Tretinoin Micro 0.04% Gel 20gm
It is used to treat pimples (acne).
Drug Class
Anti-acne agent; Antipsoriatic; Keratolytic
Pharmacologic Class
Retinoid
Pregnancy Category
Category C
FDA Approved
Jan 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tretinoin Micro 0.04% Gel is a medication applied to the skin to treat acne and reduce the appearance of fine wrinkles and rough skin caused by sun exposure. It works by helping the skin renew itself more quickly and by unclogging pores.
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 only a pea-sized amount to the entire affected area, not just individual spots.
- Apply to clean, dry skin, usually once daily at bedtime.
- Avoid contact with eyes, mouth, angles of the nose, and mucous membranes.
- Sun protection is crucial: Tretinoin increases sensitivity to sunlight. Use a broad-spectrum sunscreen (SPF 30 or higher) daily, wear protective clothing, and avoid excessive sun exposure, including tanning beds.
- Moisturize regularly: Use a non-comedogenic moisturizer to help manage dryness and irritation.
- Be patient: It takes time to see results (weeks to months), and skin may worsen initially (purging) before improving.
- Avoid harsh skin products: Do not use other irritating topical products (e.g., abrasive cleansers, strong astringents, other acne treatments like benzoyl peroxide or salicylic acid) at the same time unless directed by your doctor, as this can increase irritation. If using other topical agents, apply them at different times of the day (e.g., tretinoin at night, other agents in the morning).
- Do not use if pregnant or planning to become pregnant.
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 at bedtime.
Condition-Specific Dosing:
acne vulgaris:
Apply a thin layer to affected areas once daily at bedtime.
photodamage:
Apply a thin layer to affected areas once daily at bedtime.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and efficacy not established in pediatric patients younger than 10 years of age for acne, or for any age for photodamage)
Adolescent:
Apply a thin layer to affected areas once daily at bedtime (for acne, generally 10 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, a retinoid, binds to specific retinoic acid receptors (RARs) and retinoid X receptors (RXRs) in the nucleus, which then modulate gene expression. In acne, it reduces follicular keratinization, leading to decreased microcomedone formation and expulsion of existing comedones. It also has anti-inflammatory effects. In photodamage, it influences cellular differentiation and proliferation, promoting epidermal cell turnover and collagen synthesis.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (typically <2% of applied dose)
Tmax:
Not well-defined for topical application due to minimal systemic absorption; local peak effect takes weeks to months.
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 (e.g., >95% to plasma proteins)
CnssPenetration:
No (minimal systemic absorption)
Elimination:
HalfLife:
Not well-defined for topical application due to minimal systemic absorption; systemic half-life of absorbed tretinoin is approximately 0.5 to 2 hours.
Clearance:
Not applicable for topical formulation.
ExcretionRoute:
If systemically absorbed, primarily renal and biliary excretion.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Initial improvement typically seen within 2-3 weeks, but full therapeutic effects may take 6-12 weeks for acne and several months for photodamage.
PeakEffect:
3-6 months for optimal results in acne; 6-12 months for photodamage.
DurationOfAction:
Effects persist with continued use; regression occurs upon discontinuation.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention 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, 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, or 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:
- A feeling of warmth
- Burning or stinging sensations
- Changes in skin color
- Skin reactions, including dry skin, redness, swelling, blisters, and peeling
If you experience 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 about side effects, consult your doctor. For medical advice about side effects, 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 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, or 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:
- A feeling of warmth
- Burning or stinging sensations
- Changes in skin color
- Skin reactions, including dry skin, redness, swelling, blisters, and peeling
If you experience 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 about side effects, consult your doctor. For medical advice about side effects, 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 redness, burning, stinging, or itching that does not subside.
- Excessive peeling or blistering of the skin.
- Significant swelling of the treated area.
- Allergic reaction symptoms (rash, hives, difficulty breathing, swelling of face/lips/tongue/throat - seek immediate medical attention).
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 other skin conditions that may be affected by this medication.
If you are currently taking any medications that may increase your skin's sensitivity to light. There are several medications 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.
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 medications
Natural products
Vitamins
Health problems
with your doctor and pharmacist to ensure safe treatment. Do not initiate, discontinue, 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 other skin conditions that may be affected by this medication.
If you are currently taking any medications that may increase your skin's sensitivity to light. There are several medications 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.
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 medications
Natural products
Vitamins
Health problems
with your doctor and pharmacist to ensure safe treatment. Do not initiate, discontinue, 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, consult your doctor before using this product, as some formulations may contain fish protein.
You may not experience 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 going outside, 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 experience 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 going outside, 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:
- Topical overdose is unlikely to cause systemic toxicity due to minimal absorption.
- Excessive application may lead to severe local irritation, redness, peeling, and discomfort.
What to Do:
If excessive application occurs, wash the area with mild soap and water. Symptomatic treatment for irritation (e.g., moisturizers, cool compresses). In case of accidental ingestion, contact a poison control center immediately. Call 1-800-222-1222.
Drug Interactions
Moderate Interactions
- Topical products containing sulfur, resorcinol, salicylic acid, or benzoyl peroxide (may increase irritation; use with caution or at different times of day).
- Astringents, abrasive soaps, cleansers, medicated soaps/cleansers, peeling agents, alcohol-containing products (may increase irritation).
- Photosensitizing agents (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines) - increased risk of photosensitivity.
Monitoring
Baseline Monitoring
Skin assessment (type, condition, presence of acne/photodamage, baseline irritation)
Rationale: To establish baseline for efficacy and tolerability assessment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin irritation (redness, peeling, dryness, burning, stinging)
Frequency: Weekly for first few weeks, then as needed.
Target: Mild to moderate irritation is common and expected; severe irritation warrants dose adjustment or temporary discontinuation.
Action Threshold: Severe irritation, blistering, crusting, or significant discomfort should prompt re-evaluation.
Therapeutic response (reduction in lesions, improvement in skin texture)
Frequency: Monthly for first 3-6 months, then every 3-6 months.
Target: Gradual improvement over weeks to months.
Action Threshold: Lack of improvement after 3-6 months may warrant re-evaluation of therapy.
Symptom Monitoring
- Excessive dryness
- Peeling/flaking
- Redness (erythema)
- Stinging or burning sensation
- Itching
- Swelling
- Blistering or crusting (rare, severe reaction)
- Increased sensitivity to sunlight
Special Patient Groups
Pregnancy
Category C. While systemic absorption is minimal, oral retinoids are highly teratogenic. Tretinoin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Many clinicians advise against use during pregnancy due to the theoretical risk and availability of alternative treatments.
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). Minimal systemic absorption makes transfer into breast milk unlikely to be clinically significant. However, caution is advised. Avoid applying to areas where the infant may come into direct contact with the medication (e.g., chest).
Infant Risk:
Low risk of adverse effects to the infant due to minimal maternal systemic absorption and likely negligible transfer into breast milk. Monitor for skin irritation if direct contact occurs.
Pediatric Use
Safety and efficacy for acne have been established in patients 10 years of age and older. Not established for photodamage in pediatric patients. Use with caution in younger children due to potentially increased skin sensitivity and surface area to body weight ratio.
Geriatric Use
No specific dose adjustments are typically needed. Efficacy and safety are generally similar to younger adults. May be more susceptible to skin dryness and irritation, requiring careful monitoring and increased use of moisturizers.
Clinical Information
Clinical Pearls
- Start with a lower strength or less frequent application (e.g., every other night) if skin is very sensitive, then gradually increase frequency as tolerated.
- The 'purging' phase (initial worsening of acne) is common and temporary; counsel patients to continue treatment.
- Apply to completely dry skin (wait 20-30 minutes after washing face) to minimize irritation.
- A pea-sized amount is sufficient for the entire face; using more does not improve efficacy but increases irritation.
- Consistent daily use is key for optimal results.
- Emphasize strict sun protection due to increased photosensitivity.
- Combine with a good, non-comedogenic moisturizer to combat dryness and irritation.
- Avoid waxing on treated areas as skin may be more fragile and prone to tearing.
Alternative Therapies
- Adapalene (topical retinoid)
- Tazarotene (topical retinoid)
- Benzoyl peroxide (topical)
- Salicylic acid (topical)
- Azelaic acid (topical)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe acne)
- Chemical peels
- Laser therapy (for photodamage)
Cost & Coverage
Average Cost:
$100 - $300 per 20gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization or step therapy for brand-name, generics may be Tier 1 or 2)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. Some medications may come with additional patient information leaflets, so it's a good idea to check with your pharmacist for more details. 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 for clarification. 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 information about the medication taken, the amount, and the time it happened, as this will help healthcare professionals provide the best possible care.