BEPROGENT CREAM

Ország: Szingapúr

Nyelv: angol

Forrás: HSA (Health Sciences Authority)

Aktív összetevők:

BETAMETHASONE DIPROPIONATE EQV BETAMETHASONE; GENTAMICIN SULPHATE EQV GENTAMICIN

Beszerezhető a:

ZUELLIG PHARMA PTE. LTD.

ATC-kód:

D07CC01

Adagolás:

0.05% w/w

Gyógyszerészeti forma:

CREAM

Összetétel:

BETAMETHASONE DIPROPIONATE EQV BETAMETHASONE 0.05% w/w; GENTAMICIN SULPHATE EQV GENTAMICIN 0.1% w/w

Az alkalmazás módja:

TOPICAL

Recept típusa:

Prescription Only

Gyártó:

HOE PHARMACEUTICALS SDN BHD

Engedélyezési státusz:

ACTIVE

Engedély dátuma:

1996-11-28

Termékjellemzők

ENCLOSURE 2
PROPOSED PRODUCT LABELLING
BEPROGENT CREAM
Est. 1979
DESRIPTION : White cream contains 0.064% w/w of betamethasone
dipropionate (equivalent
to 0.05% of betamethasone) and 0.17% w/w of gentamicin sulphate
(equivalent to 0.1% of
gentamicin) with methyl paraben 0.16% w/w & propyl paraben 0.03% w/w
as preservatives.
PHARMACODYNAMICS
:
_Betamethasone _
_dipropionate_
is
a
topically
active
flourinated
corticosteroid which has anti-inflammatory, antipruritic and
vasoconstrictive actions. _Gentamicin _
_sulphate_ is a broad spectrum aminoglycoside antibiotic which is
bactericidal. It is effective against
many strains of gram-negative bacteria and _Staphylococcus aureus._
PHARMACOKINETICS : _Corticosteroids_ are extensively bound to plasma
protein. Only unbound
corticosteroids has pharmacological effects or is metabolised.
They are metabolised mainly in the liver and also in the kidney, and
are excreted in the urine.
_Gentamicin sulphate_ is a bactericidal antibiotic which is active
against a wide variety of
pathogenic gram-positive and gram-negative bacteria. When applied
topically to large areas of
denuded body surface as the case of burn patients, plasma
concentrations can reach 1mcg/ml,
and 2% of the drug used may appear in the urine.
INDICATIONS : Treatment of impetigo, erythyma and other localised
primary bacterial skin
infection with a Gram-negative component and also for secondary
bacterial infections complicat-
ing other pre-existing dermatoses.
CONTRAINDICATION : Hypersensitivity to betamethasone dipropionate,
gentamicin sulphate or
any component in the base.
DRUG INTERACTION : Not known.
ADVERSE EFFECT : _ Betamethasone Dipropionate_ - Reported local
adverse reactions are
burning sensation, itching, irritation, dryness, folliculitis,
hypertrichosis, acneiform eruptions,
hypopigmentation, maceration of the skin, secondary infection, skin
atrophy, striae and miliria.
_Gentamicin Sulphate_ - Ototoxicity and nephrotoxicity has been
reported often in the topical
treatment of severe burns with gentamicin.