Tretinoin Micro 0.04% Gel Pump 50gm
It is used to treat pimples (acne).
Drug Class
Anti-acne agent
Pharmacologic Class
Retinoid
Pregnancy Category
C
FDA Approved
Aug 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tretinoin is a medication derived from vitamin A that helps treat acne by promoting the normal growth of skin cells and preventing pores from becoming clogged. It also helps reduce inflammation associated with acne.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all provided 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 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 on using this medication.
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 provided 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 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 on using this medication.
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
- Always use a broad-spectrum sunscreen (SPF 30 or higher) daily, even on cloudy days, as tretinoin increases sun sensitivity.
- Avoid excessive sun exposure, tanning beds, and sunlamps.
- Use gentle, non-comedogenic (non-pore clogging) moisturizers to help with dryness and irritation.
- Avoid harsh skin products, abrasive cleansers, or products containing alcohol, astringents, or strong perfumes.
- Do not apply to sunburned, windburned, dry, chapped, irritated, or broken skin.
- Be patient; it may take 6-12 weeks to see significant improvement, and acne may initially worsen.
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 thin layer to affected areas once daily in the evening.
Condition-Specific Dosing:
acne_vulgaris:
Apply a pea-sized amount to cover the entire affected area (e.g., face) once daily in the evening, 20-30 minutes after cleansing and drying the skin.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and efficacy not established for children under 12 years of age)
Adolescent:
Apply a thin layer to affected areas once daily in the evening (for ages 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) in the nucleus, modulating gene expression. It normalizes the differentiation of follicular epithelial cells, leading to decreased cohesiveness of these cells and reduced formation of microcomedones. It also promotes the expulsion of existing comedones and has anti-inflammatory effects.
Pharmacokinetics
Absorption:
Bioavailability:
<2-6% (systemic absorption from topical application)
Tmax:
Not well-defined for topical due to minimal systemic absorption
FoodEffect:
Not relevant for topical application
Distribution:
Vd:
Not clinically relevant for topical application
ProteinBinding:
Not clinically relevant for topical application
CnssPenetration:
Limited/Not relevant (minimal systemic absorption)
Elimination:
HalfLife:
Not clinically relevant for topical application
Clearance:
Not clinically relevant for topical application
ExcretionRoute:
Renal and biliary (if systemically absorbed)
Unchanged:
Not clinically relevant for topical application
Pharmacodynamics
OnsetOfAction:
Initial improvement typically seen in 2-3 weeks
PeakEffect:
Optimal therapeutic effects usually observed after 6-12 weeks of continuous use
DurationOfAction:
Effects persist with continued application
Safety & Warnings
Side Effects
Serious 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
+ 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, such as:
+ Dry skin
+ Redness
+ Swelling
+ Blisters
+ Peeling
If you experience any skin reactions, consult your doctor. They may recommend stopping the medication temporarily, 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, 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, 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
+ 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, such as:
+ Dry skin
+ Redness
+ Swelling
+ Blisters
+ Peeling
If you experience any skin reactions, consult your doctor. They may recommend stopping the medication temporarily, 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, 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
- Blistering
- Crusting
- Excessive swelling
- Severe redness that does not subside
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, sensitive skin, or any other skin conditions that may be relevant.
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 affect the safety of taking this medication.
Additionally, it is crucial to disclose all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any existing health problems. This will enable your doctor to assess potential interactions and ensure safe treatment. Never start, stop, or modify the dosage of any medication without first consulting your doctor to confirm that 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, sensitive skin, or any other skin conditions that may be relevant.
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 affect the safety of taking this medication.
Additionally, it is crucial to disclose all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any existing health problems. This will enable your doctor to assess potential interactions and ensure safe treatment. Never start, stop, or modify the dosage of any medication without first consulting your doctor to confirm that 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, 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 usage. Do not exceed the recommended dose, and do not use the medication more frequently or for a longer duration than prescribed.
Avoid applying this medication to sunburned skin, cuts, scrapes, eczema, or damaged skin. Instead, practice good skin care and take measures 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, be cautious when handling lime peels, as they may cause irritation. Using other skin products in conjunction with this medication may increase the risk of irritation, so it is essential to discuss their use with your doctor before application. This includes soaps and other topical products. If you experience dry skin due to this medication, you may use a moisturizer; however, consult your doctor or pharmacist to determine the most suitable type of moisturizer for your skin.
You can use makeup while taking this medication, unless your doctor has advised against it. If you do plan to use makeup, ensure the area to be treated is clean before applying the medication.
In case of accidental ingestion, this medication can be harmful. If you or someone else swallows this medication, immediately contact a doctor or poison control center.
If you are pregnant or plan to become pregnant, inform your doctor, as this medication may harm the unborn baby. If you suspect you may be pregnant or are planning to conceive while taking this medication, contact your doctor right away.
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 usage. Do not exceed the recommended dose, and do not use the medication more frequently or for a longer duration than prescribed.
Avoid applying this medication to sunburned skin, cuts, scrapes, eczema, or damaged skin. Instead, practice good skin care and take measures 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, be cautious when handling lime peels, as they may cause irritation. Using other skin products in conjunction with this medication may increase the risk of irritation, so it is essential to discuss their use with your doctor before application. This includes soaps and other topical products. If you experience dry skin due to this medication, you may use a moisturizer; however, consult your doctor or pharmacist to determine the most suitable type of moisturizer for your skin.
You can use makeup while taking this medication, unless your doctor has advised against it. If you do plan to use makeup, ensure the area to be treated is clean before applying the medication.
In case of accidental ingestion, this medication can be harmful. If you or someone else swallows this medication, immediately contact a doctor or poison control center.
If you are pregnant or plan to become pregnant, inform your doctor, as this medication may harm the unborn baby. If you suspect you may be pregnant or are planning to conceive while taking this medication, contact your doctor right away.
If you are breastfeeding, consult your doctor to discuss any potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Severe local irritation (redness, peeling, discomfort)
- Unlikely to cause systemic toxicity due to minimal absorption
What to Do:
Discontinue use immediately. Cleanse the area gently. Apply a soothing, non-comedogenic moisturizer. Seek medical advice if irritation is severe or persistent. For accidental ingestion, call a poison control center (e.g., 1-800-222-1222) or seek emergency medical attention.
Drug Interactions
Moderate Interactions
- Other topical acne preparations (e.g., benzoyl peroxide, salicylic acid, sulfur, resorcinol) - may cause excessive irritation.
- Astringents, medicated soaps/cleansers, abrasive soaps/cleansers, chemical depilatories, alcohol-containing products (e.g., toners, aftershaves) - may cause excessive irritation.
- Photosensitizing agents (e.g., tetracyclines, fluoroquinolones, thiazide diuretics) - may increase risk of photosensitivity.
Monitoring
Baseline Monitoring
Skin assessment
Rationale: To evaluate acne severity, skin type, and identify any pre-existing irritation or sensitivity.
Timing: Prior to initiation of therapy
Routine Monitoring
Skin irritation (erythema, scaling, dryness, burning, stinging)
Frequency: Regularly during initial treatment (first 2-4 weeks), then as needed
Target: Mild to moderate irritation is expected; severe irritation should prompt dose adjustment or temporary discontinuation.
Action Threshold: Severe or persistent irritation; patient discomfort
Acne lesion count and overall improvement
Frequency: Every 4-6 weeks initially, then as clinically indicated
Target: Reduction in inflammatory and non-inflammatory lesions
Action Threshold: Lack of improvement after 12 weeks, or worsening of condition
Symptom Monitoring
- Excessive dryness
- Peeling or flaking of skin
- Redness (erythema)
- Burning sensation
- Stinging sensation
- Itching
- Swelling
- Blistering or crusting (rare, severe reaction)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. While systemic absorption from topical application is minimal, caution is advised. Oral tretinoin is contraindicated in pregnancy (Category X).
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though risk from topical is considered low due to minimal absorption.
Second Trimester:
Risk considered low due to minimal absorption.
Third Trimester:
Risk considered low due to minimal absorption.
Lactation
L3 (Moderately Safe). Minimal systemic absorption suggests low risk to a breastfed infant. However, caution is advised. Avoid applying to areas where the infant may come into direct contact with the medication (e.g., breast area). Consult a healthcare professional.
Infant Risk:
Low risk due to minimal systemic absorption, but potential for irritation if direct contact occurs.
Pediatric Use
Safety and efficacy have been established for adolescents 12 years of age and older. Not recommended for use in children under 12 years of age.
Geriatric Use
No specific dose adjustments are necessary. However, geriatric patients may have more fragile or sensitive skin and should be monitored closely for irritation.
Clinical Information
Clinical Pearls
- Apply tretinoin to completely dry skin, typically 20-30 minutes after washing, to minimize irritation.
- A 'purge' or initial worsening of acne (increased breakouts, redness, peeling) is common during the first few weeks of treatment. This is usually temporary as the skin adjusts.
- Use only a pea-sized amount for the entire face; applying more does not improve efficacy and significantly increases irritation.
- Consistency is crucial for results; skip days only if irritation is severe, then resume gradually.
- Always emphasize the importance of daily sunscreen use due to increased photosensitivity.
- Micro-gel formulations (like Tretinoin Micro) are designed to release tretinoin slowly, potentially reducing irritation compared to conventional gel/cream formulations.
Alternative Therapies
- Other topical retinoids (e.g., adapalene, tazarotene)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Benzoyl peroxide
- Salicylic acid
- Azelaic acid
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe, recalcitrant acne)
- Hormonal therapies (e.g., oral contraceptives, spironolactone for hormonal acne)
- Light and laser therapies
Cost & Coverage
Average Cost:
Variable, typically $100-$500+ per 50gm pump
Generic Available:
Yes
Insurance Coverage:
Tier 2-3 (may require prior authorization or step therapy)
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'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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.