Tazorac 0.05% 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
Topical Retinoid
Pharmacologic Class
Retinoid, Acetylenic
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's a type of vitamin A derivative that helps to normalize skin cell growth and reduce 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, 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.
Do not apply this medication to the vagina.
Before applying the medication, wash your hands thoroughly. If the treated area is on your hand, do not wash your hand after application.
Clean the affected area before applying the medication and dry it well.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Avoid applying 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
If you are able to become pregnant, start using this medication during your normal menstrual period.
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 this medication at room temperature, avoiding freezing temperatures.
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 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, 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.
Do not apply this medication to the vagina.
Before applying the medication, wash your hands thoroughly. If the treated area is on your hand, do not wash your hand after application.
Clean the affected area before applying the medication and dry it well.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Avoid applying 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
If you are able to become pregnant, start using this medication during your normal menstrual period.
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 this medication at room temperature, avoiding freezing temperatures.
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 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 contact with eyes, eyelids, mouth, and mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not apply to eczematous, broken, or sunburned skin.
- Use sunscreen and protective clothing, and limit sun exposure (including sunlamps) while using this medication, as it can increase sensitivity to sunlight.
- Use a mild cleanser and moisturizer regularly to help manage potential skin dryness or irritation.
- Avoid waxing on treated areas as it may cause excessive skin irritation or peeling.
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 affected areas once daily in the evening. Use enough to cover the entire lesion with a thin film.
Acne Vulgaris:
Apply a thin layer to affected areas once daily in the evening. Cleanse the face gently before application.
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 once daily in the evening to affected areas for patients 12 years of age and older.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended due to minimal systemic absorption.
Moderate:
No specific adjustment recommended due to minimal systemic absorption.
Severe:
No specific adjustment recommended due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment recommended due to minimal systemic absorption.
Moderate:
No specific adjustment recommended due to minimal systemic absorption.
Severe:
No specific adjustment recommended 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 retinoic acid receptors (RARs), specifically RAR-β and RAR-Îŗ, but not RAR-Îą. Binding to these receptors modulates gene expression, which in turn influences 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 promotes desquamation, preventing comedone formation.
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 for topical administration.
Distribution:
Vd:
Not precisely quantified due to minimal systemic absorption.
ProteinBinding:
Tazarotenic acid is highly bound to plasma proteins (>99%).
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 7-12 hours (for tazarotenic acid after systemic absorption, though systemic levels are very low).
Clearance:
Not precisely quantified due to minimal systemic absorption.
ExcretionRoute:
Renal and fecal (for systemically absorbed tazarotenic acid).
Unchanged:
Negligible
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 1-4 weeks for acne, and 4-8 weeks for psoriasis.
PeakEffect:
Peak therapeutic effect may take 12-16 weeks for psoriasis and 12 weeks for acne.
DurationOfAction:
Effects persist as long as treatment is continued; relapse occurs upon discontinuation.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
While rare, some individuals 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
- Swelling
Other Possible Side Effects
As with all medications, side effects can occur. Although many people do not experience side effects or only have mild ones, it's essential to be aware of the potential risks. 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, which may include:
- Burning
- Dry skin
- Itching
- Peeling
- Redness
- 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 individuals 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
- Swelling
Other Possible Side Effects
As with all medications, side effects can occur. Although many people do not experience side effects or only have mild ones, it's essential to be aware of the potential risks. 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, which may include:
- Burning
- Dry skin
- Itching
- Peeling
- Redness
- 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 burning, stinging, itching, or redness that does not subside.
- Excessive peeling or blistering of the skin.
- Significant swelling or crusting of the treated area.
- Signs of an allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat) - 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 treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are pregnant or think you might 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. Many medications can have this effect, so it is crucial to ask your doctor or pharmacist if you have any concerns.
Additionally, it is vital to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This information will help your doctor and pharmacist determine whether it is safe for you to take this medication in combination with your other treatments. Never start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are pregnant or think you might 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. Many medications can have this effect, so it is crucial to ask your doctor or pharmacist if you have any concerns.
Additionally, it is vital to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This information will help your doctor and pharmacist determine whether it is safe for you to take this medication in combination with your other treatments. Never start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
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. When going outside, use sunscreen and wear protective clothing and eyewear to shield yourself 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 starting this medication. 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, inform your doctor, as you will need to discuss any potential risks to your baby. To avoid any potential harm, do not apply this medication directly to the nipple or the surrounding area while breastfeeding.
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. When going outside, use sunscreen and wear protective clothing and eyewear to shield yourself 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 starting this medication. 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, inform your doctor, as you will need to discuss any potential risks to your baby. To avoid any potential harm, do not apply this medication directly to the nipple or the surrounding area while breastfeeding.
Overdose Information
Overdose Symptoms:
- Excessive skin irritation (severe redness, peeling, discomfort) if applied in large amounts or too frequently.
- Systemic toxicity is highly unlikely with topical application due to minimal absorption.
What to Do:
Discontinue use and apply emollients. If severe irritation occurs, consult a healthcare professional. For accidental ingestion, call a poison control center (1-800-222-1222) or seek emergency medical attention, though systemic effects are unlikely.
Drug Interactions
Moderate Interactions
- Photosensitizing agents (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides): May increase risk of photosensitivity reactions.
- Other topical preparations with strong drying or irritating effects (e.g., abrasive soaps, cleansers, medicated soaps, astringents, alcohol-containing products, other retinoids, benzoyl peroxide, salicylic acid): May increase skin irritation.
Monitoring
Baseline Monitoring
Skin assessment (type, severity, extent of condition)
Rationale: To establish baseline for efficacy and adverse effect monitoring.
Timing: Prior to initiation of therapy.
Pregnancy test (for females of childbearing potential)
Rationale: Tazarotene is teratogenic (Pregnancy Category X).
Timing: Within 2 weeks prior to initiating therapy.
Routine Monitoring
Skin irritation (erythema, peeling, burning, dryness, pruritus)
Frequency: Regularly during treatment, especially during the first few weeks.
Target: Minimal to mild irritation.
Action Threshold: Moderate to severe irritation may require temporary discontinuation, reduction in frequency, or use of emollients.
Clinical response to therapy
Frequency: Every 4-8 weeks initially, then as clinically indicated.
Target: Improvement in lesions (e.g., reduction in scaling, thickness, erythema for psoriasis; reduction in comedones, inflammatory lesions for acne).
Action Threshold: Lack of improvement after 12-16 weeks may warrant re-evaluation of diagnosis or treatment plan.
Symptom Monitoring
- Severe skin irritation (redness, peeling, burning, itching, dryness)
- Sunburn-like reactions
- Swelling
- Blistering
- Crusting
Special Patient Groups
Pregnancy
CONTRAINDICATED in pregnancy. Tazarotene is teratogenic 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
Caution is 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 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 suggests low risk, but direct application to areas where an infant might come into contact should be avoided.
Infant Risk:
Low risk, but potential for systemic effects if absorbed by infant or if applied to areas where infant could ingest.
Pediatric Use
Approved for acne vulgaris in patients 12 years of age and older. Safety and effectiveness for psoriasis in pediatric patients under 18 years of age have not been established. Safety and effectiveness for acne in pediatric patients under 12 years of age have not been established.
Geriatric Use
No specific dosage adjustments are required. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, due to minimal systemic absorption, age-related systemic pharmacokinetic differences are unlikely to be clinically significant.
Clinical Information
Clinical Pearls
- Tazorac Gel is a potent retinoid; a 'pea-sized' amount is usually sufficient for the entire face for acne.
- Patients should be educated on the importance of strict sun protection due to increased photosensitivity.
- Initial irritation (retinoid dermatitis) is common and usually subsides with continued use. Strategies like applying every other day or using a moisturizer can help manage this.
- Emphasize the absolute contraindication in pregnancy and the need for effective contraception for females of childbearing potential.
- Results are not immediate; consistent, long-term use is necessary for optimal efficacy.
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)
- Salicylic acid (for acne and psoriasis)
- Systemic therapies (e.g., oral retinoids, biologics, immunosuppressants for severe cases of acne or psoriasis)
Cost & Coverage
Average Cost:
Varies widely, typically $300-$800+ per 30gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 (Generic)
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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.