Tretinoin 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?
Tretinoin is a form of vitamin A that helps the skin renew itself. When applied to the skin, it helps to clear up acne by preventing clogged pores and promoting the shedding of old skin cells. 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 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.
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 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 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.
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 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 a double dose or extra doses to make up for the missed dose.
Lifestyle & Tips
- Apply only a pea-sized amount to the entire affected area, not just individual pimples.
- Apply once daily in the evening, after gently washing and thoroughly drying the skin (wait 20-30 minutes after washing).
- Avoid applying to eyes, mouth, angles of the nose, or mucous membranes.
- Use a gentle, non-medicated cleanser and moisturizer.
- Sun protection is CRITICAL: Tretinoin increases sensitivity to sunlight. Use a broad-spectrum sunscreen (SPF 30 or higher) daily, wear protective clothing, and avoid prolonged sun exposure, including tanning beds.
- Initial worsening of acne (purging) is common during the first few weeks of treatment; continue use as directed.
- Avoid waxing on 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 affected areas once daily in the evening, 20-30 minutes after washing and drying the skin.
Condition-Specific Dosing:
acne vulgaris:
Apply a thin layer to the entire affected area (not just individual lesions) 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 pea-sized amount to affected areas once daily in the evening, 20-30 minutes after washing and drying the skin (for patients 12 years and older).
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) in the nucleus, including RAR-alpha, RAR-beta, and RAR-gamma. This binding modulates gene expression, leading to altered cellular differentiation, proliferation, and intercellular communication. 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:
Minimal systemic absorption (typically <2%)
Tmax:
Not applicable for topical effect; systemic Tmax if absorbed is variable (e.g., 1-2 hours)
FoodEffect:
Not applicable for topical formulation
Distribution:
Vd:
Not applicable for topical formulation; minimal systemic distribution
ProteinBinding:
Highly protein bound if systemically absorbed (e.g., >95%)
CnssPenetration:
Limited
Elimination:
HalfLife:
Not applicable for topical effect; systemic half-life is variable (e.g., 0.5-2 hours)
Clearance:
Not applicable for topical effect; rapid systemic clearance if absorbed
ExcretionRoute:
Primarily through skin turnover; systemically absorbed drug is excreted via bile and urine
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Typically 2-3 weeks, with significant improvement often seen after 6-12 weeks
PeakEffect:
12-16 weeks
DurationOfAction:
Effects persist as long as treatment is continued; relapse occurs upon discontinuation
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 when taking this medication. If you experience 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 with your doctor, as they may recommend temporarily stopping the medication, adjusting the dosage, or changing the frequency of use.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, 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 when taking this medication. If you experience 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 with your doctor, as they may recommend temporarily stopping the medication, adjusting the dosage, or changing the frequency of use.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, 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 that does not subside
- Excessive redness, swelling, blistering, or crusting of the skin
- Signs of 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 a sunburn, skin sensitivity to light, or any other skin problems.
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 or planning to become pregnant.
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. Do not initiate, discontinue, or modify 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.
If you have a sunburn, skin sensitivity to light, or any other skin problems.
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 or planning to become pregnant.
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. Do not initiate, discontinue, or modify 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, 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 this 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 outdoors, 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 your doctor or pharmacist for guidance on how 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 your doctor to ensure safe use. If this medication causes dry skin, you may use a moisturizer, but be sure to discuss the suitable type with your doctor or pharmacist. You can use makeup unless your doctor has advised against it; however, clean the treatment area before applying this medication.
In case of accidental ingestion, this medication can be harmful. If you swallow this medication, immediately contact a doctor or poison control center. Furthermore, 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, 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 this 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 outdoors, 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 your doctor or pharmacist for guidance on how 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 your doctor to ensure safe use. If this medication causes dry skin, you may use a moisturizer, but be sure to discuss the suitable type with your doctor or pharmacist. You can use makeup unless your doctor has advised against it; however, clean the treatment area before applying this medication.
In case of accidental ingestion, this medication can be harmful. If you swallow this medication, immediately contact a doctor or poison control center. Furthermore, 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
- Swelling
What to Do:
Topical overdose is unlikely to cause systemic toxicity. Discontinue use temporarily or reduce frequency. Symptomatic and supportive care for local irritation. Call a poison control center (1-800-222-1222) if accidental ingestion occurs, though systemic effects from topical overdose are rare.
Drug Interactions
Moderate Interactions
- Topical products containing sulfur, resorcinol, or salicylic acid (may cause excessive irritation)
- Astringents, medicated soaps/cleansers, abrasive soaps/cleansers, strong drying agents (may cause excessive irritation)
- Alcohol-containing products (e.g., toners, aftershaves, perfumes) (may cause excessive irritation)
- Products containing alpha hydroxy acids (AHAs) or glycolic acid (may increase irritation)
- Photosensitizing agents (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines) (may increase risk of sunburn)
Monitoring
Baseline Monitoring
Skin assessment (type, condition, presence of lesions)
Rationale: To establish baseline for efficacy and adverse effects monitoring.
Timing: Prior to initiation of therapy
Routine Monitoring
Skin irritation (erythema, scaling, dryness, burning, stinging)
Frequency: Weekly for first few weeks, then as needed
Target: Mild to moderate irritation is expected; severe irritation requires dose adjustment or temporary discontinuation.
Action Threshold: Severe or persistent irritation: reduce frequency of application, temporarily discontinue, or switch to lower strength.
Efficacy (reduction in acne lesions)
Frequency: Monthly or every 2-3 months
Target: Gradual improvement in lesion count and overall skin appearance.
Action Threshold: No improvement after 12-16 weeks: re-evaluate diagnosis or treatment plan.
Symptom Monitoring
- Redness
- Scaling
- Dryness
- Itching
- Burning sensation
- Stinging sensation
- Peeling
- Photosensitivity (sunburn)
Special Patient Groups
Pregnancy
Tretinoin is Pregnancy Category C. While systemic absorption from topical application is minimal, oral retinoids are highly teratogenic. Use during pregnancy should be avoided unless the potential benefit justifies the potential risk to the fetus. Discuss risks with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though risk from topical minimal.
Second Trimester:
Potential for teratogenicity, though risk from topical minimal.
Third Trimester:
Potential for teratogenicity, though risk from topical minimal.
Lactation
It is not known whether tretinoin is excreted in human milk. Due to minimal systemic absorption, the risk to a breastfed infant is considered low. However, caution should be exercised, and the drug should not be applied to the breast area to prevent infant exposure.
Infant Risk:
Low risk (L3)
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 generally consistent with adult dosing, with careful monitoring for irritation.
Geriatric Use
No specific dose adjustments are required. However, geriatric patients may have more fragile or sensitive skin, potentially increasing susceptibility to irritation. Use with caution and monitor for adverse skin reactions.
Clinical Information
Clinical Pearls
- Tretinoin Micro gel uses a microsphere delivery system designed to release tretinoin slowly, potentially reducing irritation compared to conventional tretinoin formulations.
- Patients should be advised that a temporary worsening of acne (purging) may occur during the first few weeks of treatment.
- Consistency is key; results take time (typically 8-12 weeks) and continuous use is necessary to maintain improvement.
- Emphasize strict sun protection due to increased photosensitivity.
- Start with a lower strength (e.g., 0.025% or 0.04%) if skin is sensitive, and gradually increase strength or frequency as tolerated.
- Apply to dry skin (wait 20-30 minutes after washing) to minimize irritation.
Alternative Therapies
- Other topical retinoids (e.g., adapalene, tazarotene)
- Benzoyl peroxide (topical)
- Salicylic acid (topical)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe, recalcitrant acne)
- Azelaic acid (topical)
Cost & Coverage
Average Cost:
$150 - $400 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 this 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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.