Tazarotene 0.1% Cream 60gm
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 receptor agonist
Pregnancy Category
Category X
FDA Approved
May 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tazarotene cream is a medication similar to vitamin A that is applied to the skin to treat acne and psoriasis. It works by helping skin cells grow and shed normally, and by reducing inflammation.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication only as directed.
Application Instructions
Apply this medication only to your skin, 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 make sure it is completely dry.
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.
Timing and Skin Care
Some products are designed to be used 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 the 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 make sure it is completely dry.
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.
Timing and Skin Care
Some products are designed to be used 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 the missed dose.
Lifestyle & Tips
- Avoid use if pregnant or planning to become pregnant. Use effective contraception during treatment.
- Avoid excessive sun exposure, including tanning beds and sunlamps, as tazarotene can increase sensitivity to sunlight. Use sunscreen (SPF 30 or higher) and wear protective clothing when outdoors.
- Do not apply to eyes, mouth, nostrils, or mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not apply to eczematous, abraded, or sunburned skin.
- Avoid using other topical products that may cause skin irritation (e.g., abrasive soaps, astringents, alcohol-containing products) unless directed by your doctor.
- Apply a thin layer only to affected areas. Using more than directed will not improve results faster but may increase irritation.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer of Tazarotene 0.1% Cream once daily in the evening to affected areas.
Condition-Specific Dosing:
Plaque Psoriasis:
Apply to psoriatic lesions. Use enough to cover the lesion with a thin layer. Not for use on more than 20% of body surface area.
Acne Vulgaris:
Apply to the entire affected area (e.g., face, chest, back) where acne lesions appear.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 12 years of age.
Adolescent:
For acne vulgaris and plaque psoriasis: Apply a thin layer of Tazarotene 0.1% Cream once daily in the evening to affected areas (β₯12 years of age).
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 adjustment needed (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 metabolite, tazarotenic acid, by esterases in the skin. Tazarotenic acid binds to and activates retinoic acid receptors (RARs), specifically RARΞ² and RARΞ³, but not RARΞ±. 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 (<5% of applied dose)
Tmax:
Plasma concentrations of tazarotenic acid are very low and typically peak 2-8 hours after topical application.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not precisely quantified due to minimal systemic absorption.
ProteinBinding:
Tazarotenic acid is highly protein bound (>99%) in plasma.
CnssPenetration:
Limited (due to minimal systemic absorption and high protein binding).
Elimination:
HalfLife:
Approximately 18 hours (for tazarotenic acid)
Clearance:
Not precisely quantified due to minimal systemic absorption.
ExcretionRoute:
Primarily renal and fecal excretion of tazarotenic acid and its metabolites.
Unchanged:
Negligible systemic excretion of unchanged tazarotene.
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 1-2 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
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., extreme redness, burning, itching, peeling, blistering, crusting)
- Signs of allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)
- Unusual or severe photosensitivity reaction (sunburn)
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, such as foods or drugs. Describe the allergic reaction you experienced, including the 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.
To ensure your safety, it is vital to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your medical history, including any health problems you have
This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the 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.
To ensure your safety, it is vital to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your medical history, including any health problems you have
This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
Important Information About Your Medication
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. To ensure safe and effective use, follow the dosage instructions provided by your doctor carefully and do not exceed the recommended amount.
Protecting Your Skin
Certain weather conditions, such as cold and wind, may irritate your skin. Consult with your doctor or pharmacist about measures to protect your skin from these conditions. Additionally, be aware that your skin may appear 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 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 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 potential, 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. This medication may cause harm to an unborn baby, so if you may become pregnant, you must use birth control while taking this medication. 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 any potential harm.
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 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 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 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 potential, 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. This medication may cause harm to an unborn baby, so if you may become pregnant, you must use birth control while taking this medication. 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 any potential harm.
Overdose Information
Overdose Symptoms:
- Excessive skin irritation (severe redness, peeling, discomfort)
- While systemic overdose from topical application is unlikely due to minimal absorption, symptoms of oral retinoid overdose (e.g., headache, nausea, vomiting, dizziness, dry skin/mucous membranes) are theoretical but highly improbable.
What to Do:
Discontinue use. For severe local irritation, symptomatic treatment (e.g., emollients, cool compresses) may be used. In case of accidental ingestion, seek medical attention immediately or call a poison control center (1-800-222-1222).
Drug Interactions
Moderate Interactions
- Photosensitizing agents (e.g., tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) - increased risk of photosensitivity.
Minor Interactions
- Topical preparations with strong drying or irritating effects (e.g., abrasive soaps, astringents, alcohol-containing products, medicated cleansers, other peeling agents) - may increase irritation.
Monitoring
Baseline Monitoring
Pregnancy test (for females of childbearing potential)
Rationale: Tazarotene is teratogenic and contraindicated in pregnancy. A negative pregnancy test must be obtained within 2 weeks prior to initiating therapy.
Timing: Within 2 weeks prior to initiation of therapy.
Skin condition assessment (severity of acne/psoriasis)
Rationale: To establish baseline for efficacy monitoring.
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin irritation (erythema, peeling, burning, itching, dryness)
Frequency: Regularly during treatment, especially during the first few weeks.
Target: Minimal to mild irritation.
Action Threshold: Severe or persistent irritation may require temporary discontinuation, reduction in frequency, or use of a lower concentration.
Clinical response (improvement in acne lesions or psoriatic plaques)
Frequency: Monthly or as clinically indicated.
Target: Reduction in lesion count/severity.
Action Threshold: Lack of improvement after 12-16 weeks may warrant re-evaluation of treatment.
Pregnancy status (for females of childbearing potential)
Frequency: Monthly or as clinically indicated.
Target: Negative.
Action Threshold: Positive pregnancy test requires immediate discontinuation of tazarotene and counseling.
Symptom Monitoring
- Severe skin irritation (redness, peeling, burning, itching, dryness)
- Swelling
- Blistering
- Crusting
- Photosensitivity (severe sunburn-like reaction)
Special Patient Groups
Pregnancy
Tazarotene is contraindicated in pregnancy (Pregnancy Category X) due to its teratogenic potential. 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 severe birth defects (teratogenicity).
Second Trimester:
High risk of severe birth defects (teratogenicity).
Third Trimester:
High risk of severe birth defects (teratogenicity).
Lactation
It is not known whether tazarotene is excreted in human milk. Due to the potential for systemic absorption and the teratogenic nature 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. Caution is advised.
Infant Risk:
Potential for adverse effects on the infant due to systemic absorption, though minimal. Risk is considered moderate to potentially hazardous (L4).
Pediatric Use
Safety and effectiveness have been established in pediatric patients 12 years of age and older for acne vulgaris and plaque psoriasis. Safety and effectiveness in pediatric patients younger than 12 years have not been established.
Geriatric Use
No specific dosage adjustments are required for geriatric patients. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, due to minimal systemic absorption, age-related pharmacokinetic differences are unlikely to be clinically significant.
Clinical Information
Clinical Pearls
- Tazarotene is a potent retinoid; 'less is more' when applying to minimize irritation.
- Initial irritation (redness, peeling, burning) is common, especially during the first few weeks of treatment. This often subsides with continued use or by reducing application frequency (e.g., every other night).
- Always use a broad-spectrum sunscreen (SPF 30+) daily and wear protective clothing, as tazarotene significantly increases sun sensitivity.
- For psoriasis, apply only to the lesions, avoiding surrounding healthy skin to minimize irritation.
- For acne, apply to the entire affected area, not just individual pimples, to prevent new breakouts.
- Therapeutic effects are not immediate; consistent use for several weeks (12-16 weeks) is often required to see full benefits.
- Emollients or moisturizers can be used to help manage dryness and irritation, but apply them at a different time of day (e.g., moisturizer in the morning, tazarotene at night) or allow tazarotene to fully absorb first.
Alternative Therapies
- Other topical retinoids (e.g., tretinoin, adapalene, trifarotene)
- 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)
- 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:
$200 - $600+ per 60gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (for brand), Tier 1 or 2 (for 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.