Tretinoin Micro 0.1% Gel Pump 50gm
It is used to treat pimples (acne).
Drug Class
Anti-acne agent
Pharmacologic Class
Retinoid; Vitamin A derivative
Pregnancy Category
Category C
FDA Approved
Aug 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tretinoin Micro is a topical gel containing a form of Vitamin A. It works by helping your skin renew itself more quickly and by preventing clogged pores, which helps treat and prevent acne. The 'micro' part means it's designed to release the medicine slowly, which can help reduce skin 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 interference with daily 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 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, away from 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 interference with daily 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 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, away from 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 to clean, dry skin (wait 20-30 minutes after washing).
- Use only a pea-sized amount for the entire face.
- Apply once daily in the evening.
- Avoid contact with eyes, mouth, angles of the nose, and mucous membranes.
- Sun sensitivity is significantly increased; use a broad-spectrum sunscreen (SPF 30 or higher) daily and wear protective clothing when outdoors.
- Avoid excessive sun exposure, sunlamps, and tanning beds.
- Use a gentle, non-comedogenic moisturizer to help manage dryness and irritation.
- Avoid harsh soaps, astringents, or other irritating topical products.
- Do not wax 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 to the entire affected area of the face once daily in the evening, 20-30 minutes after gently washing and drying the skin.
Condition-Specific Dosing:
acne_vulgaris:
Apply a pea-sized amount to the entire affected area of the face once daily in the evening.
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 entire affected area of the face 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 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) in the nucleus, modulating gene expression. This leads to: 1. Normalization of follicular keratinization, preventing microcomedone formation. 2. Increased cell turnover, promoting expulsion of existing comedones. 3. Anti-inflammatory effects. The microsphere formulation of Tretinoin Micro allows for a slower, more sustained release of tretinoin, which may reduce local irritation compared to conventional tretinoin formulations.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal (<2% of applied dose) systemic absorption after topical application.
Tmax:
Not well-defined 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 if systemically absorbed (primarily to albumin).
CnssPenetration:
Limited/Not clinically relevant for topical application.
Elimination:
HalfLife:
Not clinically relevant for topical application due to minimal systemic levels.
Clearance:
Not clinically relevant for topical application.
ExcretionRoute:
If systemically absorbed, metabolites are excreted in urine and feces.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen after 2-3 weeks, but full therapeutic effect may take 6-12 weeks.
PeakEffect:
6-12 weeks
DurationOfAction:
Maintained with continued use.
Confidence:
Medium
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 does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice 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.
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 does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice 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 redness, burning, stinging, or itching that does not improve or worsens.
- Excessive peeling or blistering.
- Swelling of the face or lips (signs of allergic reaction).
- Crusting or oozing of the skin.
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.
Skin conditions, including sunburn, sensitivity to light, or other skin problems.
Any medications you are taking 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 all of your:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Health problems
with your doctor and pharmacist to ensure safe use. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm 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.
Skin conditions, including sunburn, sensitivity to light, or other skin problems.
Any medications you are taking 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 all of your:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Health problems
with your doctor and pharmacist to ensure safe use. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm 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, 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 use. 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 a broad-spectrum sunscreen and lip balm with a Sun Protection Factor (SPF) of 15 or higher, and wear protective clothing and eyewear.
Certain environmental conditions, such as cold and wind, may irritate your skin. Consult your doctor or pharmacist for guidance on protecting your skin in these situations. Additionally, avoid contact with lime peels, as they may cause irritation.
Using other skin products in conjunction with this medication may increase the risk of irritation. Before using any other skin products, including soaps, consult your doctor to ensure safe use. 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. If you plan to use makeup, clean the treatment area thoroughly before applying this medication.
In the event that this medication is swallowed, 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.
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 use. 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 a broad-spectrum sunscreen and lip balm with a Sun Protection Factor (SPF) of 15 or higher, and wear protective clothing and eyewear.
Certain environmental conditions, such as cold and wind, may irritate your skin. Consult your doctor or pharmacist for guidance on protecting your skin in these situations. Additionally, avoid contact with lime peels, as they may cause irritation.
Using other skin products in conjunction with this medication may increase the risk of irritation. Before using any other skin products, including soaps, consult your doctor to ensure safe use. 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. If you plan to use makeup, clean the treatment area thoroughly before applying this medication.
In the event that this medication is swallowed, 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:
- Topical overdose is unlikely to cause systemic symptoms due to minimal absorption.
- Local symptoms may include severe redness, peeling, and discomfort.
What to Do:
If excessive application occurs, wash the area with mild soap and water. Symptomatic treatment for local irritation. In case of accidental ingestion, contact a poison control center immediately. Call 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Not available
Major Interactions
- Not available
Moderate Interactions
- Other topical preparations that are highly irritating, strong astringents, medicated soaps or cleansers, products containing alcohol, sulfur, resorcinol, or salicylic acid (may increase irritation).
- Products containing alpha hydroxy acids (AHAs) or beta hydroxy acids (BHAs)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Skin condition and acne severity
Rationale: To establish baseline for treatment efficacy and tolerability.
Timing: Prior to initiation of therapy.
Routine Monitoring
Local skin irritation (erythema, scaling, dryness, burning, stinging, pruritus)
Frequency: Regularly during initial weeks of therapy and as needed.
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 weeks to months.
Action Threshold: Lack of improvement after 12 weeks: re-evaluate diagnosis or treatment plan.
Symptom Monitoring
- Dryness
- Peeling/Scaling
- Redness (Erythema)
- Burning sensation
- Stinging sensation
- Itching (Pruritus)
- Swelling
- Blistering
- Crusting
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 with topical application, caution is advised. Oral retinoids (e.g., isotretinoin) are highly teratogenic (Category X).
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm, though systemic absorption is minimal. Avoid if possible.
Second Trimester:
Potential for fetal harm, though systemic absorption is minimal. Avoid if possible.
Third Trimester:
Potential for fetal harm, though systemic absorption is minimal. Avoid if possible.
Lactation
L3 (Moderate risk). It is not known whether tretinoin is excreted in human milk after topical application. Due to minimal systemic absorption, infant exposure is expected to be low. However, caution should be exercised. 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 infant due to minimal systemic absorption, but potential for direct exposure if applied to areas accessible to the infant.
Pediatric Use
Safety and effectiveness have been established in pediatric patients 12 years of age and older. Use in children younger than 12 years has not been established.
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 dose adjustments are recommended, but older patients may have more fragile or sensitive skin and may experience increased irritation.
Clinical Information
Clinical Pearls
- Patients may experience a 'purging' phase during the first few weeks of treatment, where acne may appear to worsen before improving. This is normal and indicates the medication is working.
- Consistency is key; encourage daily application even if initial irritation occurs (unless severe).
- Emphasize strict sun protection due to increased photosensitivity.
- Advise patients to use a gentle, non-comedogenic cleanser and moisturizer to minimize dryness and irritation.
- Avoid applying to eczematous, sunburned, or broken skin.
- Results are not immediate; patience and adherence to the regimen are crucial for success.
Alternative Therapies
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe, recalcitrant acne)
- Hormonal therapies (e.g., oral contraceptives, spironolactone)
- Chemical peels
- Laser therapy
Cost & Coverage
Average Cost:
$100 - $500+ per 50gm pump
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (preferred or non-preferred brand/generic). Coverage 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 details. 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 emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.