Tretinoin 0.05% Gel 45gm
It is used to treat pimples (acne).
Drug Class
Antiacne agent; Keratolytic
Pharmacologic Class
Retinoid
Pregnancy Category
Category D
FDA Approved
May 1971
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tretinoin gel is a topical medication, a form of Vitamin A, used to treat acne and improve the appearance of fine wrinkles and dark spots. It works by helping your skin cells turn over more quickly, which helps to unclog pores and smooth the skin.
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, 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 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, 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 a pea-sized amount to clean, dry skin once daily at bedtime.
- Avoid applying to eyes, mouth, angles of the nose, or mucous membranes.
- Use a gentle, non-comedogenic moisturizer daily to help manage dryness and irritation.
- Strictly use sunscreen (SPF 30 or higher) daily and wear protective clothing, as tretinoin increases sun sensitivity.
- Avoid excessive sun exposure, sunlamps, and tanning beds.
- Do not use waxing for hair removal on treated areas, as it can cause severe irritation or skin tearing.
- Be patient; it may take several weeks to months to see full results, and acne may initially worsen before improving.
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 of Tretinoin 0.05% Gel to the affected areas once daily at bedtime.
Condition-Specific Dosing:
acne_vulgaris:
Apply a pea-sized amount to cover the entire affected area lightly.
fine_wrinkles_hyperpigmentation:
Apply a pea-sized amount to the entire face, avoiding eyes and mouth.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (safety and efficacy not established in children under 12 years of age)
Adolescent:
Apply a thin layer to affected areas once daily at bedtime (for ages 12 years and older).
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Tretinoin is a metabolite of Vitamin A 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, it reduces the cohesion of follicular epithelial cells, leading to increased cell turnover and expulsion of existing comedones. It also suppresses Propionibacterium acnes by reducing sebum production and has anti-inflammatory effects. For photoaging, it promotes collagen synthesis, reduces epidermal melanin, and improves skin texture.
Pharmacokinetics
Absorption:
Bioavailability:
<5% (systemic after topical application)
Tmax:
Not well-defined for topical application due to minimal systemic absorption.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not applicable for topical formulation due to minimal systemic absorption.
ProteinBinding:
Highly protein bound if absorbed systemically (e.g., >95% to plasma proteins).
CnssPenetration:
Limited
Elimination:
HalfLife:
Not well-defined for topical application due to minimal systemic absorption; if absorbed, rapidly metabolized and eliminated.
Clearance:
Not applicable for topical formulation.
ExcretionRoute:
Renal and biliary (if absorbed systemically)
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
2-3 weeks for initial improvement in acne; 3-6 months for significant improvement in photoaging.
PeakEffect:
6-12 weeks for full therapeutic effect in acne; 6-12 months for photoaging.
DurationOfAction:
Effects persist as long as treatment is continued; regression occurs upon discontinuation.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate 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, difficulty 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 resolve on its own.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they persist, consult your doctor:
- 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, discuss them with your doctor. Your doctor 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, contact your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate 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, difficulty 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 resolve on its own.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they persist, consult your doctor:
- 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, discuss them with your doctor. Your doctor 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, contact your doctor for advice. 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, or blistering of the skin.
- 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.
Skin conditions, including sunburn, sensitivity to light, or other skin problems.
Medications that may increase your skin's sensitivity to light, as many drugs can cause this interaction. If you are unsure, consult your doctor or pharmacist for guidance.
Additionally, if you are pregnant, notify your doctor, as this may impact your treatment.
To ensure safe use, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Natural products and vitamins you are using
Any health problems you have
This information will help your doctor determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose 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.
Skin conditions, including sunburn, sensitivity to light, or other skin problems.
Medications that may increase your skin's sensitivity to light, as many drugs can cause this interaction. If you are unsure, consult your doctor or pharmacist for guidance.
Additionally, if you are pregnant, notify your doctor, as this may impact your treatment.
To ensure safe use, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Natural products and vitamins you are using
Any health problems you have
This information will help your doctor determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose 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, do not exceed the dosage or frequency prescribed by your doctor. Using more than the recommended amount or for a longer period than instructed can increase the chance of adverse reactions.
Skin Precautions
Avoid applying this medication to sunburned skin, cuts, scrapes, eczema, or damaged skin. Practice good skin care and limit your sun exposure. You may be more susceptible to sunburn, so take precautions to protect your skin:
Avoid direct sunlight, sunlamps, and tanning beds
Use sunscreen and lip balm with an SPF of 15 or higher when outdoors
Wear protective clothing and eyewear to shield your skin from the sun
Be aware that cold and windy weather conditions can irritate your skin; consult your doctor or pharmacist for guidance on protecting your skin
Additionally, avoid contact with lime peels, as they may cause irritation.
Using Other Skin Products
Using other skin products while taking this medication may increase the risk of irritation. Before using any other products, 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 this medication is swallowed, call a doctor or poison control center immediately, as it can 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, discuss the potential risks to your baby with your doctor.
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, do not exceed the dosage or frequency prescribed by your doctor. Using more than the recommended amount or for a longer period than instructed can increase the chance of adverse reactions.
Skin Precautions
Avoid applying this medication to sunburned skin, cuts, scrapes, eczema, or damaged skin. Practice good skin care and limit your sun exposure. You may be more susceptible to sunburn, so take precautions to protect your skin:
Avoid direct sunlight, sunlamps, and tanning beds
Use sunscreen and lip balm with an SPF of 15 or higher when outdoors
Wear protective clothing and eyewear to shield your skin from the sun
Be aware that cold and windy weather conditions can irritate your skin; consult your doctor or pharmacist for guidance on protecting your skin
Additionally, avoid contact with lime peels, as they may cause irritation.
Using Other Skin Products
Using other skin products while taking this medication may increase the risk of irritation. Before using any other products, 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 this medication is swallowed, call a doctor or poison control center immediately, as it can 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, discuss the potential risks to your baby with your doctor.
Overdose Information
Overdose Symptoms:
- Severe local irritation (erythema, peeling, discomfort)
- No systemic overdose symptoms expected from topical application.
What to Do:
Discontinue use temporarily or reduce frequency. Apply soothing moisturizers. If severe irritation persists, seek medical attention. For accidental ingestion, call a poison control center (e.g., 1-800-222-1222) or seek emergency medical care, though systemic toxicity from topical ingestion is unlikely.
Drug Interactions
Moderate Interactions
- Other topical preparations containing peeling agents (e.g., sulfur, resorcinol, salicylic acid, benzoyl peroxide) - concurrent use may increase irritation.
- Photosensitizing drugs (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines) - may increase risk of photosensitivity.
Minor Interactions
- Astringents, abrasive soaps, medicated cleansers, or drying agents - may exacerbate skin irritation.
- Cosmetics or soaps with strong drying effects.
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of acne, wrinkles, or hyperpigmentation and identify any pre-existing skin irritation or sensitivity.
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin irritation (erythema, scaling, dryness, burning, stinging)
Frequency: Weekly for the first few 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: reduce frequency of application, use lower concentration, or temporarily discontinue. Advise use of moisturizers.
Therapeutic response (reduction in lesions, improvement in skin texture)
Frequency: Monthly for the first 3-6 months, then every 3-6 months.
Target: Gradual improvement over weeks to months.
Action Threshold: Lack of improvement after 12 weeks for acne or 6-12 months for photoaging: re-evaluate diagnosis or treatment plan.
Symptom Monitoring
- Excessive dryness
- Peeling
- Redness
- Burning sensation
- Stinging sensation
- Itching
- Increased sensitivity to sunlight
- Swelling or blistering (rare, indicates severe irritation/allergic reaction)
Special Patient Groups
Pregnancy
Tretinoin is classified as Pregnancy Category D. It should not be used during pregnancy or in women who may become pregnant unless the potential benefit justifies the potential risk to the fetus. Oral retinoids are known teratogens, and while systemic absorption of topical tretinoin is minimal, caution is advised.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, especially during organogenesis. Avoid use.
Second Trimester:
Continued caution; risk of fetal harm, though less critical than first trimester.
Third Trimester:
Continued caution; risk of fetal harm.
Lactation
Caution should be exercised when tretinoin is administered to a nursing woman. While systemic absorption is minimal, it is unknown if tretinoin is excreted in human milk. The potential for infant exposure is low, but direct application to the breast area should be avoided to prevent infant ingestion.
Infant Risk:
Low risk, but caution advised.
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 considered safe and effective for acne vulgaris.
Geriatric Use
No specific dose adjustments are required for geriatric patients. However, older skin may be more fragile and prone to dryness or irritation, so careful monitoring and use of moisturizers are recommended.
Clinical Information
Clinical Pearls
- Start with a lower concentration (e.g., 0.025%) or less frequent application (every other night) if skin is sensitive, then gradually increase as tolerated.
- The 'purging' phase (initial worsening of acne) is common in the first few weeks of treatment; advise patients this is temporary and indicates the medication is working.
- 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 will not speed up results and will only increase irritation.
- Consistent daily use is crucial for optimal results; skipping applications can delay improvement.
- Emphasize the importance of daily broad-spectrum sunscreen use (SPF 30+) due to increased photosensitivity.
Alternative Therapies
- Other topical retinoids (e.g., adapalene, tazarotene)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Topical anti-inflammatory agents (e.g., azelaic acid, dapsone)
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe, recalcitrant acne)
- Benzoyl peroxide
- Salicylic acid
Cost & Coverage
Average Cost:
$50 - $200+ per 45gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (varies by insurance plan)
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 your 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, including the amount and time of ingestion.