Tazarotene 0.1% Aer Foam 50gm
It is used to treat pimples (acne).It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antipsoriatic, Anti-acne
Pharmacologic Class
Topical Retinoid
Pregnancy Category
X
FDA Approved
Apr 2012
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tazarotene foam is a medication applied to the skin to treat conditions like acne and psoriasis. It's a type of vitamin A-like medicine that helps skin cells grow normally and reduces inflammation. It's important to use it exactly as prescribed and be aware of potential side effects like skin irritation and increased sensitivity to the sun.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all provided information carefully. It is essential to use this medication as directed.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not ingest it.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. If accidental contact occurs, rinse the affected area thoroughly with water.
Do not apply the medication to the vaginal area.
If you are able to become pregnant, start using this medication during your normal menstrual period.
Before and after applying the medication, wash your hands thoroughly.
Clean the affected area before application and ensure it is dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Precautions
Do not apply the medication to cuts, scrapes, eczema, or damaged skin.
Unless instructed to do so by your doctor, avoid covering the treated area with bandages, dressings, or makeup.
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.
General Skin Care and Safety
Practice good skin care and limit your exposure to the sun.
Avoid applying the medication to healthy skin.
Before use, shake the medication well and hold the container upright. Do not turn it upside down.
Be aware that this medication is flammable, so avoid using it near open flames or while smoking.
Storage and Disposal
Store the medication at room temperature, avoiding freezing.
Keep the container upright with the cap securely in place.
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 provided information carefully. It is essential to use this medication as directed.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not ingest it.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. If accidental contact occurs, rinse the affected area thoroughly with water.
Do not apply the medication to the vaginal area.
If you are able to become pregnant, start using this medication during your normal menstrual period.
Before and after applying the medication, wash your hands thoroughly.
Clean the affected area before application and ensure it is dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Precautions
Do not apply the medication to cuts, scrapes, eczema, or damaged skin.
Unless instructed to do so by your doctor, avoid covering the treated area with bandages, dressings, or makeup.
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.
General Skin Care and Safety
Practice good skin care and limit your exposure to the sun.
Avoid applying the medication to healthy skin.
Before use, shake the medication well and hold the container upright. Do not turn it upside down.
Be aware that this medication is flammable, so avoid using it near open flames or while smoking.
Storage and Disposal
Store the medication at room temperature, avoiding freezing.
Keep the container upright with the cap securely in place.
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
- 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 apply to sunburned, eczematous, or irritated skin.
- Avoid contact with eyes, mouth, angles of the nose, and mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not use on open wounds or broken skin.
- Avoid waxing on treated areas, as skin may be more fragile.
- Inform your doctor if you are pregnant, planning to become pregnant, or breastfeeding.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer of foam to the affected areas once daily in the evening.
Condition-Specific Dosing:
Plaque Psoriasis:
Apply once daily to affected areas. Treatment duration should be individualized based on patient response and tolerability.
Acne Vulgaris:
Apply once daily to affected areas. Treatment duration should be individualized based on patient response and tolerability.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for children under 12 years of age.
Adolescent:
For acne vulgaris: 12 years of age and older, apply once daily. For plaque psoriasis: Not indicated for patients under 18 years of age.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Tazarotene is a retinoid prodrug that is hydrolyzed to its active metabolite, tazarotenic acid, by esterases in the skin and plasma. Tazarotenic acid selectively binds to retinoic acid receptors (RARs), specifically RARΞ² and RARΞ³, which are found in the skin. Binding to these receptors modulates gene expression, leading to normalization of keratinocyte differentiation and proliferation, and reduction of inflammation. In psoriasis, this helps to reduce the hyperproliferation and inflammation characteristic of the disease. In acne, it helps to normalize follicular keratinization, preventing comedone formation, and has anti-inflammatory effects.
Pharmacokinetics
Absorption:
Bioavailability:
<1% (systemic absorption after topical application)
Tmax:
2-8 hours (for tazarotenic acid)
FoodEffect:
Not applicable (topical administration)
Distribution:
Vd:
Not available (minimal systemic distribution)
ProteinBinding:
>99% (tazarotenic acid)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
7-18 hours (tazarotenic acid)
Clearance:
Not available
ExcretionRoute:
Renal and Fecal
Unchanged:
Not available (minimal unchanged drug excreted)
Pharmacodynamics
OnsetOfAction:
Weeks (typically 2-4 weeks for initial improvement, full effect may take longer)
PeakEffect:
8-12 weeks
DurationOfAction:
Varies, continued application needed for sustained effect
Safety & Warnings
BLACK BOX WARNING
Pregnancy: 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. Females of childbearing potential should be warned of the potential risk and use adequate contraception.
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
While rare, some individuals 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, or 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 or may only have mild symptoms. If you encounter any of the following side effects or any other unusual symptoms that bother you or do not resolve, contact your doctor or seek medical help:
- Skin irritation is a common side effect of this medication, which may include burning sensations, dry skin, itching, peeling, redness, and scaling. If you experience severe skin irritation or if it persists and bothers you, notify your doctor.
Reporting Side Effects
This list does not encompass all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice regarding 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.
While rare, some individuals 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, or 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 or may only have mild symptoms. If you encounter any of the following side effects or any other unusual symptoms that bother you or do not resolve, contact your doctor or seek medical help:
- Skin irritation is a common side effect of this medication, which may include burning sensations, dry skin, itching, peeling, redness, and scaling. If you experience severe skin irritation or if it persists and bothers you, notify your doctor.
Reporting Side Effects
This list does not encompass all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice regarding 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 (e.g., extreme redness, peeling, burning, itching)
- Blistering or crusting of the skin
- Significant swelling of the treated area
- Signs of an allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat)
- Unusual or severe photosensitivity reaction
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 any 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 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 be sure to ask your doctor or pharmacist if you have any concerns.
Additionally, it is crucial to disclose all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This information will help your doctor and pharmacist 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 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 any 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 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 be sure to ask your doctor or pharmacist if you have any concerns.
Additionally, it is crucial to disclose all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This information will help your doctor and pharmacist 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 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 to your doctor's instructions regarding the dosage and administration of this drug, and do not exceed the recommended amount.
Skin Care and Protection
Certain weather conditions, such as cold and wind, may exacerbate skin irritation. Consult with your doctor or pharmacist to discuss ways to protect your skin. Be aware that your skin may appear worse before it starts to improve.
Before using any other medications or products on your skin, including soaps, consult 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 broad-spectrum sunscreen and wear protective clothing and eyewear to safeguard your skin from the sun.
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. Discuss the risks and benefits of this medication with your doctor.
This medication may cause harm to an unborn baby. If you become pregnant while taking this medication, notify your doctor immediately. You must use effective birth control methods while taking this medication to prevent pregnancy.
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. Adhere to your doctor's instructions regarding the dosage and administration of this drug, and do not exceed the recommended amount.
Skin Care and Protection
Certain weather conditions, such as cold and wind, may exacerbate skin irritation. Consult with your doctor or pharmacist to discuss ways to protect your skin. Be aware that your skin may appear worse before it starts to improve.
Before using any other medications or products on your skin, including soaps, consult 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 broad-spectrum sunscreen and wear protective clothing and eyewear to safeguard your skin from the sun.
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. Discuss the risks and benefits of this medication with your doctor.
This medication may cause harm to an unborn baby. If you become pregnant while taking this medication, notify your doctor immediately. You must use effective birth control methods while taking this medication to prevent pregnancy.
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:
- Topical overdose is unlikely to cause systemic effects due to minimal absorption. However, excessive application may lead to marked redness, peeling, or discomfort.
- If ingested orally (e.g., by a child), symptoms could resemble hypervitaminosis A (e.g., headache, nausea, vomiting, dizziness, dry skin, fatigue).
What to Do:
For topical overdose, discontinue use and provide symptomatic relief. For accidental oral ingestion, seek immediate medical attention. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Moderate Interactions
- Photosensitizing agents (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides): May increase risk of photosensitivity.
- Other topical preparations with strong drying or irritating effects (e.g., abrasive soaps, cleansers, medicated cosmetics, other retinoids, salicylic acid, benzoyl peroxide): May increase skin irritation.
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of acne or psoriasis and identify areas for treatment.
Timing: Prior to initiation of therapy
Pregnancy status (for females of childbearing potential)
Rationale: Tazarotene is teratogenic and contraindicated in pregnancy. A negative pregnancy test is required prior to initiation.
Timing: Within 2 weeks prior to initiating therapy
Routine Monitoring
Skin irritation (erythema, peeling, dryness, burning, itching)
Frequency: Regularly during treatment, especially during the first few weeks
Target: Mild to moderate irritation is common; severe irritation should prompt dose reduction or temporary discontinuation.
Action Threshold: Severe or persistent irritation: Reduce frequency of application, temporarily discontinue, or discontinue permanently if intolerable.
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: Re-evaluate diagnosis or consider alternative therapies.
Symptom Monitoring
- Redness
- Scaling
- Dryness
- Itching
- Burning
- Stinging
- Photosensitivity (increased sensitivity to sunlight)
- Blistering
- Swelling
Special Patient Groups
Pregnancy
CONTRAINDICATED. Tazarotene is a known teratogen and can cause fetal harm. Females of childbearing potential must use effective contraception during treatment and for at least one month after discontinuing therapy. A negative pregnancy test is required prior to initiation.
Trimester-Specific Risks:
First Trimester:
High risk of teratogenicity (e.g., craniofacial, cardiovascular, central nervous system defects).
Second Trimester:
Risk of fetal harm remains.
Third Trimester:
Risk of fetal harm remains.
Lactation
Use with caution. It is not known whether tazarotene is excreted in human milk. Due to minimal systemic absorption, infant exposure is expected to be low. However, advise breastfeeding women to apply to areas not likely to come into contact with the infant's skin and to wash hands thoroughly after application.
Infant Risk:
Low risk, but potential for irritation if direct contact occurs. Monitor infant for adverse effects.
Pediatric Use
Approved for acne vulgaris in patients 12 years and older. Approved for plaque psoriasis in patients 18 years and older. Safety and efficacy have not been established in pediatric patients younger than 12 years of age for acne or younger than 18 years of age for psoriasis.
Geriatric Use
No specific dose adjustments are recommended 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 differences are not expected to be clinically significant.
Clinical Information
Clinical Pearls
- Tazarotene foam is a potent retinoid; counsel patients on proper application technique (thin layer, once daily in the evening) to minimize irritation.
- Emphasize the importance of strict sun protection (sunscreen, protective clothing) due to increased photosensitivity.
- For females of childbearing potential, reinforce the absolute contraindication in pregnancy and the need for reliable contraception.
- Initial irritation (redness, peeling, dryness) is common and often subsides with continued use. Advise patients to contact their provider if irritation is severe or persistent.
- Improvement may not be seen for several weeks; encourage patient adherence and patience.
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)
- Topical antibiotics (e.g., clindamycin, erythromycin for acne)
- Benzoyl peroxide (for acne)
- Salicylic acid (for acne/psoriasis)
- Systemic therapies (e.g., oral retinoids, biologics, immunosuppressants for severe cases of acne or psoriasis)
Cost & Coverage
Average Cost:
$500 - $1500+ per 50gm can
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (varies by plan, may require prior authorization)
General Drug Facts
If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may have additional patient information leaflets, so it is a good idea to consult with your pharmacist for more information. 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 name of the medication taken, the amount, and the time it occurred.