Retin-A 0.01% Gel 45gm
It is used to treat pimples (acne).
Drug Class
Retinoid, Anti-acne, Keratolytic
Pharmacologic Class
Retinoid
Pregnancy Category
Category C
FDA Approved
Apr 1971
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tretinoin is a medication derived from Vitamin A that is applied to the skin to treat acne. It works by helping skin cells turn over more quickly and preventing pores from getting clogged. It can also help reduce inflammation. It's important to use it exactly as prescribed and to protect your skin from the sun.
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 to ensure safe and effective treatment.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not ingest it or apply it to your mouth, nose, or eyes, as it may cause burning.
If you accidentally get the medication in your mouth, nose, or eyes, rinse the area thoroughly with water.
Apply the medication at bedtime to minimize potential interference with daily activities.
Before and after applying the medication, wash your hands thoroughly to prevent cross-contamination.
Gently wash the affected skin area with a mild, non-medicated soap and pat it dry before applying the medication.
You may need to wait 20 to 30 minutes after washing the affected area 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 area and gently rub it in.
Important Safety Precautions
This medication is flammable, so avoid using it near open flames 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 a double dose or extra doses to make up for the 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 to ensure safe and effective treatment.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not ingest it or apply it to your mouth, nose, or eyes, as it may cause burning.
If you accidentally get the medication in your mouth, nose, or eyes, rinse the area thoroughly with water.
Apply the medication at bedtime to minimize potential interference with daily activities.
Before and after applying the medication, wash your hands thoroughly to prevent cross-contamination.
Gently wash the affected skin area with a mild, non-medicated soap and pat it dry before applying the medication.
You may need to wait 20 to 30 minutes after washing the affected area 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 area and gently rub it in.
Important Safety Precautions
This medication is flammable, so avoid using it near open flames 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 a double dose or extra doses to make up for the missed dose.
Lifestyle & Tips
- Apply a thin layer to clean, dry skin once daily at bedtime.
- Avoid applying to eyes, mouth, angles of the nose, or mucous membranes.
- Use a gentle, non-medicated cleanser and moisturizer.
- Avoid excessive sun exposure, including sunlamps and tanning beds, as tretinoin increases sensitivity to sunlight. Use sunscreen (SPF 30 or higher) and wear protective clothing when outdoors.
- Do not use other topical acne medications (e.g., benzoyl peroxide, salicylic acid) at the same time of day as tretinoin unless directed by your doctor, as this can increase irritation.
- Initial worsening of acne (purging) and skin irritation (redness, peeling, dryness) are common during the first few weeks of treatment; this usually subsides.
- Results may take 6-12 weeks to become noticeable.
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 to affected areas once daily at bedtime
Condition-Specific Dosing:
acne vulgaris:
Apply a thin layer to affected areas once daily at bedtime. Initial irritation (redness, peeling) is common and usually subsides with continued use. May start with less frequent application (every other night) if irritation is severe.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 12 years of age. Safety and efficacy not established.
Adolescent:
Apply a thin layer to affected areas once daily at bedtime (typically for ages 12 and older with acne vulgaris).
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed (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) and retinoid X receptors (RXRs) in the nucleus, which then modulate gene expression. In acne, it decreases cohesion 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. Tretinoin also has anti-inflammatory properties.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (approximately 1-2% of topically applied dose)
Tmax:
Not clinically significant for topical application due to minimal absorption
FoodEffect:
Not applicable for topical formulation
Distribution:
Vd:
Not clinically significant due to minimal systemic absorption
ProteinBinding:
Highly protein bound if systemically absorbed (primarily to albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
Not clinically significant for topical application due to minimal absorption
Clearance:
Not clinically significant for topical application
ExcretionRoute:
Primarily renal and biliary if systemically absorbed
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
2-3 weeks (initial improvement), 6-12 weeks (maximal effect)
PeakEffect:
6-12 weeks
DurationOfAction:
Continues as long as treatment is maintained
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
+ 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 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 develop any skin reactions, consult your doctor, as 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. 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
+ 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 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 develop any skin reactions, consult your doctor, as 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. 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 blistering
- Crusting
- Swelling
- Excessive redness
- Severe burning or stinging 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, 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.
Additionally, it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This is not an exhaustive list of potential interactions, and you must verify that it is safe to take this medication with all of your other medications and health conditions. Never start, stop, or modify 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.
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.
Additionally, it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This is not an exhaustive list of potential interactions, and you must verify that it is safe to take this medication with all of your other medications and health conditions. Never start, stop, or modify the dosage of any medication without first consulting your doctor.
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 notice the full effects of this medication for several weeks. To minimize the risk of severe side effects, adhere strictly to 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, as this medication may increase your susceptibility to 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 eyes 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 in these conditions.
Additionally, avoid contact with lime peels while using this medication. Be cautious when using other skin products, as they may increase irritation. Before using any other drugs or products on your skin, including soaps, consult your doctor. If this medication causes dry skin, you may use a moisturizer; however, discuss the suitable type of moisturizer with your doctor or pharmacist. You can use makeup unless your doctor has advised against it; if you do use makeup, ensure the area to be treated is clean before applying this medication.
In case of accidental ingestion, this medication can be harmful; if swallowed, immediately contact a doctor or a 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 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, adhere strictly to 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, as this medication may increase your susceptibility to 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 eyes 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 in these conditions.
Additionally, avoid contact with lime peels while using this medication. Be cautious when using other skin products, as they may increase irritation. Before using any other drugs or products on your skin, including soaps, consult your doctor. If this medication causes dry skin, you may use a moisturizer; however, discuss the suitable type of moisturizer with your doctor or pharmacist. You can use makeup unless your doctor has advised against it; if you do use makeup, ensure the area to be treated is clean before applying this medication.
In case of accidental ingestion, this medication can be harmful; if swallowed, immediately contact a doctor or a 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 are breastfeeding, consult your doctor to discuss any potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Excessive redness
- Severe peeling
- Discomfort
What to Do:
Topical overdose is unlikely to cause systemic toxicity. Discontinue use and apply a cold compress. If severe irritation occurs, contact your healthcare provider. For accidental ingestion, contact a poison control center (e.g., 1-800-222-1222) or seek emergency medical attention.
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
Monitoring
Baseline Monitoring
Skin assessment (type, sensitivity, existing lesions)
Rationale: To establish baseline skin condition and identify potential contraindications or sensitivities.
Timing: Prior to initiation of therapy
Patient education on proper application and expected side effects
Rationale: To ensure patient adherence and manage expectations regarding initial irritation.
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 expected; severe irritation should prompt dose adjustment or temporary discontinuation.
Action Threshold: Severe blistering, crusting, swelling, or persistent burning/stinging
Therapeutic response (reduction in acne lesions)
Frequency: Monthly
Target: Gradual improvement over 6-12 weeks
Action Threshold: No improvement after 12 weeks or worsening of condition
Symptom Monitoring
- Redness
- Peeling
- Dryness
- Itching
- Stinging
- Burning sensation
- Photosensitivity (increased sensitivity to sunlight)
Special Patient Groups
Pregnancy
Tretinoin topical is Pregnancy Category C. While systemic absorption is minimal, oral retinoids are highly teratogenic. Use during pregnancy should be avoided unless the potential benefit justifies the potential risk to the fetus. Women of childbearing potential should use effective contraception.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though risk with topical is considered low due to minimal absorption. Avoid if possible.
Second Trimester:
Avoid if possible.
Third Trimester:
Avoid if possible.
Lactation
L3 - Moderate risk. Minimal systemic absorption is expected, making infant exposure via breast milk unlikely to be significant. However, caution is advised. Avoid applying to areas where the infant may come into direct contact with the medication.
Infant Risk:
Low to moderate risk; monitor infant for adverse effects.
Pediatric Use
Safety and efficacy have not been established in pediatric patients younger than 12 years of age. Used in adolescents (12 years and older) for acne vulgaris.
Geriatric Use
No specific dosage adjustments are required. However, geriatric patients may have more fragile or sensitive skin and may experience increased irritation. Use with caution and monitor for adverse skin reactions.
Clinical Information
Clinical Pearls
- The 'retinization' period (first 2-4 weeks) is characterized by increased redness, dryness, and peeling. This is normal and indicates the medication is working. Patients should be counseled on this to improve adherence.
- Always apply to completely dry skin (wait 20-30 minutes after washing face) to minimize irritation.
- A pea-sized amount is usually sufficient for the entire face.
- Strict sun protection is crucial due to increased photosensitivity.
- Tretinoin can be used long-term for maintenance therapy once acne is controlled.
- Avoid concomitant use of other topical products that may cause excessive drying or irritation, especially during the initial phase of treatment.
Alternative Therapies
- Adapalene (Differin)
- Tazarotene (Tazorac)
- Benzoyl peroxide
- Salicylic acid
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe, recalcitrant acne)
- Azelaic acid
Cost & Coverage
Average Cost:
$100 - $250 per 45g tube (0.01% gel)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (often requires prior authorization for brand)
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 this 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 overdose, including the medication taken, the amount, and the time it occurred.