Expiration date: 12/2025

The composition and form of issue:

A topical cream, 100 g contains:

diflucortolone valerate 0.1 g

of isoconazole nitrate 1 g

excipients: Polysorbate 60 — 3.5 g sorbitan stearate 1 g cetostearyl alcohol (cetyl alcohol 60%, stearyl alcohol 40%) — 5 g liquid paraffin 10 g white vaseline 10 g disodium edetate 0.1 g purified water — 69,3 g 

in the aluminium tubes to 15 grams in a cardboard bundle 1 tuba.

Description pharmaceutical form:

White or slightly yellowish opaque, smooth cream.

Pharmacokinetics:

Studies on pharmacokinetics was conducted.

Description pharmacological action:

The isoconazole — synthetic derivative of imidazole. It has a broad antifungal and antibacterial spectrum of action. Acts fungicidal and bactericidal. Inhibits the synthesis of ergosterol of cell membranes of the fungus, causing his death, inhibits protein synthesis of bacteria. Active against dermatophytes (Trichophyton spp., Microsporum spp. Epidermophyton spp. etc.), molds, yeasts and yeast-like fungi (Candida spp., Pityrosporum orbiculare/ovale (Malassezia furfur), Corynebacterium minutissimum, the causative agent of erythrasma and gram-positive bacteria Staphylococcus spp. Streptococcus spp.

Diflucortolone valerate — a corticosteroids for local use. Anti-inflammatory, antiexudative, anti-allergic and antipruritic effect.

Indications:

Dermatoses combined etiologies that are sensitive to therapy GCS infected with a fungal/bacterial infection.

Fungal skin infections, including secondarily infected, accompanied by severe inflammatory or ekzemopodibnymy symptoms:

• fungal infections of feet and smooth skin, including localization in the folds, interdigital spaces of the vulva (including balanoposthitis): mikrosporia, rubrofitii, athlete
  
• candidiasises
  
• eritrazma.
  

Contraindications:

• hypersensitivity to the drug
  
• tuberculosis, syphilis, viral (chickenpox, shingles) lesions of the skin
  
• post-vaccination skin reaction
  
• The first trimester of pregnancy.
  

Caution: second and third trimesters of pregnancy, lactation.

Application of pregnancy and breast-feeding:

Like all medications for topical use containing corticosteroids, Travocort is not recommended during the first trimester of pregnancy.

The use of the drug in II and III trimester of pregnancy is possible in cases when the potential benefit to the mother outweighs the potential risk to the fetus.

If necessary, use of the drug during lactation should decide the issue with a doctor about stopping breastfeeding.

Side effects:

Travocort usually well tolerated, even when applied to sensitive skin. In rare cases may develop skin irritation and allergic reactions. Given that part of the drug Travocort included corticosteroids for external use, the application of the cream on large surfaces (more than 10% of skin surface) for a long time (over 4 weeks) and/or when using occlusive dressings may cause side effects characteristic of corticosteroids: skin atrophy, telangiectasia, striae, acne-like dermatitis, perioral dermatitis, hypertrichosis, as well as systemic side effects (suppression of the function of the hypothalamic-pituitary-adrenal system).

Drug interactions:

It is not revealed.

Method of application and dose:

Externally. Travocort apply a thin layer to the affected area and RUB gently, 2 times a day (morning and night).

The maximum duration of treatment is 2 weeks.

Overdose:

The symptoms of acute overdose have not been described, however, excessive or prolonged use of the drug may chronic overdose involving described under "Side effects" symptoms

Treatment: symptomatic.

Special instructions:

Use only for external use.

Avoid contact with eyes and open wounds. In case of accidental contact with eyes, thoroughly rinse them with warm water.

Patients with rosacea or perioral dermatitis do not use this product on the skin.

Effects on ability to drive and use mechanisms

It is not revealed.