Altreno 0.05% Lotion 20gm
It is used to treat pimples (acne).
Drug Class
Retinoid; Anti-acne agent
Pharmacologic Class
Retinoid
Pregnancy Category
Category C
FDA Approved
Aug 2018
DEA Schedule
Not Controlled
Overview
What is this medicine?
Altreno is a topical lotion containing tretinoin, a form of vitamin A. It works by helping your skin renew itself more quickly, which can help clear up acne and prevent new breakouts. It also helps to reduce inflammation associated with acne.
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 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.
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 the 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.
Storage and Disposal
Store this medication at room temperature, avoiding freezing.
Keep all medications in a safe and 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 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.
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 the 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.
Storage and Disposal
Store this medication at room temperature, avoiding freezing.
Keep all medications in a safe and 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 once daily in the evening to clean, dry skin. Use a pea-sized amount for the entire face.
- Avoid contact with eyes, lips, angles of the nose, and mucous membranes.
- Sun protection is crucial: Use sunscreen (SPF 15 or higher) and wear protective clothing when outdoors, as tretinoin increases sensitivity to sunlight.
- Avoid excessive exposure to sunlight, sunlamps, and tanning beds.
- Use a gentle, non-comedogenic moisturizer and cleanser to help manage dryness and irritation.
- Do not use other topical products that can dry or irritate the skin (e.g., astringents, abrasive soaps, alcohol-containing products) unless directed by your doctor.
- Results are not immediate; it may take several weeks to months to see significant improvement. Continue treatment as prescribed.
- Initial worsening of acne (purging) can occur during the first few weeks of treatment; this is usually temporary.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to the affected areas once daily in the evening.
Condition-Specific Dosing:
acne vulgaris:
Apply a thin layer to the affected areas once daily in the evening.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 9 years of age.
Adolescent:
For patients 9 years of age and older: Apply a thin layer to the affected areas once daily in the evening.
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, tretinoin 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. Additionally, tretinoin has anti-inflammatory effects.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (typically <1% of applied dose)
Tmax:
Not well-defined for topical application due to minimal systemic absorption; systemic Cmax < 1 ng/mL after repeated application.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not clinically relevant for topical application due to minimal systemic absorption.
ProteinBinding:
Highly protein bound (>95%) if systemically absorbed.
CnssPenetration:
Limited (minimal systemic absorption).
Elimination:
HalfLife:
Not clinically relevant for topical application due to minimal systemic absorption; endogenous tretinoin has a short half-life (0.5-2 hours).
Clearance:
Not clinically relevant for topical application.
ExcretionRoute:
If systemically absorbed, primarily renal and fecal excretion.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Typically 2-3 weeks, but optimal results may take 6-12 weeks.
PeakEffect:
Optimal results seen after 6-12 weeks of continuous use.
DurationOfAction:
Effects persist as long as treatment is continued; relapse may occur upon discontinuation.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 immediately or seek 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
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. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
Feeling of warmth
Burning or stinging
Change in skin color
Skin reactions, including:
+ 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, 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 immediately or seek 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
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. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
Feeling of warmth
Burning or stinging
Change in skin color
Skin reactions, including:
+ 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 redness, burning, stinging, or peeling that does not improve or worsens significantly.
- 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 allergic reaction you experienced, including any symptoms that occurred.
If you have a sunburn, skin sensitivity to light, or any other skin problems.
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 plan 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 medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. This will help ensure your safety while taking this medication.
To guarantee your safety, always verify with your doctor before starting, stopping, or changing the dosage of any 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 allergic reaction you experienced, including any symptoms that occurred.
If you have a sunburn, skin sensitivity to light, or any other skin problems.
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 plan 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 medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. This will help ensure your safety while taking this medication.
To guarantee your safety, always verify with your doctor before starting, stopping, or changing the dosage of any 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. 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. Using more than prescribed or for a longer period than recommended may increase the risk of severe side effects.
Skin Precautions
Do not apply this medication to sunburned, cut, scraped, eczematous, or damaged skin, as this may exacerbate skin irritation. To minimize the risk of skin reactions, practice good skin care and avoid excessive sun exposure. You may be more susceptible to sunburn while using this medication, so take necessary precautions:
Avoid direct sunlight, sunlamps, and tanning beds
Use sunscreen and lip balm with a Sun Protection Factor (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 may irritate your skin; consult your doctor or pharmacist for guidance on protecting your skin
Additional Precautions
Avoid contact with lime peels, as this may cause skin irritation. Using other skin products in conjunction with this medication may increase the risk of irritation; consult your doctor before using any other skin products, including soaps. If you experience dry skin, you may use a moisturizer; however, consult your doctor or pharmacist to determine the best type of moisturizer to use. You may 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.
Safety Warnings
If this medication is swallowed, it may cause harm; if ingestion occurs, contact a doctor or poison control center immediately. Additionally, this medication may pose a risk to the unborn baby if taken during pregnancy. If you suspect you may be pregnant or plan to become pregnant while using this medication, notify your doctor promptly.
Breastfeeding Considerations
If you are breastfeeding, inform your doctor, as they will need to discuss potential risks to your baby and determine the best course of action.
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. Using more than prescribed or for a longer period than recommended may increase the risk of severe side effects.
Skin Precautions
Do not apply this medication to sunburned, cut, scraped, eczematous, or damaged skin, as this may exacerbate skin irritation. To minimize the risk of skin reactions, practice good skin care and avoid excessive sun exposure. You may be more susceptible to sunburn while using this medication, so take necessary precautions:
Avoid direct sunlight, sunlamps, and tanning beds
Use sunscreen and lip balm with a Sun Protection Factor (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 may irritate your skin; consult your doctor or pharmacist for guidance on protecting your skin
Additional Precautions
Avoid contact with lime peels, as this may cause skin irritation. Using other skin products in conjunction with this medication may increase the risk of irritation; consult your doctor before using any other skin products, including soaps. If you experience dry skin, you may use a moisturizer; however, consult your doctor or pharmacist to determine the best type of moisturizer to use. You may 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.
Safety Warnings
If this medication is swallowed, it may cause harm; if ingestion occurs, contact a doctor or poison control center immediately. Additionally, this medication may pose a risk to the unborn baby if taken during pregnancy. If you suspect you may be pregnant or plan to become pregnant while using this medication, notify your doctor promptly.
Breastfeeding Considerations
If you are breastfeeding, inform your doctor, as they will need to discuss potential risks to your baby and determine the best course of action.
Overdose Information
Overdose Symptoms:
- Excessive redness
- Peeling
- Discomfort
What to Do:
Topical overdose is unlikely to cause systemic toxicity due to minimal absorption. If excessive application occurs, discontinue use temporarily. Symptomatic and supportive care for local irritation. Call 1-800-222-1222 for poison control advice if accidental ingestion occurs, though systemic effects are unlikely.
Drug Interactions
Major Interactions
- Concomitant use with other topical preparations that have a strong drying effect (e.g., products containing alcohol, astringents, spices, or lime) should be avoided due to increased irritation.
- Concomitant use with other topical medications that are known to be strong irritants or have a strong drying effect (e.g., sulfur, resorcinol, salicylic acid) should be used with caution or avoided.
Moderate Interactions
- Photosensitizing agents (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides): May increase risk of photosensitivity reactions when used concurrently with tretinoin.
Monitoring
Baseline Monitoring
Skin assessment (type, severity of acne, presence of irritation)
Rationale: To establish baseline condition and guide treatment plan.
Timing: Prior to initiation of therapy.
Routine Monitoring
Efficacy (reduction in acne lesions)
Frequency: Every 4-8 weeks initially, then as needed.
Target: Improvement in acne lesions.
Action Threshold: Lack of improvement after 12 weeks may warrant re-evaluation of treatment.
Skin irritation (erythema, scaling, dryness, burning, stinging)
Frequency: Regularly, especially during the first few weeks of treatment.
Target: Mild to moderate irritation is expected; severe irritation should be addressed.
Action Threshold: Severe or persistent irritation may require temporary discontinuation, reduced frequency of application, or use of moisturizers.
Symptom Monitoring
- Redness
- Scaling
- Dryness
- Burning
- Stinging
- Itching
- Peeling
- Photosensitivity (sunburn)
Special Patient Groups
Pregnancy
Altreno is Pregnancy Category C. Based on data from human and animal studies, Altreno may cause fetal harm when administered to a pregnant woman. While systemic absorption is minimal, the potential for teratogenicity with retinoids is a concern. Use should be avoided during pregnancy unless the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, especially during organogenesis, though systemic absorption is minimal.
Second Trimester:
Risk considered low due to minimal systemic absorption, but caution advised.
Third Trimester:
Risk considered low due to minimal systemic absorption, but caution advised.
Lactation
It is not known whether tretinoin is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants from tretinoin, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Caution is advised.
Infant Risk:
Risk level L4 (Potentially Hazardous) due to theoretical risk and lack of data, despite minimal systemic absorption.
Pediatric Use
Safety and effectiveness have been established in pediatric patients 9 years of age and older. Safety and effectiveness have not been established in pediatric patients younger than 9 years of age.
Geriatric Use
Clinical studies of Altreno did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. No specific dose adjustments are generally needed due to minimal systemic absorption.
Clinical Information
Clinical Pearls
- Altreno is a unique lotion formulation of tretinoin, which may be better tolerated than cream or gel formulations for patients with sensitive or dry skin.
- Patients should be advised that an initial 'purging' or worsening of acne may occur during the first few weeks of treatment, which is a normal part of the process and indicates the medication is working.
- Strict adherence to sun protection measures (sunscreen, protective clothing, avoiding peak sun hours) is critical due to increased photosensitivity.
- Emphasize the importance of consistency and patience, as significant improvement often takes 2-3 months of daily use.
- Start with a small amount (pea-sized for the entire face) and apply to dry skin 20-30 minutes after cleansing to minimize irritation.
Alternative Therapies
- Other topical retinoids (e.g., adapalene, tazarotene)
- Topical antibiotics (e.g., clindamycin, erythromycin)
- Topical benzoyl peroxide
- Topical dapsone
- Oral antibiotics (e.g., doxycycline, minocycline)
- Oral isotretinoin (for severe, recalcitrant acne)
- Hormonal therapies (e.g., oral contraceptives, spironolactone for females)
- Azelaic acid
Cost & Coverage
Average Cost:
$500 - $700 per 20gm tube
Insurance Coverage:
Tier 3 or higher (Specialty/Non-preferred Brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to discuss them with 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.