Retin-A Micro 0.08% Gel Pump 50gm

Manufacturer BAUSCH HEALTH Active Ingredient Tretinoin Gel(TRET i noyn) Pronunciation RET-in-AY MY-kroh
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
Sep 1997
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Retin-A Micro is a gel pump containing tretinoin, a form of vitamin A. It's used to treat acne by helping your skin shed old cells and grow new ones, which prevents pores from getting clogged. It also helps reduce inflammation.
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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 to ensure safe and effective treatment.

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 applying the medication, wash your hands thoroughly.
Gently wash the affected skin 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 before applying the medication; consult with your pharmacist for specific guidance.
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, away from freezing temperatures.

Missed Dose Instructions

* If you miss a dose, skip it and resume your regular application schedule. Do not apply two doses at the same time or use extra doses to make up for the missed application.
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Lifestyle & Tips

  • Apply only a pea-sized amount to the entire affected area, not just individual pimples.
  • Apply to clean, dry skin, usually once daily in the evening.
  • Avoid contact with eyes, mouth, angles of the nose, and mucous membranes.
  • Use a gentle, non-medicated cleanser and moisturizer daily.
  • Sun protection is crucial: use sunscreen (SPF 30 or higher), wear protective clothing, and limit sun exposure, as this medication increases sensitivity to sunlight.
  • Avoid waxing on treated skin, as it may cause severe irritation or skin tearing.
  • Initial worsening of acne (purging) is common during the first few weeks of treatment; continue use as directed.
  • Be patient; it can take 8-12 weeks to see significant improvement.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin layer to affected areas once daily, in the evening, before bedtime.

Condition-Specific Dosing:

acne vulgaris: Apply a thin layer to affected areas once daily, in the evening, before bedtime. Wash hands after application.
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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 thin layer to affected areas once daily, in the evening, before bedtime (for patients 12 years of age 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) in the nucleus, including RAR-alpha, RAR-beta, and RAR-gamma. This binding modulates gene expression, leading to altered cellular differentiation, proliferation, and intercellular communication. 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 existing comedones. Additionally, it has anti-inflammatory properties.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (less than 2% of applied dose)
Tmax: Not applicable for systemic Tmax due to minimal absorption; local effects are gradual.
FoodEffect: Not applicable (topical administration)

Distribution:

Vd: Not applicable (minimal systemic distribution)
ProteinBinding: Highly protein bound if systemically absorbed (e.g., >95% to plasma proteins)
CnssPenetration: Limited (minimal systemic absorption)

Elimination:

HalfLife: Not applicable for topical application due to minimal systemic absorption; if systemically absorbed, plasma half-life is approximately 0.7 hours.
Clearance: Not applicable for topical application due to minimal systemic absorption.
ExcretionRoute: Not applicable for topical application; if systemically absorbed, primarily renal and biliary excretion.
Unchanged: Not applicable (minimal systemic absorption)
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Pharmacodynamics

OnsetOfAction: Weeks (typically 2-3 weeks for initial improvement)
PeakEffect: 8-12 weeks (full therapeutic effect)
DurationOfAction: Maintained with continued use; effects reverse 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. If you notice any of the following symptoms, seek medical attention 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, 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 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 burning, stinging, or itching
  • Excessive redness, swelling, or blistering of the skin
  • Severe peeling or crusting
  • Signs of an allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat)
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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 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 several drugs can cause this interaction. 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, verify that it is acceptable to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

Important Information About Your Medication

It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you have a fish allergy, discuss this with your doctor, as some products contain fish protein.

Using Your Medication Safely

It may take several weeks to experience the full effects of this medication. To minimize the risk of severe side effects, it is essential that you use this medication exactly as directed by your doctor. Do not exceed the recommended dose, frequency, or duration of treatment.

Skin Precautions

Avoid applying this medication to sunburned skin, cuts, scrapes, eczema, or damaged skin. Practice good skin care and take measures to protect your skin from the sun, as this medication may increase your sensitivity to sunlight. You can reduce your risk of sunburn by:

Avoiding sun exposure, sunlamps, and tanning beds
Using sunscreen and lip balm with an SPF of 15 or higher when outdoors
* Wearing protective clothing and eyewear

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

Using Other Skin Products

Using other skin products while taking this medication may increase the risk of irritation. Before using any other skin products, including soaps, consult with your doctor. If you experience dry skin, you may use a moisturizer, but be sure to discuss the type of moisturizer to use with your doctor or pharmacist. You can use makeup unless your doctor has advised against it; however, make sure to clean the area to be treated before applying this medication.

Safety Precautions

If you accidentally swallow this medication, call a doctor or poison control center immediately, as it can cause harm. Women who are pregnant or plan to become pregnant should notify their doctor, as this medication may harm the unborn baby. If you are breastfeeding, consult with your doctor to discuss any potential risks to your baby.
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Overdose Information

Overdose Symptoms:

  • Excessive redness
  • Severe peeling
  • Discomfort

What to Do:

Discontinue use. Symptomatic and supportive care. Call 1-800-222-1222 (Poison Control) if accidental ingestion occurs, though systemic toxicity from topical overdose is unlikely.

Drug Interactions

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Moderate Interactions

  • Topical products containing sulfur, resorcinol, or salicylic acid (may increase irritation)
  • Astringents, abrasive soaps, cleansers, or medicated soaps/cleansers (may increase irritation)
  • Products containing alcohol, spices, or lime (may increase irritation)
  • Other topical acne preparations (use with caution due to potential for cumulative irritation)
  • Photosensitizing agents (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines) - may increase risk of photosensitivity

Monitoring

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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

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Routine Monitoring

Skin irritation (redness, dryness, peeling, burning, stinging)

Frequency: Regularly, especially during the first few weeks of therapy

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

Action Threshold: Severe or persistent irritation: reduce frequency of application, temporarily discontinue, or switch to lower strength.

Acne lesion count and severity

Frequency: Monthly or every 2-3 months

Target: Reduction in inflammatory and non-inflammatory lesions

Action Threshold: No improvement after 8-12 weeks: re-evaluate diagnosis or treatment plan.

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Symptom Monitoring

  • Excessive dryness of skin
  • Peeling or flaking of skin
  • Redness or erythema
  • Burning or stinging sensation
  • Itching
  • Photosensitivity (increased sensitivity to sunlight)
  • Swelling or blistering (rare, severe irritation)

Special Patient Groups

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Pregnancy

Category C. While systemic absorption is minimal with topical application, oral retinoids are highly teratogenic. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Advise women of childbearing potential to use effective contraception.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though risk from topical application is considered low due to minimal systemic absorption.
Second Trimester: Risk considered low due to minimal systemic absorption.
Third Trimester: Risk considered low due to minimal systemic absorption.
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Lactation

L3 (Moderately Safe). It is not known whether tretinoin is excreted in human milk. Due to minimal systemic absorption, significant transfer to breast milk is unlikely. Use with caution; avoid applying to areas where the infant may come into direct contact with the medication.

Infant Risk: Low risk of adverse effects due to minimal systemic absorption by the mother and unlikely significant transfer to breast milk.
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Pediatric Use

Safety and efficacy have not been established in pediatric patients under 12 years of age. Use in adolescents (12 years and older) is common and generally well-tolerated with appropriate guidance.

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Geriatric Use

No specific dosage 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

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Clinical Pearls

  • A 'less is more' approach is best; a pea-sized amount is sufficient for the entire face.
  • Apply to completely dry skin (wait 20-30 minutes after washing) to minimize irritation.
  • Start with a lower strength or less frequent application (e.g., every other night) if skin sensitivity is a concern, then gradually increase as tolerated.
  • Combine with a gentle, non-comedogenic moisturizer to help manage dryness and irritation.
  • Emphasize consistent daily sunscreen use, even on cloudy days or indoors near windows.
  • Inform patients about the initial 'purging' phase (temporary worsening of acne) and encourage them to continue treatment.
  • Avoid concomitant use of other harsh topical products (e.g., benzoyl peroxide, salicylic acid) unless directed by a healthcare provider, due to increased irritation risk. If used, apply at different times of day.
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Alternative Therapies

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

Average Cost: $150 - $300+ per 50gm pump
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (brand); Tier 1 (generic)
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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 occurred.