Tazarotene 0.05% Cream 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, Anti-acne
Pharmacologic Class
Topical Retinoid
Pregnancy Category
Category X
FDA Approved
May 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tazarotene cream is a medication that belongs to a group of drugs called retinoids. It's used on the skin to treat conditions like acne and psoriasis. It works by helping your skin cells grow and shed normally, which can reduce breakouts and calm skin inflammation.
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. 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 take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. If accidental contact occurs, rinse the area thoroughly with water.
Do not apply this medication to the vagina.
Before applying the medication, wash your hands thoroughly. If the treated area is on your hand, do not wash your hand after application.
Clean the affected area before applying the medication, and make sure it is completely dry.
Apply a thin layer of the medication to the affected skin and gently rub 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.
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 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 the information provided. 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 take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. If accidental contact occurs, rinse the area thoroughly with water.
Do not apply this medication to the vagina.
Before applying the medication, wash your hands thoroughly. If the treated area is on your hand, do not wash your hand after application.
Clean the affected area before applying the medication, and make sure it is completely dry.
Apply a thin layer of the medication to the affected skin and gently rub 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.
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 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
- Apply a thin layer to clean, dry skin once daily in the evening.
- Avoid applying to eyes, mouth, angles of the nose, or mucous membranes.
- Use a mild cleanser and moisturizer regularly to help manage dryness and irritation.
- Avoid excessive sun exposure and artificial UV light (tanning beds) while using this medication, as it can increase sensitivity to sunlight. Use sunscreen (SPF 30 or higher) and wear protective clothing when outdoors.
- Do not use if you are pregnant, planning to become pregnant, or breastfeeding. Use effective birth control if you are a woman of childbearing potential.
- Initial worsening of acne or irritation may occur during the first few weeks of treatment; this is often temporary.
- Avoid waxing on treated areas as skin may be more fragile.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer of Tazarotene 0.05% Cream once daily in the evening to the affected areas.
Condition-Specific Dosing:
Psoriasis Vulgaris:
Apply a thin layer to psoriatic lesions once daily in the evening. Use enough to cover the lesion with a thin film.
Acne Vulgaris:
Apply a thin layer to the entire affected area (e.g., face) once daily in the evening, after cleansing and drying the skin.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 12 years of age.
Adolescent:
For acne vulgaris, approved for patients 12 years of age and older. Apply a thin layer once daily in the evening.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed for topical application.
Moderate:
No adjustment needed for topical application.
Severe:
No adjustment needed for topical application.
Dialysis:
No specific considerations for topical application, as systemic absorption is minimal.
Hepatic Impairment:
Mild:
No adjustment needed for topical application.
Moderate:
No adjustment needed for topical application.
Severe:
No adjustment needed for topical application.
Pharmacology
Mechanism of Action
Tazarotene is a retinoid prodrug that is converted to its active metabolite, tazarotenic acid, by esterase hydrolysis in the skin. Tazarotenic acid binds to and activates retinoic acid receptors (RARs), specifically RAR-beta and RAR-gamma, but not RAR-alpha. It modulates gene expression, which in turn normalizes abnormal keratinocyte differentiation and proliferation, and reduces inflammation. In psoriasis, this leads to a reduction in epidermal hyperplasia and inflammation. In acne, it helps to normalize follicular keratinization, preventing microcomedone formation and promoting the expulsion of existing comedones.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (typically <1% of applied dose)
Tmax:
Approximately 2-8 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:
Tazarotenic acid is highly protein bound (>99%) to plasma proteins.
CnssPenetration:
Limited/Not significant due to minimal systemic absorption.
Elimination:
HalfLife:
Approximately 7-18 hours for tazarotenic acid after topical application (variable)
Clearance:
Not precisely quantified for topical application.
ExcretionRoute:
Renal and fecal excretion of tazarotenic acid and its metabolites.
Unchanged:
Negligible amount of unchanged tazarotene excreted systemically.
Pharmacodynamics
OnsetOfAction:
Weeks (typically 2-4 weeks for initial improvement, full effects may take 12 weeks or longer)
PeakEffect:
12-16 weeks
DurationOfAction:
Effects persist as long as treatment continues; relapse occurs upon discontinuation.
Safety & Warnings
BLACK BOX WARNING
Tazarotene is a retinoid that may cause fetal harm when administered to a pregnant woman. It 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
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
- Signs of an allergic reaction, such as:
- Rash
- Hives
- Itching
- Red, swollen, blistered, or peeling skin with or without fever
- Wheezing
- Tightness in the chest or throat
- Trouble breathing, swallowing, or talking
- Unusual hoarseness
- Swelling of the mouth, face, lips, tongue, or throat
- Swelling
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people 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
- Scaling
If you experience severe skin irritation or if it bothers you and does not improve, inform 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, you can also contact your doctor. Additionally, you can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
- Signs of an allergic reaction, such as:
- Rash
- Hives
- Itching
- Red, swollen, blistered, or peeling skin with or without fever
- Wheezing
- Tightness in the chest or throat
- Trouble breathing, swallowing, or talking
- Unusual hoarseness
- Swelling of the mouth, face, lips, tongue, or throat
- Swelling
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people 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
- Scaling
If you experience severe skin irritation or if it bothers you and does not improve, inform 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, you can also contact your doctor. Additionally, you can 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., extreme redness, burning, blistering, swelling)
- Signs of allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat)
- Unexpected or severe systemic side effects (though rare with topical use)
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:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. 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, such as certain antibiotics or antihistamines. Consult your doctor or pharmacist if you are unsure about the medications you are taking.
If you are using any medications that may cause dry skin, such as diuretics or retinoids. Ask your doctor or pharmacist if you are unsure about the potential effects of your medications.
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, including any health problems you have
This information will help your doctor 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:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. 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, such as certain antibiotics or antihistamines. Consult your doctor or pharmacist if you are unsure about the medications you are taking.
If you are using any medications that may cause dry skin, such as diuretics or retinoids. Ask your doctor or pharmacist if you are unsure about the potential effects of your medications.
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, including any health problems you have
This information will help your doctor 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
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.
Protecting Your Skin
Certain weather conditions, such as cold and wind, may exacerbate skin irritation. Consult with your doctor or pharmacist to discuss ways to safeguard your skin. 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, consult with your doctor. The concurrent use of other skin products 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 broad-spectrum sunscreen with a high SPF and wear protective clothing and eyewear when outdoors.
Accidental Ingestion
If this medication is accidentally ingested, seek immediate medical attention by calling a doctor or poison control center.
Pregnancy and Breastfeeding Precautions
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. This medication may cause harm to an unborn baby, so it is essential to use birth control while taking this drug. 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.
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.
Protecting Your Skin
Certain weather conditions, such as cold and wind, may exacerbate skin irritation. Consult with your doctor or pharmacist to discuss ways to safeguard your skin. 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, consult with your doctor. The concurrent use of other skin products 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 broad-spectrum sunscreen with a high SPF and wear protective clothing and eyewear when outdoors.
Accidental Ingestion
If this medication is accidentally ingested, seek immediate medical attention by calling a doctor or poison control center.
Pregnancy and Breastfeeding Precautions
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. This medication may cause harm to an unborn baby, so it is essential to use birth control while taking this drug. 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:
- Excessive skin redness
- Peeling
- Discomfort
What to Do:
Topical overdose is unlikely to cause systemic toxicity due to minimal absorption. Discontinue use and apply emollients. For accidental ingestion, call a poison control center (1-800-222-1222) or seek medical attention immediately.
Drug Interactions
Moderate Interactions
- Photosensitizing agents (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides): Increased risk of photosensitivity.
- 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
Skin condition assessment (e.g., severity of acne/psoriasis, presence of irritation)
Rationale: To establish baseline for efficacy and tolerability monitoring.
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 initiating therapy.
Routine Monitoring
Skin irritation (e.g., erythema, peeling, dryness, itching, burning)
Frequency: Regularly, especially during the initial weeks of treatment.
Target: Minimal to mild irritation.
Action Threshold: Moderate to severe irritation may require temporary discontinuation, reduction in frequency, or use of emollients.
Therapeutic response (improvement in acne lesions or psoriatic plaques)
Frequency: Monthly or as clinically indicated.
Target: Reduction in lesion count/severity.
Action Threshold: Lack of improvement after 12-16 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
- Photosensitivity (increased sunburn risk)
Special Patient Groups
Pregnancy
Contraindicated in pregnancy due to potential for fetal harm. Tazarotene is a known teratogen.
Trimester-Specific Risks:
First Trimester:
High risk of severe birth defects (e.g., craniofacial, cardiovascular, central nervous system abnormalities).
Second Trimester:
Continued high risk of fetal abnormalities.
Third Trimester:
Continued high risk of fetal abnormalities.
Lactation
Not recommended during breastfeeding. It is not known whether tazarotene or its metabolites are excreted in human milk. Due to the potential for serious adverse reactions in nursing infants from the systemic exposure of tazarotenic acid, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
High (potential for systemic effects in infant, though absorption from topical application is minimal, the teratogenic risk is significant).
Pediatric Use
Approved for acne vulgaris in patients 12 years of age and older. Safety and effectiveness for psoriasis in pediatric patients under 18 years of age have not been established. Use with caution due to potential for increased systemic absorption in younger children due to higher surface area to body weight ratio.
Geriatric Use
No specific dosage adjustments are required for elderly patients. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, elderly patients may have more fragile skin and may be more susceptible to irritation.
Clinical Information
Clinical Pearls
- A 'less is more' approach is often best; applying too much cream can increase irritation without improving efficacy.
- Initial worsening of acne (purging) is common during the first few weeks of treatment as the skin adjusts and comedones are brought to the surface.
- Strict adherence to sun protection measures (sunscreen, protective clothing, avoiding peak sun hours) is crucial due to increased photosensitivity.
- For patients with sensitive skin, starting with a lower concentration (e.g., 0.025% gel) or using a short-contact therapy approach (applying for a limited time, then washing off) may improve tolerability.
- Consistent use is key for optimal results; improvements may not be noticeable for several weeks to months.
Alternative Therapies
- Other topical retinoids (e.g., tretinoin, adapalene)
- Topical vitamin D analogs (e.g., calcipotriene for psoriasis)
- Topical corticosteroids (for psoriasis)
- Topical antibiotics (e.g., clindamycin, erythromycin for acne)
- Benzoyl peroxide (for acne)
- Azelaic acid (for acne)
- Systemic retinoids (e.g., isotretinoin for severe acne, acitretin for severe psoriasis)
- Biologic agents (for severe psoriasis)
- Phototherapy (for psoriasis)
Cost & Coverage
Average Cost:
Price range varies significantly by pharmacy and insurance plan, typically $150-$500+ per 30gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (Brand), Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.