Retin-A Micro 0.04% Gel Pump 50gm
It is used to treat pimples (acne).
Drug Class
Retinoid, Anti-acne agent
Pharmacologic Class
Retinoic acid derivative
Pregnancy Category
Category C
FDA Approved
Aug 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tretinoin is a form of Vitamin A that helps your skin renew itself. For acne, it helps prevent clogged pores and promotes the shedding of old skin cells. For fine wrinkles and sun damage, it helps improve the skin's texture and appearance. It can cause initial irritation like redness and peeling, which usually lessens over time.
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.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not ingest it.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation or burning. If accidental contact occurs, rinse the affected area thoroughly with water.
Apply the medication at bedtime.
Before and after application, wash your hands thoroughly.
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, avoiding freezing temperatures.
Missed Dose Instructions
* If you miss a dose, skip it and resume your regular application schedule. Do not apply a double dose or 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.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not ingest it.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation or burning. If accidental contact occurs, rinse the affected area thoroughly with water.
Apply the medication at bedtime.
Before and after application, wash your hands thoroughly.
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, avoiding freezing temperatures.
Missed Dose Instructions
* If you miss a dose, skip it and resume your regular application schedule. Do not apply a double dose or extra doses to make up for the missed dose.
Lifestyle & Tips
- Apply once daily in the evening to clean, dry skin.
- Use only a pea-sized amount for the entire face.
- Avoid contact with eyes, mouth, angles of the nose, and mucous membranes.
- Use a gentle, non-comedogenic moisturizer and sunscreen daily (SPF 30 or higher) as skin will be more sensitive to the sun.
- Avoid excessive sun exposure, including sunlamps and tanning beds.
- Do not use other irritating topical products (e.g., harsh soaps, astringents, products with alcohol, salicylic acid, benzoyl peroxide) unless directed by your doctor.
- Be patient; it may take 6-12 weeks to see significant improvement, and initial worsening of acne can occur.
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 pea-sized amount to affected areas once daily in the evening
Condition-Specific Dosing:
acne vulgaris:
Apply a pea-sized amount to affected areas once daily in the evening, after washing and drying the skin. Avoid eyes, lips, and mucous membranes.
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 pea-sized amount to 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 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, 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. In photoaging, it promotes epidermal cell turnover, compacts the stratum corneum, and increases collagen synthesis in the dermis.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (approximately 1-2% of applied dose)
Tmax:
Not well-defined for topical application due to minimal systemic absorption; peak plasma concentrations are very low and often undetectable.
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 (due to minimal systemic absorption).
Elimination:
HalfLife:
Not well-defined for topical application due to minimal systemic absorption; systemic half-life of oral tretinoin is 0.5-2 hours.
Clearance:
Not well-defined for topical application.
ExcretionRoute:
Primarily renal and biliary excretion if systemically absorbed.
Unchanged:
Very little unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Several weeks (typically 2-3 weeks for initial improvement, up to 6-12 weeks for full effect)
PeakEffect:
6-12 weeks
DurationOfAction:
Continuous use required for sustained effect.
Safety & Warnings
Side Effects
Important Side Effects to Report to Your Doctor Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, seek medical attention 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
+ 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. 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 experience any skin reactions, consult your doctor, as 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, 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.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, seek medical attention 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
+ 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. 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 experience any skin reactions, consult your doctor, as 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, 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 burning, stinging, or itching
- Excessive redness, swelling, blistering, or crusting
- Signs of an allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat)
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 is not an exhaustive list of potential interactions, and you must verify that it is safe to take this medication with all of your other medications and health conditions. Do not initiate, discontinue, 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 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 is not an exhaustive list of potential interactions, and you must verify that it is safe to take this medication with all of your other medications and health conditions. Do not initiate, discontinue, or modify the dosage 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, discuss this with your doctor, as some products contain fish protein.
Using Your Medication Correctly
It may take several weeks to experience the full effects of this medication. To minimize the risk of severe side effects, use this medication only as directed by your doctor. Do not exceed the recommended dosage, frequency, or duration of treatment.
Skin Precautions
Avoid applying this medication to sunburned skin, cuts, scrapes, eczema, or damaged skin. Practice good skin care and protect your skin from the sun. You may be more susceptible to sunburn, so take precautions to avoid sun exposure, sunlamps, and tanning beds. When outdoors, use sunscreen and lip balm with an SPF of 15 or higher, and wear protective clothing and eyewear. Be aware that cold and windy weather conditions may irritate your skin; consult your doctor or pharmacist for guidance on protecting your skin.
Interactions with Other Products
Avoid contact with lime peels, as this may cause irritation. Using other skin products while taking this medication may increase the risk of irritation. Before using any other medications or products on your skin, including soaps, consult your doctor. If you experience dry skin, you may use a moisturizer; however, discuss the type of moisturizer to use with your doctor or pharmacist. You can use makeup unless your doctor advises against it; if you do use makeup, clean the treatment area before applying this medication.
Safety Precautions
If you accidentally swallow this medication, call a doctor or poison control center immediately, as it may 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, discuss this with your doctor, as some products contain fish protein.
Using Your Medication Correctly
It may take several weeks to experience the full effects of this medication. To minimize the risk of severe side effects, use this medication only as directed by your doctor. Do not exceed the recommended dosage, frequency, or duration of treatment.
Skin Precautions
Avoid applying this medication to sunburned skin, cuts, scrapes, eczema, or damaged skin. Practice good skin care and protect your skin from the sun. You may be more susceptible to sunburn, so take precautions to avoid sun exposure, sunlamps, and tanning beds. When outdoors, use sunscreen and lip balm with an SPF of 15 or higher, and wear protective clothing and eyewear. Be aware that cold and windy weather conditions may irritate your skin; consult your doctor or pharmacist for guidance on protecting your skin.
Interactions with Other Products
Avoid contact with lime peels, as this may cause irritation. Using other skin products while taking this medication may increase the risk of irritation. Before using any other medications or products on your skin, including soaps, consult your doctor. If you experience dry skin, you may use a moisturizer; however, discuss the type of moisturizer to use with your doctor or pharmacist. You can use makeup unless your doctor advises against it; if you do use makeup, clean the treatment area before applying this medication.
Safety Precautions
If you accidentally swallow this medication, call a doctor or poison control center immediately, as it may 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:
- Topical overdose is unlikely to cause systemic toxicity due to minimal absorption.
- Local symptoms may include severe redness, peeling, discomfort, and irritation.
What to Do:
If excessive application occurs, wash the area with mild soap and water. Discontinue use temporarily until irritation subsides. If severe irritation persists, consult a healthcare professional. For accidental ingestion, contact a poison control center (e.g., 1-800-222-1222) or seek immediate medical attention, though systemic toxicity from topical ingestion is rare.
Drug Interactions
Moderate Interactions
- Topical products containing sulfur, resorcinol, or salicylic acid (concurrent use may increase irritation)
- Astringents, abrasive soaps, cleansers, or medicated cosmetics (may increase irritation)
- Products with high concentrations of alcohol, spices, or lime (may increase irritation)
- Photosensitizing agents (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines) - increased risk of photosensitivity
Monitoring
Baseline Monitoring
Skin assessment (type, sensitivity, existing lesions)
Rationale: To establish baseline skin condition and identify potential contraindications or sensitivities.
Timing: Prior to initiation of therapy
Patient education on proper application and expected side effects
Rationale: To ensure patient adherence and manage expectations regarding initial irritation.
Timing: Prior to initiation of therapy
Routine Monitoring
Skin irritation (erythema, scaling, dryness, burning, stinging)
Frequency: Daily/Weekly (patient self-monitoring), Monthly (clinical review)
Target: Mild to moderate irritation is expected; severe irritation requires dose adjustment or temporary discontinuation.
Action Threshold: Severe or persistent irritation; signs of allergic reaction
Therapeutic response (reduction in acne lesions)
Frequency: Monthly to every 3 months
Target: Gradual improvement over 6-12 weeks
Action Threshold: No improvement after 12 weeks, or worsening condition
Symptom Monitoring
- Excessive redness
- Severe peeling
- Intense dryness
- Burning sensation
- Stinging sensation
- Swelling
- Blistering
- Crusting
Special Patient Groups
Pregnancy
Category C. While systemic absorption is minimal with topical use, oral tretinoin is highly teratogenic (Category X). Due to theoretical risk and the availability of safer alternatives, use during pregnancy is generally not recommended unless the potential benefit justifies the potential risk to the fetus. Women of childbearing potential should be advised to use effective contraception.
Trimester-Specific Risks:
First Trimester:
Theoretical risk of teratogenicity, though systemic absorption is minimal.
Second Trimester:
Theoretical risk, but less critical period for major organogenesis compared to first trimester.
Third Trimester:
Theoretical risk, but less critical period for major organogenesis compared to first trimester.
Lactation
L3 (Moderately Safe). It is not known whether tretinoin is excreted in human milk after topical application. However, systemic absorption is minimal, making infant exposure unlikely. If used, avoid applying to areas where the infant may come into direct contact with the medication (e.g., breast area).
Infant Risk:
Low risk due to minimal maternal systemic absorption.
Pediatric Use
Safety and efficacy have not been established in pediatric patients under 12 years of age. Use in adolescents (12 years and older) is similar to adults.
Geriatric Use
No specific dosage adjustments are required. However, geriatric patients may have more fragile or sensitive skin, potentially leading to increased irritation. Use with caution and monitor for skin reactions.
Clinical Information
Clinical Pearls
- Start with a lower concentration (e.g., 0.025% or 0.04% micro) and gradually increase as tolerated to minimize irritation.
- Apply to completely dry skin (wait 20-30 minutes after washing) to reduce irritation.
- The 'pea-sized' amount is crucial; using more does not speed up results and only increases irritation.
- Initial worsening of acne (purging) is common during the first few weeks; reassure patients this is temporary.
- Consistent daily use is key for efficacy; skipping days can prolong the adjustment period.
- Always emphasize strict sun protection (sunscreen, hats, sun avoidance) due to increased photosensitivity.
- Combine with a good non-comedogenic moisturizer to combat dryness and irritation.
- Avoid applying to broken, eczematous, or sunburned skin.
Alternative Therapies
- Adapalene (Differin)
- Tazarotene (Tazorac)
- Benzoyl peroxide
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Oral antibiotics (e.g., doxycycline, minocycline)
- Azelaic acid
- Salicylic acid
- Isotretinoin (oral, for severe recalcitrant acne)
Cost & Coverage
Average Cost:
$200 - $600 per 50gm pump
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (Specialty/Non-preferred Brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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 emergency 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.