat it dry before applying the medication. You may need to wait 20 to 30 minutes after washing before applying the medication; consult with your pharmacist for specific guidance.
Apply a thin layer of the medication to the affected skin 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 two doses at the same time 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 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 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 mild, non-medicated soap and pat it dry before applying the medication. You may need to wait 20 to 30 minutes after washing before applying the medication; consult with your pharmacist for specific guidance.
Apply a thin layer of the medication to the affected skin 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 two doses at the same time or use extra doses to make up for the missed dose.
Lifestyle & Tips
- Apply a thin layer to clean, dry skin once daily in the evening.
- Avoid contact with eyes, mouth, angles of the nose, and mucous membranes.
- Use a mild, non-medicated cleanser and moisturizer daily.
- Avoid excessive sun exposure, including sunlamps and tanning beds. Use sunscreen (SPF 30 or higher) and protective clothing when outdoors, even on cloudy days.
- Do not use on sunburned, windburned, dry, chapped, irritated, or broken skin.
- Avoid waxing for hair removal on treated areas, as it may cause severe irritation.
- Be patient; it may take 6-12 weeks to see significant improvement, and acne may worsen initially.
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 Micro 0.1% Gel to the affected areas once daily, in the evening, before bedtime.
Condition-Specific Dosing:
acne vulgaris:
Apply once daily in the evening.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and efficacy not established in pediatric patients under 12 years of age.
Adolescent:
For patients 12 years and older, apply a thin layer to affected areas once daily in the evening.
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 adjustment needed (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) and retinoid X receptors (RXRs) in the nucleus, which then modulate gene expression. In acne, tretinoin reduces the cohesiveness of follicular epithelial cells, leading to decreased microcomedone formation. It also stimulates mitotic activity and increased turnover of follicular epithelial cells, causing extrusion of comedones. Additionally, it has anti-inflammatory effects.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (approximately 1-2% of applied dose).
Tmax:
Not clinically relevant for topical application due to minimal systemic absorption.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not clinically relevant for topical application.
ProteinBinding:
Highly protein bound (primarily to albumin) if systemically absorbed, but systemic levels are negligible.
CnssPenetration:
Limited (due to minimal systemic absorption).
Elimination:
HalfLife:
Systemic half-life is approximately 0.7 hours for endogenous tretinoin; not clinically relevant for topical application.
Clearance:
Rapid systemic clearance if absorbed; not clinically relevant for topical application.
ExcretionRoute:
Primarily renal and biliary excretion if systemically absorbed.
Unchanged:
Minimal unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Initial improvement may be seen within 2-3 weeks, but optimal therapeutic effects typically require 6-12 weeks of continuous use.
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 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
While many people may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects. If you experience any of these or any other side effects that concern 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 experience any skin reactions, discuss them with your doctor, as they may recommend temporarily stopping the medication, adjusting the dosage, or changing the frequency of use.
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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 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
While many people may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects. If you experience any of these or any other side effects that concern 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 experience any skin reactions, discuss them with your doctor, as they may recommend temporarily stopping the medication, adjusting the dosage, or changing the frequency of use.
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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 does not subside.
- Blistering or crusting of the skin.
- Swelling of the face or lips (rare, severe allergic reaction).
- Unusual skin discoloration.
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 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 impact your treatment plan.
This is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to discuss all of your:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Health problems
with your doctor and pharmacist to ensure safe treatment. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have sunburned, sensitive, or problematic skin, as this may affect your treatment.
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 impact your treatment plan.
This is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to discuss all of your:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Health problems
with your doctor and pharmacist to ensure safe treatment. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you have a fish allergy, 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.
Additionally, be aware that certain weather conditions, such as cold and wind, may irritate your skin. Consult with your doctor or pharmacist for guidance on protecting your skin in these conditions. It is also important to avoid contact with lime peels while using this medication.
Using other skin products in conjunction with this medication may increase the risk of irritation. Before using any other skin products, including soaps, consult with your doctor. If you experience dry skin as a result of using this medication, you may use a moisturizer. However, it is recommended to discuss the type of moisturizer to use with your doctor or pharmacist.
You can use makeup while taking this medication, unless your doctor has advised against it. If you do plan to use makeup, ensure that you clean the area to be treated before applying the medication.
In case of accidental ingestion, this medication can be harmful. If you swallow this medication, immediately contact a doctor or a poison control center.
If you are pregnant or plan to become pregnant, it is essential to discuss the potential risks with your doctor, as this medication may harm the unborn baby. If you suspect you may be pregnant or are planning to become pregnant while taking this medication, contact your doctor right away.
If you are breastfeeding, inform your doctor, as you will need 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, 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.
Additionally, be aware that certain weather conditions, such as cold and wind, may irritate your skin. Consult with your doctor or pharmacist for guidance on protecting your skin in these conditions. It is also important to avoid contact with lime peels while using this medication.
Using other skin products in conjunction with this medication may increase the risk of irritation. Before using any other skin products, including soaps, consult with your doctor. If you experience dry skin as a result of using this medication, you may use a moisturizer. However, it is recommended to discuss the type of moisturizer to use with your doctor or pharmacist.
You can use makeup while taking this medication, unless your doctor has advised against it. If you do plan to use makeup, ensure that you clean the area to be treated before applying the medication.
In case of accidental ingestion, this medication can be harmful. If you swallow this medication, immediately contact a doctor or a poison control center.
If you are pregnant or plan to become pregnant, it is essential to discuss the potential risks with your doctor, as this medication may harm the unborn baby. If you suspect you may be pregnant or are planning to become pregnant while taking this medication, contact your doctor right away.
If you are breastfeeding, inform your doctor, as you will need to discuss any potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Excessive redness
- Severe peeling
- Discomfort
What to Do:
Topical overdose is unlikely to cause systemic toxicity due to minimal absorption. If excessive application occurs, wash the area with mild soap and water. Symptomatic treatment for irritation (e.g., emollients) may be used. If accidentally ingested, seek medical attention. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Moderate Interactions
- Topical products containing sulfur, resorcinol, salicylic acid, or benzoyl peroxide (may cause excessive irritation).
- Astringents, abrasive soaps, medicated cleansers, or other drying agents (may cause excessive irritation).
- Products containing alcohol, spices, or lime (may cause excessive irritation).
Minor Interactions
- Photosensitizing agents (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines) - increased risk of photosensitivity.
Monitoring
Baseline Monitoring
Skin assessment (type, sensitivity, baseline acne severity)
Rationale: To establish a baseline for treatment efficacy and to identify potential for irritation.
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin irritation (erythema, scaling, dryness, burning, stinging)
Frequency: Daily during initial weeks, then as needed.
Target: Minimal to mild irritation.
Action Threshold: Severe or persistent irritation may require temporary discontinuation or reduction in frequency.
Acne lesion count and severity
Frequency: Every 4-6 weeks during initial treatment, then every 3-6 months.
Target: Reduction in inflammatory and non-inflammatory lesions.
Action Threshold: Lack of improvement after 12 weeks may warrant re-evaluation of treatment plan.
Symptom Monitoring
- Excessive dryness
- Peeling/flaking
- Redness
- Stinging/burning sensation
- Itching
- Swelling
- Blistering/crusting (rare, severe reaction)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy should be avoided unless the potential benefit justifies the potential risk to the fetus. While systemic absorption is minimal, there have been rare reports of birth defects associated with topical tretinoin use, though a causal relationship has not been established. Oral retinoids are highly teratogenic.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though low risk with topical use due to minimal absorption.
Second Trimester:
Lower theoretical risk compared to first trimester, but still generally avoided.
Third Trimester:
Lower theoretical risk compared to first trimester, but still generally avoided.
Lactation
L3 (Moderately Safe). It is not known whether tretinoin is excreted in human milk. Due to minimal systemic absorption, infant exposure is expected to be very low. Use with caution; avoid applying to areas where the infant may come into direct contact with the medication (e.g., chest).
Infant Risk:
Low risk of adverse effects due to minimal systemic absorption by the mother and low likelihood of transfer to milk or direct infant exposure.
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 similar to adults.
Geriatric Use
Clinical studies of tretinoin micro gel did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. No specific dosage adjustments are recommended based on age, but older patients may have more fragile or sensitive skin, requiring careful monitoring for irritation.
Clinical Information
Clinical Pearls
- Start with a lower concentration (e.g., 0.025% or 0.04% micro gel) if skin is very sensitive, then titrate up if tolerated and needed.
- The 'micro' formulation is designed to be less irritating than conventional tretinoin creams/gels due to its slow-release properties.
- A 'purging' phase (initial worsening of acne) is common during the first few weeks of treatment; reassure patients this is temporary.
- Apply to completely dry skin (wait 20-30 minutes after washing face) to minimize irritation.
- Use a pea-sized amount for the entire face; more is not better and will increase irritation.
- Consistent daily use is key for efficacy.
- Emphasize strict sun protection due to increased photosensitivity.
Alternative Therapies
- Adapalene (Differin)
- Tazarotene (Tazorac)
- Benzoyl peroxide
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Azelaic acid
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe, recalcitrant acne)
Cost & Coverage
Average Cost:
$150 - $400 per 45gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization for brand, generic may be Tier 1 or 2)
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 taken, the amount, and the time it happened.