BETAMETHASONE DIPROPIONATE USP, 0.05% ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BETAMETHASONE DIPROPIONATE (UNII: 826Y60901U) (BETAMETHASONE - UNII:9842X06Q6M)

Available from:

Tasman Pharma Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Product summary:

Betamethasone dipropionate ointment USP, 0.05% is supplied as follows:         15 g tubes NDC 72641-004-15         45 g tubes NDC 72641-004-45 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light and freezing.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BETAMETHASONE DIPROPIONATE USP, 0.05%- BETAMETHASONE DIPROPIONATE
USP, 0.05% OINTMENT
TASMAN PHARMA INC.
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BETAMETHASONE DIPROPIONATE OINTMENT USP, 0.05%
(POTENCY EXPRESSED AS BETAMETHASONE)
RX ONLY
FOR DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC USE.
DESCRIPTION
Betamethasone dipropionate ointment contains betamethasone
dipropionate USP, a
synthetic adrenocorticosteroid, for dermatologic use. Betamethasone,
an analog of
prednisolone, has a high degree of glucocorticoid activity and a
slight degree of
mineralocorticoid activity. Betamethasone dipropionate is a white to
cream white
odorless crystalline powder insoluble in water. Chemically, it is
9-fluoro-11β,17,21-
trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21- dipropionate.
The structural
formula is:
Each gram of the 0.05% ointment contains 0.64 mg betamethasone
dipropionate
(equivalent to 0.5 mg betamethasone) in an ointment base of mineral
oil and white
petrolatum.
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, anti-pruritic and
vasoconstrictive
actions.
The mechanism of anti-inflammatory activity of the topical
corticosteroids is unclear.
Various laboratory methods, including vasoconstrictor assays, are used
to compare and
predict potencies and/or clinical efficacies of the topical
corticosteroids. There is some
evidence to suggest that a recognizable correlation exists between
vasoconstrictor
potency and therapeutic efficacy in man (See DOSAGE AND
ADMINISTRATION).
PHARMACOKINETICS: 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.
Topical corticosteroids can be absorbed from normal intact skin.
Inflammation and/or
other disease processes in the skin increase percutaneous absorption.
Occlusive
dressings substantially increase the percutaneous absorption of
topical corticosteroids
(See DOSAGE AND ADMINISTRATION).
Once absorbed through the skin, topical corticosteroids are handl