ALCLOMETASONE DIPROPIONATE ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Alclometasone dipropionate (UNII: S56PQL4N1V) (Alclometasone - UNII:136H45TB7B)

Available from:

Taro Pharmaceuticals U.S.A., Inc.

INN (International Name):

Alclometasone dipropionate

Composition:

Alclometasone dipropionate 0.5 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Alclometasone Dipropionate Ointment USP, 0.05% is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate ointment may be used in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see PRECAUTIONS: Pediatric Use ). Since the safety and efficacy of alclometasone dipropionate ointment has not been established in pediatric patients below 1 year of age, their use in this age-group is not recommended. Alclometasone Dipropionate Ointment USP, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components in this preparation.

Product summary:

Alclometasone Dipropionate Ointment USP, 0.05% is supplied in 5 g (professional sample only), 15 g (NDC 51672-1316-1), 45 g (NDC 51672-1316-6), and 60 g (NDC 51672-1316-3) tubes. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ALCLOMETASONE DIPROPIONATE- ALCLOMETASONE DIPROPIONATE OINTMENT
TARO PHARMACEUTICALS U.S.A., INC.
----------
ALCLOMETASONE DIPROPIONATE
OINTMENT USP, 0.05%
FOR DERMATOLOGIC USE ONLY - - NOT FOR OPHTHALMIC USE.
RX ONLY
DESCRIPTION
Alclometasone Dipropionate Ointment USP, 0.05% contains alclometasone
dipropionate (7α-chloro-
11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione
17,21-dipropionate), a synthetic
corticosteroid for topical dermatologic use. The corticosteroids
constitute a class of primarily
synthetic steroids used topically as anti-inflammatory and
antipruritic agents.
Chemically, alclometasone dipropionate is C
H ClO . It has the following structural formula:
Alclometasone dipropionate has the molecular weight of 521. It is a
white powder, insoluble in water,
slightly soluble in propylene glycol, and moderately soluble in
hexylene glycol.
Each gram of alclometasone dipropionate ointment contains 0.5 mg of
alclometasone dipropionate in an
ointment base of hexylene glycol, propylene glycol stearate, white
petrolatum and white wax.
CLINICAL PHARMACOLOGY
Like other topical corticosteroids, alclometasone dipropionate has
anti-inflammatory, antipruritic, and
vasoconstrictive properties. The mechanism of the anti-inflammatory
activity of the topical steroids, in
general, is unclear. However, corticosteroids are thought to act by
the induction of phospholipase A
inhibitory proteins, collectively called lipocortins. It is postulated
that these proteins control the
biosynthesis of potent mediators of inflammation such as
prostaglandins and leukotrienes by inhibiting
the release of their common precursor, arachidonic acid. Arachidonic
acid is released from membrane
phospholipids by phospholipase A .
PHARMACOKINETICS
The extent of percutaneous absorption of topical corticosteroids is
determined by many factors,
including the vehicle and the integrity of the epidermal barrier.
Occlusive dressings with
hydrocortisone for up to 24 hours have not been demonstrated to
increase penetration; however,
occlusion