Betamethasone Dipropionate .5 mg/g
Betamethasone Dipropionate · CREAM · Cosette Pharmaceuticals, Inc.
Betamethasone dipropionate cream is a prescription topical corticosteroid used to reduce inflammation and itching associated with various skin conditions. It is applied directly to the affected area of skin as directed by your doctor.
Key Facts
- Brand Name
- Betamethasone Dipropionate
- Generic Name
- Betamethasone Dipropionate
- NDC Code (Product)
0713-0659- Manufacturer
- Cosette Pharmaceuticals, Inc.
- Strength
- .5 mg/g
- Dosage Form
- CREAM
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA210217
- Marketing Start
- 10/12/2018
Recall History
LEO PHARMA INC
Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.
Teligent Pharma, Inc.
Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing
Well Care Compounding Pharmacy
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Teligent Pharma, Inc.
Failed Impurities/Degradation Specifications
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Teligent Pharma, Inc.
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Glenmark Pharmaceuticals Inc., USA
Temperature Abuse: Complaints received of liquidy texture.
Teligent Pharma, Inc.
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
McKesson Corporation dba McKesson Drug Company
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Teligent Pharma, Inc.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Betamethasone dipropionate cream (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 cream (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 thin film of betamethasone dipropionate cream (augmented) to the affected skin areas once or twice daily. Therapy should be discontinued when control is achieved. Betamethasone dipropionate cream (augmented) is a high-potency corticosteroid. Treatment with betamethasone dipropionate cream (augmented) should not exceed 50 g 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 cream (augmented) should not be used with occlusive dressings unless directed by a physician. Avoid contact with eyes. Wash hands after each application. Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. Betamethasone dipropionate cream (augmented) is for topical use only. It is not for oral, ophthalmic, or intravaginal use. Apply a thin film to the affected skin areas once or twice daily. ( 2 ) Discontinue therapy when control is achieved. ( 2 ) Use no more than 50 g 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…
Contraindications
4 CONTRAINDICATIONS Betamethasone dipropionate cream (augmented), is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation. Hypersensitivity to any component of this medicine. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reaction reported in 0.4% of adult patients is stinging. ( 6.1 ) The most common adverse reactions reported in 10% of pediatric patients are signs of skin atrophy, telangiectasia, bruising, shininess. ( 6.1 , 8.4 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, 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, involving 242 adult subjects, the adverse reaction associated with the use of betamethasone dipropionate cream (augmented) reported at a frequency of 0.4% was stinging. It occurred in 1 subject. In a controlled clinical trial involving 67 pediatric subjects from 3 months to 12 years of age, the adverse reactions associated with the use of betamethasone dipropionate cream (augmented) occurred in 7 of 67 (10%) subjects. Reported reactions included sign…
Frequently Asked Questions
What is Betamethasone Dipropionate used for?
Betamethasone dipropionate cream is a prescription topical corticosteroid used to reduce inflammation and itching associated with various skin conditions. It is applied directly to the affected area of skin as directed by your doctor.
Is Betamethasone Dipropionate a controlled substance?
Betamethasone Dipropionate is not classified as a controlled substance by the DEA.
What is the generic name for Betamethasone Dipropionate?
The generic name for Betamethasone Dipropionate is Betamethasone Dipropionate. There are 4 other brand versions of Betamethasone Dipropionate.
What is the NDC code for Betamethasone Dipropionate .5 mg/g?
The NDC (National Drug Code) for Betamethasone Dipropionate .5 mg/g is 0713-0659, listed by Cosette Pharmaceuticals, Inc..
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Other Betamethasone Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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