Lexette 0.05% Topical Foam 50gm
It is used to treat plaque psoriasis.
Drug Class
Corticosteroid, Topical
Pharmacologic Class
Glucocorticoid Receptor Agonist, Anti-inflammatory
Pregnancy Category
Category C
FDA Approved
Apr 2018
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lexette foam contains a strong medicine called halobetasol, which is a type of steroid. It works by reducing redness, swelling, and itching caused by skin conditions like psoriasis. It's applied directly to the skin.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue using the medication as directed, even if your symptoms improve.
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.
Do not apply the medication to the vaginal area.
Wash your hands before and after use, unless your hand is the area being treated. In that case, do not wash your hand after applying the medication.
Clean and dry the affected area before applying the medication.
Shake the can well before use.
To apply, turn the can upside down and dispense a small amount of foam into the palm of your hand or directly onto the affected area. Gently rub it in.
Replace the cap after use.
Important Safety Precautions
This medication is flammable, so avoid using it near an open flame or while smoking.
Unless directed by your doctor, do not apply the medication to your face, underarms, or groin area.
Do not cover the treated area with bandages or dressings unless instructed to do so by your doctor.
Storage and Disposal
Store the medication at room temperature, away from heat and open flames. Do not freeze.
Do not puncture or burn the can, even if it appears empty.
Keep all medications in a safe place, out of the reach of children and pets.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not apply extra doses or double doses to make up for a missed dose.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue using the medication as directed, even if your symptoms improve.
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.
Do not apply the medication to the vaginal area.
Wash your hands before and after use, unless your hand is the area being treated. In that case, do not wash your hand after applying the medication.
Clean and dry the affected area before applying the medication.
Shake the can well before use.
To apply, turn the can upside down and dispense a small amount of foam into the palm of your hand or directly onto the affected area. Gently rub it in.
Replace the cap after use.
Important Safety Precautions
This medication is flammable, so avoid using it near an open flame or while smoking.
Unless directed by your doctor, do not apply the medication to your face, underarms, or groin area.
Do not cover the treated area with bandages or dressings unless instructed to do so by your doctor.
Storage and Disposal
Store the medication at room temperature, away from heat and open flames. Do not freeze.
Do not puncture or burn the can, even if it appears empty.
Keep all medications in a safe place, out of the reach of children and pets.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not apply extra doses or double doses to make up for a missed dose.
Lifestyle & Tips
- Wash hands before and after applying the foam.
- Shake the can well before use.
- Invert the can and dispense a small amount of foam onto a clean surface (not directly onto hands, as it will melt).
- Gently massage the foam into the affected skin area until it disappears.
- Do not use more than directed or for longer than 2 weeks, as this can increase the risk of side effects.
- Do not use on the face, groin, or armpits, or for diaper rash unless specifically directed by a doctor.
- Avoid contact with eyes.
- Do not cover the treated area with bandages or other dressings unless instructed by your doctor, as this can increase absorption.
- Keep the foam away from open flames or heat, as it is flammable.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected skin areas once daily for up to 2 weeks. Treatment should be limited to 2 weeks and total dosage should not exceed 50 grams per week.
Condition-Specific Dosing:
plaquePsoriasis:
Apply a thin layer to affected skin areas once daily for up to 2 weeks. Treatment should be limited to 2 weeks and total dosage should not exceed 50 grams per week.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established. Safety and effectiveness in pediatric patients under 12 years of age have not been established. Use in children is generally not recommended due to higher risk of systemic absorption and adrenal suppression.
Adolescent:
Not established. Safety and effectiveness in pediatric patients under 12 years of age have not been established. Use in children is generally not recommended due to higher risk of systemic absorption and adrenal suppression.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended due to minimal systemic absorption.
Moderate:
No specific adjustment recommended due to minimal systemic absorption.
Severe:
No specific adjustment recommended due to minimal systemic absorption.
Dialysis:
No specific adjustment recommended due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment recommended due to minimal systemic absorption.
Moderate:
No specific adjustment recommended due to minimal systemic absorption.
Severe:
No specific adjustment recommended due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Halobetasol propionate is a super-high potency corticosteroid. Corticosteroids exert their effects by binding to glucocorticoid receptors in the cytoplasm, forming a complex that translocates to the nucleus. This complex then binds to specific DNA sequences (glucocorticoid response elements), modulating gene transcription. This leads to the synthesis of anti-inflammatory proteins (e.g., lipocortins, which inhibit phospholipase A2, thereby reducing the synthesis of prostaglandins and leukotrienes) and the repression of pro-inflammatory proteins (e.g., cytokines, adhesion molecules). This results in anti-inflammatory, antipruritic, and vasoconstrictive actions.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption; varies with skin integrity, vehicle, duration of exposure, and use of occlusive dressings. Approximately 6% of the applied dose was absorbed systemically in one study with halobetasol propionate cream.
Tmax:
Not applicable for topical systemic absorption, as peak plasma levels are often below detection limits or highly variable.
FoodEffect:
Not applicable (topical administration).
Distribution:
Vd:
Not available (minimal systemic absorption)
ProteinBinding:
Not available (minimal systemic absorption)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not precisely determined for topical application due to minimal systemic absorption; systemically absorbed corticosteroids are generally eliminated renally.
Clearance:
Not available (minimal systemic absorption)
ExcretionRoute:
Renal (primarily for systemically absorbed drug)
Unchanged:
Not available (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Within hours to days for anti-inflammatory and antipruritic effects.
PeakEffect:
Within days to 1-2 weeks of consistent application.
DurationOfAction:
Effects persist as long as treatment is continued; rapid relapse upon discontinuation if underlying condition is not resolved.
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 attention immediately:
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
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of Cushing's syndrome, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Signs of a weak adrenal gland, including:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Irritation where the medication was applied
Thinning of the skin
Changes in eyesight
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Burning or stinging
Dry skin
* Itching
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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 attention immediately:
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
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of Cushing's syndrome, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Signs of a weak adrenal gland, including:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Irritation where the medication was applied
Thinning of the skin
Changes in eyesight
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Burning or stinging
Dry skin
* Itching
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Increased redness, itching, or irritation at the application site.
- Signs of skin thinning (e.g., easy bruising, shiny skin, stretch marks).
- New or worsening skin infection (e.g., pus, fever).
- Unusual hair growth.
- Acne-like breakouts.
- Symptoms of systemic steroid absorption: unexplained weight gain, swelling in ankles/feet, increased thirst/urination, muscle weakness, fatigue, mood changes.
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 symptoms you experienced with the allergy.
The presence of an infection at the site where this medication will be administered.
Special Considerations for Children:
If the patient is under 12 years of age, do not administer this medication. This medication is not approved for use in children younger than 12 years.
Interactions with Other Medications and Health Conditions:
This is not an exhaustive list of all potential interactions. Therefore, it is crucial to discuss the following with your doctor and pharmacist:
All medications you are currently taking, including prescription and over-the-counter (OTC) medications, natural products, and vitamins.
Any health problems you have or have had in the past.
To ensure safe use, verify that it is safe to take this medication with all 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 symptoms you experienced with the allergy.
The presence of an infection at the site where this medication will be administered.
Special Considerations for Children:
If the patient is under 12 years of age, do not administer this medication. This medication is not approved for use in children younger than 12 years.
Interactions with Other Medications and Health Conditions:
This is not an exhaustive list of all potential interactions. Therefore, it is crucial to discuss the following with your doctor and pharmacist:
All medications you are currently taking, including prescription and over-the-counter (OTC) medications, natural products, and vitamins.
Any health problems you have or have had in the past.
To ensure safe use, verify that it is safe to take this medication with all 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. Before using any other medications or skin products, such as soaps, consult with your doctor to ensure safe use.
To minimize potential risks, avoid applying this medication to cuts, scrapes, or damaged skin. When applying it to a large area of skin or near open wounds, exercise caution and discuss the use with your doctor.
Adhere to your doctor's prescribed treatment duration and do not use this medication for longer than recommended. Additionally, do not use this medication to treat acne, rosacea, or perioral dermatitis (a rash around the mouth).
Be aware that this medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to weigh the benefits and risks of using this medication. When breastfeeding, avoid applying the medication directly to the nipple or the surrounding area.
For pediatric patients, use this medication with caution, as children may be more susceptible to certain side effects. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Consult your doctor to discuss the potential risks and benefits.
To minimize potential risks, avoid applying this medication to cuts, scrapes, or damaged skin. When applying it to a large area of skin or near open wounds, exercise caution and discuss the use with your doctor.
Adhere to your doctor's prescribed treatment duration and do not use this medication for longer than recommended. Additionally, do not use this medication to treat acne, rosacea, or perioral dermatitis (a rash around the mouth).
Be aware that this medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to weigh the benefits and risks of using this medication. When breastfeeding, avoid applying the medication directly to the nipple or the surrounding area.
For pediatric patients, use this medication with caution, as children may be more susceptible to certain side effects. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Consult your doctor to discuss the potential risks and benefits.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic absorption and symptoms of hypercorticism (Cushing's syndrome), including moon face, buffalo hump, central obesity, skin thinning, easy bruising, muscle weakness, and adrenal suppression.
- Acute overdose is unlikely due to topical route.
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call a poison control center (1-800-222-1222) or seek emergency medical attention if severe symptoms occur.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition (e.g., erythema, scaling, pruritus)
Rationale: To assess baseline severity of the dermatosis and guide treatment.
Timing: Prior to initiation of therapy.
Adrenal function (e.g., plasma cortisol levels, ACTH stimulation test)
Rationale: To assess for potential hypothalamic-pituitary-adrenal (HPA) axis suppression, especially with extensive use, prolonged duration, or in pediatric patients.
Timing: Consider for patients at high risk of systemic absorption (e.g., large surface area, occlusive dressings, prolonged use).
Routine Monitoring
Skin condition (e.g., signs of improvement, adverse reactions like atrophy, striae, telangiectasias, folliculitis)
Frequency: Regularly during treatment (e.g., weekly or bi-weekly)
Target: Improvement of dermatosis symptoms without significant local adverse effects.
Action Threshold: Worsening of condition, development of local adverse effects, or lack of improvement after 2 weeks should prompt re-evaluation.
Signs and symptoms of HPA axis suppression (e.g., fatigue, weakness, nausea, vomiting, hypotension)
Frequency: Periodically, especially with prolonged or extensive use.
Target: Absence of symptoms.
Action Threshold: If symptoms occur, consider HPA axis testing and/or discontinuation/tapering of the topical corticosteroid.
Symptom Monitoring
- Skin irritation (burning, itching, stinging)
- Folliculitis
- Acneiform eruptions
- Hypopigmentation
- Perioral dermatitis
- Allergic contact dermatitis
- Skin atrophy (thinning, striae, telangiectasias)
- Signs of secondary infection
- Symptoms of systemic corticosteroid effects (e.g., Cushing's syndrome, hyperglycemia, glucosuria, adrenal suppression)
Special Patient Groups
Pregnancy
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. High-potency corticosteroids should generally be avoided or used with extreme caution during pregnancy.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity with high doses of corticosteroids in animal studies; human data are limited but generally do not show increased risk with topical use.
Second Trimester:
Risk of fetal growth restriction or other adverse effects with prolonged or extensive use of potent corticosteroids.
Third Trimester:
Risk of HPA axis suppression in the newborn if used extensively by the mother near term.
Lactation
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when Lexette is administered to a nursing woman. Advise nursing mothers to use the medication for the shortest duration and on the smallest area of skin possible. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with minimal systemic absorption, but potential for growth suppression or other adverse effects if significant amounts are absorbed by the infant.
Pediatric Use
Safety and effectiveness in pediatric patients under 12 years of age have not been established. Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature adults due to a larger skin surface area to body weight ratio. Prolonged use should be avoided. Not recommended for use in children under 12 years.
Geriatric Use
Clinical studies of Lexette foam did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Elderly patients may have thinner skin, increasing susceptibility to local adverse effects.
Clinical Information
Clinical Pearls
- Lexette foam is a super-high potency topical corticosteroid; limit treatment duration to 2 weeks to minimize risk of local and systemic side effects.
- Total dosage should not exceed 50 grams per week.
- Avoid use on the face, groin, or axillae due to increased risk of skin atrophy and other local side effects in these sensitive areas.
- Instruct patients to shake the can well and dispense foam onto a cool surface (e.g., saucer) rather than directly into hands, as the foam melts quickly on warm skin.
- Monitor for signs of HPA axis suppression, especially in pediatric patients or with extensive/prolonged use.
- Flammable product; advise patients to avoid fire, flame, or smoking during and immediately after application.
Alternative Therapies
- Clobetasol propionate (various formulations: cream, ointment, foam, solution, spray) - another super-high potency topical corticosteroid.
- Betamethasone dipropionate, augmented (cream, ointment, lotion) - super-high potency.
- Fluocinonide (cream, ointment, gel, solution) - high potency.
- Other topical corticosteroids of varying potencies depending on the severity and location of the dermatosis.
Cost & Coverage
Average Cost:
Varies widely, typically $500 - $1000+ per 50gm can
Insurance Coverage:
Tier 3 or 4 (Non-preferred brand or Specialty)
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's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.