Tazarotene 0.1% 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
Topical Retinoid, Antipsoriatic, Anti-acne
Pharmacologic Class
Retinoid Receptor Agonist
Pregnancy Category
Category X
FDA Approved
Dec 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tazarotene gel is a medication derived from vitamin A (a retinoid) that is applied to the skin to treat conditions like acne and psoriasis. It works by helping to normalize how skin cells grow and mature, reducing inflammation and improving the appearance of 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. This medication is for topical use only, meaning it should be applied directly to the affected skin area. 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 treated area, in which case you should not wash it after application. 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
To get the most out of your treatment, practice good skin care and avoid excessive sun exposure.
Storage and Disposal
Store the medication at room temperature, avoiding freezing temperatures. Keep all medications in a safe place, 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 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 affected skin area. 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 treated area, in which case you should not wash it after application. 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
To get the most out of your treatment, practice good skin care and avoid excessive sun exposure.
Storage and Disposal
Store the medication at room temperature, avoiding freezing temperatures. Keep all medications in a safe place, 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 the missed one.
Lifestyle & Tips
- Apply a thin layer to clean, dry skin, typically in the evening.
- Use only a pea-sized amount for the entire face for acne treatment.
- Avoid contact with eyes, mouth, nostrils, and mucous membranes. If contact occurs, rinse thoroughly with water.
- Use sunscreen (SPF 30 or higher) and wear protective clothing (hats, long sleeves) when outdoors, as tazarotene increases sensitivity to sunlight and risk of sunburn.
- Limit sun exposure, including tanning beds and sunlamps.
- Use a gentle, non-comedogenic moisturizer regularly to help manage dryness and irritation.
- Do not use if pregnant, planning to become pregnant, or breastfeeding without consulting your doctor. Effective contraception is essential for women of childbearing potential.
- Avoid using other harsh or irritating topical products (e.g., strong astringents, abrasive soaps, other acne treatments like benzoyl peroxide or salicylic acid) at the same time, unless directed by your doctor, as this can increase irritation.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer of Tazarotene 0.1% Gel to affected areas once daily in the evening.
Condition-Specific Dosing:
Plaque Psoriasis:
Apply a thin layer to affected psoriatic lesions once daily in the evening. Limit application to no more than 20% of body surface area.
Acne Vulgaris:
Apply a thin layer to affected areas of acne 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 patients 12 years of age and older: Apply a thin layer to affected areas once daily in the evening for acne or psoriasis.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Tazarotene is a prodrug that is rapidly hydrolyzed to its active metabolite, tazarotenic acid, by esterases in the skin and plasma. Tazarotenic acid is a retinoid that selectively binds to and activates retinoic acid receptors (RARs), specifically RARΞ² and RARΞ³, but not RARΞ±. Binding to these receptors modulates gene expression, leading to normalization of keratinocyte differentiation and proliferation, and reduction of inflammation. In psoriasis, this helps to resolve the abnormal proliferation and differentiation of keratinocytes. In acne, it helps to normalize follicular keratinization, reduce comedone formation, and exert anti-inflammatory effects.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (typically <5% of applied dose)
Tmax:
Approximately 2-9 hours (for tazarotenic acid after topical application)
FoodEffect:
Not applicable for topical formulation
Distribution:
Vd:
Not precisely quantified for topical application due to minimal systemic absorption
ProteinBinding:
>99% (tazarotenic acid)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 18 hours (for tazarotenic acid)
Clearance:
Not precisely quantified for topical application
ExcretionRoute:
Biliary/fecal and renal
Unchanged:
<1% (tazarotenic acid)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically observed within 4-8 weeks for acne and 8-12 weeks for psoriasis.
PeakEffect:
Full therapeutic effect may take up to 12-16 weeks of consistent use.
DurationOfAction:
Effects persist as long as treatment continues; relapse occurs 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. While many people may not experience any side effects or only minor 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, and 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.
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. While many people may not experience any side effects or only minor 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, and 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, stinging, itching)
- Excessive peeling or flaking of the skin
- Blistering or swelling of the treated area
- Severe dryness that is not relieved by moisturizers
- Signs of an 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. Describe the allergic reactions you have 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 can make your skin more sensitive 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 can cause dry skin. Many drugs can have this effect, so it is crucial to ask your doctor or pharmacist for guidance if you are uncertain.
To ensure your safety, it is vital to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your health problems, including any medical conditions or previous reactions to medications
This information will help your doctor determine whether it is safe for you to take this medication with your other drugs and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reactions you have 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 can make your skin more sensitive 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 can cause dry skin. Many drugs can have this effect, so it is crucial to ask your doctor or pharmacist for guidance if you are uncertain.
To ensure your safety, it is vital to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your health problems, including any medical conditions or previous reactions to medications
This information will help your doctor determine whether it is safe for you to take this medication with your other drugs 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 to discuss ways to protect your skin under these conditions. Additionally, 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 the increased risk of sunburn, and take preventive measures by avoiding direct sunlight, sunlamps, and tanning beds. Use a broad-spectrum sunscreen and wear protective clothing and eyewear to minimize sun exposure.
In the event that this medication is ingested, seek immediate medical attention by contacting a doctor or poison control center.
If you are of childbearing potential, a pregnancy test will be required to confirm that you are not pregnant before initiating treatment with this medication. It is essential to discuss the risks associated with this medication during pregnancy, and you must use effective birth control methods to prevent pregnancy while taking this drug. If you become pregnant, notify your doctor promptly.
If you are breastfeeding, consult with your doctor to assess the potential risks to your baby. When applying this medication, avoid direct contact with the nipple and surrounding area to minimize 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 to discuss ways to protect your skin under these conditions. Additionally, 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 the increased risk of sunburn, and take preventive measures by avoiding direct sunlight, sunlamps, and tanning beds. Use a broad-spectrum sunscreen and wear protective clothing and eyewear to minimize sun exposure.
In the event that this medication is ingested, seek immediate medical attention by contacting a doctor or poison control center.
If you are of childbearing potential, a pregnancy test will be required to confirm that you are not pregnant before initiating treatment with this medication. It is essential to discuss the risks associated with this medication during pregnancy, and you must use effective birth control methods to prevent pregnancy while taking this drug. If you become pregnant, notify your doctor promptly.
If you are breastfeeding, consult with your doctor to assess the potential risks to your baby. When applying this medication, avoid direct contact with the nipple and surrounding area to minimize exposure to your infant.
Overdose Information
Overdose Symptoms:
- Excessive local irritation (severe redness, peeling, discomfort, burning, stinging) at the application site.
What to Do:
Systemic overdose from topical application is highly unlikely due to minimal absorption. If excessive amounts are applied, wash off the medication. Apply emollients to soothe the skin. If irritation is severe or persistent, seek medical attention. For accidental ingestion or concerns, call a poison control center (1-800-222-1222) or emergency services.
Drug Interactions
Moderate Interactions
- Other topical preparations that are severely irritating, drying, or desquamating (e.g., alpha hydroxy acids, salicylic acid, benzoyl peroxide, sulfur, resorcinol)
- Photosensitizing agents (e.g., tetracyclines, fluoroquinolones, thiazide diuretics, phenothiazines, sulfonamides)
Monitoring
Baseline Monitoring
Skin assessment
Rationale: To evaluate the severity and extent of acne or psoriasis and identify any pre-existing irritation or sensitivity.
Timing: Prior to initiation of therapy
Pregnancy test (for women of childbearing potential)
Rationale: Tazarotene is teratogenic; a negative pregnancy test is required before starting treatment.
Timing: Within 2 weeks prior to initiating therapy
Routine Monitoring
Skin irritation (erythema, peeling, dryness, burning, stinging)
Frequency: Daily/weekly initially, then as needed
Target: Minimal to mild irritation
Action Threshold: If severe irritation occurs, reduce frequency of application, temporarily discontinue, or use a lower concentration (if available). Use emollients as needed.
Efficacy (improvement in lesions)
Frequency: Monthly for first 3-4 months, then as needed
Target: Gradual reduction in lesion count/severity
Action Threshold: If no significant improvement after 12-16 weeks, re-evaluate diagnosis or consider alternative therapies.
Symptom Monitoring
- Excessive dryness
- Peeling
- Redness (erythema)
- Burning sensation
- Stinging sensation
- Itching
- Photosensitivity (sunburn-like reaction)
- Blistering or swelling (rare, severe irritation)
Special Patient Groups
Pregnancy
Tazarotene is contraindicated in pregnancy (Pregnancy Category X). It is a known teratogen when administered systemically, and while systemic absorption from topical application is minimal, the risk of fetal harm cannot be completely excluded. Women of childbearing potential must have a negative pregnancy test within 2 weeks prior to starting therapy and 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) if significant systemic exposure occurs. Avoidance is critical.
Second Trimester:
Risk of fetal harm, though less studied than first trimester. Continued avoidance is recommended.
Third Trimester:
Risk of fetal harm, though less studied than first trimester. Continued avoidance is recommended.
Lactation
Use with caution. It is not known whether tazarotene or its active metabolite are excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants from 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. If used, avoid applying to areas where infants may ingest it (e.g., breast area).
Infant Risk:
Moderate risk (L3) due to potential for systemic absorption and retinoid class effects, despite minimal data on excretion into breast milk.
Pediatric Use
Safety and effectiveness have been established for pediatric patients 12 years of age and older for acne and psoriasis. Safety and effectiveness in pediatric patients younger than 12 years have not been established.
Geriatric Use
No specific dose adjustments are required for geriatric patients. However, elderly patients may have more fragile or sensitive skin and may be more susceptible to irritation. Use with caution and monitor for adverse skin reactions.
Clinical Information
Clinical Pearls
- Tazarotene is a potent retinoid; patients should be advised that initial irritation (redness, peeling, dryness) is common and often subsides with continued use. Starting with a lower concentration (0.05% if available) or less frequent application (e.g., every other night) can help mitigate initial irritation.
- Apply to clean, dry skin, typically 20-30 minutes after washing, to minimize irritation.
- A pea-sized amount is usually sufficient for the entire face when treating acne.
- Emphasize strict sun protection (sunscreen, protective clothing, limiting sun exposure) due to increased photosensitivity.
- Consistent, long-term use is necessary for optimal results, as improvement can take several weeks to months.
- For women of childbearing potential, reinforce the absolute necessity of effective contraception and the teratogenic risk.
Alternative Therapies
- Other topical retinoids (e.g., tretinoin, adapalene, trifarotene)
- Benzoyl peroxide (for acne)
- Topical antibiotics (e.g., clindamycin, erythromycin for acne)
- Azelaic acid (for acne)
- Topical corticosteroids (for psoriasis)
- Vitamin D analogues (e.g., calcipotriene, calcitriol for psoriasis)
- Coal tar (for psoriasis)
- Salicylic acid (for acne and psoriasis)
- Phototherapy (UVB, PUVA for psoriasis)
- Systemic agents (e.g., oral antibiotics for acne; methotrexate, cyclosporine, biologics, oral PDE4 inhibitors for psoriasis)
- Oral isotretinoin (for severe acne)
Cost & Coverage
Average Cost:
$300 - $800+ per 100gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (may require prior authorization)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 information about what was taken, the amount, and the time it happened.