Tazorac 0.1% Gel 30gm
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
Antipsoriatic; Antiacne
Pharmacologic Class
Retinoid
Pregnancy Category
Category X
FDA Approved
May 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tazorac gel is a topical medication, similar to Vitamin A, used to treat skin conditions like acne and psoriasis. It works by helping your skin cells grow and shed normally, and by reducing inflammation. It's applied directly to the skin.
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. 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 area thoroughly with water.
Do not apply the medication to the vagina.
If you are able to become pregnant, start using this medication during your normal menstrual period.
Wash your hands before and after applying the medication, unless your hand is the treated area. In this case, do not wash your hand after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Do not apply the medication to cuts, scrapes, eczema, or damaged skin.
Unless instructed by your doctor, do not cover the treated area with bandages, dressings, or makeup.
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 while using this medication.
Apply the medication only to the affected skin, avoiding healthy skin areas.
Storage and Disposal
Store this medication at room temperature, avoiding freezing.
Keep all medications in a safe place, out of the reach of children and pets.
Missed Dose
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. 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 area thoroughly with water.
Do not apply the medication to the vagina.
If you are able to become pregnant, start using this medication during your normal menstrual period.
Wash your hands before and after applying the medication, unless your hand is the treated area. In this case, do not wash your hand after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Do not apply the medication to cuts, scrapes, eczema, or damaged skin.
Unless instructed by your doctor, do not cover the treated area with bandages, dressings, or makeup.
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 while using this medication.
Apply the medication only to the affected skin, avoiding healthy skin areas.
Storage and Disposal
Store this medication at room temperature, avoiding freezing.
Keep all medications in a safe place, out of the reach of children and pets.
Missed Dose
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. If contact occurs, rinse thoroughly with water.
- Avoid excessive exposure to sunlight, sunlamps, or tanning beds. Use sunscreen (SPF 30 or higher) and wear protective clothing when outdoors.
- Do not use if you are pregnant, planning to become pregnant, or breastfeeding. Use effective birth control if you are a female of childbearing potential.
- Moisturizers can be used, but apply them at a different time of day (e.g., morning) to avoid diluting the gel or interfering with its absorption.
- Avoid waxing for hair removal on treated areas as it may cause excessive skin irritation.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer of 0.05% or 0.1% gel once daily in the evening to affected areas.
Condition-Specific Dosing:
Plaque Psoriasis:
Apply a thin layer of 0.05% or 0.1% gel once daily in the evening to psoriatic lesions. Use the lowest concentration that provides benefit.
Acne Vulgaris:
Apply a thin layer of 0.1% gel once daily in the evening to the affected areas.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 12 years of age.
Adolescent:
Acne Vulgaris (β₯12 years): Apply a thin layer of 0.1% gel once daily in the evening to the affected areas. Plaque Psoriasis (β₯18 years): Apply a thin layer of 0.05% or 0.1% gel once daily in the evening to psoriatic lesions.
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
Mechanism of Action
Tazarotene is a retinoid prodrug that is converted to its active metabolite, tazarotenic acid, by esterase hydrolysis in the skin. Tazarotenic acid binds to all three members of the retinoic acid receptor (RAR) family: RARΞ±, RARΞ², and RARΞ³, but shows relative selectivity for RARΞ² and RARΞ³. Activation of these receptors can modify gene expression, leading to normalization of keratinocyte differentiation and proliferation, and reduction of inflammation, which are beneficial in the treatment of psoriasis and acne.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (typically <1% of applied dose)
Tmax:
Not applicable for topical absorption, but plasma concentrations of tazarotenic acid are generally below the limit of quantification (0.005 ng/mL) after topical application.
FoodEffect:
Not applicable (topical administration)
Distribution:
Vd:
Not precisely quantified due to minimal systemic absorption
ProteinBinding:
Tazarotenic acid is highly bound to plasma proteins (>99%)
CnssPenetration:
Limited (due to minimal systemic absorption and high protein binding)
Elimination:
HalfLife:
Approximately 7-12 hours for tazarotenic acid (when detectable systemically)
Clearance:
Not precisely quantified due to minimal systemic absorption
ExcretionRoute:
Renal and fecal excretion (for systemically absorbed drug)
Unchanged:
Negligible (for systemically absorbed drug)
Pharmacodynamics
OnsetOfAction:
Acne: 4-12 weeks; Psoriasis: 4-8 weeks
PeakEffect:
Acne: 12 weeks; Psoriasis: 12 weeks
DurationOfAction:
Maintained with continued use; effects may persist for some time after discontinuation due to cellular changes.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, some individuals may experience severe and potentially life-threatening side effects while taking this medication. If you encounter 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. 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 effects that bother you or do not go away, contact your doctor for advice:
- Skin irritation is a common side effect of this medication, which may include burning, 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.
Although rare, some individuals may experience severe and potentially life-threatening side effects while taking this medication. If you encounter 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. 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 effects that bother you or do not go away, contact your doctor for advice:
- Skin irritation is a common side effect of this medication, which may include burning, 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 skin irritation (excessive redness, peeling, burning, itching, dryness)
- Severe sunburn reaction
- Signs of allergic reaction (e.g., rash, hives, swelling of face/lips/tongue)
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. Be sure to describe the allergic reaction and its symptoms.
If you are pregnant or think you may be pregnant. This medication is not recommended for use during pregnancy.
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 sensitivity to the medication.
If you are taking any medications that may increase your skin's sensitivity to light. There are several 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. Again, there are many medications that can have this effect, so it is crucial to check with your doctor or pharmacist if you are uncertain.
To ensure your safety, it is vital to provide your doctor and pharmacist with a comprehensive list of all your medications, including:
Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins
Additionally, inform them about 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. Be sure to describe the allergic reaction and its symptoms.
If you are pregnant or think you may be pregnant. This medication is not recommended for use during pregnancy.
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 sensitivity to the medication.
If you are taking any medications that may increase your skin's sensitivity to light. There are several 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. Again, there are many medications that can have this effect, so it is crucial to check with your doctor or pharmacist if you are uncertain.
To ensure your safety, it is vital to provide your doctor and pharmacist with a comprehensive list of all your medications, including:
Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins
Additionally, inform them about 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 for guidance on how to protect your skin from these conditions. Additionally, be aware that your skin may appear to worsen before it improves.
Using Other Skin Products
Before using any other drugs 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 accidentally swallowed, contact a doctor or poison control center immediately, as it may cause harm.
Pregnancy and Breastfeeding Precautions
If you are of childbearing age, a pregnancy test will be conducted to confirm that you are not pregnant before initiating treatment with this medication. It is essential to discuss the risks associated with this medication with your doctor, as it may harm an unborn baby. If you become pregnant while taking this medication, notify your doctor right away. You must use birth control while taking this medication to prevent pregnancy.
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 for guidance on how to protect your skin from these conditions. Additionally, be aware that your skin may appear to worsen before it improves.
Using Other Skin Products
Before using any other drugs 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 accidentally swallowed, contact a doctor or poison control center immediately, as it may cause harm.
Pregnancy and Breastfeeding Precautions
If you are of childbearing age, a pregnancy test will be conducted to confirm that you are not pregnant before initiating treatment with this medication. It is essential to discuss the risks associated with this medication with your doctor, as it may harm an unborn baby. If you become pregnant while taking this medication, notify your doctor right away. You must use birth control while taking this medication to prevent pregnancy.
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:
- Excessive skin irritation (redness, peeling, discomfort)
- While systemic overdose is unlikely due to minimal absorption, symptoms of oral retinoid overdose (e.g., headache, nausea, vomiting, dizziness) are theoretical but highly improbable with topical use.
What to Do:
Discontinue use. Symptomatic and supportive care for skin irritation. If accidental ingestion occurs, call Poison Control (1-800-222-1222) or seek immediate medical attention.
Drug Interactions
Moderate Interactions
- Photosensitizing agents (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides): Increased risk of photosensitivity.
- Other topical preparations with strong drying or irritating effects (e.g., abrasive soaps, cleansers, medicated cosmetics, other retinoids, salicylic acid, benzoyl peroxide): May cause cumulative irritation.
Monitoring
Baseline Monitoring
Pregnancy status
Rationale: Tazarotene is teratogenic (Pregnancy Category X). Must rule out pregnancy before initiation in females of childbearing potential.
Timing: Before initiating treatment in females of childbearing potential.
Skin condition assessment
Rationale: To establish baseline severity of acne or psoriasis and identify areas for application.
Timing: Before initiating treatment.
Routine Monitoring
Skin irritation (erythema, peeling, burning, dryness, pruritus)
Frequency: Regularly during treatment, especially during the first few weeks.
Target: Minimal to mild
Action Threshold: If severe irritation occurs, reduce frequency of application, temporarily discontinue, or discontinue permanently.
Response to therapy
Frequency: Every 4-8 weeks or as clinically indicated.
Target: Improvement in lesions
Action Threshold: If no significant improvement after 12 weeks, re-evaluate diagnosis or treatment plan.
Symptom Monitoring
- Severe skin irritation (redness, peeling, burning, itching, dryness)
- Increased sensitivity to sunlight (sunburn)
- Signs of allergic reaction (rash, hives, swelling)
Special Patient Groups
Pregnancy
Contraindicated in pregnancy (Pregnancy Category X). Tazarotene is teratogenic in animals and can cause fetal harm. Females of childbearing potential must have a negative pregnancy test within 2 weeks prior to initiating therapy and use effective contraception during treatment.
Trimester-Specific Risks:
First Trimester:
High risk of teratogenicity (birth defects).
Second Trimester:
High risk of teratogenicity (birth defects).
Third Trimester:
High risk of teratogenicity (birth defects).
Lactation
Use with caution. 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 absorption 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:
Moderate risk (L3) - potential for adverse effects, but systemic absorption is minimal. Avoid applying to areas that may come into contact with the infant.
Pediatric Use
Safety and effectiveness for acne have been established in pediatric patients 12 years and older. Safety and effectiveness for psoriasis have not been established in pediatric patients under 18 years of age.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. Use with caution due to potentially thinner and more fragile skin.
Clinical Information
Clinical Pearls
- Tazarotene is a potent retinoid; start with the lowest concentration (0.05% if available for psoriasis) and gradually increase if tolerated and needed.
- Apply only a pea-sized amount for the entire face for acne, or a thin layer just enough to cover the lesions for psoriasis.
- Initial worsening of acne (purging) can occur during the first few weeks of treatment, which is normal and usually resolves with continued use.
- Photosensitivity is a significant side effect; emphasize strict sun protection measures.
- Counsel female patients of childbearing potential extensively on the teratogenic risk and the absolute necessity of effective contraception.
- Skin irritation is common, especially during the first 2-4 weeks. Advise patients to use a gentle cleanser and non-comedogenic moisturizer. Reducing frequency (e.g., every other night) can help manage irritation.
- Avoid concomitant use of other topical products that are highly irritating or drying.
Alternative Therapies
- Other topical retinoids (e.g., tretinoin, adapalene)
- Topical vitamin D analogs (e.g., calcipotriene for psoriasis)
- Topical corticosteroids (for psoriasis)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus for psoriasis)
- Topical antibiotics (e.g., clindamycin, erythromycin for acne)
- Benzoyl peroxide (for acne)
- Salicylic acid (for acne and psoriasis)
- Systemic therapies for severe acne (e.g., oral antibiotics, oral isotretinoin)
- Systemic therapies for severe psoriasis (e.g., biologics, methotrexate, cyclosporine, apremilast)
Cost & Coverage
Average Cost:
$400 - $1000+ per 30gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 or 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with 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 information about the medication taken, the amount, and the time it occurred.