Altreno 0.05% Lotion 45gm

Manufacturer BAUSCH HEALTH Active Ingredient Tretinoin Lotion(TRET i noyn) Pronunciation TRET i noyn
It is used to treat pimples (acne).
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Drug Class
Anti-acne agent
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Pharmacologic Class
Retinoid
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Pregnancy Category
Category C
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FDA Approved
Aug 2018
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Altreno is a lotion containing tretinoin, a type of vitamin A. It works by helping your skin cells turn over more quickly and reducing inflammation, which helps to clear up acne. It's applied to the skin once a day.
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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.
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Lifestyle & Tips

  • Apply to clean, dry skin in the evening.
  • 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 15 or higher), wear protective clothing, and limit sun exposure, as tretinoin increases sensitivity to sunlight.
  • Avoid excessive exposure to wind and cold.
  • Use a gentle, non-comedogenic moisturizer to help with dryness and irritation.
  • Do not use other topical products that may cause irritation (e.g., abrasive soaps, astringents, products with high alcohol content) unless directed by your doctor.
  • Be patient; it may take 8-12 weeks to see significant improvement, and acne may appear worse initially.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin layer to the affected areas of the face once daily in the evening.

Condition-Specific Dosing:

acne_vulgaris: Apply a thin layer to the affected areas of the face once daily in the evening.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: For patients 9 years of age and older: Apply a thin layer to the affected areas of the face once daily in the evening.
Adolescent: Apply a thin layer to the affected areas of the face once daily in the evening.
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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)
Confidence: Medium

Pharmacology

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Mechanism of Action

Tretinoin is a retinoid that modulates the differentiation and proliferation of epithelial cells. 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. Tretinoin also has anti-inflammatory effects.
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Pharmacokinetics

Absorption:

Bioavailability: <2% (systemic absorption after topical application)
Tmax: Not well-defined for topical due to minimal systemic absorption
FoodEffect: Not applicable for topical formulation

Distribution:

Vd: Not applicable for topical due to minimal systemic absorption
ProteinBinding: Highly protein bound (>95%) if systemically absorbed
CnssPenetration: Limited (minimal systemic absorption)

Elimination:

HalfLife: Not well-defined for topical due to minimal systemic absorption
Clearance: Not well-defined for topical due to minimal systemic absorption
ExcretionRoute: Urine and feces (if systemically absorbed)
Unchanged: Not significant for topical use
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Pharmacodynamics

OnsetOfAction: Several weeks (initial worsening may occur)
PeakEffect: 8-12 weeks
DurationOfAction: Continuous use required for sustained effect

Safety & Warnings

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Side Effects

Important Side Effects to Report to Your Doctor Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. Seek medical attention right away if you notice any of the following symptoms, which could be signs of a serious reaction:

Allergic reaction symptoms, 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, 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe redness
  • Excessive peeling
  • Blistering
  • Crusting
  • Severe burning or stinging
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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 conditions that may be relevant to your treatment.
If you are currently taking any medications that may increase your skin's sensitivity to light. There are numerous drugs that can cause this interaction, so it is crucial to consult with your doctor or pharmacist if you are unsure.
If you are pregnant, as this may affect your treatment plan.

Additionally, it is vital to provide your doctor and pharmacist with a comprehensive list of all the medications you are taking, including:

Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins

You should also inform them about any existing health problems. This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. The full effects of this drug may not be apparent for several weeks.

To minimize the risk of severe side effects, it is crucial to adhere to your doctor's instructions regarding dosage and frequency of application. Using more of the medication than prescribed, or using it more often or for a longer period than recommended, can increase the risk of adverse effects.

When applying this medication, avoid using it on 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 can make you more susceptible to sunburn. To reduce this risk, avoid exposure to sunlight, sunlamps, and tanning beds, and use sunscreen and lip balm with a Sun Protection Factor (SPF) of 15 or higher when outdoors. Additionally, wear protective clothing and eyewear to shield your skin from the sun. Certain weather conditions, such as cold and wind, may also irritate your skin; consult your doctor or pharmacist for guidance on how to protect your skin in these situations.

Be aware that contact with lime peels may cause adverse effects, and using other skin products in conjunction with this medication can increase the risk of irritation. Before using any other skin products, including soaps, consult your doctor to discuss potential interactions.

If this medication causes dry skin, you may use a moisturizer; however, consult your doctor or pharmacist to determine the most suitable type of moisturizer for your skin. You can use makeup unless your doctor has advised against it; if you do use makeup, ensure that you clean the area to be treated before applying this medication.

In the event that this medication is swallowed, seek immediate medical attention by calling a doctor or poison control center. Additionally, 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.
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Overdose Information

Overdose Symptoms:

  • Excessive redness
  • Peeling
  • Discomfort

What to Do:

Discontinue use temporarily. Symptoms are usually self-limiting. If severe or persistent, seek medical attention. In case of accidental ingestion, call a poison control center (1-800-222-1222) or seek emergency medical attention.

Drug Interactions

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Moderate Interactions

  • Other topical acne preparations (e.g., benzoyl peroxide, salicylic acid, sulfur, resorcinol) - may cause excessive irritation or dryness.
  • Photosensitizing agents (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines) - may increase risk of photosensitivity.
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Minor Interactions

  • Astringents, abrasive soaps and cleansers, medicated soaps or shampoos, permanent wave solutions, electrolysis, hair depilatories or waxes, products with high concentrations of alcohol, spices, or lime - may cause excessive irritation.

Monitoring

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Baseline Monitoring

Skin assessment (severity of acne, presence of irritation)

Rationale: To establish baseline for treatment efficacy and tolerability.

Timing: Prior to initiation of therapy

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Routine Monitoring

Skin irritation (erythema, scaling, dryness, stinging/burning)

Frequency: Regularly during initial weeks of therapy, 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; consider reducing frequency or temporarily stopping.

Acne lesion count and overall appearance

Frequency: Monthly or every 2-3 months

Target: Reduction in inflammatory and non-inflammatory lesions

Action Threshold: No improvement after 8-12 weeks, or worsening of condition.

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Symptom Monitoring

  • Redness
  • Scaling
  • Dryness
  • Stinging
  • Burning
  • Itching
  • Photosensitivity (sunburn)

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. While systemic absorption is minimal, oral retinoids are highly teratogenic. Avoid use during pregnancy if possible.

Trimester-Specific Risks:

First Trimester: Potential for fetal harm, though systemic absorption is low.
Second Trimester: Potential for fetal harm, though systemic absorption is low.
Third Trimester: Potential for fetal harm, though systemic absorption is low.
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Lactation

Minimal systemic absorption is expected, making transfer into breast milk unlikely to be clinically significant. Use with caution. Consider applying after breastfeeding and avoiding application to areas where the infant may come into direct contact with the treated skin.

Infant Risk: Low risk due to minimal systemic absorption.
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Pediatric Use

Approved for use in patients 9 years of age and older. Safety and effectiveness in pediatric patients younger than 9 years have not been established.

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Geriatric Use

No specific dose adjustments are necessary. However, geriatric patients may have more fragile skin and may be more susceptible to irritation. Use with caution and monitor for skin reactions.

Clinical Information

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Clinical Pearls

  • Altreno is a lotion formulation of tretinoin, which may be better tolerated than other tretinoin formulations (creams, gels) due to its moisturizing base.
  • Patients should be advised that an initial worsening of acne (purging) may occur during the first few weeks of treatment.
  • Consistent daily use is key for efficacy; skipping doses can delay results.
  • Emphasize strict sun protection due to increased photosensitivity.
  • Start with a small amount and gradually increase if tolerated to minimize irritation.
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Alternative Therapies

  • Other topical retinoids (e.g., adapalene, tazarotene)
  • Topical antibiotics (e.g., clindamycin, erythromycin)
  • Topical antimicrobials (e.g., benzoyl peroxide, azelaic acid)
  • Oral antibiotics (e.g., doxycycline, minocycline)
  • Oral isotretinoin (for severe, recalcitrant acne)
  • Hormonal therapies (e.g., oral contraceptives, spironolactone)
  • Chemical peels
  • Laser/light therapies
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Cost & Coverage

Average Cost: $500 - $700 per 45gm tube
Insurance Coverage: Tier 2 or 3 (Brand-name prescription)
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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.