The instruction for medical use
of Triderm® medicine
the Trade name
of Triderm®
the International unlicensed name
Is not present
the Dosage form
Ointment
Structure
1 g of ointment contains
active agents: betamethasone Dipropionas of 0.643 mg (0.500 mg of betamethasone), Clotrimazolum of 10.0 mg, gentamycin of 1.0 mg or 1000 ME (in the form of Gentamycini sulfas are equivalent)
excipients: liquid paraffin, paraffin white soft
the Description
Uniform ointment from white till light yellow color, without visible mechanical inclusions
Pharmacotherapeutic group
Glucocorticosteroids for topical treatment of diseases of skin. Corticosteroids active in a combination with other drugs. Betamethasone in a combination with other drugs.
The ATX D07XC01 code
the Pharmacological
Pharmacokinetics Data properties about pharmacokinetics of the drug Triderm® are absent.
The pharmacodynamics
the Combined drug Triderm® combines anti-inflammatory, antipruritic and vasoconstrictive effect of betamethasone of Dipropionas with antifungal activity of Clotrimazolum and broad antibacterial action of Gentamycini sulfas.
Clotrimazolum has antifungal effect due to disturbance of synthesis of the ergosterol which is a component of a cellular membrane of mushrooms.
Gentamycin is effective topical drug at therapy of primary and consecutive bacterial infections of skin. Gentamycin is active concerning gram-positive bacteria: Staphylococcus aureus (a coagualase - positive, a coagualase - the negative and some strains producing penicillinase) and concerning gram-negative bacteria: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris and Klebsiella pneumoniae.
Indications
-
- multi-colored deprive inflammatory manifestations at the dermatosis sensitive to corticosteroids which is complicated by the consecutive infection caused by the organisms sensitive to components of drug or at suspicion of this infection - mycoses of feet, an inguinal epidermophitia, a crotch trichophytia, the bordered eczema, a trichophytia of smooth skin caused by Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum and Microsporum canis - the candidiasis caused by Candida albicans,
the Route of administration and doses
of Triderm® apply the caused Malassezia furfur (Pityrosporum obiculare) with a thin layer on all struck surface of skin and adjacent area 2 times a day, in the morning and in the evening. It is regularly necessary to apply to obtaining effect of Triderm®. Duration of therapy depends on the amount of localization of defeat and sensitivity of the patient to treatment. If the clinical effect is not observed within 3-4 weeks, the diagnosis has to be revised.
The route of administration at children does not differ from that at adults (see the section Special Instructions).
Side effects
˗ pigmentation disturbance, decolouration of skin (hypopigmentation), burning sensation, an erythema, exudation, an itching
the Side reactions caused by Clotrimazolum:
˗ an erythema, emergence of bubbles, peeling, local hypostasis, a small tortoiseshell, the general irritation of skin
the Side reactions caused by gentamycin:
˗ passing irritation of skin
the Side reactions which arose when using occlusive bandages:
˗ burning, an itching, irritation and xeroderma
a folliculitis
˗ a hypertrichosis
˗ ugrepodobny manifestations
˗ hypopigmentation
˗ perioral dermatitis
˗ allergic contact dermatitis
˗ maceration of skin
˗ consecutive infection
˗ an atrophy of skin, a striya, a heat rash
Side reactions at children
˗ oppression gipotalamo - a hypophysial and adrenal system
˗ Cushing's syndrome
˗ a linear growth inhibition
˗ an insufficient increase of body weight
˗ the increase in intracranial pressure which is shown protrusion of a fontanel, a headache, bilateral hypostasis of disks of optic nerves (papillary stasis sign)
of the Contraindication
- hypersensitivity to any of drug components
- a tuberculosis cutis, skin manifestations of syphilis
- chicken pox, a herpes simplex, skin vaccine-challenged reactions
- open wounds
With care: pregnancy the I trimester, children's age
Medicinal interactions
are not established.
Special instructions
If irritation or sensitivity amplify in process of Triderm® ointment use, treatment has to be the corresponding therapy is stopped and is carried out.
Any side effects which are found at use of system glucocorticosteroids, including oppression of function of bark of adrenal glands, can be noted also at topical administration of glucocorticosteroids, in particular at babies and children.
Cross allergic reactions with aminoglikozidny antibiotics were observed.
System absorption of glucocorticosteroids or gentamycin at topical administration will be higher if treatment is carried out on big body surfaces or when using occlusive bandages. It is necessary to avoid putting gentamycin on open wounds or injuries of skin as development of system side effects of gentamycin is possible. It is necessary to observe the appropriate measures of precaution in such cases, especially at treatment of babies and children.
Long local use of antibiotics can sometimes lead to growth of resistant microflora. In this case and also at development of irritation, a sensitization or superinfection against the background of the Triderm® drug treatment, treatment it is necessary to stop and appoint the corresponding therapy. At long use of drug its cancellation is recommended to be carried out gradually.
Тридерм® it is not intended for use in ophthalmology.
Use in pediatrics. Тридерм® it is not recommended at children 2 years are younger. At children perhaps more frequent emergence of signs of oppression gipotalamo - a hypophysial and adrenal system and emergence of outer corticosteroid effects under the influence of local corticosteroids, than at adult patients that is connected with bigger absorption because of a bigger ratio of surface area of skin to body weight. Oppression of an adrenal system can be shown in the form of the low level of cortisol in blood plasma and lack of the response to therapy by adrenocorticotropic hormones.
Pregnancy and the period of a lactation
Safety of use of local glucocorticosteroids for pregnant women is not proved. Appointment of this group of drugs during pregnancy is justified only if the potential advantage for the woman exceeds potential risk for a fruit. During pregnancy, drugs of this group should not be used in high doses or it is long.
It is not known whether can lead topical administration of corticosteroids through system absorption to emergence them in mother's milk. The decision on the termination of breastfeeding or drug withdrawal should be accepted taking into account need of use of drug for mother.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms.
Not established
Overdose
Symptoms. Excessive or prolonged use of local glucocorticosteroids can cause oppression of hypophysial and adrenal function that there can be the reason of oppression of secondary insufficiency of bark of adrenal glands and emergence of symptoms of a hypercorticoidism, including Cushing's syndrome.
Treatment: Symptomatic treatment. As a rule, symptoms of a sharp hypercorticoidism are reversible. If necessary carry out correction of electrolytic balance. In case of chronic toxic action the gradual cancellation of corticosteroids is recommended. With an excess growth of resistant microorganisms, it is recommended to stop the Triderm® drug treatment and to appoint necessary therapy.
The form of release and packing
On 15 g of drug place in tubas aluminum with internal varnish coating, with a membrane, the screwing-up plastic cap, with a pin for piercing of a membrane.
On 1 tuba together with the instruction for medical use in the state and Russian languages place in a pack from cardboard
Storage conditions
to Store at a temperature not over 25 ºС.
To store out of children's reach!
3 years
not to apply a period of storage after an expiration date.
Prescription status
According to the prescription
Shering-Plau Labo Producer H. B., Belgium
the Owner of the registration certificate
Shering-Plau Sentral East AG, Switzerland
5 etazhtet the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) Representative office of Shering-Plau Sentral East AG in Kazakhstan, Almaty, Dostyk Ave., 38, business center Ken Dala. +7 (727) 330-42-66, 259-80-84факс +7 (727) 259-80-90e-mail: dðoсñ³s2@mårck.com, pharmacovigilance.ukraine&cis@merck.com
to Develop
of Triderm® medicine
the Trade name
of Triderm®
the International unlicensed name
Is not present
the Dosage form
Ointment
Structure
1 g of ointment contains
active agents: betamethasone Dipropionas of 0.643 mg (0.500 mg of betamethasone), Clotrimazolum of 10.0 mg, gentamycin of 1.0 mg or 1000 ME (in the form of Gentamycini sulfas are equivalent)
excipients: liquid paraffin, paraffin white soft
the Description
Uniform ointment from white till light yellow color, without visible mechanical inclusions
Pharmacotherapeutic group
Glucocorticosteroids for topical treatment of diseases of skin. Corticosteroids active in a combination with other drugs. Betamethasone in a combination with other drugs.
The ATX D07XC01 code
the Pharmacological
Pharmacokinetics Data properties about pharmacokinetics of the drug Triderm® are absent.
The pharmacodynamics
the Combined drug Triderm® combines anti-inflammatory, antipruritic and vasoconstrictive effect of betamethasone of Dipropionas with antifungal activity of Clotrimazolum and broad antibacterial action of Gentamycini sulfas.
Clotrimazolum has antifungal effect due to disturbance of synthesis of the ergosterol which is a component of a cellular membrane of mushrooms.
Gentamycin is effective topical drug at therapy of primary and consecutive bacterial infections of skin. Gentamycin is active concerning gram-positive bacteria: Staphylococcus aureus (a coagualase - positive, a coagualase - the negative and some strains producing penicillinase) and concerning gram-negative bacteria: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris and Klebsiella pneumoniae.
Indications
-
- multi-colored deprive inflammatory manifestations at the dermatosis sensitive to corticosteroids which is complicated by the consecutive infection caused by the organisms sensitive to components of drug or at suspicion of this infection - mycoses of feet, an inguinal epidermophitia, a crotch trichophytia, the bordered eczema, a trichophytia of smooth skin caused by Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum and Microsporum canis - the candidiasis caused by Candida albicans,
the Route of administration and doses
of Triderm® apply the caused Malassezia furfur (Pityrosporum obiculare) with a thin layer on all struck surface of skin and adjacent area 2 times a day, in the morning and in the evening. It is regularly necessary to apply to obtaining effect of Triderm®. Duration of therapy depends on the amount of localization of defeat and sensitivity of the patient to treatment. If the clinical effect is not observed within 3-4 weeks, the diagnosis has to be revised.
The route of administration at children does not differ from that at adults (see the section Special Instructions).
Side effects
˗ pigmentation disturbance, decolouration of skin (hypopigmentation), burning sensation, an erythema, exudation, an itching
the Side reactions caused by Clotrimazolum:
˗ an erythema, emergence of bubbles, peeling, local hypostasis, a small tortoiseshell, the general irritation of skin
the Side reactions caused by gentamycin:
˗ passing irritation of skin
the Side reactions which arose when using occlusive bandages:
˗ burning, an itching, irritation and xeroderma
a folliculitis
˗ a hypertrichosis
˗ ugrepodobny manifestations
˗ hypopigmentation
˗ perioral dermatitis
˗ allergic contact dermatitis
˗ maceration of skin
˗ consecutive infection
˗ an atrophy of skin, a striya, a heat rash
Side reactions at children
˗ oppression gipotalamo - a hypophysial and adrenal system
˗ Cushing's syndrome
˗ a linear growth inhibition
˗ an insufficient increase of body weight
˗ the increase in intracranial pressure which is shown protrusion of a fontanel, a headache, bilateral hypostasis of disks of optic nerves (papillary stasis sign)
of the Contraindication
- hypersensitivity to any of drug components
- a tuberculosis cutis, skin manifestations of syphilis
- chicken pox, a herpes simplex, skin vaccine-challenged reactions
- open wounds
With care: pregnancy the I trimester, children's age
Medicinal interactions
are not established.
Special instructions
If irritation or sensitivity amplify in process of Triderm® ointment use, treatment has to be the corresponding therapy is stopped and is carried out.
Any side effects which are found at use of system glucocorticosteroids, including oppression of function of bark of adrenal glands, can be noted also at topical administration of glucocorticosteroids, in particular at babies and children.
Cross allergic reactions with aminoglikozidny antibiotics were observed.
System absorption of glucocorticosteroids or gentamycin at topical administration will be higher if treatment is carried out on big body surfaces or when using occlusive bandages. It is necessary to avoid putting gentamycin on open wounds or injuries of skin as development of system side effects of gentamycin is possible. It is necessary to observe the appropriate measures of precaution in such cases, especially at treatment of babies and children.
Long local use of antibiotics can sometimes lead to growth of resistant microflora. In this case and also at development of irritation, a sensitization or superinfection against the background of the Triderm® drug treatment, treatment it is necessary to stop and appoint the corresponding therapy. At long use of drug its cancellation is recommended to be carried out gradually.
Тридерм® it is not intended for use in ophthalmology.
Use in pediatrics. Тридерм® it is not recommended at children 2 years are younger. At children perhaps more frequent emergence of signs of oppression gipotalamo - a hypophysial and adrenal system and emergence of outer corticosteroid effects under the influence of local corticosteroids, than at adult patients that is connected with bigger absorption because of a bigger ratio of surface area of skin to body weight. Oppression of an adrenal system can be shown in the form of the low level of cortisol in blood plasma and lack of the response to therapy by adrenocorticotropic hormones.
Pregnancy and the period of a lactation
Safety of use of local glucocorticosteroids for pregnant women is not proved. Appointment of this group of drugs during pregnancy is justified only if the potential advantage for the woman exceeds potential risk for a fruit. During pregnancy, drugs of this group should not be used in high doses or it is long.
It is not known whether can lead topical administration of corticosteroids through system absorption to emergence them in mother's milk. The decision on the termination of breastfeeding or drug withdrawal should be accepted taking into account need of use of drug for mother.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms.
Not established
Overdose
Symptoms. Excessive or prolonged use of local glucocorticosteroids can cause oppression of hypophysial and adrenal function that there can be the reason of oppression of secondary insufficiency of bark of adrenal glands and emergence of symptoms of a hypercorticoidism, including Cushing's syndrome.
Treatment: Symptomatic treatment. As a rule, symptoms of a sharp hypercorticoidism are reversible. If necessary carry out correction of electrolytic balance. In case of chronic toxic action the gradual cancellation of corticosteroids is recommended. With an excess growth of resistant microorganisms, it is recommended to stop the Triderm® drug treatment and to appoint necessary therapy.
The form of release and packing
On 15 g of drug place in tubas aluminum with internal varnish coating, with a membrane, the screwing-up plastic cap, with a pin for piercing of a membrane.
On 1 tuba together with the instruction for medical use in the state and Russian languages place in a pack from cardboard
Storage conditions
to Store at a temperature not over 25 ºС.
To store out of children's reach!
3 years
not to apply a period of storage after an expiration date.
Prescription status
According to the prescription
Shering-Plau Labo Producer H. B., Belgium
the Owner of the registration certificate
Shering-Plau Sentral East AG, Switzerland
5 etazhtet the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) Representative office of Shering-Plau Sentral East AG in Kazakhstan, Almaty, Dostyk Ave., 38, business center Ken Dala. +7 (727) 330-42-66, 259-80-84факс +7 (727) 259-80-90e-mail: dðoсñ³s2@mårck.com, pharmacovigilance.ukraine&cis@merck.com
to Develop
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