Retin-A Micro 0.06% Gel Pump 50gm

Manufacturer BAUSCH HEALTH Active Ingredient Tretinoin Gel(TRET i noyn) Pronunciation TRET i noyn
It is used to treat pimples (acne).
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Drug Class
Retinoid; Anti-acne agent; Anti-wrinkle agent
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Pharmacologic Class
Retinoic acid receptor agonist
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Pregnancy Category
Category C
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FDA Approved
Jan 2007
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Retin-A Micro 0.06% Gel is a topical medication containing tretinoin, a form of vitamin A. It works by helping your skin renew itself more quickly, which can unclog pores and reduce acne breakouts. For sun-damaged skin, it helps improve the appearance of fine wrinkles and rough skin texture. It's important to use it exactly as directed and protect your skin from the sun.
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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 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.
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Lifestyle & Tips

  • Apply only a pea-sized amount to the entire affected area, not just individual spots.
  • Apply to clean, dry skin (wait 20-30 minutes after washing).
  • Use once daily in the evening.
  • Avoid contact with eyes, mouth, angles of the nose, and mucous membranes.
  • Use sunscreen daily (SPF 30 or higher) and wear protective clothing, as tretinoin increases sun sensitivity.
  • Avoid excessive sun exposure, including sunlamps and tanning beds.
  • Avoid waxing on treated areas, as skin may be more fragile.
  • Avoid other irritating topical products (e.g., abrasive soaps, astringents, alcohol-containing products) unless directed by your doctor.
  • Moisturize regularly to combat dryness, but choose non-comedogenic products.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a pea-sized amount to the entire affected area of the face once daily in the evening, 20-30 minutes after washing and drying the skin.

Condition-Specific Dosing:

Acne Vulgaris: Apply a thin layer to the entire affected area once daily in the evening.
Photodamage/Wrinkles: Apply a thin layer to the entire affected area once daily in the evening.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (Safety and efficacy not established in pediatric patients under 12 years of age)
Adolescent: Apply a pea-sized amount to the entire affected area of the face once daily in the evening, 20-30 minutes after washing and drying the skin (for patients 12 years and older).
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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)

Pharmacology

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Mechanism of Action

Tretinoin is a retinoid that binds to specific retinoic acid receptors (RARs) and retinoid X receptors (RXRs) in the nucleus, which then modulate gene expression. In acne, it reduces follicular keratinization, leading to a decrease in microcomedone formation and an increase in the turnover of follicular epithelial cells. It also has anti-inflammatory effects. In photodamaged skin, it promotes epidermal cell turnover, compacts the stratum corneum, and may increase collagen synthesis in the dermis.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (<2-6% of applied dose)
Tmax: Not well-defined for topical application due to minimal systemic absorption; plasma levels are often below quantification limits.
FoodEffect: Not applicable for topical formulation.

Distribution:

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

Elimination:

HalfLife: Not well-defined for topical application due to minimal systemic absorption; if absorbed, systemic half-life is short (e.g., 0.7 hours for oral).
Clearance: Not applicable for topical formulation due to minimal systemic absorption.
ExcretionRoute: Biliary and renal excretion if systemically absorbed.
Unchanged: Negligible
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Pharmacodynamics

OnsetOfAction: Acne: 2-3 weeks, with optimal results in 6-12 weeks. Photodamage: Several months (e.g., 3-6 months) for noticeable improvement.
PeakEffect: Acne: 12-16 weeks. Photodamage: 6-12 months.
DurationOfAction: Effects persist with continued use; regression occurs upon discontinuation.

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 experience any of the following symptoms, which may indicate a serious allergic reaction:

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

Additionally, report any severe skin reactions that bother you or do not go away to your doctor.

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 if you experience any of the following side effects or if they bother you or do not go away:

Feeling of warmth
Burning or stinging
Change in skin color
Dry skin
Redness
Swelling
Blisters
* Peeling

If you experience any skin reactions, your doctor may recommend stopping the medication temporarily, adjusting the dosage, or changing the frequency of application.

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects not mentioned here. 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe redness, burning, stinging, itching, or peeling that does not subside.
  • Blistering or crusting of the skin.
  • Significant swelling of the treated area.
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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 disclose all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any existing health problems. This information will enable your doctor to assess potential interactions and ensure that it is safe for you to take this medication in conjunction with your other treatments. Never start, stop, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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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. If you have a fish allergy, consult your doctor before using this product, as some formulations may contain fish protein.

You may not experience 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 or use the medication more frequently or for a longer duration than prescribed.

Avoid applying this medication to sunburned skin, cuts, scrapes, eczema, or damaged skin. Instead, practice good skin care and protect your skin from the sun. You may be more susceptible to sunburn while using this medication, so take precautions to avoid sun exposure, sunlamps, and tanning beds. When outdoors, use sunscreen and lip balm with a Sun Protection Factor (SPF) of 15 or higher, and wear protective clothing and eyewear.

Certain environmental conditions, such as cold and wind, may irritate your skin. Consult your doctor or pharmacist for guidance on protecting your skin in these situations. Additionally, avoid contact with lime peels, as they may cause irritation.

Using other skin products concurrently with 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, but be sure to discuss the suitable type with your doctor or pharmacist. Makeup can be used unless your doctor has advised against it; however, clean the treatment area before applying the medication.

In case of accidental ingestion, this medication can be harmful. If swallowed, immediately contact a doctor or poison control center. Furthermore, 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 potential risks to your baby.
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Overdose Information

Overdose Symptoms:

  • Excessive redness
  • Severe peeling
  • Discomfort

What to Do:

Topical overdose is unlikely to cause systemic toxicity due to minimal absorption. If excessive application occurs, wash the area with mild soap and water. Symptomatic treatment for irritation. In case of accidental ingestion, contact a poison control center (e.g., 1-800-222-1222) or seek medical attention immediately.

Drug Interactions

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Moderate Interactions

  • Other topical acne preparations (e.g., benzoyl peroxide, salicylic acid, sulfur, resorcinol) - concurrent use may increase irritation.
  • Products with strong drying or irritating effects (e.g., abrasive soaps, cleansers, astringents, alcohol-containing products, medicated soaps/shampoos, permanent wave solutions, hair removers/waxes, products with lime or spices).
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Minor Interactions

  • Cosmetics or soaps that are highly drying or irritating.

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of acne or photodamage and identify any pre-existing irritation or sensitivity.

Timing: Prior to initiation of therapy.

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Routine Monitoring

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

Frequency: Regularly during treatment, especially during the initial weeks.

Target: Mild to moderate irritation is expected; severe irritation warrants dose adjustment or temporary discontinuation.

Action Threshold: If severe irritation occurs, reduce frequency of application or temporarily discontinue until irritation subsides. Re-initiate at a lower frequency.

Therapeutic response (reduction in lesions, improvement in skin texture)

Frequency: Monthly or as clinically indicated.

Target: Gradual improvement over weeks to months.

Action Threshold: Lack of improvement after 12-16 weeks for acne, or 6-12 months for photodamage, may warrant re-evaluation of therapy.

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Symptom Monitoring

  • Excessive skin dryness
  • Peeling/flaking of skin
  • Redness (erythema)
  • Burning sensation
  • Stinging sensation
  • Itching
  • Swelling
  • Blistering
  • Crusting

Special Patient Groups

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Pregnancy

Tretinoin is Pregnancy Category C. While systemic absorption from topical application is minimal, oral retinoids are known teratogens. Therefore, use is generally not recommended during pregnancy, and women of childbearing potential should use effective contraception.

Trimester-Specific Risks:

First Trimester: Potential risk, avoid use.
Second Trimester: Potential risk, avoid use.
Third Trimester: Potential risk, avoid use.
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Lactation

Systemic absorption of topical tretinoin is minimal, making it unlikely to be excreted into breast milk in clinically significant amounts. Generally considered compatible with breastfeeding, but caution is advised to avoid application to areas where the infant might ingest it or come into direct contact.

Infant Risk: Low risk (L2)
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Pediatric Use

Safety and efficacy have not been established in pediatric patients under 12 years of age. For adolescents 12 years and older, dosing is similar to adults for acne vulgaris.

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Geriatric Use

No specific dosage adjustments are required. However, geriatric patients may have more fragile or sensitive skin, potentially leading to increased irritation. Use with caution and monitor for adverse reactions.

Clinical Information

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Clinical Pearls

  • The 'pea-sized amount' is crucial; using more does not speed up results and significantly increases irritation.
  • A 'purging' phase (initial worsening of acne) is common in the first few weeks of treatment; patients should be counseled on this to encourage adherence.
  • Consistent daily use is key for optimal results; skipping applications can prolong the treatment period.
  • Always emphasize strict sun protection (sunscreen, hats, protective clothing) due to increased photosensitivity.
  • Start with a lower strength (e.g., 0.025% or 0.04%) if skin is very sensitive, then titrate up if tolerated.
  • Apply to completely dry skin (20-30 minutes after washing) to minimize irritation.
  • Moisturizers should be applied after tretinoin, or in the morning, to help manage dryness and irritation.
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Alternative Therapies

  • Other topical retinoids (e.g., adapalene, tazarotene)
  • Topical antibiotics (e.g., clindamycin, erythromycin)
  • Topical benzoyl peroxide
  • Topical salicylic acid
  • Azelaic acid
  • Oral antibiotics (e.g., doxycycline, minocycline)
  • Oral isotretinoin (for severe acne)
  • Hormonal therapies (e.g., spironolactone, oral contraceptives for acne in females)
  • Chemical peels
  • Laser therapy
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Cost & Coverage

Average Cost: $150 - $500+ per 50gm pump
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (Brand-name products often require prior authorization or step therapy)
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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 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.