The instruction for medical use
of Travokort® medicine
the Trade name
of Travokort®
the International unlicensed name
Is not present
the Dosage form
Cream, 15 g
Structure
of 100 g of cream contain
active agents: izokonazola nitrate of 1.0 g
of a diflukortolon valerate of 0.1 g,
excipients: sodium edetat, polysorbate 60, sorbitan stearate, alcohol ketostearyl, heavy liquid paraffin, paraffin white soft, the water purified.
The description
From white till slightly yellowish color opaque cream.
Pharmacotherapeutic group
Glucocorticosteroids highly active in a combination with antiseptic agents. Diflukortolon in a combination with antiseptic agents.
The ATX D07BC04 code
the Pharmacological
Izokonazol's Pharmacokinetics properties
Izokonazol nitrate quickly gets from cream into skin and reaches the maximum concentration in its corneal layer and in a derma already in 1 h after drawing. After external use in skin of rabbits noted higher level of antifungal substance in comparison with use of the drugs which are not containing corticosteroids. It is explained by delay of absorption through skin owing to vasopressor action of glucocorticosteroids (GKS).
The ratio of concentration of antifungal means and GKS in skin is more in comparison with that ratio in Travokort® cream (10:1) that indicates lack of influence of a corticosteroid on antifungal effect of drug.
Izokonazol is not inactivated in skin by metabolism. System loading by dermal absorption low. Even after removal of horn layer of less than 1% of the put dose reaches a system blood-groove within 4 h after drawing.
Intravenous administration of 0.5 mg of a 3H-mechenny izokonazol of nitrate, revealed that izokonazol is completely metabolized and is quickly brought out of an organism. The most important metabolites in quantitative ratio are 2.4-dikhloromandelovy acid and 2 (2.6-dikhlorobenziloks)-2-(2.4 dichlorophenyl) - acetic acid. A third it is radioactive marked substances it was allocated with urine and two thirds — with bile. 75% of the general dose were excreted for day.
Diflukortolona
Izokonazol valerate does not affect permeability and absorption through skin of a diflukortolon of valerate. Diflukortolona valerate quickly gets into skin, in a corneal layer its concentration makes about 150 mkg/ml (300 µmol/l) in 1 h. This level is supported for not less than 7 h. Corticosteroid level in the deepest layer of epidermis was about 0.15 mkg/ml (0.3 µmol/l). Diflukortolona valerate is partially hydrolyzed in skin and turns in diflukortolon, having similar efficiency. A part of the corticosteroid which is absorbed through skin, low. Within 4 h after drawing less than 1% of a dose of Travokort® cream it was completely soaked up through skin.
Getting to a system blood stream, a diflukortolon valerate is quickly hydrolyzed in diflukortolon and the corresponding fatty acid. Except a diflukortolon, in blood plasma were revealed a 11-Siberian salmon-diflukortolon and two other metabolites.
Diflukortolon and all metabolites are brought out of blood plasma, the period of their semi-removal is 4–5 h and about 9 h respectively (elimination half-life after an intravenous injection) and are excreted in the ratio 75:25 with urine and a stake.
A pharmacodynamics
Izokonazol – synthetic derivative an imidazole. Possesses a wide antifungal and antibacterial range of action. Works fungicidally and bakteritsidno. Suppresses synthesis of ergosterol of cell membranes of a mushroom, causing his death, blocks synthesis of proteins of bacteria. It is active concerning dermatophytes (Trichophyton spp., Microsporum spp., Epidermophyton spp., etc.), mold, barmy and yeast-like mushrooms (Candida spp., Pityrosporum orbiculare/ovale (Malassezia furfur), Corynebacterium minutissimum - the activator of an erythrasma, trichomonads and gram-positive bacteria of Staphylococcus spp., Streptococcus spp.
Diflukortolona valerate – a glucocorticosteroid for external use. The mechanism of action is connected with suppression of function of leukocytes and fabric macrophages, restriction of migration of leukocytes to the area of inflammation. Reduces the permeability of capillaries caused by release of a histamine. Renders anti-inflammatory, anti-exudative, antiallergic and antipruritic action.
Indications
- initial or landmark treatment of the fungal infections of a surface of skin which are followed by the expressed inflammatory or ekzemopodobny skin symptoms, for example on hands in interdigital sites of feet and also inguinal area and area of genitals.
The route of administration and doses
of Travokort® apply with a thin layer on affected areas of skin and slightly rub: the procedure is carried out by 2 times a day (in the morning and for the night). The maximum duration of treatment is 2 weeks.
After regression of inflammatory process it is necessary to continue therapy by the Travogen® cream which is not containing glucocorticosteroids. It is especially important when putting drug on area of genitals and inguinal folds.
Side effects
In isolated cases
- an itching, burning, an erythema or vesiculation
the Following reactions can be noted when using glucocorticosteroids for topical administration on extensive surfaces (more than 10% of a surface of skin) or for a long time (more than 4 weeks):
- local symptoms such as atrophy of skin, teleangiectasias, striya, akneformny changes of skin
- system side effects of a glucocorticosteroid owing to absorption (function suppression gipotalamo - a hypophysial and adrenal system)
it is rare
- a folliculitis, perioral dermatitis, a hypertrichosis, discoloration of skin
- allergic reactions to any of ingredients of drug
It is impossible to exclude completely development of side effects in newborns whose mothers during pregnancy or a lactation received long-term treatment or applied drug on extensive body surfaces (for example, depression of function of bark of adrenal glands when using drug to pregnancy in recent months).
Contraindications
- hypersensitivity to drug components
- tubercular, syphilitic, virus (chicken pox, shingles) damages of skin in sites of application of drug
- a rozatse, perioral dermatitis and skin vaccine-challenged reactions in sites of application of drug
- the I trimester of pregnancy
- children's age up to 2 years
Medicinal interactions
are not revealed
Special instructions
in the presence of a bacterial dermatosis and/or dermatomycoses in addition to therapy of Travokortom® it is necessary to carry out specific antibacterial treatment.
It is necessary to avoid hit of cream in eyes when putting drug on the person.
Causing excessively large number of local glucocorticosteroids on the extensive surfaces of skin for a long time, especially under an occlusive bandage, considerably increases risk of development of side effects.
As well as at use of system corticosteroids, glaucoma at use of local corticosteroids can develop (for example, after high doses, or at extensive putting drug for a long time, uses of occlusive bandages or putting drug on skin around eyes).
In infections of interdigital sites the placement of a tampon with the applied Travokorta® cream between fingers is reasonable.
For avoidance of developing of repeated infections it is necessary to follow rules of personal hygiene (daily replacement and boiling of towels, underwear (it is preferable from cotton)).
Regular observance of measures of hygiene is very important for achievement of effect of treatment of Travokortom®. It is necessary to wipe carefully to dryness interdigital areas after each washing of feet, and to change socks and tights daily.
Травокорт® cream contains cytostearyl alcohol which can cause local skin reactions (including, contact dermatitis).
Pregnancy and the period of a lactation
As a rule, it is necessary to avoid use of the local drugs containing corticosteroids during the first trimester of pregnancy. At the clinical indication for treatment of Travokort® cream during pregnancy in II and III trimesters it is necessary to weigh carefully potential risk for a fruit and the expected advantage of treatment for mother. In particular, during these periods it is necessary to avoid prolonged use of drug on the extensive surfaces of skin.
Nursing mothers should not use drug for treatment of a breast.
Use in pediatrics
to Children drug is appointed from two-year age only according to strict indications and under medical control as development of the system side effects connected with diflukortolony is possible.
Features of influence of medicine on ability to run motor transport and potentially dangerous mechanisms
Use of drug does not affect ability to run motor transport and potentially dangerous mechanisms.
Overdose
According to results of studying acute toxicity the risk of acute intoxication after single skin drawing the raised dose (drawing on a big surface is improbable under the conditions promoting absorption) or at inadvertent consuming.
A form of release and packing
On 15 g of cream in a tuba aluminum with a membrane and the polyethylene screwing-up cover.
1 tuba together with the instruction for medical use in the state and Russian languages is placed in a pack from cardboard.
To Store storage conditions at a temperature not above 25 °C.
To store in places inaccessible for children!
Not to use a period of storage of 5 years after an expiration date.
Prescription status
According to the prescription
the Producer/packer Bayer Helsker Manufacturing of Neuter of l., Segreyt, Italy
the Holder of the registration certificate
of Bayer Pharm AG, Berlin, Germany
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of a product (goods): TOO "Bayer KAZ" Timiryazev St., 42, business center "Expo-City", peahens. 15 050057 Almaty, Republic of Kazakhstan, ph. +7 727 258 80 40, fax: +7 727 258 80 39, e-mail:
To develop kz.claims@bayer.com
of Travokort® medicine
the Trade name
of Travokort®
the International unlicensed name
Is not present
the Dosage form
Cream, 15 g
Structure
of 100 g of cream contain
active agents: izokonazola nitrate of 1.0 g
of a diflukortolon valerate of 0.1 g,
excipients: sodium edetat, polysorbate 60, sorbitan stearate, alcohol ketostearyl, heavy liquid paraffin, paraffin white soft, the water purified.
The description
From white till slightly yellowish color opaque cream.
Pharmacotherapeutic group
Glucocorticosteroids highly active in a combination with antiseptic agents. Diflukortolon in a combination with antiseptic agents.
The ATX D07BC04 code
the Pharmacological
Izokonazol's Pharmacokinetics properties
Izokonazol nitrate quickly gets from cream into skin and reaches the maximum concentration in its corneal layer and in a derma already in 1 h after drawing. After external use in skin of rabbits noted higher level of antifungal substance in comparison with use of the drugs which are not containing corticosteroids. It is explained by delay of absorption through skin owing to vasopressor action of glucocorticosteroids (GKS).
The ratio of concentration of antifungal means and GKS in skin is more in comparison with that ratio in Travokort® cream (10:1) that indicates lack of influence of a corticosteroid on antifungal effect of drug.
Izokonazol is not inactivated in skin by metabolism. System loading by dermal absorption low. Even after removal of horn layer of less than 1% of the put dose reaches a system blood-groove within 4 h after drawing.
Intravenous administration of 0.5 mg of a 3H-mechenny izokonazol of nitrate, revealed that izokonazol is completely metabolized and is quickly brought out of an organism. The most important metabolites in quantitative ratio are 2.4-dikhloromandelovy acid and 2 (2.6-dikhlorobenziloks)-2-(2.4 dichlorophenyl) - acetic acid. A third it is radioactive marked substances it was allocated with urine and two thirds — with bile. 75% of the general dose were excreted for day.
Diflukortolona
Izokonazol valerate does not affect permeability and absorption through skin of a diflukortolon of valerate. Diflukortolona valerate quickly gets into skin, in a corneal layer its concentration makes about 150 mkg/ml (300 µmol/l) in 1 h. This level is supported for not less than 7 h. Corticosteroid level in the deepest layer of epidermis was about 0.15 mkg/ml (0.3 µmol/l). Diflukortolona valerate is partially hydrolyzed in skin and turns in diflukortolon, having similar efficiency. A part of the corticosteroid which is absorbed through skin, low. Within 4 h after drawing less than 1% of a dose of Travokort® cream it was completely soaked up through skin.
Getting to a system blood stream, a diflukortolon valerate is quickly hydrolyzed in diflukortolon and the corresponding fatty acid. Except a diflukortolon, in blood plasma were revealed a 11-Siberian salmon-diflukortolon and two other metabolites.
Diflukortolon and all metabolites are brought out of blood plasma, the period of their semi-removal is 4–5 h and about 9 h respectively (elimination half-life after an intravenous injection) and are excreted in the ratio 75:25 with urine and a stake.
A pharmacodynamics
Izokonazol – synthetic derivative an imidazole. Possesses a wide antifungal and antibacterial range of action. Works fungicidally and bakteritsidno. Suppresses synthesis of ergosterol of cell membranes of a mushroom, causing his death, blocks synthesis of proteins of bacteria. It is active concerning dermatophytes (Trichophyton spp., Microsporum spp., Epidermophyton spp., etc.), mold, barmy and yeast-like mushrooms (Candida spp., Pityrosporum orbiculare/ovale (Malassezia furfur), Corynebacterium minutissimum - the activator of an erythrasma, trichomonads and gram-positive bacteria of Staphylococcus spp., Streptococcus spp.
Diflukortolona valerate – a glucocorticosteroid for external use. The mechanism of action is connected with suppression of function of leukocytes and fabric macrophages, restriction of migration of leukocytes to the area of inflammation. Reduces the permeability of capillaries caused by release of a histamine. Renders anti-inflammatory, anti-exudative, antiallergic and antipruritic action.
Indications
- initial or landmark treatment of the fungal infections of a surface of skin which are followed by the expressed inflammatory or ekzemopodobny skin symptoms, for example on hands in interdigital sites of feet and also inguinal area and area of genitals.
The route of administration and doses
of Travokort® apply with a thin layer on affected areas of skin and slightly rub: the procedure is carried out by 2 times a day (in the morning and for the night). The maximum duration of treatment is 2 weeks.
After regression of inflammatory process it is necessary to continue therapy by the Travogen® cream which is not containing glucocorticosteroids. It is especially important when putting drug on area of genitals and inguinal folds.
Side effects
In isolated cases
- an itching, burning, an erythema or vesiculation
the Following reactions can be noted when using glucocorticosteroids for topical administration on extensive surfaces (more than 10% of a surface of skin) or for a long time (more than 4 weeks):
- local symptoms such as atrophy of skin, teleangiectasias, striya, akneformny changes of skin
- system side effects of a glucocorticosteroid owing to absorption (function suppression gipotalamo - a hypophysial and adrenal system)
it is rare
- a folliculitis, perioral dermatitis, a hypertrichosis, discoloration of skin
- allergic reactions to any of ingredients of drug
It is impossible to exclude completely development of side effects in newborns whose mothers during pregnancy or a lactation received long-term treatment or applied drug on extensive body surfaces (for example, depression of function of bark of adrenal glands when using drug to pregnancy in recent months).
Contraindications
- hypersensitivity to drug components
- tubercular, syphilitic, virus (chicken pox, shingles) damages of skin in sites of application of drug
- a rozatse, perioral dermatitis and skin vaccine-challenged reactions in sites of application of drug
- the I trimester of pregnancy
- children's age up to 2 years
Medicinal interactions
are not revealed
Special instructions
in the presence of a bacterial dermatosis and/or dermatomycoses in addition to therapy of Travokortom® it is necessary to carry out specific antibacterial treatment.
It is necessary to avoid hit of cream in eyes when putting drug on the person.
Causing excessively large number of local glucocorticosteroids on the extensive surfaces of skin for a long time, especially under an occlusive bandage, considerably increases risk of development of side effects.
As well as at use of system corticosteroids, glaucoma at use of local corticosteroids can develop (for example, after high doses, or at extensive putting drug for a long time, uses of occlusive bandages or putting drug on skin around eyes).
In infections of interdigital sites the placement of a tampon with the applied Travokorta® cream between fingers is reasonable.
For avoidance of developing of repeated infections it is necessary to follow rules of personal hygiene (daily replacement and boiling of towels, underwear (it is preferable from cotton)).
Regular observance of measures of hygiene is very important for achievement of effect of treatment of Travokortom®. It is necessary to wipe carefully to dryness interdigital areas after each washing of feet, and to change socks and tights daily.
Травокорт® cream contains cytostearyl alcohol which can cause local skin reactions (including, contact dermatitis).
Pregnancy and the period of a lactation
As a rule, it is necessary to avoid use of the local drugs containing corticosteroids during the first trimester of pregnancy. At the clinical indication for treatment of Travokort® cream during pregnancy in II and III trimesters it is necessary to weigh carefully potential risk for a fruit and the expected advantage of treatment for mother. In particular, during these periods it is necessary to avoid prolonged use of drug on the extensive surfaces of skin.
Nursing mothers should not use drug for treatment of a breast.
Use in pediatrics
to Children drug is appointed from two-year age only according to strict indications and under medical control as development of the system side effects connected with diflukortolony is possible.
Features of influence of medicine on ability to run motor transport and potentially dangerous mechanisms
Use of drug does not affect ability to run motor transport and potentially dangerous mechanisms.
Overdose
According to results of studying acute toxicity the risk of acute intoxication after single skin drawing the raised dose (drawing on a big surface is improbable under the conditions promoting absorption) or at inadvertent consuming.
A form of release and packing
On 15 g of cream in a tuba aluminum with a membrane and the polyethylene screwing-up cover.
1 tuba together with the instruction for medical use in the state and Russian languages is placed in a pack from cardboard.
To Store storage conditions at a temperature not above 25 °C.
To store in places inaccessible for children!
Not to use a period of storage of 5 years after an expiration date.
Prescription status
According to the prescription
the Producer/packer Bayer Helsker Manufacturing of Neuter of l., Segreyt, Italy
the Holder of the registration certificate
of Bayer Pharm AG, Berlin, Germany
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of a product (goods): TOO "Bayer KAZ" Timiryazev St., 42, business center "Expo-City", peahens. 15 050057 Almaty, Republic of Kazakhstan, ph. +7 727 258 80 40, fax: +7 727 258 80 39, e-mail:
To develop kz.claims@bayer.com
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