Olux
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Questions & Answers
Side Effects & Adverse Reactions
FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION. Keep out of reach of children. Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C).
Manufactured for
Stiefel Laboratories, Inc.
Research Triangle Park, NC 27709
For additional information:
1-888-784-3335 (STIEFEL)
or visit
www.olux.com
OLX:1PI
OLUX is a registered trademark of Stiefel Laboratories, Inc.
©2011 Stiefel Laboratories, Inc.
March 2011
Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146
Legal Issues
There is currently no legal information available for this drug.
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
Olux Foam is a super-potent topical corticosteroid indicated for short-term topical treatment of the inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp, and for short-term topical treatment of mild to moderate plaque-type psoriasis of non-scalp regions excluding the face and intertriginous areas.
Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. In a controlled pharmacokinetic study, some subjects experienced reversible suppression of the adrenals following 14 days of OLUX Foam therapy (See ADVERSE REACTIONS).
Use in children under 12 years of age is not recommended.
History
There is currently no drug history available for this drug.
Other Information
Olux Foam contains 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 pregna-1,4-diene-3,20-dione, 21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-, (11β,16β)-, with the empirical formula C25H32CIFO5, a molecular weight of 466.97. The following is the chemical structure:
clobetasol propionate
Clobetasol propionate is a white or almost white, odorless, crystalline powder and is insoluble in water.
Olux® (clobetasol propionate) Foam, 0.05%, contains 0.5 mg clobetasol propionate, USP, per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, citric acid, ethanol (60%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant.
Sources
Olux Manufacturers
-
Physicians Total Care, Inc.
![Olux (Clobetasol Propionate) Aerosol, Foam [Physicians Total Care, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Olux | Physicians Total Care, Inc.
Note: For proper dispensing of foam, hold the can upside down and depress the actuator.
Olux Foam should be applied to the affected area twice daily, once in the morning and once at night. Invert the can and dispense a small amount of Olux Foam (up to a maximum of a golf-ball-size dollop or one and a half capfuls) into the cap of the can, onto a saucer or other cool surface, or to the lesion, taking care to avoid contact with the eyes. Dispensing directly onto hands is not recommended (unless the hands are the affected area), as the foam will begin to melt immediately upon contact with warm skin. When applying Olux Foam to a hair-bearing area, move the hair away from the affected area so that the foam can be applied to each affected area. Pick up small amounts with fingertips and gently massage into affected area until the foam disappears. Repeat until entire affected area is treated.
Apply the smallest amount possible that sufficiently covers the affected area(s). No more than one and a half capfuls of foam should be used at each application. Do not apply to face or intertriginous areas.
Olux Foam is a super-high-potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used. Use in pediatric patients under 12 years of age is not recommended.
Unless directed by a physician, Olux Foam should not be used with occlusive dressings.
-
Stiefel Laboratories Inc
Olux | Stiefel Laboratories Inc
Note: For proper dispensing of foam, hold the can upside down and depress the actuator.
Olux Foam should be applied to the affected area twice daily, once in the morning and once at night. Invert the can and dispense a small amount of Olux Foam (up to a maximum of a golf-ball-size dollop or one and a half capfuls) into the cap of the can, onto a saucer or other cool surface, or to the lesion, taking care to avoid contact with the eyes. Dispensing directly onto hands is not recommended (unless the hands are the affected area), as the foam will begin to melt immediately upon contact with warm skin. When applying Olux Foam to a hair-bearing area, move the hair away from the affected area so that the foam can be applied to each affected area. Pick up small amounts with fingertips and gently massage into affected area until the foam disappears. Repeat until entire affected area is treated.
Apply the smallest amount possible that sufficiently covers the affected area(s). No more than one and a half capfuls of foam should be used at each application. Do not apply to face or intertriginous areas.
Olux Foam is a super-high-potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used. Use in pediatric patients under 12 years of age is not recommended.
Unless directed by a physician, Olux Foam should not be used with occlusive dressings.
-
Prestium Pharma, Inc.
Olux | Prestium Pharma, Inc.
Note: For proper dispensing of foam, hold the can upside down and depress the actuator.
Olux Foam should be applied to the affected area twice daily, once in the morning and once at night. Invert the can and dispense a small amount of Olux Foam (up to a maximum of a golf-ball-size dollop or one and a half capfuls) into the cap of the can, onto a saucer or other cool surface, or to the lesion, taking care to avoid contact with the eyes. Dispensing directly onto hands is not recommended (unless the hands are the affected area), as the foam will begin to melt immediately upon contact with warm skin. When applying Olux Foam to a hair-bearing area, move the hair away from the affected area so that the foam can be applied to each affected area. Pick up small amounts with fingertips and gently massage into affected area until the foam disappears. Repeat until entire affected area is treated.
Apply the smallest amount possible that sufficiently covers the affected area(s). No more than one and a half capfuls of foam should be used at each application. Do not apply to face or intertriginous areas.
Olux Foam is a super-high-potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used. Use in pediatric patients under 12 years of age is not recommended.
Unless directed by a physician, Olux Foam should not be used with occlusive dressings.
![Olux (Clobetasol Propionate) Aerosol, Foam [Stiefel Laboratories Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8e913e0c-24c8-4e4b-9212-8d7bd6aabdb4&name=4f12a9d1-60f9-4a98-ae04-af63a251f9e3-03.jpg)
![Olux (Clobetasol Propionate) Aerosol, Foam [Prestium Pharma, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=39dd7b1d-fc08-403a-b032-eff906be136d&name=olux-foam-4.jpg)
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