Retin-A Micro 0.1% Gel 20gm
It is used to treat pimples (acne).
Drug Class
Antiacne agent; Keratolytic
Pharmacologic Class
Retinoid; Vitamin A derivative
Pregnancy Category
Category C
FDA Approved
Aug 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Retin-A Micro 0.1% Gel is a topical medication containing tretinoin, a form of vitamin A. It works by helping your skin renew itself more quickly, which can clear up acne and reduce the appearance of fine wrinkles. It's applied to the skin, usually once a day in the evening.
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 normal application schedule. Do not apply two doses at the same time or use 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 normal application schedule. Do not apply two doses at the same time or use extra doses to make up for the missed one.
Lifestyle & Tips
- Apply a thin layer to clean, dry skin, usually at night.
- Avoid contact with eyes, mouth, angles of the nose, and mucous membranes.
- Use sunscreen daily (SPF 15 or higher) and wear protective clothing when outdoors, as tretinoin increases sensitivity to sunlight.
- Avoid excessive sun exposure, sunlamps, and tanning beds.
- Do not use on sunburned, windburned, dry, chapped, irritated, or broken skin.
- Avoid waxing for hair removal on treated areas.
- Be patient; it may take 6-12 weeks to see significant improvement, and acne may appear to worsen initially ('purging').
- Avoid other topical products that may cause irritation or dryness (e.g., harsh soaps, astringents, alcohol-containing products, other acne treatments like benzoyl peroxide or salicylic acid, unless directed by a doctor).
Available Forms & Alternatives
Available Strengths:
- Retin-A 0.025% Gel 15gm
- Retin-A 0.025% Cream 20gm
- Retin-A Micro 0.08% Gel Pump 50gm
- Retin-A 0.05% Cream 20gm
- Retin-A 0.05% Cream 45gm
- Retin-A 0.025% Cream 45gm
- Retin-A 0.1% Cream 20gm
- Retin-A 0.01% Gel 15gm
- Retin-A 0.01% Gel 45gm
- Retin-A Micro 0.04% Gel 45gm
- Retin-A 0.1% Cream 45gm
- Retin-A Micro 0.1% Gel 20gm
- Retin-A 0.025% Gel 45gm
- Retin-A Micro 0.1% Gel 45gm
- Retin-A Micro 0.04% Gel Pump 50gm
- Retin-A Micro 0.1% Gel Pump 50gm
- Retin-A Micro 0.04% Gel 20gm
- Retin-A Micro 0.06% Gel Pump 50gm
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to the affected areas of the face and/or trunk once daily in the evening, after washing and drying the skin.
Condition-Specific Dosing:
acne vulgaris:
Apply a thin layer to the entire affected area once daily in the evening.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and efficacy not established in pediatric patients under 12 years of age)
Adolescent:
Apply a thin layer to the affected areas once daily in the evening (for patients 12 years and older).
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) 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:
<2% (systemic absorption after topical application)
Tmax:
Not well-defined for topical application due to minimal systemic absorption; systemic levels are typically below quantification limits.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not clinically relevant for topical application due to minimal systemic absorption.
ProteinBinding:
Highly protein bound (>95%) if systemically absorbed.
CnssPenetration:
Limited (not expected to penetrate CNS significantly after topical application).
Elimination:
HalfLife:
0.5-2 hours (for systemically absorbed tretinoin)
Clearance:
Rapid (for systemically absorbed tretinoin)
ExcretionRoute:
Primarily via bile and urine (for systemically absorbed tretinoin)
Unchanged:
Negligible (systemically)
Pharmacodynamics
OnsetOfAction:
Several weeks (typically 2-3 weeks for initial improvement, up to 6-12 weeks for full effect)
PeakEffect:
6-12 weeks
DurationOfAction:
Continues as long as treatment is maintained.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- 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 medication, 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.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- 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 medication, 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 redness
- Excessive dryness or peeling
- Severe burning or stinging
- Swelling
- Blistering or crusting 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, such as sunburn, sensitivity to light, or other skin problems.
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 affect the safety of taking this medication.
This is not an exhaustive list of all potential interactions. Therefore, it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. This will help ensure it is safe to take this medication in conjunction with your other treatments 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. Be sure to describe the symptoms you experienced.
Skin conditions, such as sunburn, sensitivity to light, or other skin problems.
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 affect the safety of taking this medication.
This is not an exhaustive list of all potential interactions. Therefore, it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. This will help ensure it is safe to take this medication in conjunction with your other treatments 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.
Avoid applying this medication to sunburned skin, cuts, scrapes, eczema, or damaged skin. Instead, practice good skin care and take precautions 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 with your doctor or pharmacist about ways to protect your skin in these conditions. 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 with your doctor. If you experience dry skin due to this medication, you may use a moisturizer, but be sure to discuss the type of moisturizer to use with your doctor or pharmacist. You can use makeup unless your doctor has advised against it; however, make sure to clean the area to be treated before applying the medication.
If this medication is swallowed, it can cause harm. In the event of accidental ingestion, immediately contact a doctor or poison control center. Women who are pregnant or plan to become pregnant should be aware that this medication may harm the unborn baby. If you think you may be pregnant or are planning to become pregnant, notify 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.
Avoid applying this medication to sunburned skin, cuts, scrapes, eczema, or damaged skin. Instead, practice good skin care and take precautions 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 with your doctor or pharmacist about ways to protect your skin in these conditions. 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 with your doctor. If you experience dry skin due to this medication, you may use a moisturizer, but be sure to discuss the type of moisturizer to use with your doctor or pharmacist. You can use makeup unless your doctor has advised against it; however, make sure to clean the area to be treated before applying the medication.
If this medication is swallowed, it can cause harm. In the event of accidental ingestion, immediately contact a doctor or poison control center. Women who are pregnant or plan to become pregnant should be aware that this medication may harm the unborn baby. If you think you may be pregnant or are planning to become pregnant, notify 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:
- Severe skin irritation (redness, peeling, discomfort)
What to Do:
Discontinue use. Wash the area with mild soap and water. Apply a bland emollient. Symptoms are usually self-limiting. If severe or persistent, seek medical advice. For accidental ingestion, call a poison control center (e.g., 1-800-222-1222) or emergency services.
Drug Interactions
Moderate Interactions
- Topical products containing sulfur, resorcinol, salicylic acid, or benzoyl peroxide (may cause increased irritation)
- Astringents, abrasive soaps, cleansers, or cosmetics with strong drying effects (may cause increased irritation)
- Products containing alcohol, spices, or lime (may cause increased irritation)
- Medications with photosensitizing effects (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines) - increased risk of photosensitivity.
Monitoring
Baseline Monitoring
Skin assessment (type, condition, severity of acne)
Rationale: To establish baseline for treatment efficacy and tolerability.
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin irritation (erythema, scaling, dryness, burning, stinging)
Frequency: Regularly during initial weeks of therapy, then as needed.
Target: Mild to moderate irritation is expected; severe irritation requires dose adjustment or temporary discontinuation.
Action Threshold: Severe or persistent irritation; consider reducing frequency or strength, or temporarily stopping treatment.
Acne lesion count and overall appearance
Frequency: Monthly or every 2-3 months.
Target: Reduction in inflammatory and non-inflammatory lesions.
Action Threshold: No improvement after 8-12 weeks, or worsening of condition.
Symptom Monitoring
- Redness
- Scaling
- Dryness
- Peeling
- Burning sensation
- Stinging sensation
- Itching
- Photosensitivity (sunburn)
Special Patient Groups
Pregnancy
Tretinoin topical is Pregnancy Category C. While systemic absorption is minimal, use during pregnancy should be avoided unless the potential benefit justifies the potential risk to the fetus. Oral retinoids are highly teratogenic.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though risk is considered low with topical application due to minimal systemic absorption. Avoid use.
Second Trimester:
Risk considered low due to minimal systemic absorption, but still generally avoided.
Third Trimester:
Risk considered low due to minimal systemic absorption, but still generally avoided.
Lactation
It is not known whether tretinoin is excreted in human milk. Due to minimal systemic absorption, the risk to a nursing infant is considered low. However, caution should be exercised. Avoid applying to areas where the infant may come into direct contact with the medication.
Infant Risk:
Low risk (L3 - Moderate risk, due to theoretical possibility of absorption, but generally considered compatible with caution).
Pediatric Use
Safety and effectiveness have not been established in pediatric patients under 12 years of age. Use in adolescents (12 years and older) is common and generally well-tolerated with appropriate guidance.
Geriatric Use
No specific dosage adjustments are necessary. However, geriatric patients may have more fragile or sensitive skin, which could increase susceptibility to irritation. Use with caution and monitor for skin reactions.
Clinical Information
Clinical Pearls
- Start with a lower strength or less frequent application (e.g., every other night) if skin irritation is a concern, then gradually increase as tolerated.
- A 'purging' phase (initial worsening of acne) is common during the first few weeks of treatment; counsel patients that this is temporary and indicates the medication is working.
- Apply to completely dry skin (wait 20-30 minutes after washing) to minimize irritation.
- Use a pea-sized amount for the entire face; more is not better and will only increase irritation.
- Consistent use is key for efficacy; skipping applications will delay results.
- Emphasize strict sun protection due to increased photosensitivity.
Alternative Therapies
- Adapalene (Differin)
- Tazarotene (Tazorac)
- Benzoyl Peroxide
- Salicylic Acid
- Azelaic Acid
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe, recalcitrant acne)
- Hormonal therapies (e.g., oral contraceptives, spironolactone for females)
Cost & Coverage
Average Cost:
$150 - $300+ per 20gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand name); Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about your 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 medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.