Betamethasone Valerate

Betamethasone valerate foam, 0.12% is contraindicated in patients who are hypersensitive to betamethasone valerate, to other corticosteroids, or to any ingredient in this preparation.

• 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: Xiromed, LLC.
• Florham Park, NJ 07932 Made in Spain For additional information:
• 844-XIROMED (844-947-6633) Or visit www.xiromed.com Revised:
• November 2018 PI-141-01
• General Systemic absorption of topical corticosteroids has caused reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment.
• Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.
• Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.
• Therefore, patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression.
• If HPA axis 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 PRECAUTIONS-Pediatric Use .) If irritation develops, betamethasone valerate foam, 0.12% 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.
• 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 betamethasone valerate foam, 0.12% should be discontinued until the infection has been adequately controlled.
• Information for Patients Patients using topical corticosteroids should receive the following information and instructions:
• Laboratory Tests The following tests may be helpful in evaluating patients for HPA axis suppression:
• ACTH stimulation test A.M. plasma cortisol test Urinary free cortisol test Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of betamethasone valerate.
• Betamethasone was genotoxic in the in vitro human peripheral blood lymphocyte chromosome aberration assay with metabolic activation and in the in vivo mouse bone marrow micronucleus assay.
• Pregnancy Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels.
• Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.
• There are no adequate and well-controlled studies in pregnant women.
• Therefore, betamethasone valerate foam, 0.12% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
• Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.
• Pediatric Use Safety and effectiveness in pediatric patients have not been established.
• General Systemic absorption of topical corticosteroids has caused reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment.
• Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.
• Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.
• Therefore, patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression.
• If HPA axis 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 PRECAUTIONS-Pediatric Use .) If irritation develops, betamethasone valerate foam, 0.12% 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.
• 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 betamethasone valerate foam, 0.12% should be discontinued until the infection has been adequately controlled.

• Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.
• It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk.
• Because many drugs are excreted in human milk, caution should be exercised when betamethasone valerate foam, 0.12% is administered to a nursing woman.

Topically applied betamethasone valerate foam, 0.12% can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS )