DIPROLENE AF Cream (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Merck Sharp & Dohme Corp.

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1. Indications and Usage

DIPROLENE AF Cream 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.

2. Dosage and Administration

Apply a thin film of DIPROLENE AF Cream to the affected skin areas once or twice daily. Therapy should be discontinued when control is achieved. DIPROLENE AF Cream is a high-potency corticosteroid. Treatment ...

3. Dosage Forms and Strengths

Cream, 0.05%. Each gram of DIPROLENE AF Cream, 0.05% contains 0.643 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a white cream base.

4. Contraindications

DIPROLENE AF Cream is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.

5. Warnings and Precautions

5.1 Effects on Endocrine System DIPROLENE AF Cream can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur ...

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 ...

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. ...

8.1. Pregnancy

Risk Summary There are no available data on DIPROLENE AF Cream use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Observational ...

8.2. Lactation

Risk Summary There are no data regarding the excretion of betamethasone dipropionate in breast milk, the effects on the breastfed infant, or the effects on milk production after topical application of ...

8.4. Pediatric Use

Use of DIPROLENE AF Cream in pediatric patients younger than 13 years of age is not recommended due to the potential for HPA axis suppression <em>[see Warnings and Precautions (5.1)]</em>. In an open-label ...

8.5. Geriatric Use

Clinical trials of DIPROLENE AF Cream included 104 subjects who were 65 years of age and over and 8 subjects who were 75 years of age and over. No overall differences in safety or effectiveness were observed ...

11. Description

DIPROLENE AF (augmented betamethasone dipropionate) Cream 0.05% contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for topical use in a cream base. Betamethasone, an analog of prednisolone, ...

12.1. Mechanism of Action

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action of DIPROLENE AF Cream in corticosteroid responsive dermatoses ...

12.2. Pharmacodynamics

Vasoconstrictor Assay. Trials performed with DIPROLENE AF Cream, 0.05% indicate that it is in the high range of potency as demonstrated in vasoconstrictor trials in healthy subjects when compared with ...

12.3. Pharmacokinetics

No pharmacokinetics trials have been conducted with DIPROLENE AF Cream 0.05%. The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate. Betamethasone was negative in the bacterial mutagenicity assay <em>(Salmonella typhimurium ...

14. Clinical Studies

The safety and efficacy of DIPROLENE AF Cream for the treatment of corticosteroid-responsive dermatoses have been established in two randomized and active controlled trials in subjects with chronic plaque ...

16.1. How Supplied

DIPROLENE AF Cream 0.05% is a white cream supplied in 15-g (NDC 0085-0517-01) and 50-g (NDC 0085-0517-04) tubes. Distributed by: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse ...

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

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. ...