ELOMET OINTMENT 0.1%

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

MOMETASONE FUROATE ANHYDROUS

Available from:

ORGANON SINGAPORE PTE. LTD.

ATC code:

D07AC13

Dosage:

0.10%

Pharmaceutical form:

OINTMENT

Composition:

MOMETASONE FUROATE ANHYDROUS 0.1%

Administration route:

TOPICAL

Prescription type:

Prescription Only

Manufactured by:

Organon Heist bv

Authorization status:

ACTIVE

Authorization date:

1993-12-06

Patient Information leaflet

ELOMETⓇ Ointment 0.1% 
Brand of mometasone furoate 

FOR DERMATOLOGIC USE ONLY 

DESCRIPTION: 
Each  gram  of  ELOMET  Ointment  0.1%  contains  1 mg  mometasone  furoate,  hexylene  glycol, 
white  wax,  propylene  glycol  stearate,  white  petrolatum,  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
  =  0.02µg/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
  =  0.002µg/ear/day  vs 
0.014µg/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
  =  5.3µg/ear/day)  was  less  potent  than  betamethasone  valerate 
(ED
50
 = 3.1µg/ear/day) in suppressing the HPA axis in mice after fi

Summary of Product characteristics

S-CCDS-MK0887-MTL-082017
ELOMET® Ointment 0.1%
Brand of mometasone furoate
FOR DERMATOLOGIC USE ONLY
DESCRIPTION:
Each gram of ELOMET Ointment 0.1% contains 1 mg mometasone furoate,
hexylene glycol,
white wax, propylene glycol stearate, white petrolatum, 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 betamethasone 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/mouse). At doses five to 5000 times the effective
anti-inflammatory doses, mometasone