Lexette 0.05% Top Foam 50gm (2pk)
It is used to treat plaque psoriasis.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Corticosteroid, Anti-inflammatory
Pregnancy Category
Category C
FDA Approved
Jun 2018
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lexette foam is a strong medicine called a corticosteroid that is applied to the skin to help reduce redness, itching, and scaling caused by plaque psoriasis. It works by calming down the skin's immune response.
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 vagina.
Wash your hands before and after applying the medication, unless your hand is the treated area. In that case, do not wash your hand after application.
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 two doses at the same time or use extra doses.
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 vagina.
Wash your hands before and after applying the medication, unless your hand is the treated area. In that case, do not wash your hand after application.
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 two doses at the same time or use extra doses.
Lifestyle & Tips
- Apply a thin layer of foam to the affected skin areas once daily. Gently rub it in until it disappears.
- Wash your hands before and after applying the foam.
- Do not use more than 50 grams of foam per week.
- Do not use for longer than 2 weeks unless directed by your doctor.
- Avoid applying the foam to your face, groin, or armpits, or if skin atrophy is present at the treatment site, unless specifically instructed by your doctor.
- Do not cover the treated area with bandages or other dressings unless directed by your doctor, as this can increase absorption.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- This medicine is for external use only. Do not swallow it.
- Keep out of reach of children.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected areas once daily for up to 2 weeks.
Condition-Specific Dosing:
maxWeeklyDose:
Do not exceed 50 grams per week.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and efficacy not established in patients under 12 years of age)
Adolescent:
Apply a thin layer to affected areas once daily for up to 2 weeks (for patients 12 years and older with plaque psoriasis).
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed due to minimal systemic absorption.
Moderate:
No specific adjustment needed due to minimal systemic absorption.
Severe:
No specific adjustment needed due to minimal systemic absorption.
Dialysis:
No specific adjustment needed due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment needed due to minimal systemic absorption.
Moderate:
No specific adjustment needed due to minimal systemic absorption.
Severe:
No specific adjustment needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Halobetasol propionate is a high-potency synthetic corticosteroid. It exhibits anti-inflammatory, antipruritic, and vasoconstrictive properties. The exact mechanism of action of corticosteroids in treating dermatoses is unclear, but it is thought to involve the induction of phospholipase A2 inhibitory proteins (lipocortins), which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid.
Pharmacokinetics
Absorption:
Bioavailability:
Not precisely quantified for topical application; systemic absorption is minimal but can occur, especially with prolonged use, large surface areas, occlusive dressings, or compromised skin barrier.
Tmax:
Not applicable for topical application; systemic absorption is variable.
FoodEffect:
Not applicable
Distribution:
Vd:
Not well-defined for topical application; systemically absorbed corticosteroids are bound to plasma proteins.
ProteinBinding:
Not well-defined for topical application; systemically absorbed corticosteroids are bound to plasma proteins, primarily transcortin and albumin.
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not precisely quantified for topical application; systemically absorbed corticosteroids are primarily excreted renally.
Clearance:
Not precisely quantified for topical application.
ExcretionRoute:
Primarily renal (for systemically absorbed drug), also biliary.
Unchanged:
Not precisely quantified for topical application.
Pharmacodynamics
OnsetOfAction:
Within days for anti-inflammatory and antipruritic effects.
PeakEffect:
Typically within 1-2 weeks of consistent application.
DurationOfAction:
Effects persist as long as applied; treatment duration is limited to 2 weeks.
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 potential 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 potential 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.
- Thinning of the skin, stretch marks, or changes in skin color where the foam is applied.
- Acne-like breakouts or hair bumps (folliculitis).
- Signs of infection (e.g., pus, worsening redness, warmth, fever).
- Unusual tiredness, weakness, nausea, vomiting, dizziness, or low blood pressure (signs of adrenal gland problems).
- Increased thirst or urination (signs of high blood sugar).
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. Be sure to describe the symptoms you experienced.
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. It is not intended for use in children younger than 12 years old.
To ensure safe use, it is crucial to disclose all of the following to your doctor and pharmacist:
A complete list of your current medications, including prescription and over-the-counter drugs, natural products, and vitamins.
Any existing health problems.
Your doctor and pharmacist will help determine whether it is safe to take this medication with your other drugs and health conditions. 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:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
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. It is not intended for use in children younger than 12 years old.
To ensure safe use, it is crucial to disclose all of the following to your doctor and pharmacist:
A complete list of your current medications, including prescription and over-the-counter drugs, natural products, and vitamins.
Any existing health problems.
Your doctor and pharmacist will help determine whether it is safe to take this medication with your other drugs and health conditions. Never start, stop, or adjust the dosage 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 use this medication safely, avoid applying it to cuts, scrapes, or damaged skin. When applying it to a large area of skin or near open wounds, exercise caution and discuss with your doctor. Do not use this medication for a longer duration than prescribed by your doctor.
This medication is not intended to treat acne, rosacea, or rashes around the mouth. Be aware that it may increase the risk of developing cataracts or glaucoma, and consult with your doctor about this potential risk.
If you are pregnant, planning to become pregnant, or breastfeeding, discuss the benefits and risks of using this medication with your doctor. When breastfeeding, avoid applying the medication directly to the nipple or the surrounding area.
For children, this medication should be used with caution, as the risk of certain side effects may be higher. In some cases, it may affect growth in children and teenagers, and regular growth checks may be necessary. Consult with your doctor to discuss the potential risks and benefits.
To use this medication safely, avoid applying it to cuts, scrapes, or damaged skin. When applying it to a large area of skin or near open wounds, exercise caution and discuss with your doctor. Do not use this medication for a longer duration than prescribed by your doctor.
This medication is not intended to treat acne, rosacea, or rashes around the mouth. Be aware that it may increase the risk of developing cataracts or glaucoma, and consult with your doctor about this potential risk.
If you are pregnant, planning to become pregnant, or breastfeeding, discuss the benefits and risks of using this medication with your doctor. When breastfeeding, avoid applying the medication directly to the nipple or the surrounding area.
For children, this medication should be used with caution, as the risk of certain side effects may be higher. In some cases, it may affect growth in children and teenagers, and regular growth checks may be necessary. Consult with your doctor to discuss the potential risks and benefits.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic absorption, potentially causing Cushing's syndrome (e.g., moon face, buffalo hump, central obesity), hyperglycemia, glucosuria, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis.
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control Center) for advice.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of plaque psoriasis and identify areas for treatment.
Timing: Prior to initiation of therapy.
Area of body surface affected
Rationale: To ensure appropriate application area and avoid excessive use, which can increase systemic absorption.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical response (reduction in plaque psoriasis symptoms)
Frequency: Weekly or as clinically indicated during the 2-week treatment period.
Target: Improvement in erythema, induration, and scaling.
Action Threshold: If no improvement or worsening, re-evaluate diagnosis and treatment.
Signs of local adverse reactions (e.g., atrophy, striae, telangiectasias, folliculitis, irritation)
Frequency: At each follow-up visit and patient self-monitoring.
Target: Absence of or minimal local reactions.
Action Threshold: Discontinue if severe reactions occur; consider alternative therapy.
Signs/symptoms of HPA axis suppression (e.g., fatigue, weakness, nausea, vomiting, hypotension)
Frequency: Periodically, especially with prolonged use, large surface areas, or occlusive dressings.
Target: Normal adrenal function.
Action Threshold: If suspected, perform HPA axis suppression tests (e.g., ACTH stimulation test, morning plasma cortisol). Discontinue or reduce frequency if suppression occurs.
Symptom Monitoring
- Application site reactions (burning, stinging, itching, dryness, erythema, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, miliaria)
- Signs of systemic absorption (Cushing's syndrome, hyperglycemia, glucosuria, HPA axis suppression)
- Signs of infection (redness, swelling, pus, fever)
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant women. Corticosteroids have been shown to be teratogenic in animals. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity observed in animal studies with corticosteroids.
Second Trimester:
Risk of fetal growth restriction or other adverse effects with prolonged or high-dose use of potent corticosteroids.
Third Trimester:
Risk of HPA axis suppression in the newborn if used extensively or for prolonged periods near term.
Lactation
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Use with caution in nursing mothers. If used, avoid application to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with limited, short-term use on small areas; higher risk with extensive or prolonged use due to potential for systemic absorption and excretion into breast milk.
Pediatric Use
Safety and efficacy in patients under 12 years of age have not been established. Pediatric patients may be more susceptible to systemic toxicity from topical corticosteroids due to a larger skin surface area to body weight ratio. Monitor for HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may have thinner skin and be more prone to skin atrophy or other local side effects.
Clinical Information
Clinical Pearls
- Lexette foam is a high-potency topical corticosteroid; limit treatment duration to 2 weeks to minimize risk of local and systemic side effects.
- Educate patients on proper application technique: apply a thin layer, gently rub in, and do not exceed the recommended amount or duration.
- Warn patients about potential for HPA axis suppression, especially with extensive use, occlusive dressings, or in pediatric patients.
- Avoid use on the face, groin, or axillae unless specifically directed by a physician, due to increased risk of adverse effects in these sensitive areas.
- If no improvement is seen after 2 weeks, re-evaluate the diagnosis and consider alternative treatments.
Alternative Therapies
- Other high-potency topical corticosteroids (e.g., clobetasol propionate, betamethasone dipropionate)
- Medium-potency topical corticosteroids (e.g., triamcinolone acetonide, fluocinolone acetonide)
- Vitamin D analogs (e.g., calcipotriene)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus)
- Topical retinoids (e.g., tazarotene)
- Systemic therapies for psoriasis (e.g., biologics, methotrexate, cyclosporine, apremilast)
- Phototherapy
Cost & Coverage
Average Cost:
$800 - $1200 per 50gm (2pk)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (Specialty/Non-preferred Brand)
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 this 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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.