Tazorac 0.1% Cream 60gm
It is used to treat pimples (acne).It is used to treat plaque psoriasis.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antipsoriatic, Anti-acne
Pharmacologic Class
Retinoid, Acetylenic retinoid
Pregnancy Category
Contraindicated (formerly Category X)
FDA Approved
Jun 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tazorac Cream is a medicine applied to the skin to treat acne and psoriasis. It belongs to a group of medicines called retinoids, which are related to Vitamin A. It works by helping 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 directly to the affected skin area, avoiding ingestion or contact with your mouth, nose, eyes, or vagina, as it may cause irritation or burning.
If accidental contact occurs, rinse the affected area thoroughly with water.
For individuals who can become pregnant, start using this medication during your normal menstrual period.
Before and after applying the medication, wash your hands thoroughly, unless your hand is the treated area, in which case you should not wash it after application.
Clean and dry the affected skin area before applying a thin layer of the medication, gently rubbing it in.
Avoid applying the medication to cuts, scrapes, eczema, or damaged skin.
Unless instructed to do so by your doctor, refrain from covering the treated area with bandages, dressings, or makeup.
Usage Schedule
Some products are designed for use at bedtime, while others may be used at any time. Consult with your pharmacist to determine the best application schedule for your specific product.
Skin Care and Sun Protection
Practice good skin care and avoid excessive sun exposure to minimize potential side effects.
Storage and Disposal
Store this medication at room temperature, avoiding freezing temperatures.
Keep all medications in a secure location, out of reach of children and pets.
Missed Dose Instructions
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 accompanying information carefully. It is essential to use this medication only as directed.
Application Instructions
Apply this medication directly to the affected skin area, avoiding ingestion or contact with your mouth, nose, eyes, or vagina, as it may cause irritation or burning.
If accidental contact occurs, rinse the affected area thoroughly with water.
For individuals who can become pregnant, start using this medication during your normal menstrual period.
Before and after applying the medication, wash your hands thoroughly, unless your hand is the treated area, in which case you should not wash it after application.
Clean and dry the affected skin area before applying a thin layer of the medication, gently rubbing it in.
Avoid applying the medication to cuts, scrapes, eczema, or damaged skin.
Unless instructed to do so by your doctor, refrain from covering the treated area with bandages, dressings, or makeup.
Usage Schedule
Some products are designed for use at bedtime, while others may be used at any time. Consult with your pharmacist to determine the best application schedule for your specific product.
Skin Care and Sun Protection
Practice good skin care and avoid excessive sun exposure to minimize potential side effects.
Storage and Disposal
Store this medication at room temperature, avoiding freezing temperatures.
Keep all medications in a secure location, out of reach of children and pets.
Missed Dose Instructions
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 cream to clean, dry skin once daily in the evening.
- Use only a pea-sized amount for the entire face or a small amount for affected areas of the body.
- Avoid contact with eyes, mouth, nostrils, and mucous membranes. If contact occurs, rinse thoroughly with water.
- Avoid excessive exposure to sunlight, sunlamps, or tanning beds. Use sunscreen (SPF 30 or higher) and wear protective clothing when outdoors, as this medication can make your skin more sensitive to the sun.
- Do not use on sunburned, eczematous, or irritated skin.
- 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, but apply them at a different time of day (e.g., morning) or wait at least an hour after applying Tazorac.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin film of Tazorac 0.1% Cream once daily in the evening to affected areas.
Condition-Specific Dosing:
Plaque Psoriasis:
Apply to psoriatic lesions once daily in the evening.
Acne Vulgaris:
Apply to affected areas 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 film of Tazorac 0.1% Cream once daily in the evening to affected areas (for acne or plaque psoriasis).
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment expected due to minimal systemic absorption.
Moderate:
No dosage adjustment expected due to minimal systemic absorption.
Severe:
No dosage adjustment expected due to minimal systemic absorption.
Dialysis:
No specific recommendations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No dosage adjustment expected due to minimal systemic absorption.
Moderate:
No dosage adjustment expected due to minimal systemic absorption.
Severe:
No dosage adjustment expected due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Tazarotene is a retinoid prodrug that is converted to its active metabolite, tazarotenic acid, in the skin. Tazarotenic acid binds to and activates retinoic acid receptors (RARs), specifically RAR-beta and RAR-gamma, which are found in epidermal and dermal cells. Activation of these receptors can modify gene expression, leading to normalization of keratinocyte differentiation and proliferation, and reduction of inflammation, which are beneficial in conditions like psoriasis and acne.
Pharmacokinetics
Absorption:
Bioavailability:
<1% (systemic after topical application)
Tmax:
Not precisely quantifiable for topical systemic absorption, but peak plasma concentrations of tazarotenic acid are very low (e.g., 0.26 ng/mL after 14 days of 0.1% cream).
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not precisely quantifiable due to minimal systemic absorption.
ProteinBinding:
Tazarotenic acid is highly bound to plasma proteins (>99%).
CnssPenetration:
Limited/Negligible systemic penetration.
Elimination:
HalfLife:
Approximately 18 hours (for tazarotenic acid)
Clearance:
Not precisely quantifiable due to minimal systemic absorption.
ExcretionRoute:
Renal and fecal (for tazarotenic acid and its metabolites)
Unchanged:
Negligible
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 4-8 weeks for acne and 4-12 weeks for psoriasis.
PeakEffect:
Peak therapeutic effect may take 12-16 weeks or longer.
DurationOfAction:
Effects persist as long as treatment is continued; relapse occurs upon discontinuation.
Safety & Warnings
BLACK BOX WARNING
Tazarotene is contraindicated in women who are or may become pregnant. Tazarotene is teratogenic in animals and may cause fetal harm when administered to pregnant women. Women of childbearing potential should be warned of the potential risk and use effective contraception during treatment. A negative pregnancy test should be obtained within 2 weeks prior to initiating therapy.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening side effect:
- 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, 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. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you and do not go away:
- Skin irritation is a common side effect of this medication. Symptoms 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.
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening side effect:
- 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, 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. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you and do not go away:
- Skin irritation is a common side effect of this medication. Symptoms 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 (excessive redness, peeling, burning, itching, blistering, or swelling)
- Signs of an allergic reaction (rash, hives, difficulty breathing, swelling of face/lips/tongue/throat)
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. Be sure to describe the allergic reaction you experienced, including the symptoms that occurred.
If you are pregnant or think you may be pregnant. This medication is not recommended for use during pregnancy.
If you are able to become pregnant and are not using a reliable form of birth control.
If you have a sunburn, as this may increase your sensitivity to the medication.
If you are taking any medications that may increase your skin's sensitivity to light. There are several 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, it is vital to disclose all your medications, including:
Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins
As well as any health problems you have, to your doctor and pharmacist. This information will help them 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. Be sure to describe the allergic reaction you experienced, including the symptoms that occurred.
If you are pregnant or think you may be pregnant. This medication is not recommended for use during pregnancy.
If you are able to become pregnant and are not using a reliable form of birth control.
If you have a sunburn, as this may increase your sensitivity to the medication.
If you are taking any medications that may increase your skin's sensitivity to light. There are several 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, it is vital to disclose all your medications, including:
Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins
As well as any health problems you have, to your doctor and pharmacist. This information will help them 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
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere to your doctor's instructions for taking this drug, and do not exceed the recommended dosage.
Certain environmental factors, such as cold weather and wind, may exacerbate skin irritation. Consult with your doctor or pharmacist to discuss ways to protect your skin from these conditions. Additionally, be aware that your skin may appear to worsen before improving.
Before using any other medications or products on your skin, including soaps, consult with your doctor to minimize the risk of increased irritation. The use of other skin products concurrently with this medication may enhance the likelihood of irritation.
You may be more susceptible to sunburn while taking this medication. To mitigate this risk, avoid exposure to direct sunlight, sunlamps, and tanning beds. Use a broad-spectrum sunscreen with a high SPF and wear protective clothing and eyewear when outdoors.
In the event that this medication is ingested, seek immediate medical attention by contacting a doctor or poison control center.
For women of childbearing potential, a pregnancy test will be conducted prior to initiating treatment with this medication to confirm that you are not pregnant. It is crucial to discuss the risks associated with this medication with your doctor.
This medication may cause harm to a developing fetus. If you are pregnant or may become pregnant, you must use effective birth control measures while taking this medication. If you become pregnant, notify your doctor promptly.
If you are breastfeeding, consult with your doctor to discuss potential risks to your baby. When applying this medication, avoid placing it directly on the nipple or the surrounding area to minimize exposure to your infant.
Certain environmental factors, such as cold weather and wind, may exacerbate skin irritation. Consult with your doctor or pharmacist to discuss ways to protect your skin from these conditions. Additionally, be aware that your skin may appear to worsen before improving.
Before using any other medications or products on your skin, including soaps, consult with your doctor to minimize the risk of increased irritation. The use of other skin products concurrently with this medication may enhance the likelihood of irritation.
You may be more susceptible to sunburn while taking this medication. To mitigate this risk, avoid exposure to direct sunlight, sunlamps, and tanning beds. Use a broad-spectrum sunscreen with a high SPF and wear protective clothing and eyewear when outdoors.
In the event that this medication is ingested, seek immediate medical attention by contacting a doctor or poison control center.
For women of childbearing potential, a pregnancy test will be conducted prior to initiating treatment with this medication to confirm that you are not pregnant. It is crucial to discuss the risks associated with this medication with your doctor.
This medication may cause harm to a developing fetus. If you are pregnant or may become pregnant, you must use effective birth control measures while taking this medication. If you become pregnant, notify your doctor promptly.
If you are breastfeeding, consult with your doctor to discuss potential risks to your baby. When applying this medication, avoid placing it directly on the nipple or the surrounding area to minimize exposure to your infant.
Overdose Information
Overdose Symptoms:
- Topical overdose is unlikely to cause significant systemic effects due to minimal absorption. However, excessive application may lead to marked redness, peeling, or discomfort.
- Oral ingestion (accidental): Symptoms could include headache, nausea, vomiting, and in severe cases, signs of hypervitaminosis A (e.g., dry skin, cheilitis, hair loss, bone pain). Seek immediate medical attention.
What to Do:
For topical overdose, discontinue use and manage symptoms symptomatically. For accidental oral ingestion, call a poison control center immediately (1-800-222-1222) or seek emergency medical care.
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., medicated soaps, astringents, abrasives, peeling agents, alcohol-containing products): May increase irritation.
Monitoring
Baseline Monitoring
Skin assessment (erythema, scaling, dryness, pruritus)
Rationale: To establish baseline severity of skin condition and identify potential for irritation.
Timing: Prior to initiation of therapy.
Pregnancy test (for women of childbearing potential)
Rationale: Tazarotene is contraindicated in pregnancy due to teratogenic risk.
Timing: Within 2 weeks prior to initiating therapy.
Routine Monitoring
Skin irritation (erythema, peeling, dryness, pruritus, burning/stinging)
Frequency: Regularly during treatment, especially during 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 lower concentration.
Clinical efficacy (improvement in acne lesions or psoriatic plaques)
Frequency: Monthly or as clinically indicated.
Target: Reduction in lesion count or plaque severity.
Action Threshold: Lack of improvement after 8-12 weeks may warrant re-evaluation of therapy.
Symptom Monitoring
- Excessive skin dryness
- Peeling or flaking of skin
- Redness (erythema)
- Itching (pruritus)
- Burning or stinging sensation
- Swelling of the skin
- Crusting or blistering
Special Patient Groups
Pregnancy
Contraindicated in women who are or may become pregnant. Tazarotene is teratogenic in animals and may cause fetal harm. Women of childbearing potential must use effective contraception during treatment and have a negative pregnancy test within 2 weeks prior to starting therapy.
Trimester-Specific Risks:
First Trimester:
High risk of teratogenicity; contraindicated.
Second Trimester:
High risk of teratogenicity; contraindicated.
Third Trimester:
High risk of teratogenicity; contraindicated.
Lactation
It is not known whether tazarotene is excreted in human milk. Due to the potential for serious adverse reactions in nursing 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 that may come into contact with the infant.
Infant Risk:
Potentially hazardous (L4)
Pediatric Use
Approved for patients 12 years of age and older for the treatment of 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 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, no overall differences in safety or effectiveness were observed.
Clinical Information
Clinical Pearls
- Tazorac Cream is a potent retinoid; start with the lowest effective concentration (0.05% if available, then 0.1%) and frequency if irritation is a concern.
- Apply to completely dry skin, typically 20-30 minutes after washing, to minimize irritation.
- A 'less is more' approach is crucial; using more than a pea-sized amount for the face will not improve efficacy but will increase irritation.
- Patients should be educated on the importance of strict sun protection due to increased photosensitivity.
- Initial worsening of acne (purging) can occur during the first few weeks of treatment before improvement is seen.
- For psoriasis, apply only to the psoriatic lesions, avoiding unaffected skin as much as possible to minimize irritation.
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., pimecrolimus, tacrolimus for psoriasis)
- 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, biologics, methotrexate, cyclosporine for severe cases of acne or psoriasis)
Cost & Coverage
Average Cost:
Highly variable, typically $300 - $800+ per 60gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 (Generic)
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 is a good idea to check with your pharmacist. If you have any questions or concerns about your medication, do not 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.