Tazarotene 0.05% Gel 100gm
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 gel is a topical medication, similar to Vitamin A, used to treat skin conditions like psoriasis and acne. It works by helping your 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 accompanying information carefully. 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 ingest it.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation. If accidental contact occurs, rinse the affected area thoroughly with water.
Do not apply this medication to the vaginal area.
Before applying the medication, wash your hands thoroughly. If the treated area is on your hand, do not wash your hand after application.
Clean and dry the affected skin area before applying the medication. Gently rub a thin layer of the medication onto the affected skin.
Important Precautions
Do not apply this medication to cuts, scrapes, eczema, or damaged skin.
Unless instructed to do so by your doctor, avoid covering 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 habits and avoid excessive sun exposure while using this medication.
Apply the medication only to the affected skin area, avoiding healthy skin.
Storage and Disposal
Store this medication at room temperature, avoiding freezing temperatures.
Keep all medications in a safe and secure location, out of reach of children and pets.
Missed Dose Instructions
* If you miss a dose, skip it and resume your regular application schedule. Do not apply a double dose or extra doses to make up for the 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, as directed by your doctor. Do not ingest it.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation. If accidental contact occurs, rinse the affected area thoroughly with water.
Do not apply this medication to the vaginal area.
Before applying the medication, wash your hands thoroughly. If the treated area is on your hand, do not wash your hand after application.
Clean and dry the affected skin area before applying the medication. Gently rub a thin layer of the medication onto the affected skin.
Important Precautions
Do not apply this medication to cuts, scrapes, eczema, or damaged skin.
Unless instructed to do so by your doctor, avoid covering 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 habits and avoid excessive sun exposure while using this medication.
Apply the medication only to the affected skin area, avoiding healthy skin.
Storage and Disposal
Store this medication at room temperature, avoiding freezing temperatures.
Keep all medications in a safe and secure location, out of reach of children and pets.
Missed Dose Instructions
* If you miss a dose, skip it and resume your regular application schedule. Do not apply a double dose or extra doses to make up for the 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. If contact occurs, rinse thoroughly with water.
- Avoid excessive sun exposure, including sunlamps and tanning beds, as tazarotene can increase sensitivity to sunlight. Use sunscreen (SPF 30 or higher) and wear protective clothing when outdoors.
- Do not use on sunburned, eczematous, or irritated skin.
- Avoid waxing on treated areas, as it may cause excessive irritation or skin peeling.
- Use a gentle, non-medicated moisturizer regularly to help with dryness and irritation.
- Do not use if you are pregnant, planning to become pregnant, or breastfeeding. Use effective birth control 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 0.05% Gel once daily in the evening to affected areas.
Condition-Specific Dosing:
Plaque Psoriasis:
Apply a thin layer to psoriatic lesions once daily in the evening. If irritation occurs, reduce frequency or concentration.
Acne Vulgaris:
Apply a thin layer to affected areas once daily in the evening. Cleanse and dry skin before application.
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 once daily in the evening to affected areas for patients 12 years of age and older.
Dose Adjustments
Renal Impairment:
Mild:
No specific dosage adjustment recommended for topical application due to minimal systemic absorption.
Moderate:
No specific dosage adjustment recommended for topical application due to minimal systemic absorption.
Severe:
No specific dosage adjustment recommended for topical application due to minimal systemic absorption.
Dialysis:
No specific considerations for topical application due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific dosage adjustment recommended for topical application due to minimal systemic absorption.
Moderate:
No specific dosage adjustment recommended for topical application due to minimal systemic absorption.
Severe:
No specific dosage adjustment recommended for topical application due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Tazarotene is a retinoid prodrug that is converted to its active metabolite, tazarotenic acid, by esterases in the skin. Tazarotenic acid binds to and activates retinoic acid receptors (RARs), specifically RAR-beta and RAR-gamma, but not RAR-alpha. Activation of these receptors modulates gene expression, which in turn normalizes keratinocyte differentiation, reduces hyperproliferation, and exhibits anti-inflammatory effects, leading to improvement in conditions like psoriasis and acne.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (typically <1% of applied dose)
Tmax:
Variable, generally 1-8 hours after topical application, with very low plasma concentrations (often below quantification limits)
FoodEffect:
Not applicable for topical formulation
Distribution:
Vd:
Not precisely quantified due to minimal systemic absorption; primarily distributed to skin
ProteinBinding:
>99% (tazarotenic acid)
CnssPenetration:
Limited/Negligible
Elimination:
HalfLife:
Approximately 18 hours (tazarotenic acid) after topical application, but highly variable and often not detectable systemically.
Clearance:
Not precisely quantified due to minimal systemic absorption.
ExcretionRoute:
Primarily renal and fecal excretion of metabolites.
Unchanged:
Negligible
Pharmacodynamics
OnsetOfAction:
Acne: 4-12 weeks; Psoriasis: 4-12 weeks
PeakEffect:
Acne: 12 weeks; Psoriasis: 12 weeks
DurationOfAction:
Effects persist as long as treatment is continued; relapse occurs upon discontinuation.
Safety & Warnings
BLACK BOX WARNING
Tazarotene is a retinoid that may cause fetal harm when administered to a pregnant woman. Tazarotene is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be warned of the potential risk and use adequate birth control measures when Tazarotene is used.
Side Effects
Important Side Effects to Report to Your Doctor Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. Seek medical attention right away if you notice any of the following symptoms, which could be signs of a serious allergic reaction:
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. 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 persist or bother you:
* Skin irritation, which is common with this medication, may include:
+ Burning
+ Dry skin
+ Itching
+ Peeling
+ Redness
+ Scaling
If you experience severe skin irritation or if it persists, contact your doctor for guidance.
Additional Information
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. Seek medical attention right away if you notice any of the following symptoms, which could be signs of a serious allergic reaction:
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. 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 persist or bother you:
* Skin irritation, which is common with this medication, may include:
+ Burning
+ Dry skin
+ Itching
+ Peeling
+ Redness
+ Scaling
If you experience severe skin irritation or if it persists, contact your doctor for guidance.
Additional Information
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe skin irritation (e.g., intense redness, burning, stinging, itching, peeling, blistering, swelling)
- Signs of an allergic reaction (e.g., rash, hives, difficulty breathing, swelling of the face, lips, tongue, or throat)
- Unusual or severe sunburn after minimal sun exposure
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.
If you are pregnant or think you might be pregnant. This medication is not recommended 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 ask your doctor or pharmacist about potential interactions.
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, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
If you are pregnant or think you might be pregnant. This medication is not recommended 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 ask your doctor or pharmacist about potential interactions.
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. To ensure safe and effective use, follow the instructions provided by your doctor precisely, and do not exceed the recommended dosage.
Protecting Your Skin
Certain weather conditions, such as cold and wind, may irritate your skin. Consult with your doctor or pharmacist to learn how 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 safeguard your skin 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 capable of becoming pregnant, a pregnancy test will be conducted to confirm that you are not pregnant before initiating treatment with this medication. It is essential to discuss this with your doctor. This medication may harm 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, inform your doctor, as you will need 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 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 instructions provided by your doctor precisely, and do not exceed the recommended dosage.
Protecting Your Skin
Certain weather conditions, such as cold and wind, may irritate your skin. Consult with your doctor or pharmacist to learn how 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 safeguard your skin 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 capable of becoming pregnant, a pregnancy test will be conducted to confirm that you are not pregnant before initiating treatment with this medication. It is essential to discuss this with your doctor. This medication may harm 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, inform your doctor, as you will need 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 to your baby.
Overdose Information
Overdose Symptoms:
- Topical overdose is unlikely to cause significant systemic effects due to minimal absorption. Excessive application may lead to marked redness, peeling, or discomfort.
- If accidentally ingested, symptoms may resemble hypervitaminosis A (e.g., headache, nausea, vomiting, dizziness, dry skin, fatigue).
What to Do:
For topical overdose, wash the area thoroughly with soap and water. For accidental ingestion, seek immediate medical attention 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.
- Other topical irritants (e.g., abrasive soaps, astringents, alcohol-containing products, other retinoids, benzoyl peroxide, salicylic acid): May cause additive irritant effects.
Monitoring
Baseline Monitoring
Skin assessment
Rationale: To establish baseline severity of acne or psoriasis and identify any pre-existing skin irritation or sensitivity.
Timing: Prior to initiation of therapy
Pregnancy status
Rationale: Tazarotene is teratogenic and contraindicated in pregnancy. A negative pregnancy test is required for women of childbearing potential before initiating therapy.
Timing: Within 2 weeks prior to initiation of therapy for women of childbearing potential
Routine Monitoring
Local skin irritation (erythema, peeling, burning, dryness, pruritus)
Frequency: Regularly during treatment (e.g., at follow-up visits)
Target: Minimize irritation while achieving therapeutic effect
Action Threshold: If severe irritation occurs, reduce frequency of application, temporarily discontinue, or discontinue permanently.
Efficacy of treatment
Frequency: Every 4-12 weeks, or as clinically indicated
Target: Improvement in lesions (reduction in severity, number, or extent)
Action Threshold: If no significant improvement after 12 weeks, reassess diagnosis or consider alternative therapies.
Symptom Monitoring
- Severe skin irritation (e.g., intense redness, blistering, severe peeling, swelling, burning, stinging)
- Signs of allergic reaction (e.g., rash, hives, itching, difficulty breathing, swelling of face/lips/tongue/throat)
- Increased sensitivity to sunlight (sunburn, photosensitivity reactions)
Special Patient Groups
Pregnancy
CONTRAINDICATED. Tazarotene is a known teratogen. Women of childbearing potential must use effective contraception during treatment and for a period after discontinuation. A negative pregnancy test is required prior to initiation.
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
Use with caution. It is not known whether tazarotene is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, 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. Avoid applying to areas where the infant may come into contact with the medication, especially the breast.
Infant Risk:
Risk cannot be ruled out (L3).
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 recommended for geriatric patients. However, older skin may be more fragile and prone to irritation, so caution and close monitoring for adverse skin reactions are advised.
Clinical Information
Clinical Pearls
- Tazarotene is a potent retinoid; start with the lowest concentration (0.05%) and frequency (every other night) if skin sensitivity is a concern, then gradually increase as tolerated.
- Always apply to completely dry skin, typically 20-30 minutes after washing, to minimize irritation.
- A 'pea-sized' amount is usually sufficient for the entire face. Applying more does not increase efficacy but increases irritation.
- Emphasize strict sun protection (sunscreen, hats, protective clothing) due to increased photosensitivity.
- Inform patients that initial worsening of acne ('purging') can occur before improvement, which is a normal part of retinoid therapy.
- Concomitant use of a gentle, non-comedogenic moisturizer is highly recommended to mitigate dryness and irritation.
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)
- Topical antibiotics (e.g., clindamycin, erythromycin for acne)
- Benzoyl peroxide (for acne)
- Salicylic acid (for acne, psoriasis)
- Systemic therapies (e.g., oral retinoids like isotretinoin for severe acne; biologics, methotrexate, cyclosporine for severe psoriasis)
Cost & Coverage
Average Cost:
Varies widely, typically $300-$1000+ per 100gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 or 2 (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 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 details about the medication taken, the amount, and the time it occurred.