Retin-A Micro 0.1% Gel 45gm
It is used to treat pimples (acne).
Drug Class
Anti-acne agent; Retinoid
Pharmacologic Class
Retinoid
Pregnancy Category
Category C
FDA Approved
Dec 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tretinoin is a medication derived from vitamin A that is used on the skin to treat acne. It works by helping skin cells turn over more quickly and preventing pores from becoming clogged. It can also help improve the appearance of fine wrinkles and rough skin.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication as directed.
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.
Before and after use, wash your hands thoroughly.
Gently wash the affected skin with a mild, non-medicated soap and pat it dry. 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 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, avoiding freezing.
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 the information provided. It is essential to use this medication as directed.
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.
Before and after use, wash your hands thoroughly.
Gently wash the affected skin with a mild, non-medicated soap and pat it dry. 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 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, avoiding freezing.
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 to clean, dry skin, usually once daily at bedtime.
- Use a pea-sized amount for the entire face.
- Avoid applying to eyes, lips, nostrils, and mucous membranes.
- Strictly avoid sun exposure and use broad-spectrum sunscreen (SPF 30+) daily, even on cloudy days. Wear protective clothing and hats.
- Avoid sunlamps and tanning beds.
- Use a gentle, non-comedogenic moisturizer to help with dryness and irritation.
- Avoid harsh cleansers, abrasive scrubs, and other irritating topical products (e.g., those containing alcohol, astringents, or strong perfumes).
- Initial worsening of acne (purging) is common during the first few weeks of treatment; continue use as directed.
- Results are not immediate; it may take 8-12 weeks to see significant improvement.
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 area once daily, usually in the evening or at bedtime.
Condition-Specific Dosing:
acne vulgaris:
Apply a thin layer to the entire affected area (e.g., face, chest, back) once daily, usually in the evening. Avoid eyes, lips, and mucous membranes.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 12 years. For children 12 years and older, dosing is similar to adults.
Adolescent:
Apply a thin layer to the affected area once daily, usually in the evening or at 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 retinoid that modulates epithelial cell differentiation, proliferation, and keratinization. In acne, it 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, tretinoin has anti-inflammatory properties.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (<2-6% of applied dose)
Tmax:
Not well-defined for topical application due to minimal systemic absorption.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not applicable for topical formulation due to minimal systemic absorption.
ProteinBinding:
Highly protein bound if systemically absorbed (primarily to albumin).
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not well-defined for topical application due to minimal systemic absorption.
Clearance:
Not well-defined for topical application.
ExcretionRoute:
If systemically absorbed, primarily renal and biliary excretion.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically observed after 8-12 weeks of treatment.
PeakEffect:
Peak therapeutic effect may take several months.
DurationOfAction:
Effects persist with continued use; acne may recur upon discontinuation.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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. Although 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 any other unusual symptoms that bother you or do not go away, contact your doctor:
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. 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, 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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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. Although 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 any other unusual symptoms that bother you or do not go away, contact your doctor:
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. 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, 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 skin irritation (excessive redness, burning, stinging, itching)
- Blistering
- Crusting
- Swelling of the treated area
- 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.
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 change the dose 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 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.
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 change the dose of any medication without first consulting your doctor.
Precautions & Cautions
Important Information About Your Medication
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.
Using Your Medication Correctly
To achieve the full benefits of this medication, it may take several weeks. It is crucial to follow your doctor's instructions regarding dosage and frequency of application. Using more than the prescribed amount, or applying it more often or for a longer period than recommended, can increase the risk of severe side effects.
Skin Precautions
Do not apply this medication to sunburned skin, cuts, scrapes, eczema, or damaged skin. Practice good skin care and avoid excessive sun exposure. You may be more susceptible to sunburn while using this medication, so take precautions to protect your skin:
Avoid direct sunlight, sunlamps, and tanning beds
Use sunscreen and lip balm with an SPF of 15 or higher when outdoors
Wear protective clothing and eyewear to shield your skin from the sun
Be aware that cold and windy weather conditions may irritate your skin; consult your doctor or pharmacist for guidance on protecting your skin
Additionally, avoid contact with lime peels, as they may cause irritation.
Using Other Skin Products
Using other skin products while taking this medication may increase the risk of irritation. Consult your doctor before using any other medications or products on your skin, including soaps. If you experience dry skin, you may use a moisturizer; however, consult your doctor or pharmacist to determine the best type of moisturizer to use. You may wear makeup unless your doctor has advised against it; if you do use makeup, clean the treatment area before applying this medication.
Safety Precautions
If this medication is swallowed, call a doctor or poison control center immediately, as it can cause harm. 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.
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.
Using Your Medication Correctly
To achieve the full benefits of this medication, it may take several weeks. It is crucial to follow your doctor's instructions regarding dosage and frequency of application. Using more than the prescribed amount, or applying it more often or for a longer period than recommended, can increase the risk of severe side effects.
Skin Precautions
Do not apply this medication to sunburned skin, cuts, scrapes, eczema, or damaged skin. Practice good skin care and avoid excessive sun exposure. You may be more susceptible to sunburn while using this medication, so take precautions to protect your skin:
Avoid direct sunlight, sunlamps, and tanning beds
Use sunscreen and lip balm with an SPF of 15 or higher when outdoors
Wear protective clothing and eyewear to shield your skin from the sun
Be aware that cold and windy weather conditions may irritate your skin; consult your doctor or pharmacist for guidance on protecting your skin
Additionally, avoid contact with lime peels, as they may cause irritation.
Using Other Skin Products
Using other skin products while taking this medication may increase the risk of irritation. Consult your doctor before using any other medications or products on your skin, including soaps. If you experience dry skin, you may use a moisturizer; however, consult your doctor or pharmacist to determine the best type of moisturizer to use. You may wear makeup unless your doctor has advised against it; if you do use makeup, clean the treatment area before applying this medication.
Safety Precautions
If this medication is swallowed, call a doctor or poison control center immediately, as it can cause harm. 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:
- Severe local irritation (excessive redness, peeling, discomfort)
- No significant systemic toxicity expected due to minimal absorption.
What to Do:
Discontinue use temporarily. Apply soothing moisturizers. If severe, seek medical advice. For accidental ingestion, contact Poison Control (1-800-222-1222) or emergency services, though systemic toxicity from topical overdose is unlikely.
Drug Interactions
Moderate Interactions
- Other topical acne preparations (e.g., benzoyl peroxide, salicylic acid, sulfur, resorcinol) - may cause excessive irritation.
- Products containing alcohol, astringents, spices, or lime - may cause excessive irritation.
- Medicated or abrasive soaps and cleansers, soaps and cosmetics with a strong drying effect - may cause excessive irritation.
- Permanent wave solutions, depilatories, waxes - may cause excessive irritation.
- Drugs with photosensitizing effects (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines) - may increase risk of photosensitivity.
Monitoring
Baseline Monitoring
Skin assessment (type, severity of acne, presence of irritation)
Rationale: To establish baseline condition and guide treatment plan.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical assessment of skin irritation (redness, dryness, peeling, burning, itching)
Frequency: Regularly, especially during the initial weeks of treatment.
Target: Mild to moderate irritation is common; severe irritation warrants dose adjustment or temporary discontinuation.
Action Threshold: Severe blistering, crusting, swelling, or excessive redness/burning should prompt re-evaluation.
Therapeutic response (reduction in acne lesions)
Frequency: Every 4-8 weeks initially, then as needed.
Target: Gradual improvement over 8-12 weeks.
Action Threshold: Lack of improvement after 12 weeks may warrant re-evaluation of diagnosis or treatment.
Symptom Monitoring
- Skin redness
- Dryness
- Peeling/flaking
- Burning sensation
- Stinging
- Itching
- Swelling
- Blistering
- Crusting
Special Patient Groups
Pregnancy
Tretinoin topical is Pregnancy Category C. While systemic absorption is minimal, it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Oral retinoids are highly teratogenic.
Trimester-Specific Risks:
First Trimester:
Potential risk, especially during organogenesis. Use generally discouraged.
Second Trimester:
Potential risk, though less critical than first trimester. Use generally discouraged.
Third Trimester:
Potential risk. Use generally discouraged.
Lactation
Minimal systemic absorption suggests low risk to a nursing infant. However, caution is advised. Avoid applying to areas where the infant may come into direct contact with the medication (e.g., breast area).
Infant Risk:
Low risk (L3 - Moderately safe, but caution advised).
Pediatric Use
Safety and effectiveness have not been established in pediatric patients younger than 12 years of age. Use in adolescents (12 years and older) is similar to adults.
Geriatric Use
No specific dose adjustments are typically required. However, geriatric patients may have more fragile or sensitive skin, potentially leading to increased irritation. Use with caution and monitor for adverse reactions.
Clinical Information
Clinical Pearls
- Start with a lower strength (e.g., 0.025% or 0.04%) or less frequent application (every other night) to minimize initial irritation, then gradually increase frequency/strength as tolerated.
- Apply to completely dry skin (wait 20-30 minutes after washing) to reduce irritation.
- A 'purging' phase (initial worsening of acne) is common during the first few weeks of treatment as the skin adjusts and comedones are brought to the surface.
- Consistent daily use and strict sun protection are crucial for efficacy and safety.
- The microsphere formulation (Retin-A Micro) is designed for slower release and potentially less irritation compared to conventional tretinoin gels/creams.
- Patients should be advised that results are not immediate and require patience and adherence to the regimen.
Alternative Therapies
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Benzoyl peroxide
- Azelaic acid
- Salicylic acid
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe, recalcitrant acne)
- Hormonal therapies (e.g., oral contraceptives, spironolactone for hormonal acne)
Cost & Coverage
Average Cost:
Varies widely, typically $100 - $500+ per 45gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand); Tier 1 (Generic)
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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.