BETAMETHASONE DIP 0.05% GEL 50 GM
Generic: Betamethasone Dipropionate
BETAMETHASONE DIP 0.05% GEL 50 GM
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Identification
Betamethasone Dipropionate
Betamethasone Dipropionate
Sun Pharmaceutical Industries, Inc.
HUMAN PRESCRIPTION DRUG
Administration
GEL
TOPICAL
ANDA076508
Active Ingredients
| Ingredient | Strength |
|---|---|
| BETAMETHASONE DIPROPIONATE | .5 mg/g |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Clinical Drug Information
Indications & Usage
INDICATIONS AND USAGE Betamethasone dipropionate gel (augmented) is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two consecutive weeks is not recommended, and the total dose should not exceed 50 g per week because of potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. This product is not recommended for use in pediatric patients under 12 years of age.
Dosage & Administration
DOSAGE AND ADMINISTRATION Apply a thin layer of betamethasone dipropionate gel (augmented) to the affected skin once or twice daily and rub it in gently and completely. Betamethasone dipropionate gel (augmented) is a super-high potency topical corticosteroid; therefore, treatment should be limited to two weeks, and amounts greater than 50 g per week should not be used. Betamethasone dipropionate gel (augmented) should not be used with occlusive dressings.
Adverse Reactions
ADVERSE REACTIONS In controlled clinical trials, the total incidence of adverse events associated with the use of betamethasone dipropionate gel (augmented) was 10%. These included stinging or burning in 6% of patients, dry skin in 4% of patients, and pruritus in 2% of patients. Less frequently reported adverse reactions were irritation, skin atrophy, telangiectasia, erythema, cracking/tightening of the skin, follicular rash, and allergic contact dermatitis. The following additional local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with super-high potency corticosteroids, such as betamethasone dipropionate gel (augmented). These reactions are listed in approximate decreasing order of occurrence: acneiform eruptions, hypopigmentation, perioral dermatitis, secondary infection, striae, and miliaria.
Information for Patients
Information for Patients Patients using topical corticosteroids should receive the following information and instructions: The medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. The medication should not be used for any disorder other than that for which it was prescribed. The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive. Patients should report to their physician any signs of local adverse reactions.
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.