Tretinoin 0.1% Cream 45gm

Manufacturer PERRIGO Active Ingredient Tretinoin Cream(TRET i noyn) Pronunciation TRET i noyn
It is used to treat pimples (acne).
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Drug Class
Anti-acne agent, Anti-wrinkle agent, Keratolytic
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Pharmacologic Class
Retinoid
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Pregnancy Category
Category C
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FDA Approved
Apr 1971
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Tretinoin cream is a medication derived from Vitamin A that is applied to the skin. It helps treat acne by promoting skin cell turnover and preventing clogged pores. For fine wrinkles and rough skin, it helps improve skin texture and appearance over time by stimulating collagen production.
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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.
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 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.

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 two doses at the same time or use extra doses to make up for the missed one.
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Lifestyle & Tips

  • Apply sunscreen daily (SPF 30 or higher) and wear protective clothing when outdoors, as tretinoin increases sun sensitivity.
  • Avoid excessive sun exposure, including tanning beds.
  • Use gentle, non-medicated cleansers and moisturizers to help manage dryness and irritation.
  • Avoid harsh skin products, including astringents, abrasive soaps, medicated cleansers, and products containing alcohol, sulfur, resorcinol, or salicylic acid.
  • Apply to dry skin, typically 20-30 minutes after washing your face.
  • Use only a pea-sized amount for the entire face.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin layer to affected areas once daily at bedtime.
Dose Range: 0.05 - 0.1 mg

Condition-Specific Dosing:

acneVulgaris: Apply a thin layer of 0.025% to 0.1% cream to the entire affected area once daily at bedtime.
photoaging: Apply a thin layer of 0.025% to 0.05% cream to the entire affected area once daily at bedtime.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (generally not recommended for children under 12 years)
Adolescent: For acne vulgaris, apply a thin layer of 0.025% to 0.1% cream to the entire affected area once daily at bedtime (typically for ages 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 metabolite of Vitamin A that binds to specific retinoic acid receptors (RARs) in the nucleus, which then bind to DNA and modulate gene expression. This leads to altered cellular differentiation, proliferation, and inflammation. In acne, it promotes follicular epithelial cell turnover, reduces cohesion of follicular epithelial cells, and facilitates extrusion of comedones, thereby reducing microcomedone formation. For photoaging, it increases collagen synthesis, reduces epidermal melanin, and promotes angiogenesis.
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Pharmacokinetics

Absorption:

Bioavailability: <5% (systemic absorption from topical application)
Tmax: Not well-defined for topical due to minimal systemic absorption
FoodEffect: Not applicable for topical administration

Distribution:

Vd: Not applicable (primarily localized to skin)
ProteinBinding: >95% (if absorbed systemically)
CnssPenetration: Limited/Not applicable for topical administration

Elimination:

HalfLife: Not well-defined for topical due to minimal systemic absorption
Clearance: Not well-defined for topical due to minimal systemic absorption
ExcretionRoute: If absorbed systemically, primarily renal and biliary excretion
Unchanged: Not available
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Pharmacodynamics

OnsetOfAction: Acne: 2-3 weeks for initial improvement; Photoaging: Months of continuous use
PeakEffect: Acne: 6-12 weeks; Photoaging: 6-12 months
DurationOfAction: Effects persist with continued use; relapse upon discontinuation

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help 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. Although many people do not experience any side effects or only have mild ones, it is 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 bother you or do not go away:

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.
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Seek Immediate Medical Attention If You Experience:

  • Severe burning
  • Severe stinging
  • Excessive redness
  • Blistering
  • Crusting
  • 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 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, including 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 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. Taking more than prescribed or using it for a longer period than recommended can increase the risk of severe side effects.

Skin Precautions

Do not apply this medication to sunburned, cut, scraped, eczematous, or damaged skin, as this can exacerbate skin irritation. To minimize the risk of skin problems, 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 can irritate the skin; consult your doctor or pharmacist for guidance on protecting your skin in these situations

Interactions with Other Products

Avoid contact with lime peels, as they may interact with this medication. Using other skin products while taking this medication can increase the risk of irritation. Before using any other skin products, including soaps, consult your doctor to ensure safe use.

Managing Dry Skin and Using Cosmetics

If this medication causes dry skin, you may use a moisturizer. However, consult your doctor or pharmacist to determine the best type of moisturizer to use. You can use makeup unless your doctor has advised against it. If you plan to use makeup, clean the treatment area before applying this medication.

Safety Precautions

If this medication is swallowed, it can cause harm. In case of accidental ingestion, immediately contact a doctor or poison control center.

Pregnancy and Breastfeeding

This medication may harm an 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. If you are breastfeeding, inform your doctor to discuss any potential risks to your baby.
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Overdose Information

Overdose Symptoms:

  • Severe local irritation (e.g., intense redness, peeling, discomfort)
  • Systemic overdose is highly unlikely with topical application due to minimal absorption.

What to Do:

Discontinue use temporarily or reduce frequency. Apply soothing moisturizers. For severe reactions, seek medical attention. Call 1-800-222-1222 for poison control advice if accidental ingestion occurs (though systemic toxicity is rare).

Drug Interactions

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Moderate Interactions

  • Other topical irritants (e.g., benzoyl peroxide, salicylic acid, sulfur, resorcinol)
  • Astringents
  • Abrasive soaps or cleansers
  • Medicated cleansers or soaps
  • Drying agents (e.g., alcohol-containing products)
  • Products containing alpha hydroxy acids (AHAs) or beta hydroxy acids (BHAs)
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Minor Interactions

  • Photosensitizing agents (e.g., tetracyclines, fluoroquinolones, thiazide diuretics) - may increase risk of photosensitivity

Monitoring

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Baseline Monitoring

Skin assessment

Rationale: To evaluate skin type, condition, and severity of acne or photoaging.

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 initial weeks

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

Action Threshold: Severe or persistent irritation; patient discomfort

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 weeks for acne or 6-12 months for photoaging

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Symptom Monitoring

  • Erythema (redness)
  • Scaling
  • Dryness
  • Burning sensation
  • Stinging sensation
  • Pruritus (itching)
  • Blistering
  • Crusting
  • Swelling

Special Patient Groups

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Pregnancy

Category C. While systemic absorption from topical application is minimal, oral retinoids are highly teratogenic. Use during pregnancy is generally discouraged unless the potential benefit justifies the potential risk to the fetus. Alternatives should be considered.

Trimester-Specific Risks:

First Trimester: Theoretical risk of teratogenicity, though systemic absorption is minimal.
Second Trimester: Theoretical risk, but less critical period for major organogenesis.
Third Trimester: Theoretical risk, but less critical period for major organogenesis.
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Lactation

Minimal systemic absorption, therefore unlikely to be excreted in breast milk in significant amounts. Use with caution. Avoid applying to areas where the infant may come into direct contact with the medication (e.g., chest, nipples).

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

Approved for acne vulgaris in patients 12 years of age and older. Safety and efficacy have not been established in younger children.

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Geriatric Use

No specific dose adjustments are required. However, older patients may have more sensitive skin and may experience increased irritation or dryness. Use with caution and monitor skin response closely.

Clinical Information

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Clinical Pearls

  • Initial worsening of acne ('purging') is common during the first few weeks of treatment and usually resolves with continued use.
  • Start with a lower strength (e.g., 0.025%) and gradually increase strength or frequency as tolerated to minimize irritation.
  • Apply a pea-sized amount to the entire affected area, not just individual lesions.
  • Consistency is key; it takes weeks to months to see significant results.
  • Strict sun protection (sunscreen, protective clothing, avoiding peak sun hours) is crucial due to increased photosensitivity.
  • Moisturizer is essential to combat dryness and irritation, especially during the initial phase of treatment.
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Alternative Therapies

  • Other topical retinoids (e.g., Adapalene, Tazarotene)
  • Topical antibiotics (e.g., Clindamycin, Erythromycin)
  • Benzoyl peroxide
  • Azelaic acid
  • Oral antibiotics (e.g., Doxycycline, Minocycline)
  • Oral isotretinoin (for severe, recalcitrant acne)
  • Chemical peels
  • Laser therapy
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Cost & Coverage

Average Cost: $50 - $250+ per 45gm tube of 0.1% cream
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (varies by insurance plan)
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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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.