Lexette foam

Lexette foam was a super high-potency, Class I corticosteroid foam that is applied to the skin to reduce inflammation and itching caused by plaque psoriasis in adults and children 12 years of age and older. Lexette contains halobetasol propionate 0.05%. Branded Lexette foam has been discontinued, but generic halobetasol propionate foam is still available.

The foam is applied as a thin layer to the affected areas of the skin for a maximum of 2 consecutive weeks. Lexette foam is flammable, and you should avoid heat, open flames, or smoking while using this product. The canister may explode if it gets too hot. Do not puncture or burn an empty canister.

Lexette foam was FDA approved on May 24, 2018.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Lexette foam is a highly potent, Class I corticosteroid that can be absorbed through the skin into the bloodstream and cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency, including Cushing’s syndrome, hyperglycemia, and glucosuria. Do not use for longer than 2 weeks and do not use more than 50 grams per week. Periodic monitoring for HPA suppression may be required.

You should not use Lexette if you are allergic to it.

Lexette foam should not be applied to lesions that are exuding serum or to skin folds (where two areas of skin touch each other).

Tell your doctor if you have ever had:

• any type of skin infection;
• a skin reaction to any steroid medicine;
• liver disease; or
• an adrenal gland disorder; or
• plan to have surgery.

Topical corticosteroids can increase the glucose (sugar) levels in your blood or urine. Tell your doctor if you have diabetes.

Children are more susceptible to systemic absorption of topical corticosteroids. Lexette foam is not approved for use by children under the age of 12.

It is not known whether Lexette foam will harm an unborn baby. Tell your doctor if you are pregnant. If you are instructed to use the foam, use a small amount for the shortest time possible.

It may not be safe to breastfeed while using this medicine. If you are instructed to Lexette foam, use a small amount for the shortest time possible. Do not apply to the breasts.

Get emergency medical help if you have signs of an allergic reaction to Lexette foam, such as hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• worsening of your skin condition;
• redness, warmth, swelling, oozing, or severe irritation of any treated skin;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor; or
• possible signs of absorbing this medicine through your skin - weight gain (especially in your face or your upper back and torso), slow wound healing, thinning or discolored skin, increased body hair, muscle weakness, nausea, diarrhea, tiredness, mood changes, menstrual changes, sexual changes.

Common Lexette side effects may include:

• headache
• pain where the foam was applied.

Other side effects reported with topical corticosteroids include:

• burning, stinging, itching, or dryness of treated skin
• redness or crusting around your hair follicles
• stretch marks
• spider veins.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Use Lexette foam exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Do not take it by mouth. Topical medicine is for use only on the skin. Do not use on open wounds or sunburned, windburned, dry, or irritated skin. Avoid getting this medicine in your eyes, mouth, or vagina. Rinse with water if contact occurs.

• Wash your hands before and after using Lexette foam unless you are using this medicine to treat the skin on your hands.
• Shake the foam before each use.
• Press down on the actuator to dispense a small amount of foam into your hand.
• Apply a thin layer of Lexette foam to the affected area twice daily as directed by your doctor. Rub in gently and completely. Do not apply this medicine over a large area of skin unless your doctor has told you to.

Do not cover the treated skin area with a bandage or other covering unless your doctor tells you to. Covering treated areas can increase the amount of medicine absorbed through your skin and may cause harmful effects.

Lexette foam is for short-term use only up to 2 weeks. Follow your doctor's dosing instructions very carefully. Do not use more than 50 grams per week.

Call your doctor if your symptoms do not improve after 2 weeks, or if they get worse. Stop using the product if your symptoms improve sooner.

Apply the product as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

High doses or long-term use of Lexette foam can lead to thinning skin, easy bruising, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

• Avoid heat, flame, or smoking during and right after applying Lexette to your skin, because it is flammable.
• Avoid applying Lexette foam to your face, scalp, underarms, or groin area.
• Do not use Lexette foam to treat any skin condition that has not been checked by your doctor.
• Avoid using other topical steroid medications on the areas you treat with Lexette foam unless your doctor tells you to.

Lexette foam is unlikely to interact with other medications you may take. But you should not use it with other topical or oral corticosteroids, because they may have an additive effect.

Tell your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Store at room temperature 20°C – 25°C (68°F – 77°F). Do not freeze.

The contents of Lexette foam are under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 49°C (120°F).

Keep out of reach of children.

Active: halobetasol propionate 0.05%.

Inactive: alcohol (specially denatured alcohol [SDA]), benzoic acid, cetostearyl alcohol, emulsifying wax, polyoxyl 20 cetostearyl ether, propylene glycol, and purified water.

Available in 50-gram aluminum canisters pressurized with a hydrocarbon propellant containing isobutane and propane.

Pharmasol Corporation for Mayne Pharma.