Retin-A Micro 0.04% Gel 20gm

Manufacturer BAUSCH HEALTH Active Ingredient Tretinoin Gel(TRET i noyn) Pronunciation RET-in-AY MY-kroh (TRET-i-noyn)
It is used to treat pimples (acne).
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Drug Class
Retinoid; Anti-acne agent
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Pharmacologic Class
Retinoid receptor agonist
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Pregnancy Category
Category C
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FDA Approved
Aug 1997
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Retin-A Micro 0.04% Gel is a topical medication containing tretinoin, a form of vitamin A. It's used to treat acne by helping skin cells turn over more quickly and preventing pores from clogging. 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 to minimize potential interference with daily activities.
Before and after applying the medication, wash your hands thoroughly to prevent the spread of the medication to other areas.
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 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 two doses at the same time or use extra doses to make up for the missed dose.
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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 once daily at bedtime.
  • Avoid contact with eyes, mouth, nostrils, and mucous membranes.
  • Use a gentle, non-medicated cleanser and moisturizer daily.
  • Sun sensitivity is significantly increased; use broad-spectrum sunscreen (SPF 30 or higher) daily and wear protective clothing. Avoid excessive sun exposure and tanning beds.
  • Initial worsening of acne (purging) is common during the first few weeks of treatment; continue use as directed.
  • Avoid waxing on treated areas as skin may be more fragile.
  • Do not use other topical products that may cause irritation (e.g., abrasive soaps, astringents, other acne medications unless directed by your doctor).

Dosing & Administration

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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, after washing and drying the skin. Avoid contact with eyes, lips, and mucous membranes.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for children under 12 years of age.
Adolescent: For adolescents 12 years and older: Apply a thin layer to affected areas once daily at bedtime.
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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, tretinoin is thought to decrease cohesiveness of follicular epithelial cells, leading to a reduction in microcomedone formation. It also stimulates mitotic activity and increased turnover of follicular epithelial cells, causing extrusion of comedones. Additionally, it has anti-inflammatory effects.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (approximately 1-2% of applied dose)
Tmax: Not well-defined for topical application due to minimal systemic absorption; peak plasma concentrations are very low.
FoodEffect: Not applicable for topical formulation.

Distribution:

Vd: Not well-defined for topical application.
ProteinBinding: Highly protein bound (over 95%) if systemically absorbed.
CnssPenetration: Limited/Negligible (due to minimal systemic absorption).

Elimination:

HalfLife: Not well-defined for topical application; systemic half-life of absorbed tretinoin is approximately 0.5-2 hours.
Clearance: Not well-defined for topical application.
ExcretionRoute: If systemically absorbed, primarily excreted in urine and feces.
Unchanged: Negligible
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Pharmacodynamics

OnsetOfAction: Initial improvement typically seen within 2-3 weeks, but optimal results may take 6-12 weeks.
PeakEffect: Optimal results typically seen after 6-12 weeks of continuous use.
DurationOfAction: Effects persist with continued use; relapse may occur 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 side effect:

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 bothers you or does not go away

Other Possible Side Effects

Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you experience any of the following side effects or any other 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 experience any skin reactions, discuss them with your doctor. Your doctor may recommend stopping the medication for a period, adjusting the dosage, or changing the frequency of application.

Reporting Side Effects

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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 burning, stinging, or itching that does not subside.
  • Excessive redness, swelling, blistering, or crusting of the skin.
  • Signs of an allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat) - seek immediate medical attention.
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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.
If you have a sunburn, sensitive skin, or any other skin conditions that may be relevant.
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 consult your doctor or pharmacist if you are unsure.
If you are pregnant, as this may affect your treatment.

This is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to discuss all of your:

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

with your doctor and pharmacist to ensure safe use. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication and your individual health profile.
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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. If you have a fish allergy, discuss this with your doctor, as some products contain fish protein.

Using Your Medication Correctly

It may take several weeks to experience the full effects of this medication. To minimize the risk of severe side effects, do not exceed the dosage or frequency prescribed by your doctor. Using more than the recommended amount or using it for a longer period than advised can increase the chance of adverse reactions.

Skin Precautions

Avoid applying this medication to sunburned skin, cuts, scrapes, eczema, or damaged skin. Practice good skin care and limit your sun exposure. You may be more susceptible to sunburn, so take precautions to protect your skin:

Avoid direct sunlight, sunlamps, and tanning beds
Use sunscreen and lip balm with an 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 can irritate your skin; consult your doctor or pharmacist for guidance on skin protection

Additionally, avoid contact with lime peels, as this may cause irritation.

Using Other Skin Products

When using this medication, be cautious with other skin products, as they may increase irritation. Consult your doctor before using any other medications or products on your skin, including soaps. If you experience dry skin, you may use a moisturizer; however, discuss the suitable type with your doctor or pharmacist. You can use makeup unless your doctor advises against it; if you do use makeup, clean the treatment area before applying this medication.

Safety Precautions

If this medication is swallowed, seek medical attention or contact a poison control center immediately, as it can cause harm. If you are pregnant or plan to become pregnant, inform your doctor, as this medication may harm the unborn baby. If you are breastfeeding, discuss the potential risks to your baby with your doctor.
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Overdose Information

Overdose Symptoms:

  • Severe skin irritation (redness, peeling, discomfort) if applied excessively.
  • Systemic toxicity is highly unlikely with topical application due to minimal absorption.

What to Do:

If excessive application occurs, wash the area with mild soap and water. If severe irritation persists, discontinue use and consult a healthcare professional. For accidental ingestion, call a poison control center (1-800-222-1222) or seek emergency medical attention, though systemic toxicity from topical product ingestion is rare.

Drug Interactions

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Moderate Interactions

  • Topical products containing sulfur, resorcinol, or salicylic acid (may cause excessive irritation).
  • Astringents, abrasive soaps, cleansers, or medicated cosmetics (may increase irritation).
  • Products with high concentrations of alcohol, spices, or lime (may increase irritation).
  • Photosensitizing agents (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines) - increased risk of photosensitivity.

Monitoring

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Baseline Monitoring

Skin assessment (type, severity of acne, presence of irritation)

Rationale: To establish baseline for efficacy and tolerability monitoring.

Timing: Prior to initiation of therapy.

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Routine Monitoring

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

Frequency: Regularly during initial weeks, then as needed.

Target: Mild to moderate irritation is common; severe irritation warrants 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 12 weeks: re-evaluate diagnosis or treatment plan.

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Symptom Monitoring

  • Excessive dryness
  • Peeling or flaking of skin
  • Redness (erythema)
  • Burning or stinging sensation
  • Itching
  • Swelling
  • Crusting

Special Patient Groups

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Pregnancy

Tretinoin is Pregnancy Category C. While systemic absorption from topical application is minimal, oral tretinoin is a known teratogen (Category X). Use during pregnancy should be avoided unless the potential benefit justifies the potential risk to the fetus. Discuss risks and benefits with a healthcare provider.

Trimester-Specific Risks:

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

Minimal systemic absorption is expected, making transfer into breast milk unlikely to be clinically significant. However, caution is advised. Avoid applying to areas where the infant may come into direct contact with the medication (e.g., chest). Consult a healthcare provider.

Infant Risk: Low risk of adverse effects to the infant due to minimal systemic absorption.
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Pediatric Use

Safety and effectiveness in pediatric patients under 12 years of age have not been established. Used in adolescents 12 years and older for acne vulgaris.

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Geriatric Use

No specific dosage adjustments are typically needed. Elderly patients may have more fragile or sensitive skin, potentially increasing susceptibility to irritation. Use with caution and monitor for excessive dryness or irritation.

Clinical Information

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Clinical Pearls

  • Start with a lower strength (e.g., 0.025% or 0.04%) and gradually increase as tolerated to minimize irritation.
  • The 'purge' phase (initial worsening of acne) is common and usually resolves within 2-4 weeks. Encourage patients to continue treatment.
  • Apply to completely dry skin (wait 20-30 minutes after washing) to reduce irritation.
  • Use a non-comedogenic moisturizer daily, especially in the morning, to combat dryness.
  • Strict sun protection is crucial due to increased photosensitivity.
  • Consistency is key; results take time (weeks to months).
  • Avoid using other harsh or irritating topical products concurrently unless specifically advised by a healthcare provider.
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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 for females)
  • Chemical peels, laser therapy, light therapy
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Cost & Coverage

Average Cost: $150 - $300+ per 20gm tube
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 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 medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.