Tazarotene 0.1% 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, Retinoid
Pharmacologic Class
Topical Retinoid
Pregnancy Category
Category X
FDA Approved
May 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tazarotene cream is a medication that belongs to a group of drugs called retinoids. It works by affecting how skin cells grow and mature, which helps to clear up skin conditions like psoriasis, acne, and sun-damaged skin. It's applied directly to the skin.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication only as directed.
Application Instructions
Apply this medication only to your skin. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. If accidental contact occurs, rinse the area thoroughly with water.
Do not apply the medication to the vagina.
If you are able to become pregnant, start using this medication during your normal menstrual period.
Wash your hands before and after applying the medication, unless your hand is the treated area. In this case, do not wash your hand after application.
Clean and dry the affected area before applying the medication. Apply a thin layer 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.
Usage Schedule
Some products are designed for use at bedtime, while others can be used at any time. Consult with your pharmacist to determine the best usage schedule for your specific product.
Skin Care and Sun Protection
Practice good skin care and avoid excessive sun exposure while using this medication.
Apply the medication only to the affected skin, avoiding healthy skin areas.
Storage and Disposal
Store this medication at room temperature, avoiding freezing temperatures.
Keep all medications in a safe and secure 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 once 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. 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 and dry the affected area before applying the medication. Apply a thin layer 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.
Usage Schedule
Some products are designed for use at bedtime, while others can be used at any time. Consult with your pharmacist to determine the best usage schedule for your specific product.
Skin Care and Sun Protection
Practice good skin care and avoid excessive sun exposure while using this medication.
Apply the medication only to the affected skin, avoiding healthy skin areas.
Storage and Disposal
Store this medication at room temperature, avoiding freezing temperatures.
Keep all medications in a safe and secure 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 once or use extra doses to make up for the missed dose.
Lifestyle & Tips
- Apply a thin layer to clean, dry skin once daily in the evening.
- Wash hands thoroughly after applying the cream.
- Avoid contact with eyes, eyelids, mouth, and mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not apply to sunburned, eczematous, or irritated skin, or to open wounds.
- Use sunscreen (SPF 30 or higher) and wear protective clothing when outdoors, as this medication can make your skin more sensitive to the sun.
- Avoid excessive sun exposure, including tanning beds and sunlamps.
- Moisturizers can be used, but apply them at a different time of day (e.g., morning) to avoid diluting the tazarotene or increasing irritation.
- Do not use if you are pregnant, planning to become pregnant, or breastfeeding. Use effective birth control during treatment if you are a woman of childbearing potential.
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:
Psoriasis:
Apply a thin layer to affected areas once daily in the evening. Use enough to cover the entire lesion with a thin film. For plaque psoriasis, treatment should be limited to 20% of body surface area.
Facial Photodamage:
Apply a thin layer to the entire face once daily in the evening, after washing and drying the face. A pea-sized amount is usually sufficient for the entire face.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for 0.1% cream for psoriasis/photodamage. For acne, Tazarotene 0.1% cream is approved for patients 12 years and older.
Adolescent:
For acne, apply a thin layer to affected areas once daily in the evening for patients 12 years and older. For psoriasis, safety and efficacy not established below 18 years for 0.1% cream.
Dose Adjustments
Renal Impairment:
Mild:
No specific dosage adjustment recommended as systemic absorption is minimal.
Moderate:
No specific dosage adjustment recommended as systemic absorption is minimal.
Severe:
No specific dosage adjustment recommended as systemic absorption is minimal.
Dialysis:
No specific dosage adjustment recommended as systemic absorption is minimal.
Hepatic Impairment:
Mild:
No specific dosage adjustment recommended as systemic absorption is minimal.
Moderate:
No specific dosage adjustment recommended as systemic absorption is minimal.
Severe:
No specific dosage adjustment recommended as systemic absorption is minimal.
Pharmacology
Mechanism of Action
Tazarotene is a retinoid prodrug that is converted to its active metabolite, tazarotenic acid, by esterase hydrolysis in the skin. Tazarotenic acid binds to all three members of the retinoic acid receptor (RAR) family: RARΞ±, RARΞ², and RARΞ³, but shows relative selectivity for RARΞ² and RARΞ³. These receptors modulate gene expression, leading to normalization of keratinocyte differentiation and proliferation, and reduction of inflammation, which are key processes in psoriasis and acne. In photodamaged skin, it promotes epidermal thickening, reduces atypical melanocytes, and increases collagen synthesis.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (typically <1% of applied dose)
Tmax:
Not well-defined due to minimal systemic absorption; peak plasma concentrations of tazarotenic acid are generally very low (e.g., <0.25 ng/mL) and occur within 1-8 hours after topical application.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not well-defined due to minimal systemic absorption.
ProteinBinding:
Tazarotenic acid is highly bound to plasma proteins (>99%).
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 7-18 hours for tazarotenic acid (systemic, though levels are very low).
Clearance:
Not well-defined due to minimal systemic absorption.
ExcretionRoute:
Approximately 60% renally and 40% fecally for tazarotenic acid.
Unchanged:
Negligible amount of unchanged tazarotene is excreted.
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 1-2 weeks for acne, 2-4 weeks for psoriasis, and several weeks to months for photodamage.
PeakEffect:
Peak therapeutic effect may take 12-16 weeks for psoriasis and photodamage, and up to 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 Help Immediately
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 medical attention 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
Like all medications, this drug can cause side effects. Although many people do not experience any side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
- Skin irritation is a common side effect of this medication. This may include:
- Burning
- Dry skin
- Itching
- Peeling
- Redness
- 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.
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 medical attention 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
Like all medications, this drug can cause side effects. Although many people do not experience any side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
- Skin irritation is a common side effect of this medication. This may include:
- Burning
- Dry skin
- Itching
- Peeling
- Redness
- 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 (excessive redness, peeling, burning, itching, stinging)
- Severe dryness or cracking of the skin
- Blistering or crusting of the skin
- Signs of an allergic reaction (rash, hives, swelling, difficulty breathing)
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 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. Again, there are many medications that can have this effect, so it is crucial to check with your doctor or pharmacist if you are uncertain.
To ensure your safety, it is vital to provide your doctor and pharmacist with a comprehensive list of all the medications you are taking, 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 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 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. Again, there are many medications that can have this effect, so it is crucial to check with your doctor or pharmacist if you are uncertain.
To ensure your safety, it is vital to provide your doctor and pharmacist with a comprehensive list of all the medications you are taking, 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. Adhere strictly to the dosage and administration instructions provided by your doctor, and never exceed the recommended dose.
Be aware that certain environmental conditions, such as cold weather and wind, may exacerbate skin irritation. Consult with your doctor or pharmacist for guidance on protecting your skin under these conditions. Additionally, your skin may appear to worsen before improving, but this is a common part of the treatment process.
Before using any other medications or products on your skin, including soaps, consult with your doctor to avoid potential interactions or increased irritation. The use of other skin products concurrently with this medication may heighten the risk of skin irritation.
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 a broad-spectrum sunscreen with a high SPF and wear protective clothing and eyewear to safeguard your skin against the sun.
In the event that this medication is ingested, it can cause harm. If accidental ingestion occurs, immediately contact a doctor or a poison control center for assistance.
For women of childbearing potential, a pregnancy test will be conducted before initiating treatment with this medication to confirm that you are not pregnant. It is essential to discuss the risks associated with this medication with your doctor, as it may cause harm to an unborn baby. If you become pregnant or plan to become pregnant, you must use effective birth control measures while taking this medication. If you do 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 placing it directly on the nipple or the surrounding area to prevent exposure to your infant.
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere strictly to the dosage and administration instructions provided by your doctor, and never exceed the recommended dose.
Be aware that certain environmental conditions, such as cold weather and wind, may exacerbate skin irritation. Consult with your doctor or pharmacist for guidance on protecting your skin under these conditions. Additionally, your skin may appear to worsen before improving, but this is a common part of the treatment process.
Before using any other medications or products on your skin, including soaps, consult with your doctor to avoid potential interactions or increased irritation. The use of other skin products concurrently with this medication may heighten the risk of skin irritation.
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 a broad-spectrum sunscreen with a high SPF and wear protective clothing and eyewear to safeguard your skin against the sun.
In the event that this medication is ingested, it can cause harm. If accidental ingestion occurs, immediately contact a doctor or a poison control center for assistance.
For women of childbearing potential, a pregnancy test will be conducted before initiating treatment with this medication to confirm that you are not pregnant. It is essential to discuss the risks associated with this medication with your doctor, as it may cause harm to an unborn baby. If you become pregnant or plan to become pregnant, you must use effective birth control measures while taking this medication. If you do 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 placing it directly on the nipple or the surrounding area to prevent exposure to your infant.
Overdose Information
Overdose Symptoms:
- Excessive skin redness
- Severe peeling
- Discomfort
- Burning
- Itching
What to Do:
Topical overdose is unlikely to cause systemic toxicity due to minimal absorption. If excessive application occurs, wash the area thoroughly. Management is symptomatic and supportive. In case of accidental ingestion, contact a poison control center immediately (e.g., 1-800-222-1222) or seek emergency medical attention.
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, cosmetics with strong drying effect, products with high alcohol content, astringents, sulfur, resorcinol, salicylic acid): May increase irritation.
Monitoring
Routine Monitoring
Skin irritation (erythema, scaling, burning, itching)
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-initiate at a lower frequency or concentration if tolerated.
Photosensitivity
Frequency: Ongoing during treatment.
Target: No excessive sunburn or photosensitivity reactions.
Action Threshold: Advise patients to use sunscreen and protective clothing, and to avoid excessive sun exposure, including sunlamps. Discontinue if severe photosensitivity occurs.
Symptom Monitoring
- Skin redness
- Peeling/scaling
- Burning sensation
- Itching
- Dryness
- Stinging
- Sunburn-like reactions
Special Patient Groups
Pregnancy
CONTRAINDICATED. Tazarotene is Pregnancy Category X. Oral retinoids are known teratogens, and although systemic absorption of topical tazarotene is minimal, there is a theoretical risk of teratogenicity. Women 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:
Highest risk of teratogenicity; absolutely contraindicated.
Second Trimester:
Contraindicated.
Third Trimester:
Contraindicated.
Lactation
Caution advised. It is not known whether tazarotene or its metabolites are excreted in human milk. Due to the potential for serious adverse reactions in nursing infants from the systemic exposure 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.
Infant Risk:
Potential for adverse effects due to theoretical systemic absorption and retinoid class effects.
Pediatric Use
Safety and efficacy of Tazarotene 0.1% Cream for psoriasis and photodamage have not been established in pediatric patients under 18 years of age. For acne, Tazarotene 0.1% cream is approved for patients 12 years and older.
Geriatric Use
No specific dosage adjustments are recommended 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, elderly patients may have more fragile skin and may be more susceptible to irritation.
Clinical Information
Clinical Pearls
- Start with a lower concentration (e.g., 0.05%) or less frequent application (e.g., every other day) if skin irritation is a concern, especially for sensitive skin or initial treatment.
- A 'pea-sized' amount is typically sufficient for the entire face for photodamage or acne. For psoriasis, apply a thin layer only to the affected lesions.
- Patients should be educated on the importance of strict sun protection due to increased photosensitivity.
- Emphasize the absolute contraindication in pregnancy and the need for effective contraception for women of childbearing potential.
- Improvement may not be seen immediately; consistent use for several weeks to months is often required for optimal results.
- Concurrent use of strong irritants or drying agents should be avoided or used with caution and at different times of the day.
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)
- Topical salicylic acid or benzoyl peroxide (for acne)
- Systemic therapies (e.g., biologics, methotrexate, cyclosporine for severe psoriasis/acne)
- Phototherapy (UVB, PUVA for psoriasis)
Cost & Coverage
Average Cost:
$200 - $600+ per 30gm tube
Generic Available:
Yes
Insurance Coverage:
Often Tier 2 or 3, may require prior authorization due to cost or availability of alternatives.
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 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. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.