Retin-A Micro 0.04% Gel 45gm
It is used to treat pimples (acne).
Drug Class
Antiacne agent
Pharmacologic Class
Retinoid
Pregnancy Category
Category C
FDA Approved
Aug 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Retin-A Micro is a gel that contains a form of vitamin A called tretinoin. It works by helping your skin cells turn over faster, which helps to unclog pores and prevent new acne from forming. It also helps to reduce inflammation. Because it's a 'micro' gel, it's designed to release the medicine slowly, which can help reduce irritation compared to other forms of tretinoin.
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 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 the affected area before applying the medication. Consult with your pharmacist for specific guidance on using this medication.
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 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 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 the affected area before applying the medication. Consult with your pharmacist for specific guidance on using this medication.
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 to clean, dry skin once daily in the evening, before bedtime.
- Use a pea-sized amount for the entire face; more is not better and can increase irritation.
- Avoid contact with eyes, mouth, angles of the nose, and mucous membranes.
- Sun sensitivity is increased; use broad-spectrum sunscreen (SPF 30 or higher) daily and wear protective clothing when outdoors.
- Avoid excessive sun exposure, including sunlamps and tanning beds.
- Avoid waxing for hair removal on treated areas.
- Moisturize regularly to combat dryness, especially non-comedogenic moisturizers.
- Be patient; it can take 6-12 weeks to see significant improvement, and acne may temporarily worsen initially.
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 the entire affected area of the face once daily in the evening, before bedtime.
Condition-Specific Dosing:
acne vulgaris:
Apply a pea-sized amount to the entire affected area of the face once daily in the evening, before bedtime.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 12 years of age.
Adolescent:
For adolescents 12 years of age and older: Apply a pea-sized amount to the entire affected area of the face once daily in the evening, before bedtime.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed; minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Tretinoin is a retinoid that binds to specific retinoic acid receptors (RARs) and retinoid X receptors (RXRs) in the nucleus, modulating gene expression. In acne, it is thought to decrease cohesiveness of follicular epithelial cells, leading to a reduction in 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 (typically <2%)
Tmax:
Not applicable for topical, systemic levels are very low and variable.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not well characterized due to minimal systemic absorption.
ProteinBinding:
Highly protein bound if systemically absorbed (primarily to albumin).
CnssPenetration:
Limited
Elimination:
HalfLife:
Not well characterized for topical due to minimal systemic absorption; systemic half-life is short (0.5-2 hours).
Clearance:
Not well characterized for topical.
ExcretionRoute:
Primarily renal and biliary excretion if systemically absorbed.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Typically 2-3 weeks, with full therapeutic effects seen in 6-12 weeks.
PeakEffect:
6-12 weeks
DurationOfAction:
Effects persist as long as treatment is continued.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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, contact your doctor immediately or seek emergency 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
Severe skin reactions that are bothersome or persistent
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 develop 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, 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.
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, contact your doctor immediately or seek emergency 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
Severe skin reactions that are bothersome or persistent
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 develop 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, 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 burning, stinging, or itching
- Excessive redness, swelling, blistering, or crusting of the skin
- Allergic reaction symptoms (e.g., rash, hives, difficulty breathing)
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. Describe the allergic reaction you experienced, including the symptoms that occurred.
If you have a sunburn, sensitive skin, or other skin problems, as these conditions may be affected by the medication.
If you are 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 medication may have potential effects on your pregnancy.
Additionally, it is crucial to provide your doctor and pharmacist with a comprehensive list of all your medications, including:
Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins
Share information about your health problems, as this will help your doctor determine if it is safe for you to take this medication. Do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
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. Describe the allergic reaction you experienced, including the symptoms that occurred.
If you have a sunburn, sensitive skin, or other skin problems, as these conditions may be affected by the medication.
If you are 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 medication may have potential effects on your pregnancy.
Additionally, it is crucial to provide your doctor and pharmacist with a comprehensive list of all your medications, including:
Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins
Share information about your health problems, as this will help your doctor determine if it is safe for you to take this medication. Do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
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, as you may be more susceptible to sunburn. When outdoors, use sunscreen and lip balm with an SPF of 15 or higher, wear protective clothing and eyewear, and avoid sunlamps and tanning beds. Certain weather conditions, such as cold and wind, may irritate your skin; consult your doctor or pharmacist for guidance on skin protection.
Additional Precautions
Avoid contact with lime peels, as this may cause irritation. Using other skin products while taking this medication may increase the risk of irritation; consult your doctor before using any other skin products, including soaps. If you experience dry skin, you may use a moisturizer; consult your doctor or pharmacist for recommendations on suitable moisturizers. You may use makeup unless your doctor has advised 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, as you may be more susceptible to sunburn. When outdoors, use sunscreen and lip balm with an SPF of 15 or higher, wear protective clothing and eyewear, and avoid sunlamps and tanning beds. Certain weather conditions, such as cold and wind, may irritate your skin; consult your doctor or pharmacist for guidance on skin protection.
Additional Precautions
Avoid contact with lime peels, as this may cause irritation. Using other skin products while taking this medication may increase the risk of irritation; consult your doctor before using any other skin products, including soaps. If you experience dry skin, you may use a moisturizer; consult your doctor or pharmacist for recommendations on suitable moisturizers. You may use makeup unless your doctor has advised 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:
- Excessive redness
- Severe peeling
- Discomfort
What to Do:
Topical overdose is unlikely to cause systemic toxicity. Discontinue use temporarily until irritation subsides. If accidental ingestion occurs, seek medical attention immediately. 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; use with caution or at different times of day).
- Astringents, medicated soaps/cleansers, abrasive soaps/cleansers, strong drying agents, cosmetics with strong drying effects (may increase irritation).
- Products containing alcohol, spices, or lime (may increase irritation).
Minor Interactions
- Photosensitizing agents (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 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 common; severe irritation warrants dose adjustment or temporary discontinuation.
Action Threshold: Severe or persistent irritation; consider reducing frequency of application or temporarily stopping.
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; consider alternative or adjunctive therapy.
Symptom Monitoring
- Redness
- Scaling
- Dryness
- Peeling
- Burning sensation
- Stinging sensation
- Itching
- Temporary worsening of acne (purging)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Systemic absorption is minimal, but caution is advised. Oral retinoids are highly teratogenic.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though systemic absorption is minimal with topical use. Avoid if possible.
Second Trimester:
Less data, but still generally advised to avoid due to retinoid class effects.
Third Trimester:
Less data, but still generally advised to avoid due to retinoid class effects.
Lactation
L3 (Moderately Safe). Minimal systemic absorption makes transfer into breast milk unlikely to cause adverse effects in the infant. Apply to areas where the infant will not come into direct contact with the medication.
Infant Risk:
Low risk due to minimal systemic absorption. Monitor infant for any signs of irritation if contact occurs.
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
No specific dosage adjustments are recommended for geriatric patients. However, older patients may have more fragile or sensitive skin and may experience increased irritation. Use with caution and monitor for adverse skin reactions.
Clinical Information
Clinical Pearls
- The 'micro' formulation uses microsphere technology to slowly release tretinoin, which can lead to less irritation compared to conventional tretinoin gels or creams.
- A temporary worsening of acne (purging) is common during the first few weeks of treatment as the skin adjusts and comedones are brought to the surface. This is usually a sign the medication is working.
- Consistency is key. Patients should be advised to use the product every night as directed, even if they don't see immediate results or experience mild irritation.
- Emphasize strict sun protection due to increased photosensitivity. This includes daily sunscreen use (SPF 30+), protective clothing, and avoiding peak sun hours.
- Advise patients to use a gentle, non-comedogenic cleanser and moisturizer to help manage dryness and irritation.
- Avoid applying to broken, eczematous, or sunburned skin.
Alternative Therapies
- Adapalene (Differin Gel)
- 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., Spironolactone, oral contraceptives for females)
Cost & Coverage
Average Cost:
$150 - $300 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 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 a separate patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this 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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.