Tazorac 0.05% Gel 100gm
It is used to treat pimples (acne).It is used to treat plaque psoriasis.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Topical Retinoid
Pharmacologic Class
Retinoid receptor agonist
Pregnancy Category
Category X
FDA Approved
May 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tazorac Gel is a topical medication used to treat skin conditions like psoriasis and acne. It belongs to a class of drugs called retinoids, which are related to Vitamin A. It works by helping skin cells grow and shed normally, and by reducing inflammation.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication only as directed.
Application Instructions
Apply this medication only to your skin, avoiding the mouth, nose, eyes, and vagina, as it may cause burning.
If accidental contact occurs, rinse the affected area thoroughly with water.
For individuals who can become pregnant, start using this medication during your normal menstrual period.
Wash your hands before and after application, unless your hand is the treated area, in which case you should not wash it after use.
Clean and dry the affected area before applying a thin layer of the medication and gently rubbing it in.
Avoid applying the medication to cuts, scrapes, eczema, or damaged skin.
Do not use bandages, dressings, or makeup on the treated area unless instructed to do so by your doctor.
Usage Schedule
Some products are designed for use at bedtime, while others can be used at any time. Consult with your pharmacist to determine the best usage schedule for your specific product.
Skin Care and Sun Protection
Practice good skin care and avoid excessive sun exposure to minimize potential side effects.
Storage and Disposal
Store this medication at room temperature, avoiding freezing.
Keep all medications in a safe location, out of the reach of children and pets.
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 a missed dose.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication only as directed.
Application Instructions
Apply this medication only to your skin, avoiding the mouth, nose, eyes, and vagina, as it may cause burning.
If accidental contact occurs, rinse the affected area thoroughly with water.
For individuals who can become pregnant, start using this medication during your normal menstrual period.
Wash your hands before and after application, unless your hand is the treated area, in which case you should not wash it after use.
Clean and dry the affected area before applying a thin layer of the medication and gently rubbing it in.
Avoid applying the medication to cuts, scrapes, eczema, or damaged skin.
Do not use bandages, dressings, or makeup on the treated area unless instructed to do so by your doctor.
Usage Schedule
Some products are designed for use at bedtime, while others can be used at any time. Consult with your pharmacist to determine the best usage schedule for your specific product.
Skin Care and Sun Protection
Practice good skin care and avoid excessive sun exposure to minimize potential side effects.
Storage and Disposal
Store this medication at room temperature, avoiding freezing.
Keep all medications in a safe location, out of the reach of children and pets.
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 a missed dose.
Lifestyle & Tips
- Apply a thin layer to clean, dry skin once daily in the evening.
- Avoid applying to eyes, mouth, nostrils, or mucous membranes.
- Avoid excessive sun exposure and artificial UV light (tanning beds) while using this medication, as it can increase sensitivity to sunlight. Use sunscreen (SPF 30 or higher) and wear protective clothing when outdoors.
- Do not use if pregnant, planning to become pregnant, or breastfeeding without consulting your doctor.
- Moisturizers can be used to help with dryness or irritation, but apply them at a different time of day (e.g., morning) or wait at least an hour after applying Tazorac.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer of Tazorac 0.05% Gel once daily in the evening to affected areas.
Condition-Specific Dosing:
Psoriasis Vulgaris:
Apply a thin layer to psoriatic lesions once daily in the evening. If irritation occurs, frequency may be reduced or concentration lowered.
Acne Vulgaris:
Apply a thin layer to affected areas once daily in the evening.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 12 years of age.
Adolescent:
For acne vulgaris: Apply a thin layer to affected areas once daily in the evening for patients 12 years of age and older. For psoriasis vulgaris: Not established for patients under 18 years of age.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed; minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed; minimal systemic absorption.
Pharmacology
Mechanism of Action
Tazarotene is a retinoid prodrug that is hydrolyzed to its active metabolite, tazarotenic acid, by esterases in the skin. Tazarotenic acid binds to and activates retinoic acid receptors (RARs), specifically RAR-beta and RAR-gamma, which are involved in regulating cell proliferation, differentiation, and inflammation. In psoriasis, it normalizes abnormal keratinocyte differentiation and reduces inflammation. In acne, it reduces hyperproliferation of follicular epithelial cells and exhibits anti-inflammatory effects.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (typically <1% of applied dose)
Tmax:
Not applicable for topical, systemic levels are very low and variable
FoodEffect:
Not applicable (topical)
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Tazarotenic acid is highly protein bound (>99%) to plasma proteins
CnssPenetration:
Limited/Not significant
Elimination:
HalfLife:
Systemic half-life of tazarotenic acid is approximately 7-18 hours (after oral administration, topical data limited due to low levels)
Clearance:
Not precisely quantified for topical application due to minimal systemic absorption
ExcretionRoute:
Renal and fecal (for systemically absorbed drug)
Unchanged:
Not applicable (prodrug)
Pharmacodynamics
OnsetOfAction:
Weeks (typically 2-4 weeks for initial improvement, full effect may take 12 weeks or longer)
PeakEffect:
12-16 weeks
DurationOfAction:
Variable, continued application required for sustained effect
Safety & Warnings
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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Swelling
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'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 for advice:
- Skin irritation is a common side effect of this medication. This may include burning sensations, dry skin, itching, peeling, redness, and scaling. If you experience severe skin irritation or if it persists and bothers you, contact your doctor.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice 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.
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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Swelling
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'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 for advice:
- Skin irritation is a common side effect of this medication. This may include burning sensations, dry skin, itching, peeling, redness, and scaling. If you experience severe skin irritation or if it persists and bothers you, contact your doctor.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice 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.
Seek Immediate Medical Attention If You Experience:
- Severe redness, burning, stinging, or peeling of the skin that does not improve or worsens.
- Swelling or blistering of the treated skin.
- Signs of an allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing) - seek immediate medical attention.
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 conditions to ensure safe use of this medication:
Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are pregnant or think you may be pregnant. Do not take this medication if you are pregnant.
If you are able to become pregnant and are not using a reliable form of birth control.
If you have a sunburn, as this may increase your risk of adverse reactions.
If you are taking any medications that may increase your skin's sensitivity to light. There are numerous medications that can cause this interaction, so consult your doctor or pharmacist if you are unsure.
If you are using any medications that may cause dry skin. Many medications can have this effect, so ask your doctor or pharmacist if you have any concerns.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your medical history, including any health problems you have
This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following conditions to ensure safe use of this medication:
Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are pregnant or think you may be pregnant. Do not take this medication if you are pregnant.
If you are able to become pregnant and are not using a reliable form of birth control.
If you have a sunburn, as this may increase your risk of adverse reactions.
If you are taking any medications that may increase your skin's sensitivity to light. There are numerous medications that can cause this interaction, so consult your doctor or pharmacist if you are unsure.
If you are using any medications that may cause dry skin. Many medications can have this effect, so ask your doctor or pharmacist if you have any concerns.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your medical history, including any health problems you have
This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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. To ensure safe and effective use, follow the dosage instructions provided by your doctor carefully and do not exceed the recommended amount.
Protecting Your Skin
Certain weather conditions, such as cold and wind, may irritate your skin. Consult with your doctor or pharmacist about measures to protect your skin from these conditions. Additionally, be aware that your skin may appear worse before it starts to improve.
Using Other Skin Products
Before using any other medications or products on your skin, including soaps, discuss this with your doctor. Using other skin products while taking this medication may increase the risk of irritation.
Sun Protection
You may be more susceptible to sunburn while taking this medication. To minimize this risk, avoid exposure to the sun, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear to safeguard your skin from the sun.
Accidental Ingestion
If this medication is swallowed, seek immediate medical attention by calling a doctor or poison control center.
Pregnancy and Breastfeeding Precautions
If you are capable of becoming pregnant, a pregnancy test will be conducted to confirm that you are not pregnant before initiating treatment with this medication. Discuss the risks and benefits with your doctor. This medication may harm an unborn baby, so it is essential to use birth control while taking it. If you become pregnant, notify your doctor right away.
If you are breastfeeding, consult with your doctor to discuss any potential risks to your baby. When applying this medication, avoid putting it directly on the nipple or the surrounding area to minimize exposure to your baby.
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. To ensure safe and effective use, follow the dosage instructions provided by your doctor carefully and do not exceed the recommended amount.
Protecting Your Skin
Certain weather conditions, such as cold and wind, may irritate your skin. Consult with your doctor or pharmacist about measures to protect your skin from these conditions. Additionally, be aware that your skin may appear worse before it starts to improve.
Using Other Skin Products
Before using any other medications or products on your skin, including soaps, discuss this with your doctor. Using other skin products while taking this medication may increase the risk of irritation.
Sun Protection
You may be more susceptible to sunburn while taking this medication. To minimize this risk, avoid exposure to the sun, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear to safeguard your skin from the sun.
Accidental Ingestion
If this medication is swallowed, seek immediate medical attention by calling a doctor or poison control center.
Pregnancy and Breastfeeding Precautions
If you are capable of becoming pregnant, a pregnancy test will be conducted to confirm that you are not pregnant before initiating treatment with this medication. Discuss the risks and benefits with your doctor. This medication may harm an unborn baby, so it is essential to use birth control while taking it. If you become pregnant, notify your doctor right away.
If you are breastfeeding, consult with your doctor to discuss any potential risks to your baby. When applying this medication, avoid putting it directly on the nipple or the surrounding area to minimize exposure to your baby.
Overdose Information
Overdose Symptoms:
- Topical overdose is unlikely to cause systemic toxicity due to minimal absorption.
- Excessive application may lead to marked redness, peeling, and discomfort.
What to Do:
Discontinue use and apply a bland emollient. If accidental ingestion occurs, contact a poison control center (Call 1-800-222-1222) or seek medical attention immediately.
Drug Interactions
Moderate Interactions
- Photosensitizing agents (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) - may increase risk of photosensitivity.
- Other topical preparations with strong drying or irritating effects (e.g., abrasive soaps, cleansers, medicated soaps, astringents, products with high concentrations of alcohol, sulfur, resorcinol, salicylic acid) - may increase irritation.
Monitoring
Baseline Monitoring
Skin condition assessment (e.g., severity of psoriasis/acne, presence of irritation)
Rationale: To establish baseline for efficacy and tolerability monitoring.
Timing: Prior to initiation of therapy
Routine Monitoring
Local skin irritation (erythema, peeling, burning, dryness, pruritus)
Frequency: Regularly during treatment, especially during initial weeks
Target: Minimal to mild irritation
Action Threshold: Moderate to severe irritation may require temporary discontinuation, reduction in frequency, or use of lower concentration.
Efficacy (improvement in lesions)
Frequency: Monthly or as clinically indicated
Target: Reduction in lesion severity and extent
Action Threshold: Lack of improvement after 12-16 weeks may warrant re-evaluation of therapy.
Symptom Monitoring
- Severe skin irritation
- Excessive dryness
- Peeling
- Burning or stinging sensation
- Pruritus (itching)
- Photosensitivity (sunburn-like reaction)
Special Patient Groups
Pregnancy
CONTRAINDICATED in pregnancy. Tazarotene is a known teratogen when administered systemically. Although systemic absorption from topical application is minimal, there is a theoretical risk of fetal harm. Women of childbearing potential must have a negative pregnancy test within 2 weeks prior to initiating therapy and should use effective contraception during treatment.
Trimester-Specific Risks:
First Trimester:
Highest risk of teratogenicity; contraindicated.
Second Trimester:
Contraindicated.
Third Trimester:
Contraindicated.
Lactation
It is not known whether tazarotene is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants from the systemic exposure of tazarotenic acid, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Minimal systemic absorption is expected with topical use.
Infant Risk:
L3 (Moderate risk - no human data, but animal data suggest risk or drug is systemically absorbed and could cause adverse effects in infant)
Pediatric Use
Safety and effectiveness for psoriasis have not been established in pediatric patients under 18 years of age. Safety and effectiveness for acne have been established in pediatric patients 12 years of age and older.
Geriatric Use
No specific dosage adjustments are recommended for geriatric patients. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, no overall differences in safety or effectiveness were observed between these subjects and younger subjects.
Clinical Information
Clinical Pearls
- Tazorac is a potent retinoid; start with the lowest concentration (0.05%) and gradually increase if tolerated and needed.
- Apply only a pea-sized amount for the entire face to avoid excessive irritation.
- Patients should be advised about potential for initial worsening of acne (purging) before improvement is seen.
- Emphasize strict sun protection due to increased photosensitivity.
- For psoriasis, it's often used in combination with topical corticosteroids to manage irritation and enhance efficacy.
- Due to its teratogenic potential, ensure women of childbearing potential are fully counselled on contraception and pregnancy testing.
Alternative Therapies
- Other topical retinoids (e.g., tretinoin, adapalene)
- Topical corticosteroids (for psoriasis)
- Vitamin D analogs (e.g., calcipotriene for psoriasis)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus for psoriasis)
- Topical antibiotics (e.g., clindamycin, erythromycin for acne)
- Benzoyl peroxide (for acne)
- Systemic therapies for severe psoriasis (e.g., biologics, methotrexate, cyclosporine)
- Oral isotretinoin (for severe acne)
Cost & Coverage
Average Cost:
$300 - $800 per 100gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (varies by plan)
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.