Betamethasone Dipropionate

Included as part of the PRECAUTIONS section.

Mechanism of Action

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

Pharmacodynamics

Trials performed with DIPROLENE Lotion, 0.05% indicate that it is in the super-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.

Pharmacokinetics

No pharmacokinetic trials have been conducted with DIPROLENE Lotion.

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].

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].

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.

Clinical Studies

The safety and efficacy of DIPROLENE Lotion for the treatment of corticosteroid-responsive dermatoses have been evaluated in two randomized vehicle controlled trials, one in scalp psoriasis and one in seborrheic dermatitis. A total of 263 subjects, of whom 131 received DIPROLENE Lotion, were included in these trials. These trials evaluated DIPROLENE Lotion applied once daily for 21 days.

DIPROLENE Lotion was shown to be effective in relieving the signs and symptoms of corticosteroid responsive dermatoses.

Betamethasone Dipropionate Cream (Augmented), 0.05% contains Betamethasone Dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use in an emollient 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-11ß,17, 21-trihydroxy-16ß -methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula:

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

Each gram of Betamethasone Dipropionate Cream (Augmented), 0.05% contains 0.643 mg Betamethasone Dipropionate, USP (equivalent to 0.5 mg betamethasone) in an emollient 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.

Betamethasone Dipropionate Cream (Augmented), 0.05% is contraindicated in patients who are hypersensitive to Betamethasone Dipropionate, to other corticosteroids, or to any ingredient in this preparation.

Apply a thin film of Betamethasone Dipropionate Cream (Augmented), 0.05% to the affected skin areas once or twice daily. Treatment with Betamethasone Dipropionate Cream (Augmented), 0.05% should be limited to 45 g per week.

Betamethasone Dipropionate Cream (Augmented), 0.05% is not to be used with occlusive dressings.

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

Manufactured By Perrigo, Bronx, NY 10457

Distributed By

Perrigo®

Allegan, MI 49010 • www.perrigo.com

Rev 08-15

: 0N200 RC JX1

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not use betamethasone topical on sunburned, windburned, irritated, or broken skin. Also avoid using this medication in open wounds.

Avoid using skin products that can cause irritation, such as harsh soaps or shampoos or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.