PROCTOFOAM HC hydrocortisone acetate and pramoxine hydrochloride aerosol

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

Beszerezhető a:

Alaven Pharmaceutical LLC

INN (nemzetközi neve):

HYDROCORTISONE ACETATE

Összetétel:

HYDROCORTISONE ACETATE 100 mg in 10 g

Recept típusa:

PRESCRIPTION DRUG

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

PROCTOFOAM HC- HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE
AEROSOL, FOAM
ALAVEN PHARMACEUTICAL LLC
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PROCTOFOAM HC
(HYDROCORTISONE ACETATE 1% AND
PRAMOXINE HYDROCHLORIDE 1%)
topical aerosol
RX ONLY
CIA71190B
Rev. 05/12
DESCRIPTION: Proctofoam -HC (hydrocortisone acetate 1% and pramoxine
hydrochloride 1%) is a
topical aerosol foam for anal use containing hydrocortisone acetate 1%
and pramoxine hydrochloride
1% in a hydrophilic base containing cetyl alcohol, emulsifying wax,
methylparaben, polyoxyethylene-
10-stearyl ether, propylene glycol, propylparaben, purified water,
trolamine and inert propellants:
isobutane and propane.
Proctofoam -HC contains a synthetic corticosteroid used as an
anti-inflammatory/antipruritic agent and
a local anesthetic.
HYDROCORTISONE ACETATE
Molecular weight: 404.50. Solubility of hydrocortisone acetate in
water: 1 mg/100 mL.
Chemical name: pregn-4-ene-3,20-dione,
21-(acetyloxy)-11,17-dihydroxy-, (11β)-.
PRAMOXINE HYDROCHLORIDE
Molecular weight: 329.86. Pramoxine hydrochloride is freely soluble in
water.
Chemical name: morpholine, 4-[3-(4-butoxyphenoxy) propyl]-,
hydrochloride.
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CLINICAL PHARMACOLOGY:
Topical corticosteroids share anti-inflammatory, antipruritic 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.
Pramoxine hydrochloride is a surface or local anesthetic which is not
chemically related to the "caine"
types of local anesthetics. Its unique chemical structure is likely to
minimize the danger of cross-
sensitivity reactions in patients allergic to other local anesthetics.
PHARMACOKINETICS: The extent of percutaneous absorption of topical
corticosteroids is determined by
many factors includin