Tazarotene 0.05% 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, Anti-acne, Anti-aging
Pharmacologic Class
Retinoid
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 you apply to your skin. It helps treat skin conditions like psoriasis, acne, and sun-damaged skin by helping your skin cells grow and shed normally, and by reducing inflammation. It's important to use it exactly as prescribed and protect your skin from the sun.
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 affected area thoroughly with water.
Do not apply this medication to the vagina.
Preparation and Application
If you are able to become pregnant, start using this medication during your normal menstrual period.
Wash your hands before and after applying the medication, unless your hand is the treated area. In this case, do not wash your hand after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Usage Guidelines
Do not apply this medication to cuts, scrapes, eczema, or damaged skin.
Unless instructed 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 to determine the best application 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 Instructions
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 a missed dose.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication only as directed.
Application Instructions
Apply this medication only to your skin. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. If accidental contact occurs, rinse the affected area thoroughly with water.
Do not apply this medication to the vagina.
Preparation and Application
If you are able to become pregnant, start using this medication during your normal menstrual period.
Wash your hands before and after applying the medication, unless your hand is the treated area. In this case, do not wash your hand after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Usage Guidelines
Do not apply this medication to cuts, scrapes, eczema, or damaged skin.
Unless instructed 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 to determine the best application 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 Instructions
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 a missed dose.
Lifestyle & Tips
- Apply a very thin layer of cream only to the affected areas, usually once daily in the evening.
- Wash your hands before and after applying the cream.
- Avoid applying the cream to eyes, mouth, nostrils, or mucous membranes. If it gets into these areas, rinse thoroughly with water.
- Avoid waxing on treated skin, as it may cause excessive irritation or skin peeling.
- Use a gentle, non-medicated moisturizer regularly to help with dryness and irritation.
- Strictly avoid excessive sun exposure, including sunlamps and tanning beds, as tazarotene increases sensitivity to sunlight. Use a broad-spectrum sunscreen (SPF 30 or higher) and wear protective clothing (hat, long sleeves) when outdoors.
- Do not use if you are pregnant, planning to become pregnant, or breastfeeding. Discuss effective birth control methods with your doctor if you are a female of childbearing potential.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin film of Tazarotene 0.05% Cream once daily in the evening to affected areas.
Condition-Specific Dosing:
Psoriasis:
Apply a thin film to psoriatic lesions once daily in the evening. If irritation occurs, frequency may be reduced or concentration lowered.
Acne Vulgaris:
Apply a thin film to the entire affected area (e.g., face, chest, back) once daily in the evening.
Photodamage (Fine Wrinkles, Mottled Hyperpigmentation, Benign Facial Lentigines):
Apply a thin film to the face once daily in the evening.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 12 years of age.
Adolescent:
For acne vulgaris, patients 12 years and older: Apply a thin film of Tazarotene 0.05% Cream once daily in the evening to affected areas.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended due to minimal systemic absorption.
Moderate:
No specific dose adjustment recommended due to minimal systemic absorption.
Severe:
No specific dose adjustment recommended due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended due to minimal systemic absorption.
Moderate:
No specific dose adjustment recommended due to minimal systemic absorption.
Severe:
No specific dose adjustment recommended due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Tazarotene is a prodrug that is rapidly converted to its active metabolite, tazarotenic acid, by esterases in the skin. Tazarotenic acid is a retinoid that binds to and activates retinoic acid receptors (RARs), specifically RARΞ² and RARΞ³. This binding modulates gene expression, leading to normalization of keratinocyte differentiation and proliferation, and reduction of inflammation. In psoriasis, it helps to normalize the abnormal keratinocyte proliferation and differentiation. In acne, it reduces follicular hyperkeratosis and inflammation. In photodamage, it promotes epidermal repair and reduces signs of photoaging.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (typically <5%) after topical application.
Tmax:
1-8 hours (for tazarotenic acid in plasma)
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not precisely quantified for topical application due to minimal systemic absorption.
ProteinBinding:
>99% (tazarotenic acid is highly bound to plasma proteins)
CnssPenetration:
Limited/Negligible
Elimination:
HalfLife:
7-18 hours (for tazarotenic acid)
Clearance:
Not precisely quantified for topical application.
ExcretionRoute:
Approximately 60% via feces and 40% via urine (for tazarotenic acid and its metabolites).
Unchanged:
<0.1% (tazarotene); negligible (tazarotenic acid)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically observed within 1-4 weeks, with full effects seen over 12-16 weeks.
PeakEffect:
12-16 weeks for optimal therapeutic effect.
DurationOfAction:
Effects persist as long as treatment is continued; relapse may occur upon discontinuation.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while 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, difficulty 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. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
- 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 that bothers you or does not improve, contact your doctor.
Additional Information
This list does not include all possible side effects. If you have questions or concerns about side effects, contact your doctor. For medical advice about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while 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, difficulty 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. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
- 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 that bothers you or does not improve, contact your doctor.
Additional Information
This list does not include all possible side effects. If you have questions or concerns about side effects, contact your doctor. For medical advice about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe skin irritation (e.g., intense redness, burning, itching, stinging)
- Excessive dryness or peeling that is unmanageable
- Blistering or crusting of the skin
- Swelling of the treated area
- Any signs of 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, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are pregnant or think you may be pregnant. This medication is not recommended for use during pregnancy.
If you are able to become pregnant and are not using a reliable form of birth control.
If you have a sunburn, as this may increase your sensitivity to the medication.
If you are taking any medications that may increase your skin's sensitivity to light. There are several drugs 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 drugs that can have this effect, so it is crucial to check with your doctor or pharmacist if you are unsure.
Additionally, to minimize potential interactions and ensure your safety, it is vital to:
Inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss any health problems you have, as these may affect the safety and efficacy of this medication.
* Always check with your doctor before starting, stopping, or changing the dose of any medication to ensure that it is safe to do so in conjunction with this treatment.
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. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are pregnant or think you may be pregnant. This medication is not recommended for use during pregnancy.
If you are able to become pregnant and are not using a reliable form of birth control.
If you have a sunburn, as this may increase your sensitivity to the medication.
If you are taking any medications that may increase your skin's sensitivity to light. There are several drugs 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 drugs that can have this effect, so it is crucial to check with your doctor or pharmacist if you are unsure.
Additionally, to minimize potential interactions and ensure your safety, it is vital to:
Inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss any health problems you have, as these may affect the safety and efficacy of this medication.
* Always check with your doctor before starting, stopping, or changing the dose of any medication to ensure that it is safe to do so in conjunction with this treatment.
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 you can take to protect your skin. 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 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. 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 minimize 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 you can take to protect your skin. 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 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. 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 minimize exposure to your baby.
Overdose Information
Overdose Symptoms:
- Topical overdose is unlikely to cause systemic toxicity due to minimal absorption.
- Local symptoms may include severe redness, peeling, discomfort, and irritation.
What to Do:
If excessive application occurs, wash the area thoroughly. If severe local irritation develops, discontinue use temporarily. In case of accidental ingestion, contact a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention. Management is supportive.
Drug Interactions
Moderate Interactions
- Other topical preparations with strong drying or irritating effects (e.g., abrasive soaps, cleansers, astringents, alcohol-containing products, other retinoids, benzoyl peroxide, salicylic acid, sulfur, resorcinol) - may increase irritation.
- Photosensitizing agents (e.g., thiazide diuretics, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) - may increase risk of photosensitivity.
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of psoriasis, acne, or photodamage and identify areas for treatment.
Timing: Prior to initiation of therapy.
Pregnancy test (for females of childbearing potential)
Rationale: Tazarotene is teratogenic (Pregnancy Category X); ensure patient is not pregnant before starting and during therapy.
Timing: Within 2 weeks prior to initiating therapy.
Routine Monitoring
Local skin irritation (erythema, peeling, dryness, burning, itching)
Frequency: Regularly during treatment, especially during the initial weeks.
Target: Mild to moderate irritation is common; severe irritation should prompt dose reduction or temporary discontinuation.
Action Threshold: Severe or persistent irritation: reduce frequency, use lower concentration, or temporarily discontinue. Consider emollients.
Response to therapy
Frequency: Monthly or as clinically indicated.
Target: Improvement in lesions (psoriasis, acne) or signs of photodamage.
Action Threshold: Lack of improvement after 8-12 weeks may warrant re-evaluation of diagnosis or treatment plan.
Symptom Monitoring
- Skin redness (erythema)
- Peeling or flaking of skin
- Dryness of skin
- Burning sensation
- Itching
- Stinging
- Photosensitivity (increased sensitivity to sunlight)
- Blistering or crusting (severe irritation)
Special Patient Groups
Pregnancy
Contraindicated in pregnancy. Tazarotene is teratogenic and can cause fetal harm. Females of childbearing potential must use effective contraception during treatment and for a period after discontinuation.
Trimester-Specific Risks:
First Trimester:
High risk of teratogenicity (e.g., craniofacial, cardiovascular, central nervous system defects) based on animal studies and class effects of retinoids.
Second Trimester:
Risk of fetal harm remains.
Third Trimester:
Risk of fetal harm remains.
Lactation
It is not known whether tazarotene or its metabolites are excreted in human milk. Due to the potential for serious adverse reactions in the nursing infant, 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. Advise against use during breastfeeding.
Infant Risk:
Not available, but potential for systemic exposure and adverse effects on infant development cannot be excluded.
Pediatric Use
Safety and effectiveness for the treatment of acne vulgaris have been established in pediatric patients 12 years and older. Safety and effectiveness in pediatric patients younger than 12 years have not been established. For psoriasis, safety and effectiveness have not been established in pediatric patients.
Geriatric Use
No specific dose 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. Elderly patients may be more susceptible to skin irritation and dryness.
Clinical Information
Clinical Pearls
- Tazarotene is a potent retinoid; a 'pea-sized' amount is usually sufficient for the entire face.
- Patients should be counseled on the potential for initial worsening of skin irritation (e.g., redness, peeling, dryness) during the first few weeks of treatment, which often subsides with continued use.
- Emphasize the critical importance of strict sun protection due to increased photosensitivity.
- For psoriasis, apply only to the lesions, avoiding unaffected skin to minimize irritation.
- For acne, apply to the entire affected area, not just individual lesions, to prevent new breakouts.
- Full therapeutic effects may take several weeks to months to become apparent, so patient adherence and patience are key.
Alternative Therapies
- For Psoriasis: Phototherapy (UVB, PUVA), systemic agents (e.g., methotrexate, cyclosporine, apremilast), biologics (e.g., adalimumab, ustekinumab, secukinumab).
- For Acne Vulgaris: Topical antibiotics (e.g., clindamycin, erythromycin), benzoyl peroxide, azelaic acid, oral antibiotics (e.g., doxycycline, minocycline), oral isotretinoin, hormonal therapies.
- For Photodamage: Other topical retinoids, alpha hydroxy acids, chemical peels, laser therapy, intense pulsed light (IPL).
Cost & Coverage
Average Cost:
Varies widely ($100 - $500+) per 60gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 (Generic) - Varies by insurance plan
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 happened.