PRAMCORT- hydrocortisone acetate and pramoxine hydrochloride cream

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ), PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)

Disponibil de la:

Rochester Pharmaceuticals

INN (nume internaţional):

HYDROCORTISONE ACETATE

Compoziție:

HYDROCORTISONE ACETATE 10 mg in 1 g

Calea de administrare:

TOPICAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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. Pediatric patients may demonstrate greater susceptibility to topical corticosteroid induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio.  Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.  Administration of topical corticosteroids to children should

Rezumat produs:

PramCort Cream 1% is supplied in 1 oz. tubes, NDC 49908-150-30. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Storage Conditions: Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted between 15ºC and 30ºC (between 59ºF and 86ºF). Brief exposure to temperatures up to 40ºC (104ºF) may be tolerated provided the mean kinetic temperature does not exceed 25ºC (77ºF); however, such exposure should be minimized. Protect from freezing. Manufactured for: Rochester Pharmaceuticals Doylestown, PA 18901 1-866-458-1772 www.RochesterPharm.com PRM-PI-0915

Statutul autorizaţiei:

unapproved drug other

Caracteristicilor produsului

PRAMCORT- HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE CREAM
ROCHESTER PHARMACEUTICALS
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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DESCRIPTION
PramCort Cream 1% is a topical preparation containing hydrocortisone
acetate 1% w/w and pramoxine
hydrochloride 1% w/w in a cream base containing: ceresin wax, cetyl
alcohol, isopropyl palmitate,
lanolin alcohol, mineral oil, panthenol, polyoxyl 40 stearate,
potassium sorbate, propylene glycol,
purified water, sorbic acid, stearic acid, triethanolamine lauryl
sulfate, and white petrolatum.
Topical corticosteroids are anti-inflammatory and anti-pruritic
agents. The structural formula, the
chemical name, molecular formula and molecular weight for active
ingredients are presented below.
chemical structure:
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, anti-pruritic and
vasoconstrictive actions. The
mechanism of anti-inflammatory activity of 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. Pramoxine
hydrochloride is a topical anesthetic agent which provides temporary
relief from itching and pain. It
acts by stabilizing the neuronal membrane of nerve endings with which
it comes into contact.
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 abso