ELOMET CREAM 0.1%

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Mometasone Furoate

Available from:

ORGANON SINGAPORE PTE. LTD.

ATC code:

D07AC13

Dosage:

0.10%

Pharmaceutical form:

CREAM

Composition:

Mometasone Furoate 1 mg/g

Administration route:

TOPICAL

Prescription type:

Prescription Only

Manufactured by:

Organon Heist bv

Authorization status:

ACTIVE

Authorization date:

1993-12-06

Patient Information leaflet

 
ELOMET
®
 Cream 0.1% 
Brand of mometasone furoate 

FOR DERMATOLOGIC USE ONLY 

DESCRIPTION: 

Each gram of ELOMET Cream 0.1% contains 1 mg mometasone furoate, white petrolatum, 
white  wax,  propylene  glycol  stearate,  stearyl  alcohol  and  ceteareth-20,  hexylene  glycol, 
titanium  dioxide,  aluminum  starch  octenylsuccinate,  purified  water  and  phosphoric  acid  to 
adjust the pH. 

ACTION:  

Mometasone  furoate,  a  synthetic  corticosteroid,  exhibits  anti-inflammatory,  antipruritic  and 
vasoconstrictive properties. 

PHARMACOLOGY: 

PRE-CLINICAL DATA:  

PHARMACODYNAMICS 

The  pharmacologic  profile  of  mometasone  furoate  was  determined  by  standard  laboratory 
methods.  Relative  to  betamethasone  valerate,  anti-inflammatory  activity  and  anti-psoriatic 
activity  of  mometasone  furoate  was  evaluated  in  mice  and  guinea  pigs,  respectively. 
Hypothalamic-pituitary-adrenal  (HPA)  axis  suppression,  thymolysis  and  skin  atrophy  were 
evaluated in mice. 

In the croton oil assay in mice, mometasone furoate (ED
50
 = 0.02
μg/ear) was equipotent to 
betamethasone  valerate  after  single  application,  and  was  approximately  eight  times  as 
potent  as  betamethasone  valerate  after  five  daily  applications  (ED
50
  =  0.002
μg/ear/day  vs 
0.014
μg/ear/day). In guinea pigs, mometasone furoate was
approximately twice as potent as 
betamethasone  valerate  in  reducing  M.  Ovalis-induced  epidermal  acanthosis  after  14  daily 
applications. 

With  respect  to  other  pharmacologic  activities  commonly  associated  with  corticosteroids, 
mometasone  furoate  (ED
50
  =  5.3
μg/ear/day)  was  less  potent  than  betametasone  valerate 
(ED
50

Summary of Product characteristics

S-CCDS-MK0887-MTL-082017
ELOMETⓇ Cream 0.1%
Brand of mometasone furoate
FOR DERMATOLOGIC USE ONLY
DESCRIPTION:
Each gram of Mometasone furoate cream 0.1% contains 1 mg mometasone
furoate in a
cream base of hexylene glycol, hydrogenated soybean lecithin, titanium
dioxide, aluminum
starch octenylsuccinate, white wax, white soft paraffin, purified
water and phosphoric acid to
adjust the pH.
ACTION:
Mometasone furoate, a synthetic corticosteroid, exhibits
anti-inflammatory, antipruritic and
vasoconstrictive properties.
PHARMACOLOGY:
PRE-CLINICAL DATA:
Pharmacodynamics
The pharmacologic profile of mometasone furoate was determined by
standard laboratory
methods. Relative to betamethasone valerate, anti-inflammatory
activity and anti-psoriatic
activity of mometasone furoate was evaluated in mice and guinea pigs,
respectively.
Hypothalamic-pituitary-adrenal (HPA) axis suppression, thymolysis and
skin atrophy were
evaluated in mice.
In the croton oil assay in mice, mometasone furoate (ED
50
= 0.02 μg/ear) was equipotent to
betamethasone valerate after single application, and was approximately
eight times as
potent as betamethasone valerate after five daily applications (ED
50
= 0.002 μg/ear/day vs
0.014 μg/ear/day). In guinea pigs, mometasone furoate was
approximately twice as potent
as betamethasone valerate in reducing M. Ovalis-induced epidermal
acanthosis after 14
daily applications.
With respect to other pharmacologic activities commonly associated
with corticosteroids,
mometasone furoate (ED
50
= 5.3 μg/ear/day) was less potent than betametasone valerate
(ED
50
= 3.1 μg/ear/day) in suppressing the HPA axis in mice after five
daily application. In
the thymolysis assay, mometasone furoate (ED
50
= 26.6 μg/ear/day) was approximately two
times as potent as betamethasone valerate (ED
50
= 51.6 μg/ear/day) when applied topically,
and following subcutaneous administration for five days, mometasone
furoate (ED
50
=
11.2 μg/mouse) was approximately six times as potent as betamethasone
valerate (ED
50
=
59.8 μg/mo