Betamethasone Dipropionate (Page 2 of 2)

8.5 Geriatric Use

Clinical trials of betamethasone dipropionate cream (augmented), 0.05% 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 between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out.

11 DESCRIPTION

Betamethasone Dipropionate Cream USP (Augmented), 0.05% contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for topical use in a cream base. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is the 17,21-dipropionate ester of betamethasone.

Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21-trihydroxy-16 β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28 H37 FO7 , a molecular weight of 504.6, and the following structural formula:

chemical-structure
(click image for full-size original)

Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water.

Each gram of Betamethasone Dipropionate Cream USP (Augmented), 0.05% contains: 0.643 mg betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone) in a white cream base of carbomer homopolymer type C; ceteareth-30; chlorocresol; cyclomethicone; glyceryl oleate/propylene glycol; propylene glycol; purified water; sodium hydroxide; sorbitol solution; white petrolatum; and white wax.

12 CLINICAL PHARMACOLOGY

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 Betamethasone Dipropionate Cream USP (Augmented), 0.05% in corticosteroid responsive dermatoses is unknown.

12.2 Pharmacodynamics

Vasoconstrictor Assay

Trials performed with betamethasone dipropionate cream (augmented), 0.05% indicate that it is in the high range of potency as demonstrated in vasoconstrictor trials in healthy subjects when compared with other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence.

12.3 Pharmacokinetics

No pharmacokinetics trials have been conducted with Betamethasone Dipropionate Cream USP (Augmented), 0.05%. 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 [see Dosage and Administration (2) ].

Topical corticosteroids can be absorbed through normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids [see Dosage and Administration (2) ].

Once absorbed through the skin, topical corticosteroids enter pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees, are metabolized primarily in the liver, and excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

13 NONCLINICAL TOXICOLOGY

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 (Salmonella typhimurium and Escherichia coli), and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the in vivo mouse bone marrow micronucleus assay.

Studies in rabbits, mice, and rats using intramuscular doses up to 1, 33, and 2 mg/kg, respectively, resulted in dose-related increases in fetal resorptions in rabbits and mice.

14 CLINICAL STUDIES

The safety and efficacy of betamethasone dipropionate cream (augmented), 0.05% for the treatment of corticosteroid-responsive dermatoses have been established in two randomized and active controlled trials in subjects with chronic plaque psoriasis. A total of 81 subjects who received betamethasone dipropionate cream (augmented), 0.05% were included in these trials. These trials evaluated betamethasone dipropionate cream (augmented), 0.05% applied once or twice daily for 14 and 21 days, respectively, on bilateral paired psoriatic lesions. Betamethasone dipropionate cream (augmented), 0.05% was shown to be effective in relieving the signs and symptoms of chronic plaque psoriasis.

16 HOW SUPPLIED/STORAGE AND HANDLING

Betamethasone Dipropionate Cream USP (Augmented), 0.05% is available as follows:

15 g tube (NDC 71205-275-15)

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Inform patients of the following:

Discontinue therapy when control is achieved, unless directed otherwise by the physician.
Use no more than 50 grams per week.
Avoid contact with the eyes.
Advise patients to report any visual symptoms to their healthcare providers.
Avoid use of Betamethasone Dipropionate Cream USP (Augmented), 0.05% 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.

Manufactured By Perrigo, Bronx, NY 10457

Distributed By

Perrigo®

Allegan, MI 49010 • www.perrigo.com

Relabeled By

Proficient Rx LP

Thousand Oaks, CA 91320

Rev 08-18 0N200 RC JX2

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Rx Only

NDC 71205-275-15

Betamethasone Dipropionate Cream USP (Augmented*), 0.05%

(Potency expressed as Betamethasone)

*Vehicle Augments the Penetration of the Steroid.

For Dermatologic Use Only. Not for Ophthalmic Use.

NET WT 15 g

71205-275-15
(click image for full-size original)
BETAMETHASONE DIPROPIONATE
betamethasone dipropionate cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71205-275(NDC:45802-376)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Betamethasone Dipropionate (Betamethasone) Betamethasone 0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
CETEARETH-30
CHLOROCRESOL
CYCLOMETHICONE
GLYCERYL OLEATE
PROPYLENE GLYCOL
WATER
SODIUM HYDROXIDE
SORBITOL
PETROLATUM
WHITE WAX
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71205-275-15 1 TUBE in 1 CARTON contains a TUBE
1 15 g in 1 TUBE This package is contained within the CARTON (71205-275-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076592 09/28/2006
Labeler — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079196022 REPACK (71205-275), RELABEL (71205-275)

Revised: 04/2022 Proficient Rx LP

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