Tazorac 0.1% 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
Antipsoriatic, Anti-acne
Pharmacologic Class
Topical Retinoid
Pregnancy Category
Category X
FDA Approved
Jun 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tazorac gel is a topical medication used to treat skin conditions like psoriasis. It's a type of vitamin A derivative that helps normalize skin cell growth and reduce inflammation. You apply a thin layer to the affected skin once a day, usually in the evening.
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.
Special Considerations
Some products are designed for use at bedtime, while others can be used at any time. Consult with your pharmacist to determine the best application schedule for your specific product.
Practice good skin care and avoid excessive sun exposure.
Apply the medication only to the affected skin, avoiding healthy skin areas.
Storage and Disposal
Store the medication at room temperature, avoiding freezing.
Keep all medications in a safe location, 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.
Special Considerations
Some products are designed for use at bedtime, while others can be used at any time. Consult with your pharmacist to determine the best application schedule for your specific product.
Practice good skin care and avoid excessive sun exposure.
Apply the medication only to the affected skin, avoiding healthy skin areas.
Storage and Disposal
Store the medication at room temperature, avoiding freezing.
Keep all medications in a safe location, 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 only to affected areas, avoiding eyes, mouth, nostrils, and mucous membranes.
- Wash hands thoroughly after application.
- Avoid excessive exposure to sunlight, including sunlamps and tanning beds, as this medication can increase sensitivity to the sun. Use sunscreen and wear protective clothing when outdoors.
- Do not use on eczematous, abraded, or inflamed skin.
- If skin irritation occurs, reduce frequency of application or temporarily stop use. Consult your doctor if irritation persists or is severe.
- For women of childbearing potential, use effective contraception during treatment and for at least one month after stopping treatment due to the risk of birth defects.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer of Tazorac 0.1% Gel once daily in the evening to affected areas.
Condition-Specific Dosing:
Plaque Psoriasis:
Apply a thin layer to psoriatic lesions once daily in the evening. Limit application to no more than 20% of body surface area.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 12 years of age for psoriasis.
Adolescent:
For plaque psoriasis, apply a thin layer of Tazorac 0.1% Gel once daily in the evening to affected areas in patients 12 years of age and older.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to 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 and activates retinoic acid receptors (RARs), specifically RARΞ² and RARΞ³, but not RARΞ±. These receptors modulate gene expression, which in turn normalizes keratinocyte differentiation, reduces hyperproliferation, and decreases inflammation, leading to therapeutic effects in psoriasis and acne.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (typically <1% of applied dose)
Tmax:
Variable, generally 1-8 hours (for active metabolite, tazarotenic acid), but systemic levels are very low.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not available (minimal systemic distribution)
ProteinBinding:
Highly protein bound (>99%) for tazarotenic acid in plasma, but systemic levels are negligible.
CnssPenetration:
Limited/Negligible (due to minimal systemic absorption)
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 and metabolites).
Unchanged:
Not available (minimal systemic absorption of parent drug)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 1-2 weeks, with maximal effects at 12 weeks.
PeakEffect:
12 weeks for psoriasis.
DurationOfAction:
Effects may persist for a period after discontinuation, but maintenance therapy is often required.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 immediate medical attention:
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
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 is 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:
* Skin irritation, which may include:
+ Burning
+ Dry skin
+ Itching
+ Peeling
+ Redness
+ Scaling
+ Severe skin irritation that bothers you or does not go away
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. 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.
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 immediate medical attention:
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
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 is 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:
* Skin irritation, which may include:
+ Burning
+ Dry skin
+ Itching
+ Peeling
+ Redness
+ Scaling
+ Severe skin irritation that bothers you or does not go away
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. 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.
Seek Immediate Medical Attention If You Experience:
- Severe skin irritation (e.g., excessive redness, peeling, burning, itching, swelling)
- Severe sunburn reaction
- Signs of allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat)
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 symptoms you experienced.
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 risk of adverse reactions.
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. Many medications can have this effect, so it is crucial to ask your doctor or pharmacist if you have any concerns.
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 existing health problems. 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 symptoms you experienced.
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 risk of adverse reactions.
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. Many medications can have this effect, so it is crucial to ask your doctor or pharmacist if you have any concerns.
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 existing health problems. 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.
Skin Care and Protection
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.
Before using any other medications or products on your skin, including soaps, discuss them with your doctor. Using other skin products concurrently with this medication may increase the risk of irritation.
Sun Protection
You may be more susceptible to sunburn while using this medication. To minimize this risk, avoid exposure to direct sunlight, sunlamps, and tanning beds. When going outside, use sunscreen and wear protective clothing and eyewear to shield 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 promptly.
If you are breastfeeding, consult with your doctor to assess any potential risks to your baby. When applying this medication, avoid putting it directly on the nipple or the surrounding area to prevent 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.
Skin Care and Protection
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.
Before using any other medications or products on your skin, including soaps, discuss them with your doctor. Using other skin products concurrently with this medication may increase the risk of irritation.
Sun Protection
You may be more susceptible to sunburn while using this medication. To minimize this risk, avoid exposure to direct sunlight, sunlamps, and tanning beds. When going outside, use sunscreen and wear protective clothing and eyewear to shield 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 promptly.
If you are breastfeeding, consult with your doctor to assess any potential risks to your baby. When applying this medication, avoid putting it directly on the nipple or the surrounding area to prevent exposure to your baby.
Overdose Information
Overdose Symptoms:
- Excessive skin irritation (redness, peeling, discomfort)
- Systemic effects are unlikely due to minimal absorption, but theoretical symptoms could include headache, nausea, vomiting if large amounts were ingested or absorbed.
What to Do:
Topical overdose is unlikely to cause systemic symptoms. Discontinue use and apply emollients to soothe irritated skin. If accidental ingestion occurs, seek medical attention. Call 1-800-222-1222 (Poison Control).
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, alcohol-containing preparations, other topical retinoids, benzoyl peroxide, salicylic acid): May increase skin irritation.
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of psoriasis and identify areas for treatment.
Timing: Prior to initiation of therapy.
Pregnancy test
Rationale: Tazarotene is teratogenic; ensure patient is not pregnant before starting therapy.
Timing: Within 2 weeks prior to initiating therapy in women of childbearing potential.
Routine Monitoring
Skin irritation (erythema, scaling, burning, pruritus)
Frequency: Regularly during treatment, especially during the first few weeks.
Target: Minimal to mild irritation.
Action Threshold: If severe irritation occurs, reduce frequency of application or temporarily discontinue use. Re-evaluate treatment if irritation persists.
Response to therapy
Frequency: Periodically (e.g., every 4-8 weeks) to assess efficacy.
Target: Improvement in psoriatic 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)
- Excessive dryness of skin
- Increased sensitivity to sunlight (sunburn)
Special Patient Groups
Pregnancy
CONTRAINDICATED. Tazarotene is teratogenic and can cause fetal harm. Women of childbearing potential must use effective contraception during treatment and for at least one month after stopping treatment.
Trimester-Specific Risks:
First Trimester:
High risk of teratogenicity (birth defects).
Second Trimester:
Risk of teratogenicity remains, though organogenesis is largely complete.
Third Trimester:
Risk of teratogenicity remains.
Lactation
Caution advised. 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 tazarotene, 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.
Infant Risk:
Potential for adverse effects due to systemic absorption, though minimal. Risk is considered low but not negligible.
Pediatric Use
Safety and effectiveness for plaque psoriasis have been established in pediatric patients 12 years of age and older. Safety and effectiveness in pediatric patients younger than 12 years have not been established for psoriasis.
Geriatric Use
No specific dose adjustments are necessary. 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 0.1% Gel is highly effective for plaque psoriasis but can cause significant skin irritation, especially during the initial weeks of treatment. Patients should be counseled on this and advised on strategies to manage irritation (e.g., applying to dry skin, using emollients).
- Emphasize strict sun protection due to increased photosensitivity.
- For women of childbearing potential, reinforce the absolute necessity of effective contraception due to the Pregnancy Category X classification.
- Applying a moisturizer before or after tazarotene application (shortly after, once the gel has dried) can help mitigate irritation without significantly reducing efficacy.
- A pea-sized amount is often sufficient for a large area, as a thin layer is all that is needed.
Alternative Therapies
- Other topical retinoids (e.g., adapalene, tretinoin)
- Topical corticosteroids (e.g., clobetasol, betamethasone)
- Vitamin D analogs (e.g., calcipotriene)
- Calcineurin inhibitors (e.g., tacrolimus, pimecrolimus)
- Coal tar preparations
- Salicylic acid
- Systemic therapies for psoriasis (e.g., methotrexate, cyclosporine, biologics) for more severe cases.
- Phototherapy (UVB, PUVA)
Cost & Coverage
Average Cost:
Varies widely, typically $500 - $1000+ per 100gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 3 or 4 (Non-preferred brand or specialty drug), may require prior authorization.
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. 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. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.