Olux Information
Olux (Clobetasol)
Olux (Clobetasol) Description
Olux (Clobetasol) 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 CH CIFO, a molecular weight of 466.97. The following is the chemical structure:
Clobetasol propionate is a white or almost white, odorless, crystalline powder and is insoluble in water.
Olux (Clobetasol) (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.
Olux (Clobetasol) Clinical Pharmacology
Like other topical corticosteroids, clobetasol propionate foam has anti-inflammatory, antipruritic, and vasoconstrictive properties. The precise mechanism of the anti-inflammatory activity of topical steroids in the treatment of steroid-responsive dermatoses, in general, is uncertain. However, corticosteroids are thought to act by the induction of phospholipase A inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A.
Olux (Clobetasol) Indications And Usage
Olux (Clobetasol) 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 (Clobetasol) Foam therapy (See ).
Use in children under 12 years of age is not recommended.
Olux (Clobetasol) Contraindications
Olux (Clobetasol) Foam is contraindicated in patients who are hypersensitive to clobetasol propionate, to other corticosteroids, or to any ingredient in this preparation.
Olux (Clobetasol) Precautions
Conditions which augment systemic absorption include the application of more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.
Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of adrenal suppression. If adrenal suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.
Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.
Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. See .
If irritation develops, Olux (Clobetasol) Foam should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than by noting a clinical exacerbation, as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.
In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, use of Olux (Clobetasol) Foam should be discontinued until the infection has been adequately controlled.
The following tests may be helpful in evaluating patients for adrenal suppression:
ACTH stimulation test
A.M. plasma cortisol test
Urinary free cortisol test
Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate.
Clobetasol propionate was non-mutagenic in three different test systems: the Ames test, the gene conversion assay, and the B WP2 fluctuation test.
Studies in the rat following subcutaneous administration of clobetasol propionate at dosage levels up to 0.05 mg/kg per day revealed that the females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose.
Safety and effectiveness of Olux (Clobetasol) Foam in pediatric patients have not been established; therefore, use in children under 12 years of age is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of adrenal suppression and Cushing’s syndrome when they are treated with topical corticosteroids. Pediatric patients are therefore at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.
Adrenal suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Olux (Clobetasol) Adverse Reactions
In a controlled pharmacokinetic study, 5 of 13 subjects experienced reversible suppression of the adrenals at any time during the 14 days of Olux (Clobetasol) Foam therapy to at least 20% of the body surface area. Of the 13 subjects studied, 1 of 9 with psoriasis were suppressed after 14 days and all 4 of the subjects with atopic dermatitis had abnormal cortisol levels indicative of adrenal suppression at some time after starting therapy with Olux (Clobetasol) Foam. (See below.)
Systemic absorption of topical corticosteroids has produced reversible adrenal suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients (see ).
In a controlled clinical trial (188 subjects) with Olux (Clobetasol) Foam in subjects with psoriasis of the scalp, there were no localized scalp adverse reactions reported in the Olux (Clobetasol) Foam treated subjects. In two controlled clinical trials (360 subjects) with Olux (Clobetasol) Foam in subjects with psoriasis of non-scalp regions, localized adverse events that occurred in the Olux (Clobetasol) Foam treated subjects included application site burning (10%), application site dryness (
In larger controlled trials with other clobetasol propionate formulations, the most frequently reported local adverse reactions have included burning, stinging, irritation, pruritus, erythema, folliculitis, cracking and fissuring of the skin, numbness of the fingers, skin atrophy, and telangiectasia (all less than 2%).
The following additional local adverse reactions have been reported with topical corticosteroids, but they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids such as Olux (Clobetasol) Foam. These reactions are listed in an approximate decreasing order of occurrence: dryness, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, striae, and miliaria.
Olux (Clobetasol) Overdosage
Topically applied Olux (Clobetasol) Foam can be absorbed in sufficient amounts to produce systemic effects. .
Olux (Clobetasol) Dosage And Administration
Note: For proper dispensing of foam, hold the can upside down and depress the actuator.
Olux (Clobetasol) 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 (Clobetasol) 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 (Clobetasol) 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 (Clobetasol) 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 (Clobetasol) Foam should not be used with occlusive dressings.
Olux (Clobetasol) How Supplied
Olux (Clobetasol) Foam is supplied as follows:
Store at controlled room temperature 68–77°F (20–25°C).
Olux (Clobetasol) Warning
Manufactured for
Stiefel Laboratories, Inc.Research Triangle Park, NC 27709
For additional information:
1-888-784-3335 (STIEFEL)
or visit
www.Olux (Clobetasol) .com
OLX:1PI
Olux (Clobetasol) is a registered trademark of Stiefel Laboratories, Inc.
©2011 Stiefel Laboratories, Inc.
March 2011
Olux (Clobetasol) Principal Display Panel
(clobetasol propionate) Foam, 0.05%
Invert can and then press firmly to dispense.
Keep away from eyes. 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).
Store at controlled room temperature, 68°-77°F (20°-25°C).
Manufactured for
Stiefel Laboratories, Inc.
Research Triangle Park, NC 27709
For additional information:
1-888-784-3335 (1-888-STIEFEL)
or visit www.Olux (Clobetasol) .com
©2011 Stiefel Laboratories, Inc.
Olux (Clobetasol) is a registered trademark of Stiefel Laboratories, Inc.
Made in Italy
10000000094168
