Olux-e label

Olux-e

Olux-e Recall

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Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

1.1 Indication

OLUX-E® Foam is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years and older.

1.2 Limitations of Use

•
OLUX-E Foam should not be applied to the face, axillae, or groin.
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OLUX-E Foam should not be used if there is skin atrophy at the treatment site.
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Treatment should be limited to 2 consecutive weeks and patients should not use greater than 50 grams or more than 21 capfuls per week.

History

There is currently no drug history available for this drug.

Other Information

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:

chemical structure of clobetasol propionate

Clobetasol propionate is a white to cream-colored 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.

Olux-e Manufacturers

  • Stiefel Laboratories Inc
    Olux-e | Stiefel Laboratories Inc
    No Recall

    Olux-e | Stiefel Laboratories Inc

    Olux-e | Stiefel Laboratories Inc

    OLUX-E Foam is not for oral, ophthalmic, or intravaginal use.

    Apply a thin layer of OLUX-E Foam to the affected area(s) twice daily, morning and evening for up to 2 consecutive weeks; therapy should be discontinued when control has been achieved. The maximum weekly dose should not exceed 50 g or an amount greater than 21 capfuls per week. For proper dispensing of foam, shake the can, hold it upside down, and depress the actuator. Dispense a small amount of foam (about a capful) and gently massage the medication into the affected areas (excluding the face, groin, and axillae) until the foam is absorbed. Avoid contact with the eyes.

  • Prestium Pharma, Inc.
    Olux-e | Costco Wholesale Company
    No Recall

    Olux-e | Costco Wholesale Company

    Olux-e | Costco Wholesale Company

    adults and children 6 years and over

    one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.

    adults 65 years and over

    ask a doctor

    children under 6 years of age

    ask a doctor

    consumers with liver or kidney disease

    ask a doctor