Tretinoin 0.08% Gel Pump 50gm
It is used to treat pimples (acne).
Drug Class
Retinoid; Anti-acne agent; Anti-wrinkle agent
Pharmacologic Class
Retinoid
Pregnancy Category
Category C
FDA Approved
Aug 2018
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tretinoin is a medication related to vitamin A that is applied to the skin. It works by helping your skin cells turn over more quickly and reducing inflammation, which can help clear up acne and improve the appearance of fine wrinkles and rough skin caused by sun damage.
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 once daily in the evening to clean, dry skin.
- Use a pea-sized amount for the entire face.
- Avoid contact with eyes, mouth, angles of the nose, and mucous membranes.
- Sun protection is crucial: use sunscreen (SPF 30 or higher), wear protective clothing, and limit sun exposure, as tretinoin increases sensitivity to sunlight.
- Avoid waxing on treated areas.
- Use a gentle, non-medicated cleanser and moisturizer daily.
- Initial irritation (redness, peeling, dryness) is common and usually subsides with continued use. If severe, contact your doctor.
- Results may take several weeks to months to appear.
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 0.08% Gel to the affected areas of the face once daily in the evening.
Condition-Specific Dosing:
acne vulgaris:
Apply once daily in the evening.
photoaging:
Apply 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 9 years of age).
Adolescent:
Apply a thin layer to affected areas once daily in the evening (for patients 9 years of age 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, including RAR-alpha, RAR-beta, and RAR-gamma. This binding modulates gene expression, leading to altered cellular differentiation, proliferation, and inflammation. In acne, it reduces follicular keratinization, leading to a decrease in microcomedone formation and an increase in the shedding of comedones. It also has anti-inflammatory effects. In photoaging, it promotes epidermal cell turnover, reduces epidermal melanin, and stimulates dermal collagen synthesis.
Pharmacokinetics
Absorption:
Bioavailability:
<2% (systemic absorption after topical application)
Tmax:
Not applicable (systemic levels often undetectable or very low)
FoodEffect:
Not applicable (topical administration)
Distribution:
Vd:
Not available (minimal systemic distribution)
ProteinBinding:
Not available (minimal systemic absorption)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not applicable (systemic levels often undetectable; if detectable, short, e.g., 0.7-3 hours for oral tretinoin, but topical is different)
Clearance:
Not available (minimal systemic absorption)
ExcretionRoute:
If absorbed systemically, primarily renal and biliary excretion.
Unchanged:
Not available (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Weeks to months (typically 2-3 weeks for initial improvement, 6-12 weeks for full therapeutic effect)
PeakEffect:
12-24 weeks
DurationOfAction:
Continues as long as treatment is maintained; effects may persist for some time after 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. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious side effect:
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 is bothersome or persistent
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people do not experience any side effects or only have mild ones, it is 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 resolve:
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, 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, contact your doctor for medical 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. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious side effect:
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 is bothersome or persistent
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people do not experience any side effects or only have mild ones, it is 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 resolve:
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, 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, contact your doctor for medical 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
- Excessive redness, swelling, blistering, or crusting of the skin
- Allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat)
- Unusual skin discoloration (hypopigmentation or hyperpigmentation)
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 conditions.
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 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, skin sensitivity to light, or any other skin conditions.
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 that it is safe to do so in conjunction with this medication.
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, it is crucial to follow your doctor's instructions carefully. 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 this medication may increase your risk of sunburn. When outdoors, use sunscreen and lip balm with a Sun Protection Factor (SPF) of 15 or higher, wear protective clothing, and use eyewear that shields your skin from the sun. Be aware that certain weather conditions, such as cold and wind, may irritate your skin. Consult your doctor or pharmacist for guidance on protecting your skin.
Additionally, avoid contact with lime peels, as this may cause irritation. If you use other skin products while taking this medication, you may experience increased irritation. Before using any other skin products, including soaps, consult your doctor.
Managing Dry Skin and Using Cosmetics
If this medication causes dry skin, you may use a moisturizer. However, consult your doctor or pharmacist to determine the best type of moisturizer to use. You can use makeup unless your doctor has advised against it. If you plan to use makeup, clean the treatment area before applying this medication.
Safety Precautions
If you accidentally swallow this medication, call your doctor or a 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, 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, it is crucial to follow your doctor's instructions carefully. 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 this medication may increase your risk of sunburn. When outdoors, use sunscreen and lip balm with a Sun Protection Factor (SPF) of 15 or higher, wear protective clothing, and use eyewear that shields your skin from the sun. Be aware that certain weather conditions, such as cold and wind, may irritate your skin. Consult your doctor or pharmacist for guidance on protecting your skin.
Additionally, avoid contact with lime peels, as this may cause irritation. If you use other skin products while taking this medication, you may experience increased irritation. Before using any other skin products, including soaps, consult your doctor.
Managing Dry Skin and Using Cosmetics
If this medication causes dry skin, you may use a moisturizer. However, consult your doctor or pharmacist to determine the best type of moisturizer to use. You can use makeup unless your doctor has advised against it. If you plan to use makeup, clean the treatment area before applying this medication.
Safety Precautions
If you accidentally swallow this medication, call your doctor or a 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, discuss the potential risks to your baby with your doctor.
Overdose Information
Overdose Symptoms:
- Excessive redness
- Severe peeling
- Discomfort
What to Do:
Topical overdose is unlikely to cause systemic toxicity due to minimal absorption. Discontinue use and apply a cold compress or soothing moisturizer. If irritation is severe, seek medical attention. For accidental ingestion, call Poison Control at 1-800-222-1222.
Drug Interactions
Moderate Interactions
- Topical products containing sulfur, resorcinol, salicylic acid, or benzoyl peroxide (may cause excessive irritation)
- Astringents, abrasive soaps, cleansers, or cosmetics with strong drying effects (may cause excessive irritation)
- Products containing alcohol, spices, or lime (may cause excessive irritation)
- Medicated soaps or shampoos (may cause excessive irritation)
- Other topical acne preparations (concurrent use may increase irritation)
Monitoring
Baseline Monitoring
Skin condition assessment (e.g., severity of acne, photoaging)
Rationale: To establish baseline for treatment efficacy and identify potential contraindications (e.g., severe sunburn).
Timing: Prior to initiation of therapy.
Patient education on proper application and potential side effects
Rationale: To ensure patient compliance and manage expectations regarding irritation and sun sensitivity.
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 expected; severe irritation warrants dose modification or temporary discontinuation.
Action Threshold: Severe or persistent irritation: reduce frequency of application, temporarily discontinue, or switch to lower strength.
Therapeutic response (reduction in lesions, improvement in skin texture)
Frequency: Every 4-8 weeks during initial treatment, then every 3-6 months for maintenance.
Target: Gradual improvement over weeks to months.
Action Threshold: No improvement after 12 weeks: re-evaluate diagnosis or treatment plan.
Symptom Monitoring
- Skin redness
- Peeling or flaking skin
- Dryness
- Itching
- Burning sensation
- Stinging sensation
- Swelling
- Blistering
- Crusting
- Hypopigmentation or hyperpigmentation
Special Patient Groups
Pregnancy
Tretinoin topical is Pregnancy Category C. While systemic absorption is minimal, oral tretinoin is a known teratogen (Category X). Therefore, use during pregnancy should be avoided unless the potential benefit justifies the potential risk to the fetus. Women of childbearing potential should be advised to use effective contraception during treatment.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm, especially during organogenesis, though systemic absorption is low. Avoid use.
Second Trimester:
Risk considered lower than first trimester due to minimal systemic absorption, but still generally avoided.
Third Trimester:
Risk considered lower than first trimester, but still generally avoided.
Lactation
Topical tretinoin is poorly absorbed through the skin, and systemic absorption is minimal. It is unlikely to reach the infant in amounts that would cause adverse effects. Use with caution; avoid applying to areas where the infant may come into direct contact with the medication (e.g., breast area).
Infant Risk:
Low risk (L3 - Probably Compatible)
Pediatric Use
Safety and efficacy have not been established in pediatric patients under 9 years of age. For patients 9 years of age and older, dosing is similar to adults. Close monitoring for irritation is important.
Geriatric Use
No specific dose adjustments are required. However, geriatric patients may have more fragile or sensitive skin, potentially leading to increased irritation. Use with caution and monitor skin response closely.
Clinical Information
Clinical Pearls
- Start with a small amount (pea-sized) and apply to dry skin 20-30 minutes after washing to minimize irritation.
- The 'retinization' period (initial irritation, redness, peeling) is common and usually subsides within 2-4 weeks. Patients should be counseled on this to encourage adherence.
- Emphasize strict sun protection (sunscreen, hats, protective clothing) as tretinoin significantly increases photosensitivity.
- Avoid concomitant use of other irritating topical products, especially those containing alcohol, astringents, or strong exfoliants.
- Results are not immediate; consistent use for 8-12 weeks is typically required to see significant improvement.
- Tretinoin can be drying; recommend a non-comedogenic moisturizer to help manage dryness and irritation.
Alternative Therapies
- Adapalene (topical retinoid)
- Tazarotene (topical retinoid)
- Benzoyl peroxide (topical anti-acne)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe acne)
- Azelaic acid (topical anti-acne, anti-inflammatory)
- Salicylic acid (topical exfoliant)
- Chemical peels
- Laser therapy (for photoaging)
- Botulinum toxin (for wrinkles)
- Dermal fillers (for wrinkles)
Cost & Coverage
Average Cost:
$100 - $200+ per 50gm pump
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (may require prior authorization or step therapy for brand-name products)
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, the amount, and the time it happened.