Tazorac 0.05% 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
Anti-psoriatic, Anti-acne
Pharmacologic Class
Topical Retinoid
Pregnancy Category
Category X
FDA Approved
Jun 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tazorac Cream contains tazarotene, a vitamin A-like medicine that helps to normalize skin cell growth and reduce inflammation. It's used to treat skin conditions like psoriasis and acne.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication only as directed.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not ingest it or apply it to your mouth, nose, eyes, or vagina, as it may cause burning.
If you accidentally get the medication in your mouth, nose, eyes, or vagina, rinse the area thoroughly with water.
If you are able to become pregnant, begin 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 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, do not cover the treated area with bandages, dressings, or makeup.
Usage Schedule
Some products are intended for use at bedtime, while others may be used at any time. Consult with your pharmacist to determine the best usage 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 safe and secure 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 dose.
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication only as directed.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not ingest it or apply it to your mouth, nose, eyes, or vagina, as it may cause burning.
If you accidentally get the medication in your mouth, nose, eyes, or vagina, rinse the area thoroughly with water.
If you are able to become pregnant, begin 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 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, do not cover the treated area with bandages, dressings, or makeup.
Usage Schedule
Some products are intended for use at bedtime, while others may be used at any time. Consult with your pharmacist to determine the best usage 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 safe and secure 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 dose.
Lifestyle & Tips
- Avoid excessive sun exposure and artificial UV light (tanning beds) while using this medication, as it can increase sun sensitivity. Use sunscreen (SPF 30 or higher) and wear protective clothing when outdoors.
- Avoid using other topical products that may dry or irritate the skin (e.g., abrasive soaps, astringents, other acne treatments) unless directed by your doctor.
- Do not apply to eczematous, broken, or sunburned skin.
- Avoid contact with eyes, eyelids, mouth, and mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not use if you are pregnant, planning to become pregnant, or breastfeeding without consulting your doctor.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer of Tazorac 0.05% Cream once daily in the evening to affected areas.
Condition-Specific Dosing:
Plaque Psoriasis:
Apply a thin layer to affected areas once daily in the evening. If irritation occurs, frequency may be reduced.
Acne Vulgaris:
Apply a thin layer 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 and older: Apply a thin layer of Tazorac 0.05% Cream once daily in the evening to affected areas (for acne or plaque psoriasis).
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 specific considerations (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 retinoid prodrug that is hydrolyzed to its active metabolite, tazarotenic acid, in the skin. Tazarotenic acid binds to and activates retinoic acid receptors (RARs), specifically RARΞ² and RARΞ³, which are found in the nucleus of keratinocytes. This binding modulates gene expression, leading to normalization of keratinocyte differentiation and proliferation, and reduction of inflammation. In psoriasis, it helps to normalize the abnormal keratinocyte proliferation and differentiation. In acne, it reduces hyperkeratinization and inflammation.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal (<5% of applied dose)
Tmax:
1-8 hours (if detectable)
FoodEffect:
Not applicable (topical)
Distribution:
Vd:
Not applicable (minimal systemic distribution)
ProteinBinding:
Greater than 99% (tazarotenic acid to plasma proteins)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Approximately 7-12 hours (for tazarotenic acid after topical application)
Clearance:
Not precisely quantified due to minimal systemic absorption
ExcretionRoute:
Urine and feces
Unchanged:
Not applicable (prodrug)
Pharmacodynamics
OnsetOfAction:
Weeks (typically 2-4 weeks for initial improvement, full effect may take 12 weeks or more)
PeakEffect:
12-16 weeks
DurationOfAction:
Variable, continued use required for sustained effect
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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, 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 or do not go away:
- 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 or if it bothers you and does not go away, contact your doctor.
Reporting 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. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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, 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 or do not go away:
- 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 or if it bothers you and does not go away, contact your doctor.
Reporting 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. 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)
- Swelling or blistering of the skin
- 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 be sure to ask your doctor or pharmacist if you are unsure.
If you are using any medications that may cause dry skin. Again, there are many medications that can have this effect, so it is crucial to consult with your doctor or pharmacist if you are unsure.
Additionally, it is vital to disclose all of your current medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any existing health problems. This information will help your doctor and pharmacist determine whether it is safe for you to take this medication in combination with your other treatments. Never start, stop, or adjust 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. 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 be sure to ask your doctor or pharmacist if you are unsure.
If you are using any medications that may cause dry skin. Again, there are many medications that can have this effect, so it is crucial to consult with your doctor or pharmacist if you are unsure.
Additionally, it is vital to disclose all of your current medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any existing health problems. This information will help your doctor and pharmacist determine whether it is safe for you to take this medication in combination with your other treatments. Never start, stop, or adjust 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. To ensure safe and effective use, follow the dosage instructions provided by your doctor carefully and do not exceed the recommended amount.
Skin Care and Protection
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.
Before using any other medications or products on your skin, including soaps, discuss them with your doctor. Using other skin products concurrently with this medication may increase the risk of irritation.
Sun Protection
You may be more susceptible to sunburn while using this medication. To minimize this risk, avoid exposure to direct sunlight, sunlamps, and tanning beds. Use a sunscreen with adequate sun protection factor (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
If you are of childbearing potential, a pregnancy test will be conducted to confirm that you are not pregnant before initiating treatment with this medication. It is essential to discuss the risks associated with this medication with your doctor.
This medication may cause harm to an unborn baby. If you 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 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 baby.
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. To ensure safe and effective use, follow the dosage instructions provided by your doctor carefully and do not exceed the recommended amount.
Skin Care and Protection
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.
Before using any other medications or products on your skin, including soaps, discuss them with your doctor. Using other skin products concurrently with this medication may increase the risk of irritation.
Sun Protection
You may be more susceptible to sunburn while using this medication. To minimize this risk, avoid exposure to direct sunlight, sunlamps, and tanning beds. Use a sunscreen with adequate sun protection factor (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
If you are of childbearing potential, a pregnancy test will be conducted to confirm that you are not pregnant before initiating treatment with this medication. It is essential to discuss the risks associated with this medication with your doctor.
This medication may cause harm to an unborn baby. If you 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 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 baby.
Overdose Information
Overdose Symptoms:
- Excessive skin irritation (severe redness, peeling, discomfort)
- While systemic overdose from topical application is unlikely due to minimal absorption, theoretical symptoms could include those of hypervitaminosis A (e.g., headache, nausea, vomiting, dry skin, hair loss, bone pain).
What to Do:
Discontinue use. For local irritation, apply emollients. If accidental ingestion occurs or severe systemic symptoms are suspected, seek immediate medical attention or call a poison control center (1-800-222-1222).
Drug Interactions
Moderate Interactions
- Other topical products with strong drying or irritating effects (e.g., abrasive soaps, cleansers, astringents, alcohol-containing products, other retinoids, alpha hydroxy acids, salicylic acid, benzoyl peroxide) - concurrent use may increase irritation.
- Photosensitizing drugs (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines) - may increase risk of phototoxicity.
Monitoring
Baseline Monitoring
Skin assessment (erythema, scaling, dryness, pruritus)
Rationale: To establish baseline skin condition and identify areas for treatment.
Timing: Prior to initiation of therapy
Pregnancy test (for females of childbearing potential)
Rationale: Tazarotene is teratogenic and contraindicated in pregnancy.
Timing: Within 2 weeks prior to initiation of therapy
Routine Monitoring
Skin irritation (erythema, peeling, burning, dryness, pruritus)
Frequency: Regularly during treatment (e.g., at follow-up visits)
Target: Mild to moderate irritation is common; severe irritation should prompt dose reduction or temporary discontinuation.
Action Threshold: Severe or persistent irritation: reduce frequency, temporarily discontinue, or switch to lower strength.
Efficacy (improvement in psoriasis/acne lesions)
Frequency: Monthly or as clinically indicated
Target: Reduction in lesion count, inflammation, and scaling.
Action Threshold: Lack of improvement after 12-16 weeks may warrant re-evaluation of therapy.
Symptom Monitoring
- Skin redness (erythema)
- Skin peeling or flaking
- Skin dryness
- Burning or stinging sensation
- Itching (pruritus)
- Photosensitivity (increased sensitivity to sunlight)
Special Patient Groups
Pregnancy
CONTRAINDICATED. Tazarotene is teratogenic and can cause fetal harm. Females 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 (birth defects).
Second Trimester:
High risk of teratogenicity (birth defects).
Third Trimester:
High risk of teratogenicity (birth defects).
Lactation
Caution advised. It is not known whether tazarotene is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Potential for serious adverse reactions; risk unknown but theoretical.
Pediatric Use
Safety and effectiveness have been established in pediatric patients 12 years of age and older for the treatment of plaque psoriasis and acne vulgaris. Not recommended for use in children under 12 years of age.
Geriatric Use
No specific dose adjustments are required. However, elderly patients may have more fragile or sensitive skin and should be monitored for increased irritation.
Clinical Information
Clinical Pearls
- Tazorac Cream is a powerful retinoid; a 'pea-sized' amount is usually sufficient for the entire face.
- Apply to clean, dry skin, typically 20-30 minutes after washing to minimize irritation.
- Start with the 0.05% strength, especially for sensitive skin, and consider reducing frequency (e.g., every other night) if irritation is significant.
- Consistent use is key for efficacy; improvements may not be noticeable for several weeks.
- Strict sun protection (sunscreen, protective clothing) is essential due to increased photosensitivity.
- Avoid applying to areas with eczema, open wounds, or sunburn, as this can cause severe irritation.
- Inform patients about the potential for initial worsening of acne ('purging') before improvement is seen.
Alternative Therapies
- Other topical retinoids (e.g., tretinoin, adapalene, trifarotene)
- Topical corticosteroids (for psoriasis)
- Vitamin D analogs (e.g., calcipotriene for psoriasis)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus for psoriasis)
- Salicylic acid (for acne and psoriasis)
- Benzoyl peroxide (for acne)
- Azelaic acid (for acne)
- Oral retinoids (e.g., isotretinoin for severe acne, acitretin for severe psoriasis)
- Biologic agents (for severe psoriasis)
- Phototherapy (for psoriasis)
Cost & Coverage
Average Cost:
$200 - $600+ per 60gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (generic often Tier 1 or 2)
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 consult with your pharmacist. If you have any questions or concerns about this 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.