BETAMETHASONE DIPROPIONATE TOPICAL LOTION 0.05% 60ML
Generic: Betamethasone Dipropionate
BETAMETHASONE DIPROPIONATE TOPICAL LOTION 0.05% 60ML
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Identification
Betamethasone Dipropionate
Betamethasone Dipropionate
Sun Pharmaceutical Industries, Inc.
HUMAN PRESCRIPTION DRUG
Administration
LOTION, AUGMENTED
TOPICAL
ANDA077477
Active Ingredients
| Ingredient | Strength |
|---|---|
| BETAMETHASONE DIPROPIONATE | .5 mg/mL |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Clinical Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Betamethasone dipropionate lotion (augmented) 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. Betamethasone dipropionate lotion USP (augmented), 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age and older. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Apply a few drops of betamethasone dipropionate lotion (augmented) to the affected skin areas once or twice daily and massage lightly until the lotion disappears. Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Betamethasone dipropionate lotion (augmented) is a super-high-potency topical corticosteroid. Treatment with betamethasone dipropionate lotion (augmented) should be limited to 2 consecutive weeks and amounts should not exceed 50 mL per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis [ see Warnings and Precautions (5.1) ]. Betamethasone dipropionate lotion (augmented) should not be used with occlusive dressings unless directed by a physician. Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. Avoid contact with eyes. Wash hands after each application. Betamethasone dipropionate lotion (augmented) is for topical use only. It is not for oral, ophthalmic, or intravaginal use. Apply a few drops to the affected skin areas once or twice daily and massage lightly until the lotion disappears. ( 2 ) Discontinue therapy when control is achieved. ( 2 ) Limit therapy to no more than 2 consecutive weeks. ( 2 ) Use no more than 50 mL per week. ( 2 ) Do not use with occlusive dressings unless directed by a physician. ( 2 ) Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. ( 2 ) Not for oral, ophthalmic, or intravaginal use. ( 2 )
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions (<1%) are: erythema, folliculitis, pruritus, and vesiculation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Taro Pharmaceuticals U.S.A., Inc. at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In controlled clinical trials, adverse reactions associated with the use of betamethasone dipropionate lotion (augmented) reported at a frequency of less than 1% included erythema, folliculitis, pruritus, and vesiculation. 6.2 Postmarketing Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Postmarketing reports for local adverse reactions to topical corticosteroids may also include: skin atrophy, striae, telangiectasias, burning, irritation, dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis, and miliaria. Hypersensitivity reactions, consisting of predominantly skin signs and symptoms, e.g., contact dermatitis, pruritus, bullous dermatitis, and erythematous rash have been reported. Ophthalmic adverse reactions of cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy have been reported with the use of topical corticosteroids, including topical betamethasone products.
Information for Patients
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Inform patients of the following: Discontinue therapy when control is achieved, unless directed otherwise by the physician. Use no more than 50 mL per week of betamethasone dipropionate lotion (augmented) and for no longer than 2 consecutive weeks. Avoid contact with the eyes. Advise patients to report any visual symptoms to their healthcare providers. Avoid use of betamethasone dipropionate lotion (augmented) on the face, underarms, or groin areas unless directed by the physician. Do not occlude the treatment area with bandage or other covering, unless directed by the physician. Note that local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Advise a woman to use betamethasone dipropionate lotion (augmented) on the smallest area of skin and for the shortest duration possible while pregnant or breastfeeding. Advise breastfeeding women not to apply betamethasone dipropionate lotion (augmented) directly to the nipple and areola to avoid direct infant exposure.
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.