Product Description.:
LUXIQ (betamethasone valerate) Foam, 0.12% is for topical use only.
Systemic absorption of topical corticosteroids has caused reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of the topical corticosteroid.
Manifestations of Cushing?s Syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids.
Conditions that augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Evaluate patients periodically for evidence of HPA axis suppression.
If irritation develops, LUXIQ Foam should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation, as with most topical products not containing corticosteroids.
Concomitant skin infections should be treated with an appropriate antimicrobial agent. If the infection persists, LUXIQ Foam should be discontinued until the infection has been adequately treated.
LUXIQ Foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Caution should be exercised when LUXIQ Foam is administered to a nursing woman.
Safety and efficacy in pediatric patients have not been established. Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin to surface body mass ratios. Chronic corticosteroid therapy may interfere with the growth and development of children.
In clinical studies, the most common adverse events associated with the use of LUXIQ Foam were burning, stinging, or itching at the application site.
Local adverse reactions that have been reported with topical steroids include: irritation dryness folliculitis acneiform eruptions hypopigmentation perioral dermatitis allergic contact dermatitis secondary infection skin atrophy striae and malaria.
Because LUXIQ Foam is flammable, you should counsel patients to avoid fire, flame, or smoking during and immediately following application.
