At 7 g per day, Augmented Betamethasone Dipropionate Ointment was shown to cause minimal inhibition of the HPA axis when applied 2 times daily for 2 to 3 weeks in healthy subjects and in subjects with psoriasis and eczematous disorders.With 6 g to 7 g of Augmented Betamethasone Dipropionate Ointment applied once daily for 3 weeks, no significant inhibition of the HPA axis was observed in subjects with psoriasis and atopic dermatitis, as measured by plasma cortisol and 24-hour urinary 17-hydroxy-corticosteroid levels.If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. 66993-897-49
To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or Important information: Augmented Betamethasone Dipropionate Ointment is for use on skin only.What is Augmented Betamethasone Dipropionate Ointment?Do not use Augmented Betamethasone Dipropionate Ointment if youBefore using Augmented Betamethasone Dipropionate Ointment, tell your healthcare provider about all of your medical conditions, including if you:Tell your healthcare provider about all the medicines you take,How should I use Augmented Betamethasone Dipropionate Ointment?What are the possible side effects of Augmented Betamethasone Dipropionate Ointment?Augmented Betamethasone Dipropionate Ointment can pass through your skinThe most common side effects of Augmented Betamethasone Dipropionate Ointment includeHow should I store Augmented Betamethasone Dipropionate Ointment?Keep Augmented Betamethasone Dipropionate Ointment and all medicines out of the reach of children.General information about the safe and effective use of Augmented Betamethasone Dipropionate Ointment.What are the ingredients in Augmented Betamethasone Dipropionate Ointment? No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. Cataracts and glaucoma have been reported postmarketing with the use of topical corticosteroid products, including betamethasone dipropionate ointment (augmented) Avoid contact of betamethasone dipropionate ointment (augmented) with eyes. • Avoid use of betamethasone dipropionate ointment (augmented) on the face, underarms, or groin areas unless directed by the physician. Advise breastfeeding women not to apply Augmented Betamethasone Dipropionate Ointment directly to the nipple and areola to avoid direct infant exposure Use of Augmented Betamethasone Dipropionate Ointment in pediatric patients younger than 13 years of age is not recommended due to the potential for HPA axis suppression In an open-label HPA axis safety trial in subjects 3 months to 12 years of age with atopic dermatitis, DIPROLENEBecause of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic toxicity when treated with topical drugs. However, similar blanching scores do not necessarily imply therapeutic equivalence.No pharmacokinetics trials have been conducted with Augmented Betamethasone Dipropionate Ointment.The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.Topical corticosteroids can be absorbed through normal intact skin.
To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X.If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. (See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Augmented Betamethasone Dipropionate Ointment is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older.Apply a thin film of Augmented Betamethasone Dipropionate Ointment to the affected skin areas once or twice daily.Therapy should be discontinued when control is achieved.
These trials evaluated Augmented Betamethasone Dipropionate Ointment applied twice daily, for 14 days. A total of 378 subjects, of whom 152 received Augmented Betamethasone Dipropionate Ointment, were included in these trials.
• Do not occlude the treatment area with bandage or other covering, unless directed by the physician. Corticosteroids are bound to plasma proteins in varying degrees, are metabolized primarily in the liver, and excreted by the kidneys. Advise pregnant women that Augmented Betamethasone Dipropionate Ointment may increase the risk of having a low birthweight infant and to use Augmented Betamethasone Dipropionate Ointment on the smallest area of skin and for the shortest duration possible.In animal reproduction studies, increased malformations, including umbilical hernias, cephalocele, and cleft palate, were observed after intramuscular administration of betamethasone dipropionate to pregnant rabbits. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids Once absorbed through the skin, topical corticosteroids enter pharmacokinetic pathways similar to systemically administered corticosteroids.
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