Olux-E

What is Olux-E?

Olux-E Foam is a prescription corticosteroid medicine used on the skin (topical) to treat people 12 years of age and older with certain skin conditions that cause red, flaky, and itchy skin.

Olux-E Foam is not recommended for use in children under 12 years of age.

Olux-E Foam should not be used:

• on your face, underarms, or groin area
• if you have skin thinning (atrophy) at the treatment area

You should not use Olux-E Foam for longer than 2 weeks in a row.

You should not use more than 50 grams or 21 capfuls of Olux-E Foam in 1 week.

Description

Olux-E (clobetasol propionate) Foam, 0.05% is a white to off-white petrolatum-based emulsion aerosol foam containing the active ingredient clobetasol propionate USP, a synthetic corticosteroid for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.

Clobetasol propionate is 21-chloro-9-fluoro-11ß,17-dihydroxy-16ß-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32ClFO5, and a molecular weight of 466.97.

The following is the chemical structure:

Clobetasol propionate is a white to almost white crystalline powder, practically insoluble in water.

Each gram of Olux-E Foam contains 0.5 mg clobetasol propionate, USP. The foam also contains anhydrous citric acid, cetyl alcohol, cyclomethicone, isopropyl myristate, light mineral oil, polyoxyl 20 cetostearyl ether, potassium citrate monohydrate, propylene glycol, purified water, sorbitan monolaurate, white petrolatum, and phenoxyethanol as a preservative.

Olux-E Foam is dispensed from an aluminum can pressurized with a hydrocarbon (propane/butane) propellant.

Mechanism of Action

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in corticosteroid-responsive dermatoses is unknown.

What is the most important information I should know about Olux-E?

Important: For skin use only. Do not get Olux-E Foam in your eyes, mouth, or vagina.

What should I tell my healthcare provider before using Olux-E?

Before using Olux-E Foam, tell your healthcare provider about all of your medical conditions, including if you:

• have had irritation or other skin reaction to a steroid medicine in the past.
• have a skin infection. You may need medicine to treat the skin infection before using Olux-E Foam.
• have diabetes.
• have adrenal gland problems.
• have liver problems.
• plan to have surgery.
• are pregnant or plan to become pregnant. It is not known if Olux-E Foam will harm your unborn baby. If you use Olux-E Foam during pregnancy, use Olux-E Foam on the smallest area of skin and for the shortest time needed.
• are breastfeeding or plan to breastfeed. It is not known if Olux-E passes into your breast milk. If you use Olux-E Foam while breastfeeding, use Olux-E Foam on the smallest area of skin and for the shortest time needed. Do not apply Olux-E Foam directly to the nipple and areola to avoid getting Olux-E Foam into your baby’s mouth.

Tell your healthcare provider about all the medicine you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not use other products containing a corticosteroid medicine during treatment with Olux-E Foam without talking to your healthcare provider first.

How should I use Olux-E?

See the “Instructions for Use” that comes with Olux-E Foam.

• Use Olux-E Foam exactly as your healthcare provider tells you to use it.
• Apply a thin layer of Olux-E Foam to the affected area 2 times each day, 1 time in the morning and 1 time at night, or as directed by your healthcare provider.
• Do not bandage, wrap or cover your treated area unless your healthcare provider tells you to.
• Talk to your healthcare provider if your skin does not improve after 2 weeks of treatment with Olux-E Foam.
• Wash your hands after using Olux-E Foam.

What should I avoid while using Olux-E?

Olux-E Foam is flammable. Avoid heat, flame, or smoking during and right after you apply Olux-E Foam to your skin.

What are the possible side effects of Olux-E?

Olux-E Foam may cause serious side effects, including:

• Olux-E Foam can pass through your skin. Too much Olux-E Foam passing through your skin can cause adrenal glands to stop working.
• Cushing’s syndrome, a condition that happens when the body is exposed to too much of the hormone cortisol.
• High blood sugar (hyperglycemia)
• Vision problems. Olux-E Foam may increase your chance of developing vision problems such as cataract(s) and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during your treatment with Olux-E Foam.
• Skin reactions at the treated site. Tell your healthcare provider if you get any skin reactions or skin infections.
• Effects on growth and weight in children.

Your healthcare provider may do certain blood tests to check for side effects.

The most common side effects of Olux-E Foam include:

• thinning of skin
• burning
• redness
• itching
• dryness
• nausea

These are not all the side effects of Olux-E Foam.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Olux-E

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Olux-E Foam for a condition for which it was not prescribed. Do not give Olux-E Foam to other people, even if they have the same condition that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about Olux-E Foam that is written for health professionals.

How should I store Olux-E?

• Store Olux-E Foam at room temperature between 68° to 77°F (20° to 25°C).
• Do not break through (puncture) Olux-E Foam can.
• Never throw the can into a fire, even if the can is empty.
• Do not store Olux-E Foam near heat or at temperatures above 120°F (49°C).

Keep Olux-E Foam and all medicines out of the reach of children.

What are the ingredients in Olux-E?

Active ingredient: clobetasol propionate

Inactive ingredients: anhydrous citric acid, cetyl alcohol, cyclomethicone, isopropyl myristate, light mineral oil, polyoxyl 20 cetostearyl ether, potassium citrate monohydrate, propylene glycol, purified water, sorbitan monolaurate, white petrolatum, and phenoxyethanol as a preservative, pressurized with a hydrocarbon (propane/butane) propellant.

Label

PRINCIPAL DISPLAY PANEL – 0.05%

• NDC 0378-8147-50
• Olux-E®
  (clobetasol
  propionate)
  Foam, 0.05%
• EMULSION
  FORMULATION
• Rx only    50 g

SRC: NLM .