Retin-A 0.1% Cream 45gm
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
Apr 1971
DEA Schedule
Not Controlled
Overview
What is this medicine?
Retin-A 0.1% Cream is a medication containing tretinoin, a form of vitamin A. It's used on the skin to treat acne by helping to clear pores and reduce breakouts. It can also be used to improve the appearance of fine wrinkles, dark spots, 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 accompanying 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 ingest it.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation. If accidental contact occurs, rinse the affected area thoroughly with water.
Apply the medication at bedtime.
Before and after applying the medication, wash your hands thoroughly.
Gently wash the affected skin area with a mild, non-medicated soap and pat it dry before application. You may need to wait 20 to 30 minutes after washing before applying the medication; consult with your pharmacist for guidance.
Apply a thin layer of the medication to the affected skin area and gently rub it in.
Storage and Disposal
Store this medication at room temperature, avoiding freezing.
Keep all medications in a secure location, out of the reach of children and pets.
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 a 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.
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. If accidental contact occurs, rinse the affected area thoroughly with water.
Apply the medication at bedtime.
Before and after applying the medication, wash your hands thoroughly.
Gently wash the affected skin area with a mild, non-medicated soap and pat it dry before application. You may need to wait 20 to 30 minutes after washing before applying the medication; consult with your pharmacist for guidance.
Apply a thin layer of the medication to the affected skin area and gently rub it in.
Storage and Disposal
Store this medication at room temperature, avoiding freezing.
Keep all medications in a secure location, out of the reach of children and pets.
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 a missed dose.
Lifestyle & Tips
- Apply a thin layer to clean, dry skin, usually once daily at bedtime.
- Avoid applying to eyes, mouth, angles of the nose, or mucous membranes.
- Use a gentle, non-medicated cleanser and moisturizer daily.
- Sun sensitivity is increased; use broad-spectrum sunscreen (SPF 30 or higher) daily and wear protective clothing.
- Avoid excessive sun exposure, including sunlamps and tanning beds.
- Do not use if pregnant or planning to become pregnant.
- Initial worsening of acne (purging) may occur during the first few weeks of treatment; this is normal.
- Be patient; it can take several weeks to months to see full results.
Available Forms & Alternatives
Available Strengths:
- Retin-A 0.025% Gel 15gm
- Retin-A 0.025% Cream 20gm
- Retin-A Micro 0.08% Gel Pump 50gm
- Retin-A 0.05% Cream 20gm
- Retin-A 0.05% Cream 45gm
- Retin-A 0.025% Cream 45gm
- Retin-A 0.1% Cream 20gm
- Retin-A 0.01% Gel 15gm
- Retin-A 0.01% Gel 45gm
- Retin-A Micro 0.04% Gel 45gm
- Retin-A 0.1% Cream 45gm
- Retin-A Micro 0.1% Gel 20gm
- Retin-A 0.025% Gel 45gm
- Retin-A Micro 0.1% Gel 45gm
- Retin-A Micro 0.04% Gel Pump 50gm
- Retin-A Micro 0.1% Gel Pump 50gm
- Retin-A Micro 0.04% Gel 20gm
- Retin-A Micro 0.06% Gel Pump 50gm
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer of Retin-A 0.1% Cream to the affected areas once daily, usually in the evening, before bedtime.
Condition-Specific Dosing:
Acne Vulgaris:
Apply once daily, usually in the evening. Initial response may take 2-3 weeks, with full therapeutic effect in 6-12 weeks.
Fine Wrinkles/Hyperpigmentation:
Apply once daily, usually in the evening. Improvement may be seen after 3-4 weeks, with more significant results after 6 months.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 12 years. Safety and efficacy not established.
Adolescent:
For acne vulgaris, apply a thin layer once daily, usually in the evening, similar to adult dosing. Use with caution and monitor for irritation.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Tretinoin is a retinoid that acts by modifying gene expression, leading to altered cellular differentiation, proliferation, and intercellular communication. In acne, it 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. For photoaging, it affects epidermal and dermal cell growth, promoting collagen synthesis and reducing collagen degradation.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal (<2%)
Tmax:
Not applicable for topical use (minimal systemic absorption)
FoodEffect:
Not applicable for topical use
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Biliary and renal (if systemically absorbed)
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
2-3 weeks for initial improvement in acne; 3-4 weeks for initial improvement in photoaging
PeakEffect:
6-12 weeks for full therapeutic effect in acne; 6 months for significant improvement in photoaging
DurationOfAction:
Requires continuous use for sustained effect
Safety & Warnings
Side Effects
Urgent 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
Severe skin reactions that are bothersome or persistent
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 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, 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
Severe skin reactions that are bothersome or persistent
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 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, 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, stinging, or itching
- Excessive redness, swelling, or blistering of the skin
- Crusting or oozing from treated areas
- Unusual skin discoloration
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 have this effect. If you are unsure, consult your doctor or pharmacist for guidance.
Additionally, if you are pregnant, notify your doctor.
This is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to discuss the following with your doctor and pharmacist:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your overall health and any existing medical conditions
To ensure your safety, always verify with your doctor that it is acceptable to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage 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 have this effect. If you are unsure, consult your doctor or pharmacist for guidance.
Additionally, if you are pregnant, notify your doctor.
This is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to discuss the following with your doctor and pharmacist:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your overall health and any existing medical conditions
To ensure your safety, always verify with your doctor that it is acceptable to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage 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. This will help ensure your safety and prevent any potential interactions with other treatments.
Using Your Medication Correctly
To achieve the full benefits of this medication, it may take several weeks of consistent use. It is crucial to follow your doctor's instructions carefully and not exceed the recommended dosage or frequency of application. Taking more than prescribed or using it for a longer period than recommended can increase the risk of severe side effects.
Skin Precautions
Avoid applying this medication to sunburned skin, cuts, scrapes, eczema, or damaged skin, as this can exacerbate skin irritation. To minimize the risk of skin problems, practice good skin care and take measures to protect your skin from the sun.
Sun Protection
You may be more susceptible to sunburn while using this medication. To reduce this risk, avoid exposure to direct sunlight, sunlamps, and tanning beds. When going outside, use a broad-spectrum sunscreen and lip balm with a Sun Protection Factor (SPF) of 15 or higher. Wear protective clothing and eyewear to shield your skin from the sun. Be aware that certain weather conditions, such as cold and wind, can irritate your skin. Consult your doctor or pharmacist for guidance on protecting your skin in these situations.
Additional Precautions
Avoid contact with lime peels, as this can cause skin irritation. Using other skin products while taking 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. 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 do use makeup, clean the area to be treated before applying this medication.
Safety Warnings
If you accidentally swallow this medication, 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, consult your doctor to discuss any potential risks to your baby.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent any potential interactions with other treatments.
Using Your Medication Correctly
To achieve the full benefits of this medication, it may take several weeks of consistent use. It is crucial to follow your doctor's instructions carefully and not exceed the recommended dosage or frequency of application. Taking more than prescribed or using it for a longer period than recommended can increase the risk of severe side effects.
Skin Precautions
Avoid applying this medication to sunburned skin, cuts, scrapes, eczema, or damaged skin, as this can exacerbate skin irritation. To minimize the risk of skin problems, practice good skin care and take measures to protect your skin from the sun.
Sun Protection
You may be more susceptible to sunburn while using this medication. To reduce this risk, avoid exposure to direct sunlight, sunlamps, and tanning beds. When going outside, use a broad-spectrum sunscreen and lip balm with a Sun Protection Factor (SPF) of 15 or higher. Wear protective clothing and eyewear to shield your skin from the sun. Be aware that certain weather conditions, such as cold and wind, can irritate your skin. Consult your doctor or pharmacist for guidance on protecting your skin in these situations.
Additional Precautions
Avoid contact with lime peels, as this can cause skin irritation. Using other skin products while taking 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. 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 do use makeup, clean the area to be treated before applying this medication.
Safety Warnings
If you accidentally swallow this medication, 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, 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 marked redness, peeling, and discomfort.
- Oral ingestion (accidental) may lead to symptoms similar to hypervitaminosis A (e.g., headache, nausea, vomiting, fatigue, dry skin, joint pain).
What to Do:
For topical overdose, discontinue use temporarily until irritation subsides. For accidental oral ingestion, seek immediate medical attention. Call a poison control center (1-800-222-1222) or emergency services.
Drug Interactions
Moderate Interactions
- Topical products containing sulfur, resorcinol, salicylic acid, or benzoyl peroxide (may increase irritation)
- Astringents, abrasive soaps, cleansers, or cosmetics with strong drying effects (may increase irritation)
- Products containing alcohol, spices, or lime (may increase irritation)
- Medicated soaps or shampoos (may increase irritation)
- Wax depilatories (may cause skin tearing or irritation)
Monitoring
Baseline Monitoring
Skin condition assessment (redness, dryness, peeling, acne lesions)
Rationale: To establish baseline for efficacy and adverse effects.
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; patient discomfort
Therapeutic response (reduction in acne lesions, improvement in skin texture/pigmentation)
Frequency: Monthly for first 3 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 months for photoaging
Symptom Monitoring
- Excessive redness
- Severe dryness
- Peeling or flaking of skin
- Burning or stinging sensation
- Itching
- Swelling
- Blistering or crusting (rare, severe reaction)
Special Patient Groups
Pregnancy
Contraindicated in pregnancy or in women who may become pregnant. While systemic absorption of topical tretinoin is minimal, oral tretinoin (isotretinoin) is a known teratogen. Due to the potential for fetal harm, use should be avoided.
Trimester-Specific Risks:
First Trimester:
Highest risk for teratogenicity if significant systemic absorption were to occur (though unlikely with topical use).
Second Trimester:
Risk of fetal harm, though less than first trimester.
Third Trimester:
Risk of fetal harm, though less than first trimester.
Lactation
Use with caution. It is not known whether tretinoin is excreted in human milk. Due to minimal systemic absorption, infant exposure is expected to be low. However, avoid applying to areas where the infant may come into direct contact with the medication.
Infant Risk:
Low risk, but monitor for any adverse effects.
Pediatric Use
Safety and efficacy have not been established in pediatric patients younger than 12 years of age. Use in adolescents (12 years and older) for acne is common, but monitor closely for irritation.
Geriatric Use
No specific dose adjustments are necessary. However, geriatric patients may have more fragile or sensitive skin, potentially leading to increased irritation. Use with caution and monitor for adverse skin reactions.
Clinical Information
Clinical Pearls
- Start with a lower concentration (e.g., 0.025%) if skin is very sensitive, and gradually increase as tolerated.
- Apply a pea-sized amount for the entire face.
- Wait 20-30 minutes after washing face before applying to ensure skin is completely dry, which can reduce irritation.
- Use a non-comedogenic moisturizer frequently, especially during the initial weeks of treatment, to combat dryness and irritation.
- Consistency is key; results take time and continuous use.
- Avoid concurrent use of other irritating topical products, especially during the initial phase of treatment.
- The 'purging' phase (initial worsening of acne) is common and usually subsides within a few weeks.
Alternative Therapies
- Adapalene (Differin)
- Tazarotene (Tazorac)
- Benzoyl Peroxide
- Salicylic Acid
- Azelaic Acid
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe acne)
- Chemical peels
- Laser therapy
Cost & Coverage
Average Cost:
$100 - $250 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 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 occurred.