PREDNICARBATE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PREDNICARBATE (UNII: V901LV1K7D) (PREDNICARBATE - UNII:V901LV1K7D)

Available from:

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

INN (International Name):

PREDNICARBATE

Composition:

PREDNICARBATE 1 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Prednicarbate cream 0.1% (emollient) is a medium-potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Prednicarbate cream 0.1% (emollient) may be used with caution in pediatric patients 1 year of age or older. The safety and efficacy of drug use for longer than 3 weeks in this population have not been established. Since safety and efficacy of prednicarbate cream 0.1% (emollient) have not been established in pediatric patients below 1 year of age, its use in this age group is not recommended. Prednicarbate cream 0.1% (emollient) is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparations.

Product summary:

Prednicarbate Cream, 0.1% (Emollient) is supplied: 15 gram tube            NDC 0168-0381-15 60 gram tube            NDC 0168-0381-60 Store between 20°-25° C (68°-77° F), with excursions permitted to 15°-30° C (59°–86°F). [ see USP Controlled Room Temperature]. E. Fougera & Co. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 I2381D R10/15 #108

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PREDNICARBATE- PREDNICARBATE CREAM
E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.
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PREDNICARBATE CREAM 0.1% (EMOLLIENT)
FOR DERMATOLOGIC USE ONLY.
RX ONLY
NOT FOR USE IN EYES.
DESCRIPTION:
Prednicarbate cream 0.1% (emollient) contains prednicarbate, a
synthetic corticosteroid for topical
dermatologic use. The chemical name of prednicarbate is 11β,
17,21-trihydroxypregna-1,4-diene- 3,20-
dione 17-(ethyl carbonate) 21-propionate. Prednicarbate has the
empirical formula C
H O and a
molecular weight of 488.58. Topical corticosteroids constitute a class
of primarily synthetic steroids
used topically as anti-inflammatory and antipruritic agents. The CAS
Registry Number is 73771-04-7.
The chemical structure is:
Prednicarbate is a practically odorless white to yellow-white powder
insoluble to practically insoluble
in water and freely soluble in ethanol.
Each gram of prednicarbate cream 0.1% (emollient) contains 1.0 mg of
prednicarbate in a base
consisting of white petrolatum, purified water, isopropyl myristate,
lanolin alcohols, mineral oil,
cetostearyl alcohol, aluminum stearate, edetate disodium, lactic acid,
and magnesium stearate.
CLINICAL PHARMACOLOGY:
In common with other topical corticosteroids, prednicarbate has
anti-inflammatory, antipruritic, and
vasoconstrictive properties. In general, the mechanism of the
anti-inflammatory activity of topical
steroids 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 .
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PHARMACOKINETICS: The extent of percutaneous absorption of topical
corticosteroids is determined by
many factors, including the vehicle and the integrity of the epidermal
barrier. Use of occlusive
dres