PREDNICARBATE- emollient cream

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

prednicarbate (UNII: V901LV1K7D) (prednicarbate - UNII:V901LV1K7D)

可用日期:

Oceanside Pharmaceuticals

给药途径:

TOPICAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Prednicarbate emollient cream 0.1% is a medium-potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Prednicarbate emollient cream 0.1% 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 emollient cream 0.1% have not been established in pediatric patients below 1 year of age, its use in this age group is not recommended. Prednicarbate emollient cream 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparations.

產品總結:

Prednicarbate emollient cream 0.1% is supplied in 60 g (NDC 68682-880-60) tubes. Store between 41° - 77°F (5° - 25°). Rx Only

授权状态:

New Drug Application Authorized Generic

产品特点

PREDNICARBATE- EMOLLIENT CREAM
OCEANSIDE PHARMACEUTICALS
----------
PREDNICARBATE EMOLLIENT CREAM 0.1%
FOR DERMATOLOGIC USE ONLY.
NOT FOR USE IN EYES.
DESCRIPTION
Prednicarbate emollient cream 0.1% contains prednicarbate, a synthetic
corticosteroid for topical
dermatologic use. The chemical name of prednicarbate is 11_β,_ 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 emollient cream 0.1% contains 1.0 mg of
prednicarbate in a base consisting
of white petrolatum USP, purified water USP, isopropyl myristate NF,
lanolin alcohols NF, mineral oil
USP, cetostearyl alcohol NF, aluminum stearate, edetate disodium USP,
lactic acid USP, and magnesium
stearate DAB 9.
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 .
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 dressings with
hydrocortisone for