Triderm, 15 g

Bayer Pharma AG, Germany

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Product Overview

Composition

1 g of cream contains:

betamethasone 0.5 mg, 

clotrimazole 10 mg, 

gentamicin 1 mg.


Excipients:

liquid paraffin,

white I petroleum jelly,

cetostearyl alcohol,

propylene glycol,

cetomacrogol-1000.

gasoline alcohol,

J sodium dibasic phosphate dihydrate,

phosphoric acid,

sodium hydroxide (to establish the required pH value),

purified water (qs ad 1000 mg).

pharmachologic effect

Pharmacological group:  

glucocorticosteroid + antibiotic aminoglycoside + antifungal agent.


Pharmachologic effect:  

Triderm is a combined drug. Triderm®
ointment and cream combine the anti-inflammatory, antipruritic, anti-allergic and anti-exudative effects of betamethasone dipropionate with the antifungal activity of clotrimazole and the broad antibacterial effect of gentamicin sulfate.


Clotrimazole has an antifungal effect (inhibits the synthesis of ergosterol in the cell membrane of fungi). Active against Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, Candida albicans, Malassezia furfur (Pityrosporum orbiculare).


Gentamicin sulfate, a broad-spectrum aminoglycoside antibiotic, is bactericidal and provides highly effective local treatment of primary and secondary bacterial skin infections. Active against gram-negative microorganisms: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris, Klebsiella pneumoniae; gram-positive microorganisms: Streptococcus spp. (sensitive strains of alpha and beta hemolytic group A streptococcus), Staphylococcus aureus (coagulase-positive, coagulase-negative and some strains producing penicillinase).

Indications

- reduction of inflammatory manifestations of dermatoses complicated by primary and secondary infection (simple and allergic dermatitis, atopic dermatitis, diffuse neurodermatitis, limited neurodermatitis);


- athlete's foot;


- pityriasis versicolor;


- simple chronic lichen;


- dermatomycosis (including inguinal and in large folds of the skin), caused by pathogens sensitive to the drug: dermatophytosis, candidiasis; versicolor versicolor.

Application during pregnancy and lactation

The use of TRIDERM during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.

It is not known whether the components of the drug are excreted in breast milk.

Therefore, when prescribing TRIDERM during lactation, the question of stopping breastfeeding should be resolved.

Contraindications

- hypersensitivity to any of the components of the drug Triderm;


- tuberculosis of the skin;


- cutaneous manifestations of syphilis;


- chicken pox;


- herpes simplex;


- post-vaccination skin reactions;


- age up to 2 years.

Side effects

Local reactions: burning sensation, erythema, exudation, pigmentation disorders, itching.


Adverse reactions caused by betamethasone: burning sensation, itching, irritation and dryness of the skin, folliculitis, hypertrichosis, acne-like rashes, hypopigmentation, perioral dermatitis, skin maceration, secondary infection, skin atrophy, striae, prickly heat.


Adverse reactions due to clotrimazole: erythema, scaling, local edema, itching, urticaria, skin maceration, paresthesia.


Adverse reactions due to gentamicin: hyperemia, itching.

How to take, course of administration and dosage

The cream is used in the treatment of acute weeping skin lesions - in processes with weeping and severe inflammation. 

TRIDERM cream should be applied in a thin layer to the entire affected skin surface and surrounding tissue twice a day - in the morning and at night. To ensure the effectiveness of treatment, TRIDERM cream must be used regularly. 

The duration of therapy depends on the size and location of the lesion, as well as the patient's response. If clinical improvement does not occur after 3-4 weeks of treatment, this may serve as a reason for clarifying the diagnosis.

Overdose

With prolonged use of glucocorticosteroids in high doses, symptoms of hypercortisolism may develop. 

The use of clotrimazole under an occlusive dressing for 6 hours did not lead to the development of overdose symptoms.

Special instructions

Cannot be used in ophthalmic practice. 

Long-term topical use of antibiotics can sometimes lead to the growth of resistant microflora. In this case, as well as with the development of irritation, sensitization or superinfection against the background of the use of Triderm , treatment should be interrupted and appropriate therapy should be prescribed. Cross-allergic reactions with aminoglycoside antibiotics have been observed.


Any side effects that occur with the use of systemic glucocorticosteroids, including inhibition of the function of the adrenal cortex, can also be observed with topical application of glucocorticosteroids, especially in children. Systemic absorption of glucocorticosteroids or gentamicin when applied topically will be higher if the treatment is carried out on large areas of the body or when using occlusive dressings. 

Avoid applying gentamicin to open wounds or skin lesions. Appropriate precautions should be taken in such cases, especially when treating children.


It is recommended to withdraw the drug gradually after prolonged use.


Use in pediatrics: children are prescribed from 2 years old only on strict indications and under medical supervision, because possible development of systemic side effects associated with betamethasone. When using Triderm , like many other topical glucocorticosteroids on large surfaces and / or with an occlusive dressing, it is possible to suppress the function of the hypothalamic-pituitary-adrenal system, there may be a decrease in the excretion of growth hormone, as well as an increase in intracranial pressure.

Release form

Cream for external use.

Storage conditions

Store at temperatures from +2 ° C to +30 ° C.

Shelf life

3 years.

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