TOPIDERM HYDROCORTISONE ACETATE 1% WW CREAM

Land: Malaysia

Sprog: engelsk

Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiv bestanddel:

HYDROCORTISONE ACETATE

Tilgængelig fra:

HOE PHARMACEUTICALS SDN. BHD.

INN (International Name):

HYDROCORTISONE ACETATE

Enheder i pakken:

30 gm

Fremstillet af:

HOE PHARMACEUTICALS SDN. BHD.

Indlægsseddel

Not Applicable

Produktets egenskaber

TOPIDERM HYDROCORTISONE ACETATE 1% W/W CREAM
NAME AND STRENGTH OF ACTIVE SUBSTANCE
Hydrocortisone acetate 1% w/w
DESCRIPTION
An opaque off-white viscous cream with characteristic odour
PHARMACODYNAMICS
Mechanism of action
On topical application, corticosteroids produce anti-inflammatory,
antipruritic and
vasoconstrictor actions. The activity of the drugs is thought to
result at least in part
from binding with a steroid receptor. Corticosteroids decrease
inflammation by
stabilising leukocyte lysomal membranes, preventing release of
destructive acid
hydrolyses from leukocytes; inhibiting macrophage accumulation in
inflamed areas;
reducing leukocyte adhesion to capillary endothelium; reducing
capillary wall
permeability and oedema formation; decreasing complement components;
antagonising histamine activity and release of kinin from substrates;
reducing
fibroblast proliferation, collagen deposition, and subsequent scar
tissue formation;
and possibly by other mechanisms as yet unknown.
PHARMACOKINETICS
The rate and extent of hydrocortisone absorption through the skin
varies among
individual patients. Following topical application of a corticosteroid
to most areas of
normal
skin,
only
minimal
amounts
of
the
lipophilic
drug
partitions
into
the predominantly
aqueous
dermo-epidermal
layer
(viable
epidermis
+
dermis)
and subsequently the systemic circulation.
Absorption is, however, markedly increased when the skin has lost its
keratin layer or
the rate limiting properties of the stratum corneum. Physical
disruption of the stratum
corneum,
inflammation
and/or
disease
of
the
epidermal
barrier
(eg.
psoriasis, eczema) may result in increased absorption. Hydrocortisone
is absorbed to
a greater degree from the skin behind and around the ear region,
scrotum, axilla,
eyelid,
face and
scalp
than
forearm,
knees,
elbow,
palm
and
sole.
Prolonged
absorption persists even after the area of application has been
washed, possibly
because the drug is retained in the stratum corneum and/or the
dermo-epidermal
layer.
Hydrocortisone is metabo