Tazarotene 0.1% 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
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 acne and psoriasis. It works by helping your skin cells grow and shed normally, and by reducing inflammation. It's applied directly to the skin.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is for topical use only, meaning it should be applied directly to the affected area of your 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.
Application Instructions
1. Wash your hands before and after applying the medication, unless your hand is the treated area.
2. Clean the affected area before application and dry it thoroughly.
3. Apply a thin layer of the medication to the affected skin and gently rub it in.
4. Do not apply the medication to cuts, scrapes, eczema, or damaged skin.
5. Unless directed by your doctor, do not cover the treated area with bandages, dressings, or makeup.
Special Considerations
If you are able to become pregnant, start using this medication during your normal menstrual period.
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.
Practice good skin care and avoid excessive sun exposure.
Apply the medication only to the affected skin, avoiding healthy skin areas.
Storage and Disposal
Store this medication at room temperature, avoiding freezing. Keep all medications in a safe location, out of the reach of children and pets.
Missed Dose
If you miss a dose, skip it and resume your normal application schedule. Do not apply extra doses or double doses to make up for a missed dose.
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 area of your 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.
Application Instructions
1. Wash your hands before and after applying the medication, unless your hand is the treated area.
2. Clean the affected area before application and dry it thoroughly.
3. Apply a thin layer of the medication to the affected skin and gently rub it in.
4. Do not apply the medication to cuts, scrapes, eczema, or damaged skin.
5. Unless directed by your doctor, do not cover the treated area with bandages, dressings, or makeup.
Special Considerations
If you are able to become pregnant, start using this medication during your normal menstrual period.
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.
Practice good skin care and avoid excessive sun exposure.
Apply the medication only to the affected skin, avoiding healthy skin areas.
Storage and Disposal
Store this medication at room temperature, avoiding freezing. Keep all medications in a safe location, out of the reach of children and pets.
Missed Dose
If you miss a dose, skip it and resume your normal application schedule. Do not apply extra doses or double doses to make up for a missed dose.
Lifestyle & Tips
- Apply a thin layer of gel to clean, dry skin once daily in the evening.
- Wash hands thoroughly after applying the gel.
- Avoid applying the gel to eyes, eyelids, 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.
- Use a gentle moisturizer regularly to help manage skin dryness or irritation.
- Do not use on sunburned, eczematous, or broken skin.
- For women of childbearing potential: Use effective birth control methods during treatment and for a period after discontinuation, as tazarotene can cause severe birth defects if used during pregnancy. Discuss contraception options with your doctor.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer of Tazarotene 0.1% Gel once daily in the evening to the affected areas.
Condition-Specific Dosing:
Psoriasis:
Apply a thin layer to psoriatic lesions once daily in the evening. If irritation occurs, frequency may be reduced or concentration lowered.
Acne Vulgaris:
Apply a thin layer to the entire affected area (e.g., face) once daily in the evening. Avoid eyes, mouth, angles of the nose, and mucous membranes.
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 of Tazarotene 0.1% Gel once daily in the evening to affected areas for patients 12 years of age and older.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption).
Moderate:
No adjustment needed (minimal systemic absorption).
Severe:
No adjustment needed (minimal systemic absorption).
Dialysis:
No adjustment needed (minimal systemic absorption).
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption).
Moderate:
No adjustment needed (minimal systemic absorption).
Severe:
No adjustment needed (minimal systemic absorption).
Pharmacology
Mechanism of Action
Tazarotene is a prodrug that is converted to its active metabolite, tazarotenic acid, by esterases in the skin and plasma. Tazarotenic acid is a retinoid that binds to and activates retinoic acid receptors (RARs), specifically RARΞ² and RARΞ³, but not RARΞ±. Activation of these receptors modulates gene expression, which is believed to normalize abnormal keratinocyte differentiation and proliferation, and reduce inflammation, thereby contributing to its therapeutic effects in psoriasis and acne.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (typically <5% of applied dose).
Tmax:
Plasma concentrations of tazarotenic acid are generally very low or undetectable. When detectable, Tmax is typically 1-2 hours after topical application.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not precisely quantified due to minimal systemic absorption; primarily distributed within the skin.
ProteinBinding:
>99% (tazarotenic acid is highly bound to plasma proteins).
CnssPenetration:
Limited/Negligible (due to minimal systemic absorption).
Elimination:
HalfLife:
Approximately 18 hours (for tazarotenic acid, when detectable systemically).
Clearance:
Not precisely quantified due to minimal systemic absorption.
ExcretionRoute:
Primarily renal and fecal excretion (for systemically absorbed tazarotenic acid).
Unchanged:
Negligible (tazarotene is rapidly metabolized to tazarotenic acid).
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically observed within 4-12 weeks for acne and 4-16 weeks for psoriasis.
PeakEffect:
Peak therapeutic effect may take several weeks to months of consistent use.
DurationOfAction:
Effects persist as long as treatment is continued; relapse may occur upon discontinuation.
Safety & Warnings
BLACK BOX WARNING
Tazarotene is a retinoid and 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 contraception when using tazarotene.
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 individuals 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 go away, contact your doctor.
Additional Information on Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, contact your doctor. For medical advice 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 individuals 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 go away, contact your doctor.
Additional Information on Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, contact your doctor. For medical advice 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, peeling, burning, stinging, itching)
- Swelling of the face or lips (rare, but seek immediate medical attention)
- Signs of allergic reaction (e.g., rash, hives, difficulty breathing)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction you experienced, including the symptoms that occurred.
If you are pregnant or think you may be pregnant. Do not take this medication if you are pregnant.
If you are of childbearing age and not using birth control, as this medication may pose risks to an unborn baby.
If you have a sunburn, as this may increase your sensitivity to the medication.
If you are taking any medications that may increase your skin's sensitivity to light. There are several medications that can cause this interaction, so consult your doctor or pharmacist if you are unsure.
If you are using any medications that may cause dry skin. Many medications can have this effect, so ask your doctor or pharmacist for guidance if you are uncertain.
To ensure your safety, it is crucial 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 medical history and any ongoing health issues
This information will help your doctor determine whether it is safe for you to take this medication in combination with your other medications and health conditions. Never start, stop, or change the dosage 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. Describe the allergic reaction you experienced, including the symptoms that occurred.
If you are pregnant or think you may be pregnant. Do not take this medication if you are pregnant.
If you are of childbearing age and not using birth control, as this medication may pose risks to an unborn baby.
If you have a sunburn, as this may increase your sensitivity to the medication.
If you are taking any medications that may increase your skin's sensitivity to light. There are several medications that can cause this interaction, so consult your doctor or pharmacist if you are unsure.
If you are using any medications that may cause dry skin. Many medications can have this effect, so ask your doctor or pharmacist for guidance if you are uncertain.
To ensure your safety, it is crucial 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 medical history and any ongoing health issues
This information will help your doctor determine whether it is safe for you to take this medication in combination with your other medications and health conditions. Never start, stop, or change the dosage 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 do not exceed the recommended dose.
Protecting Your Skin
Certain weather conditions, such as cold and wind, may irritate your skin. Consult with your doctor or pharmacist about measures 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 medications or products on your skin, including soaps, discuss this with your doctor. The concurrent use of other skin products 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 direct sunlight, sunlamps, and tanning beds. Use a sunscreen with a suitable SPF and wear protective clothing and eyewear when going outside.
Accidental Ingestion
If this medication is accidentally swallowed, contact a doctor or poison control center immediately, as it may cause harm.
Pregnancy and Breastfeeding Considerations
If you are of childbearing potential, a pregnancy test will be conducted before initiating treatment with this medication to confirm that you are not pregnant. This medication may cause harm to an unborn baby, so it is essential to use birth control while taking it. If you become pregnant, notify your doctor promptly.
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 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 do not exceed the recommended dose.
Protecting Your Skin
Certain weather conditions, such as cold and wind, may irritate your skin. Consult with your doctor or pharmacist about measures 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 medications or products on your skin, including soaps, discuss this with your doctor. The concurrent use of other skin products 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 direct sunlight, sunlamps, and tanning beds. Use a sunscreen with a suitable SPF and wear protective clothing and eyewear when going outside.
Accidental Ingestion
If this medication is accidentally swallowed, contact a doctor or poison control center immediately, as it may cause harm.
Pregnancy and Breastfeeding Considerations
If you are of childbearing potential, a pregnancy test will be conducted before initiating treatment with this medication to confirm that you are not pregnant. This medication may cause harm to an unborn baby, so it is essential to use birth control while taking it. If you become pregnant, notify your doctor promptly.
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 infant.
Overdose Information
Overdose Symptoms:
- Excessive skin irritation (if applied in large amounts or too frequently)
- Systemic toxicity is unlikely due to minimal absorption, but theoretical symptoms could include headache, nausea, vomiting, and dry skin/mucous membranes if significant systemic exposure occurred (highly improbable with topical use).
What to Do:
Discontinue use. 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). Treatment is supportive.
Drug Interactions
Moderate Interactions
- Photosensitizing agents (e.g., tetracyclines, fluoroquinolones, phenothiazines, sulfonamides): Increased risk of photosensitivity reactions.
- Other topical preparations with strong drying or irritating effects (e.g., abrasive soaps, cleansers, medicated soaps, astringents, alcohol-containing products, other peeling agents, sulfur, resorcinol, salicylic acid): May increase irritation.
Monitoring
Baseline Monitoring
Pregnancy test
Rationale: Tazarotene is teratogenic and contraindicated in pregnancy. A negative pregnancy test is required for women of childbearing potential prior to initiating therapy.
Timing: Within 2 weeks prior to starting treatment.
Skin assessment
Rationale: To establish baseline skin condition (e.g., erythema, scaling, dryness, burning, itching) and identify areas for application.
Timing: Prior to first application.
Routine Monitoring
Skin irritation (erythema, scaling, dryness, burning, itching)
Frequency: Regularly during treatment (e.g., weekly initially, then as needed).
Target: Minimize irritation while achieving therapeutic effect.
Action Threshold: If severe irritation occurs, reduce frequency of application, temporarily discontinue, or switch to a lower concentration. Consider concomitant use of moisturizers.
Pregnancy test (for women of childbearing potential)
Frequency: Monthly
Target: Negative
Action Threshold: If positive, discontinue tazarotene immediately and refer for obstetric evaluation.
Symptom Monitoring
- Severe skin irritation (redness, peeling, burning, itching, stinging)
- Excessive dryness of skin
- Increased sensitivity to sunlight (sunburn)
Special Patient Groups
Pregnancy
Contraindicated. Tazarotene is a known teratogen and can cause severe birth defects. Women of childbearing potential must use effective contraception during treatment and have a negative pregnancy test before starting therapy.
Trimester-Specific Risks:
First Trimester:
High risk of severe birth defects (e.g., craniofacial, cardiovascular, central nervous system abnormalities).
Second Trimester:
Risk of fetal harm remains.
Third Trimester:
Risk of fetal harm remains.
Lactation
Use with caution. It is not known whether tazarotene or its metabolites are excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants from the systemic exposure of retinoids, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Avoid applying to areas where the infant may come into direct contact, such as the breast.
Infant Risk:
L3 (Moderately safe; potential risk to infant cannot be excluded, but systemic absorption is minimal with topical use).
Pediatric Use
Approved for acne vulgaris and plaque psoriasis in patients 12 years of age and older. 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. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, due to minimal systemic absorption, age-related pharmacokinetic changes are not expected to be clinically significant.
Clinical Information
Clinical Pearls
- Tazarotene is a potent retinoid; start with the lowest concentration (0.05% if available) or reduced frequency if skin irritation is a concern, especially for sensitive skin.
- Irritation (redness, peeling, dryness, burning) is a common side effect, particularly during the first few weeks of treatment. This often subsides with continued use or can be managed by applying a moisturizer before or after the gel, or by reducing application frequency.
- Emphasize strict adherence to sun protection measures (sunscreen, protective clothing, avoiding peak sun hours) due to increased photosensitivity.
- For women of childbearing potential, reinforce the absolute necessity of effective contraception and monthly pregnancy testing due to the teratogenic risk.
- Therapeutic effects are not immediate; patients should be counseled on the importance of consistent, long-term use for optimal results (typically 4-12 weeks for noticeable improvement).
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 for psoriasis)
- Topical antibiotics (e.g., clindamycin, erythromycin for acne)
- Benzoyl peroxide (for acne)
- Oral retinoids (e.g., isotretinoin for severe acne, acitretin for severe psoriasis)
- Biologic therapies (for severe psoriasis)
- Phototherapy (for psoriasis)
Cost & Coverage
Average Cost:
Varies widely, typically $100-$500+ per 30gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (for generic); Tier 3 or 4 (for brand)
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 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.