Triderm

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

betamethasone (betamethasone dipropionate), clotrimazole, gentamicin (gentamicin sulfate)

Available from:

Schering-Plough Labo N.V.

INN (International Name):

betamethasone (betamethasone dipropionate), clotrimazole, gentamicin (gentamicin sulfate)

Dosage:

0,5mg/g+10mg/g+1mg/g

Pharmaceutical form:

cream

Prescription type:

Prescription

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1. NAME OF THE MEDICINAL PRODUCT
TRIDERM
CREAM
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_active ingredients:_ betamethasone, clotrimazole, gentamycin;
1 g of cream contains betamethasone 0.5 mg (0,643 mg as betamethasone
dipropionate), 10 mg
clotrimazole and 1.0 mg gentamycin (as gentamycin sulfate);
_excipients: _
liquid
paraffin,
white
soft
paraffin,
cetostearyl
alcohol,
propylene
glycol,
macrogol
cetostearyl ether, benzyl alcohol, sodium dihydrogen phosphate
dihydrate, phosphoric acid, sodium
hydroxide, phosphoric acid, purified water._ _
3. PHARMACEUTICAL FORM
Cream.
PHARMACOTHERAPEUTIC GROUP. Topical corticosteroid in combination with
other agents for treatment of
dermatological deceases.
ATC code D07С01.
4. CLINICAL PARTICULARS.
_ _
4.1. INDICATIONS.
TRIDERM is indicated for the treatment of corticosteroid-responsive
dermatoses when complicated by
infections caused by bacteria and/or fungi or when the possibility of
such infections is suspected. The
cream is suitable for the use of oozing lesions.
4.2. CONTRAINDICATIONS.
Topical corticosteroids are contraindicated in skin infections (viral,
bacterial [including tuberculosis]
and fungal origin), reaction to vaccines, skin ulcers and acne. Cream
should not be applied for face in
the case of rosacea or perioral dermatitis. _ _
Hypersensitivity to any of active components or ingredients of the
preparation, other aminoglycosides
(polyvalent allergy to gentamycin) or imidazole derives (polyvalent
allergy to clotrimazole).
Triderm is not indicated for use with occlusive dressing.
Triderm should not be applied on mucosae, skin around eyes and close
to eyes.
_ _
4.3 POSOLOGY AND METHOD OF ADMINISTRATION.
_Adolescents and adults. _
TRIDERM should be applied to cover completely the affected and
surrounding skin areas twice daily.
Duration of therapy varies depending upon the results of clinical
examination, microbiological testing
and patient response to treatment.
In the case of foot mycoses a longer course of treatment (2-4