Tazarotene 0.05% Gel 30gm
It is used to treat pimples (acne).It is used to treat plaque psoriasis.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antipsoriatic, Antiacne
Pharmacologic Class
Topical Retinoid
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 acne and psoriasis. It works by helping your skin cells grow and shed normally, which can reduce inflammation and clear up skin lesions.
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. This medication is for topical use only, meaning it should be applied directly to the skin. Avoid getting it in your mouth, nose, eyes, or vagina, as it may cause burning. If accidental contact occurs, rinse the area thoroughly with water.
When applying the medication, start during your normal menstrual period if you are able to get pregnant. Wash your hands before and after use, unless your hand is the area being treated. Clean and dry the affected area before applying a thin layer of the medication and gently rubbing it in.
Important Application Guidelines
Do not apply the medication to cuts, scrapes, eczema, or damaged skin.
Avoid using bandages, dressings, or makeup on the treated area unless instructed to do so by your doctor.
* 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 limit your exposure to the sun. Apply the medication only to the affected skin, avoiding healthy skin areas.
Storage and Disposal
Store the medication at room temperature, avoiding freezing. Keep all medications in a safe 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 a double dose or extra doses to make up for the missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is for topical use only, meaning it should be applied directly to the skin. Avoid getting it in your mouth, nose, eyes, or vagina, as it may cause burning. If accidental contact occurs, rinse the area thoroughly with water.
When applying the medication, start during your normal menstrual period if you are able to get pregnant. Wash your hands before and after use, unless your hand is the area being treated. Clean and dry the affected area before applying a thin layer of the medication and gently rubbing it in.
Important Application Guidelines
Do not apply the medication to cuts, scrapes, eczema, or damaged skin.
Avoid using bandages, dressings, or makeup on the treated area unless instructed to do so by your doctor.
* 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 limit your exposure to the sun. Apply the medication only to the affected skin, avoiding healthy skin areas.
Storage and Disposal
Store the medication at room temperature, avoiding freezing. Keep all medications in a safe 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 a double dose or extra doses to make up for the missed one.
Lifestyle & Tips
- Apply a thin layer to clean, dry skin once daily in the evening.
- Avoid applying to eyes, mouth, angles of the nose, or mucous membranes.
- Avoid excessive sun exposure and artificial UV light (tanning beds) while using this medication, as it can increase sensitivity to sunlight. Use sunscreen (SPF 30 or higher) and wear protective clothing when outdoors.
- 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.
- Moisturizers can be used to help with dryness or irritation, but apply them at a different time of day (e.g., morning) or wait at least an hour after applying tazarotene.
- Avoid waxing on treated skin, as it may cause excessive irritation or skin peeling.
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:
Psoriasis:
Apply a thin layer to affected areas once daily in the evening. Use enough to cover the entire lesion with a thin film.
Acne Vulgaris:
Apply a thin layer to the entire affected area (e.g., face, chest, or back) once daily in the evening, after the skin is clean and dry.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For acne vulgaris, safety and effectiveness have been established in pediatric patients 12 years of age and older. For psoriasis, safety and effectiveness have not been established in pediatric patients under 18 years of age.
Adolescent:
For acne vulgaris, 12 years and older: Apply a thin layer once daily in the evening to affected areas.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment is necessary for topical application.
Moderate:
No dosage adjustment is necessary for topical application.
Severe:
No dosage adjustment is necessary for topical application.
Dialysis:
No dosage adjustment is necessary for topical application, as systemic absorption is minimal.
Hepatic Impairment:
Mild:
No dosage adjustment is necessary for topical application.
Moderate:
No dosage adjustment is necessary for topical application.
Severe:
No dosage adjustment is necessary for topical application.
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. Binding to these receptors modulates gene expression, which in turn affects cell proliferation, differentiation, and keratinization. In psoriasis, this leads to normalization of keratinocyte differentiation and reduction of inflammation. In acne, it helps to normalize follicular keratinization, preventing microcomedone formation and promoting the expulsion of existing comedones.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (typically <1% of applied dose)
Tmax:
Not applicable for topical absorption leading to systemic levels; 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 formulation.
Distribution:
Vd:
Not well characterized due to minimal systemic absorption.
ProteinBinding:
Tazarotenic acid is highly bound to plasma proteins (>99%).
CnssPenetration:
Limited/Not significant due to minimal systemic absorption.
Elimination:
HalfLife:
Tazarotenic acid: Approximately 7-18 hours (systemic, after topical application).
Clearance:
Not well characterized due to minimal systemic absorption.
ExcretionRoute:
Primarily renal and fecal excretion of metabolites.
Unchanged:
Negligible amount of unchanged tazarotene or tazarotenic acid excreted.
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 1-4 weeks for acne, and 4-8 weeks for psoriasis.
PeakEffect:
Optimal results may take 12 weeks or longer for acne, and up to 12 weeks for psoriasis.
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
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 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
- 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 unusual symptoms that bother you or do not go away, contact your doctor for advice:
- Skin irritation is a common side effect of this medication, which may include:
- Burning
- Dry skin
- Itching
- Peeling
- Redness
- Scaling
If you experience severe skin irritation or if it persists and bothers you, contact your doctor.
Reporting Side Effects
This list does not include all possible side effects. 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.
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 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
- 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 unusual symptoms that bother you or do not go away, contact your doctor for advice:
- Skin irritation is a common side effect of this medication, which may include:
- Burning
- Dry skin
- Itching
- Peeling
- Redness
- Scaling
If you experience severe skin irritation or if it persists and bothers you, contact your doctor.
Reporting Side Effects
This list does not include all possible side effects. 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 (intense redness, burning, itching, peeling, or dryness that is intolerable)
- Signs of an allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing)
- Severe 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 use of this medication:
Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
If you are pregnant or think you may be pregnant. Do not take this medication if you are pregnant.
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 risk of adverse reactions.
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.
Additionally, to minimize potential interactions and ensure your safety, 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 and any ongoing health issues
It is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following conditions to ensure safe use of this medication:
Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
If you are pregnant or think you may be pregnant. Do not take this medication if you are pregnant.
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 risk of adverse reactions.
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.
Additionally, to minimize potential interactions and ensure your safety, 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 and any ongoing health issues
It is crucial to verify that it is safe to take this medication with all 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 your doctor's instructions regarding the dosage and administration of this drug, and never exceed the recommended amount.
Certain environmental factors, such as cold weather and wind, may exacerbate skin irritation. Consult with your doctor or pharmacist to discuss measures for protecting your skin under these conditions. Additionally, be aware that your skin may appear to worsen before showing signs of improvement.
Before using any other medications or products on your skin, including soaps, consult with your doctor to avoid potential interactions that may increase skin irritation. Be cautious of heightened sensitivity to the sun, as this medication may increase your risk of sunburn. To mitigate this risk, avoid exposure to direct sunlight, sunlamps, and tanning beds, and take protective measures such as using sunscreen and wearing protective clothing and eyewear.
In the event that this medication is ingested, seek immediate medical attention by contacting a doctor or a poison control center.
If you are of childbearing potential, a pregnancy test will be conducted prior to initiating treatment with this drug 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 while taking this medication, notify your doctor promptly. To prevent pregnancy, you must use effective birth control measures throughout the treatment period.
If you are breastfeeding, inform your doctor, as the risks to your baby will need to be assessed. When applying this medication, avoid direct contact with the nipple and the surrounding area to prevent 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. Adhere strictly to your doctor's instructions regarding the dosage and administration of this drug, and never exceed the recommended amount.
Certain environmental factors, such as cold weather and wind, may exacerbate skin irritation. Consult with your doctor or pharmacist to discuss measures for protecting your skin under these conditions. Additionally, be aware that your skin may appear to worsen before showing signs of improvement.
Before using any other medications or products on your skin, including soaps, consult with your doctor to avoid potential interactions that may increase skin irritation. Be cautious of heightened sensitivity to the sun, as this medication may increase your risk of sunburn. To mitigate this risk, avoid exposure to direct sunlight, sunlamps, and tanning beds, and take protective measures such as using sunscreen and wearing protective clothing and eyewear.
In the event that this medication is ingested, seek immediate medical attention by contacting a doctor or a poison control center.
If you are of childbearing potential, a pregnancy test will be conducted prior to initiating treatment with this drug 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 while taking this medication, notify your doctor promptly. To prevent pregnancy, you must use effective birth control measures throughout the treatment period.
If you are breastfeeding, inform your doctor, as the risks to your baby will need to be assessed. When applying this medication, avoid direct contact with the nipple and the surrounding area to prevent potential harm to your baby.
Overdose Information
Overdose Symptoms:
- Excessive redness, peeling, and discomfort if applied in large amounts or more frequently than prescribed.
- Systemic toxicity is unlikely with topical application due to minimal absorption, but theoretical symptoms could include headache, nausea, vomiting, and liver enzyme elevation if significant systemic exposure occurred (e.g., accidental ingestion).
What to Do:
Discontinue use. For topical overdose, wash the area with mild soap and water. Apply emollients to soothe irritation. For accidental ingestion, seek immediate medical attention. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Moderate Interactions
- Photosensitizing agents (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides): May increase risk of photosensitivity reactions.
Minor Interactions
- Topical preparations with strong drying or irritating effects (e.g., abrasive soaps, cleansers, medicated cosmetics, other retinoids, salicylic acid, benzoyl peroxide): May increase skin irritation.
Monitoring
Baseline Monitoring
Pregnancy status
Rationale: Tazarotene is teratogenic; ensure patient is not pregnant before initiating treatment.
Timing: Prior to initiation of therapy in women of childbearing potential.
Skin condition assessment
Rationale: To establish baseline severity of acne or psoriasis.
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin irritation (erythema, peeling, burning, dryness, pruritus)
Frequency: Regularly during treatment, especially in the first few weeks.
Target: Minimal to mild irritation.
Action Threshold: Moderate to severe irritation may require temporary discontinuation, reduction in frequency, or use of emollients.
Clinical response (improvement in lesions)
Frequency: Monthly or as clinically indicated.
Target: Reduction in lesion count/severity.
Action Threshold: Lack of improvement after 12 weeks may warrant re-evaluation of diagnosis or treatment.
Symptom Monitoring
- Severe skin irritation (redness, scaling, burning, itching, dryness)
- Sunburn or increased sensitivity to sun
- Allergic reactions (rash, hives, swelling)
Special Patient Groups
Pregnancy
Contraindicated in pregnancy (Pregnancy Category X). Tazarotene is teratogenic and can cause fetal harm. 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:
High risk of teratogenicity (e.g., craniofacial, cardiovascular, central nervous system defects).
Second Trimester:
Continued risk of fetal harm.
Third Trimester:
Continued risk of fetal harm.
Lactation
Use is generally not recommended during breastfeeding. It is not known whether tazarotene is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants from the systemic exposure of tazarotenic acid, 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 serious adverse reactions; unknown but possible systemic effects on infant.
Pediatric Use
Safety and effectiveness for acne vulgaris established in patients 12 years and older. Safety and effectiveness for psoriasis not established in patients under 18 years. Children may be more susceptible to irritation.
Geriatric Use
No specific dosage 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 have more fragile skin and may be more prone to irritation.
Clinical Information
Clinical Pearls
- Tazarotene is a potent retinoid; start with the lowest concentration (0.05%) and apply a pea-sized amount for the entire face to minimize irritation.
- Advise patients that initial worsening of acne (purging) can occur before improvement.
- Emphasize strict sun protection due to increased photosensitivity.
- Counsel women of childbearing potential extensively on the teratogenic risk and the absolute necessity of effective contraception.
- Application to wet skin can increase irritation; ensure skin is completely dry before application.
- Avoid concomitant use with other topical products that are highly irritating or drying.
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 antibiotics (e.g., clindamycin, erythromycin for acne)
- Benzoyl peroxide (for acne)
- Salicylic acid (for acne and psoriasis)
- Systemic therapies (e.g., oral retinoids, biologics, phototherapy for severe cases)
Cost & Coverage
Average Cost:
$200 - $600 per 30gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (may require prior authorization)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea 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 happened.