Lexette foam

Lexette foam

Lexette foam

What is Lexette?

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

Lexette foam was approved by the FDA on May 24, 2018.

Warnings

Follow all instructions on the label and packaging of your medicine. Tell each of your healthcare providers about all your medical conditions, allergies and any medications you take.

Lexette foam is a highly potent Class I corticosteroid that can be absorbed into the bloodstream through the skin and causes reversible suppression of the hypothalamic-pituitary-adrenal (HPA) axis with the possibility of 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. Regular monitoring of HPA suppression may be required.

Before you take this medicine

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

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

Tell your doctor if you have ever had:

• jede Art von Hautinfektion;
• eine Hautreaktion auf Steroidmedikamente;
• Leber erkrankung; oder
• eine Störung der Nebenniere.

Topical corticosteroids may increase the level of glucose (sugar) 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 young adults and children under 18 years of age.

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

Breastfeeding may not be safe while using this medication. When using Lexette foam, use a small amount for as short a time as possible. Do not apply to breasts.

How do I use Lexette foam?

Use Lexette foam exactly as directed by your doctor. Follow all instructions on your prescription label and read any medication guides or instructions for use.

Do not take it orally. Topical medicines should only be used on the skin. Do not use on open wounds or sunburned, windburned, dry or irritated skin. If it gets into your eyes or mouth, rinse it with water.

• Waschen Sie Ihre Hände vor und nach der Anwendung von Lexette-Schaum, es sei denn, Sie verwenden dieses Arzneimittel zur Behandlung der Haut an Ihren Händen.
• Schütteln Sie den Schaum vor jedem Gebrauch.
• Drücken Sie den Auslöser nach unten, um eine kleine Menge Schaum in Ihre Hand zu verteilen.
• Tragen Sie nach Anweisung Ihres Arztes zweimal täglich eine dünne Schicht Lexette-Schaum auf die betroffene Stelle auf. Sanft und vollständig einmassieren. Tragen Sie dieses Arzneimittel nicht auf einer großen Hautfläche auf, es sei denn, Ihr Arzt hat es Ihnen verordnet.

Do not cover the treated area of ​​skin with a bandage or other covering unless your doctor tells you to do so. Covering the treated areas may increase the absorption of the medication through the skin and may cause harmful effects.

Lexette foam is only suitable for short-term use of up to 2 weeks. Follow your doctor's dosage 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 worsen. Stop using the product if your symptoms improve sooner.

What happens if I miss a dose?

Use the product as soon as possible, but skip the missed dose if it is almost time for the next dose. Do not apply two doses at the same time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help hotline at 1-800-222-1222 if someone accidentally swallows the medication.

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

What should I avoid when using Lexette foam?

• Vermeiden Sie Hitze, Flammen oder Rauchen während und direkt nach dem Auftragen von Lexette auf Ihre Haut, da es brennbar ist.
• Vermeiden Sie es, Lexette-Schaum auf Gesicht, Kopfhaut, Achselhöhlen oder Leistengegend aufzutragen.
• Verwenden Sie Lexette-Schaum nicht zur Behandlung von Hauterkrankungen, die nicht von Ihrem Arzt untersucht wurden.
• Vermeiden Sie die Anwendung anderer topischer Steroidmedikamente an den Stellen, die Sie mit Lexette-Schaum behandeln, es sei denn, Ihr Arzt fordert Sie dazu auf.

What side effects does Lexette foam have?

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

Call your doctor immediately if you have:

• Verschlechterung Ihres Hautzustands;
• Rötung, Wärme, Schwellung, Nässen oder starke Reizung der behandelten Haut;
• verschwommenes Sehen, Tunnelblick, Augenschmerzen oder das Sehen von Lichthöfen um Lichter herum;
• hoher Blutzucker – erhöhter Durst, vermehrtes Wasserlassen, trockener Mund, fruchtiger Atemgeruch; oder
• Mögliche Anzeichen einer Aufnahme dieses Arzneimittels über die Haut – Gewichtszunahme (insbesondere im Gesicht oder im oberen Rücken und Rumpf), langsame Wundheilung, dünner werdende oder verfärbte Haut, vermehrte Körperbehaarung, Muskelschwäche, Übelkeit, Durchfall, Müdigkeit, Stimmungsschwankungen, Menstruationsveränderungen, sexuelle Veränderungen.

Common side effects of Lexette may include:

• Kopfschmerzen
• Schmerzen an der Stelle, an der der Schaum aufgetragen wurde.

Other side effects reported with topical corticosteroids include:

• Brennen, Stechen, Jucken oder Trockenheit der behandelten Haut
• Rötung oder Krustenbildung um Ihre Haarfollikel
• Dehnungsstreifen
• Besenreiser.

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

What other drugs will affect Lexette foam?

Lexette foam is unlikely to interact with other medications you may be taking. However, you should not use it with other topical or oral corticosteroids as they may have an additive effect.

Tell your doctor about all medications you take, including prescription and over-the-counter medications, vitamins, and herbal products.

storage

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

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

Keep out of the reach of children.

Ingredients

Active:Halobetasol propionate 0.05%.

Inactive:Alcohol (especially 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.

Manufacturer

Pharmasol Corporation for Mayne Pharma.

References

1. FDA-Produktinformationen

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