TRIDERM CREAM

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BETAMETHASONE AS DIPROPIONATE; CLOTRIMAZOLE; GENTAMICIN (AS SULFATE)

Available from:

ORGANON PHARMA ISRAEL LTD., ISRAEL

ATC code:

D07XC

Pharmaceutical form:

CREAM

Composition:

CLOTRIMAZOLE 10 MG/G; BETAMETHASONE AS DIPROPIONATE 0.5 MG/G; GENTAMICIN (AS SULFATE) 1 MG/G

Administration route:

TOPICAL

Prescription type:

Required

Manufactured by:

ORGANON LLC, USA

Therapeutic group:

CORTICOSTEROIDS, POTENT, OTHER COMBINATIONS

Therapeutic indications:

Treatment of corticosteroid-responsive dermatoses when complicated by infections caused by bacteria (sensitive to gentamicin) and fungi (sensitive to clotrimazole) or when the possibility of such infections is suspected. The cream is suitable for the use of oozing eczema.

Authorization date:

2022-03-31

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986
This medicine can be sold under doctor’s prescription only
Triderm
®
Cream
Composition:
Each gram contains:
Betamethasone dipropionate 0.643* mg
*Equivalent to 0.5 mg Betamethasone.
Clotrimazole 10.00 mg
Gentamicin (as sulfate) 1.00 mg
For a list of inactive ingredients, see section 6 “FURTHER
INFORMATION”. See also
section 2.5 “Important information about some of the ingredients of
Triderm Cream” .
Read all of this leaflet carefully before you start using the
medicine.
•
This leaflet contains concise information about Triderm Cream.
If you have any
further questions, refer to the doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if their medical condition seems similar to yours.
1. WHAT TRIDERM CREAM IS USED FOR?
Triderm Cream is indicated for the treatment of dermatoses responsive
to
corticosteroids when complicated by secondary infections caused by
bacteria (sensitive
to gentamicin) and fungi (sensitive to clotrimazole) or when the
possibility of such
infections is suspected.
The cream is suitable for the treatment of oozing eczema.
Therapeutic Group:
Betamethasone - potent glucocorticoid.
Clotrimazole - antifungal.
Gentamicin - aminoglycoside antibiotic.
2.
BEFORE USING TRIDERM CREAM
2.1 Do not use Triderm Cream
−
if you are sensitive (allergic) to betamethasone dipropionate,
clotrimazole, gentamicin
sulfate or any of the other ingredients of this medicine. For a list
of inactive
ingredients, see section 6.
−
in cases of skin infections [of viral, bacterial (including
tuberculosis) and fungal
aetiology] or syphilitic skin diseases, chicken pox (varicella),
herpes infections (e.g.
fever blisters), vaccine reactions, skin ulcers and acne. The doctor
should be
informed immediately.
−
facial application is not recommended in the presence of rosacea or
perioral
dermatitis.
−
in case of open wounds or damaged skin areas.
−
under

Summary of Product characteristics

TRIDERM
®
CREAM
Qualitative and Quantitative Composition
_Active substances_:_ _betamethasone (as dipropionate); clotrimazole,
gentamicin (as
sulphate).
_1 gram of TRIDERM Cream contains: 0.643 mg betamethasone
dipropionate, equivalent _
_to 0.5 mg betamethasone, 10.00 mg clotrimazole and 1.00 mg gentamicin
(as sulfate). _
_ _
_Excipients with known effect: _
Propylene glycol – 10.0% w/w, cetostearyl alcohol – 7.2% w/w,
benzyl alcohol – 1.0% w/w
_ _
_Excipients_:
White soft paraffin, propylene glycol, cetostearyl alcohol, liquid
paraffin, cetomacrogol
1000, benzyl alcohol, sodium dihydrogen phosphate dihydrate,
phosphoric acid, sodium
hydroxide, purified water.
Pharmaceutical form
Cream
Therapeutic Indications
TRIDERM Cream is indicated for the treatment of
corticosteroid-responsive dermatoses when
complicated by infections caused by bacteria (sensitive to gentamicin)
and fungi (sensitive to
clotrimazole) or when the possibility of such infections is suspected.
The cream is suitable for the
use of oozing eczema.
Posology and Method of Administration
General
N/A
Dose
_Adolescents and adults:_
_ _
Apply a thin film to the affected skin area twice daily (morning and
evening) and gently rub in. The
entire lesion, as well as surrounding healthy skin, should be covered.
Duration of treatment is based on the clinical response, as well as on
clinical and microbiological
findings.
A period of 2-3 weeks continuous treatment should preferably not be
exceeded. If clinical
improvement is not achieved by 2-3 weeks, diagnosis should be
reviewed.
2
of
9
_Children 2 to 12 years old: _
Apply a thin film to only the affected skin and carefully rub in.
Apply a sufficient amount no more
frequently than twice daily with at least 6-12 hours between
applications.
_ _
Triderm should be used with caution in children from the age of 2-12
years, not longer
_ _
than 5-7
days and not on extensive body areas. The use in children under the
age of 2 years is not
recommended.
If Triderm must be used in children from the age of 2-12 years,