Tazorac 0.05% Cream 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, Topical
Pregnancy Category
Category X
FDA Approved
May 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tazarotene is a topical medication, similar to vitamin A, that helps to normalize skin cell growth and reduce inflammation. It is used to treat skin conditions like psoriasis and acne.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication only as directed.
Application Instructions
Apply this medication only to your skin, avoiding ingestion or contact with your mouth, nose, and eyes, as it may cause burning.
Do not apply this medication to the vagina.
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, gently rubbing it in.
Important Precautions
Avoid applying this medication to cuts, scrapes, eczema, or damaged skin.
Unless instructed to do so by your doctor, do not cover the treated area with bandages, dressings, or makeup.
Some products are designed for use at bedtime, while others can be used at any time; consult with your pharmacist for specific guidance.
Skin Care and Sun Protection
Practice good skin care and avoid excessive sun exposure while using this medication.
Apply the medication only to affected skin, avoiding healthy skin areas.
Storage and Disposal
Store this medication at room temperature, avoiding freezing.
Keep all medications in a safe location, out of reach of children and pets.
Missed Dose Instructions
If you miss a dose, skip it and resume your normal application schedule.
* Do not apply extra doses or double doses to make up for a missed dose.
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication only as directed.
Application Instructions
Apply this medication only to your skin, avoiding ingestion or contact with your mouth, nose, and eyes, as it may cause burning.
Do not apply this medication to the vagina.
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, gently rubbing it in.
Important Precautions
Avoid applying this medication to cuts, scrapes, eczema, or damaged skin.
Unless instructed to do so by your doctor, do not cover the treated area with bandages, dressings, or makeup.
Some products are designed for use at bedtime, while others can be used at any time; consult with your pharmacist for specific guidance.
Skin Care and Sun Protection
Practice good skin care and avoid excessive sun exposure while using this medication.
Apply the medication only to affected skin, avoiding healthy skin areas.
Storage and Disposal
Store this medication at room temperature, avoiding freezing.
Keep all medications in a safe location, out of reach of children and pets.
Missed Dose Instructions
If you miss a dose, skip it and resume your normal application schedule.
* Do not apply extra doses or double 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.
- Use sunscreen and wear protective clothing when outdoors, as this medication can increase sensitivity to sunlight.
- Avoid excessive sun exposure, including sunlamps and tanning beds.
- Do not use on eczematous, abraded, or inflamed skin.
- Avoid waxing on treated areas as skin may be more fragile.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer of Tazorac 0.05% Cream once daily in the evening to affected areas.
Condition-Specific Dosing:
Plaque Psoriasis:
Apply a thin layer to affected areas once daily in the evening.
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. For children 12 years and older, dosing is similar to adults.
Adolescent:
Apply a thin layer of Tazorac 0.05% Cream once daily in the evening to affected areas (for patients 12 years and older).
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 hydrolyzed to its active carboxylic acid metabolite, tazarotenic acid, in the skin. Tazarotenic acid binds to retinoic acid receptors (RARs), specifically RAR-beta and RAR-gamma, modulating gene expression. This leads to normalization of keratinocyte differentiation, reduction of inflammation, and inhibition of proliferation in psoriatic lesions, and reduction of follicular hyperkeratosis and inflammation in acne.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (<5%)
Tmax:
Approximately 9-12 hours (for tazarotenic acid after topical application)
FoodEffect:
Not applicable for topical formulation
Distribution:
Vd:
Not available (minimal systemic distribution)
ProteinBinding:
Greater than 99% (tazarotenic acid)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 18 hours (for tazarotenic acid after topical application)
Clearance:
Not available
ExcretionRoute:
Primarily renal and fecal excretion of metabolites
Unchanged:
<1% (tazarotenic acid)
Pharmacodynamics
OnsetOfAction:
Weeks (typically 2-4 weeks for initial improvement)
PeakEffect:
8-12 weeks
DurationOfAction:
Variable, continued use required for sustained effect
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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, 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. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or do not go away:
- Skin irritation is a common side effect of this medication. This may include burning, dry skin, itching, peeling, redness, and scaling. If you experience severe skin irritation or if it bothers you and does not go away, contact your doctor.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, contact your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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, 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. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or do not go away:
- Skin irritation is a common side effect of this medication. This may include burning, dry skin, itching, peeling, redness, and scaling. If you experience severe skin irritation or if it bothers you and does not go away, contact your doctor.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, contact your doctor for medical advice. 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., intense redness, burning, itching, peeling)
- Swelling of the face or lips (rare, but seek immediate medical attention)
- Signs of severe sunburn despite sun protection
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 should not be used during pregnancy.
If you are capable of becoming 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 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. Again, 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 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 symptoms you experienced.
If you are pregnant or think you may be pregnant. This medication should not be used during pregnancy.
If you are capable of becoming 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 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. Again, 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 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 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 using 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 medical attention immediately 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 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.
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 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 using 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 medical attention immediately 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 prevent exposure to your baby.
Overdose Information
Overdose Symptoms:
- Excessive skin redness
- Severe peeling
- Discomfort
What to Do:
Topical overdose is unlikely to cause systemic toxicity due to minimal absorption. Discontinue use and apply emollients to soothe irritated skin. If accidental ingestion occurs, contact a poison control center (e.g., 1-800-222-1222) or seek medical attention.
Drug Interactions
Moderate Interactions
- Photosensitizing agents (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines)
- Other topical preparations with strong drying, irritating, or desquamating effects (e.g., sulfur, resorcinol, salicylic acid, alpha hydroxy acids)
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of psoriasis or acne and identify areas for treatment.
Timing: Prior to initiation of therapy
Routine Monitoring
Skin irritation (erythema, peeling, burning, itching)
Frequency: Regularly during treatment, especially in the first few weeks
Target: Minimal to mild irritation
Action Threshold: Moderate to severe irritation may require temporary discontinuation or reduction in frequency of application.
Response to therapy
Frequency: Every 4-8 weeks or as clinically indicated
Target: Improvement in lesions
Action Threshold: Lack of improvement after 8-12 weeks may warrant re-evaluation of treatment.
Symptom Monitoring
- Excessive skin redness
- Peeling or flaking of skin
- Burning or stinging sensation
- Itching
- Dryness
- Photosensitivity (increased sunburn risk)
Special Patient Groups
Pregnancy
Contraindicated in pregnancy (Pregnancy Category X). Tazarotene is a retinoid and can cause fetal harm. Even though systemic absorption is minimal, the risk cannot be completely excluded. Women of childbearing potential should be advised to use effective contraception during treatment and for at least 3 days after the last dose.
Trimester-Specific Risks:
First Trimester:
High risk of teratogenicity; contraindicated.
Second Trimester:
High risk of teratogenicity; contraindicated.
Third Trimester:
High risk of teratogenicity; contraindicated.
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 retinoids, 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. If used, avoid application to the breast area to prevent infant exposure.
Infant Risk:
Low to moderate risk (L3) due to minimal systemic absorption, but caution advised.
Pediatric Use
Approved for patients 12 years of age and older for acne and psoriasis. Safety and effectiveness in pediatric patients younger than 12 years have not been established.
Geriatric Use
No specific dose adjustments are required for geriatric patients. However, older patients may have more fragile skin and may be more susceptible to irritation. Use with caution and monitor for skin reactions.
Clinical Information
Clinical Pearls
- Tazarotene is a potent retinoid; start with the lowest strength (0.05%) and apply a pea-sized amount thinly to affected areas to minimize irritation.
- Apply only once daily in the evening, as it can increase photosensitivity.
- Patients should be educated on the importance of strict sun protection (sunscreen, protective clothing) while using tazarotene.
- Initial worsening of acne (purging) can occur in the first few weeks of treatment; this is usually temporary.
- Avoid concomitant use of other topical irritants or drying agents unless directed by a healthcare professional.
- For psoriasis, it can be used in combination with topical corticosteroids for enhanced efficacy and reduced irritation.
Alternative Therapies
- Other topical retinoids (e.g., tretinoin, adapalene, trifarotene)
- Topical corticosteroids (for psoriasis)
- Vitamin D analogs (e.g., calcipotriene for psoriasis)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus)
- 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, phototherapy for severe cases)
Cost & Coverage
Average Cost:
Varies, typically $200-$500+ 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 details. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.