Terfalin 250 mg (14 tablets)
- $39.90
The instruction for medical use
of TERFALIN® medicine
Trade name
ТЕРФАЛИН®
the International unlicensed
name Terbinafin Lekarstvennaya a form
of the Tablet, 250 mg
Structure
One tablet contains
active agent – a terbinafin a hydrochloride of 281.250 mg (250 mg are equivalent to a terbinafin)
excipients: a hydroksipropilmetiltsellyuloza 15 sr, sodium of a kroskarmeloz, cellulose microcrystalline PH 101, cellulose microcrystalline PH 102, silicon dioxide colloidal, magnesium stearate
the Description
of the Tablet of white color of round shape with risky on one party.
Pharmacotherapeutic group
Antifungal drugs for system use. Terbinafin.
The ATH D01BA 02 code
the Pharmacological
Pharmacokinetics At properties intake terbinafin is well soaked up (& by gt, 70%) and the bioavailability of drug as a result of presistemny metabolism is about 40%. After reception of a terbinafin inside in a dose of 250 mg the maximum concentration in plasma is reached in 2 hours and makes 0.97 mkg/ml. The period of semi-absorption is 0.8 hour, the semi-distribution period - 4.6 hour. Meal can have insignificant impact on biological availability of drug, however it does not demand drug dose adjustment. Terbinafin substantially contacts proteins of blood plasma (99%), quickly gets through a thermal layer of skin and concentrates in a lipophilic corneal layer, gets into secretion of sebaceous glands that leads to creation of high concentrations in hair follicles, hair and in the skin rich with sebaceous glands. It is shown also what terbinafin gets into nail plates in the first several weeks after an initiation of treatment drug. As a result of biotransformation terbinafin it will be transformed to metabolites which have no antifungal activity, metabolites are removed mainly with urine. Elimination half-life makes 17 hours. Any signs of accumulation are not revealed. Long administration of drug at observance of conditions of an equilibrium state does not cause changes of concentration of a terbinafin in plasma depending on age of patients, nevertheless, at patients with a renal failure the clearance rate can be reduced that leads to increase in level of a terbinafin in blood.
Pharmacodynamics
ТЕРФАЛИН® is to synthetic derivatives of allylamine which has the broad antifungal spectrum of action. It is supposed what terbinafin works by skvalenepoksidaza inhibition, thus, blocking ergosterol biosynthesis, the being main component of a membrane of a fungal cell. With accumulation of squalene in fungal cell ТЕРФАЛИН® has the fungicide effect. As the skvalenepoksidaza does not belong to group of enzymes R-450 cytochrome, terbinafin does not inhibit any enzyme from this system of enzymes.
ТЕРФАЛИН® has the big range of therapeutic concentration. Any of metabolites of a terbinafin has no antifungal activity identical with terbinafiny.
ТЕРФАЛИН® shows activity against the majority of strains of following microorganisms: Trichophyton mentagrophytes, Trichophyton rubrum, Candida albicans, Epidermophyton floccosum, Microsporum canis, Scopulariopsis brevicaulis.
- the onychomycosis of feet and brushes caused by dermatophytes (tinea unguinum)
- the dermatomycosis caused by trikhofita, microspores,
epidermofita (mycosis of smooth skin, crotch, feet)
- the skin infections caused by barmy mushrooms, such as Candida
(for example, Candida albicans)
the Route of administration and doses
Adults
Usually appoint indications on 1 tablet (250 mg) of 1 times a day.
Onychomycoses
therapy Duration usually is 6-12 weeks. Duration of therapy can depend on associated diseases, a condition of nails. The clinical effect occurs usually in several months after mycologic treatment and the termination of a course of treatment.
Mycoses of smooth skin
treatment Duration in mycoses of feet - 2-6 weeks, in mycoses of other sites of skin - 2-4 weeks.
Duration of therapy is: mycoses of smooth skin-1-2 weeks, mycoses of feet - 2-4 weeks, candidiasis of skin of-1 - 2 week.
To patients of advanced age drug is appointed in the same doses, as the adult.
Side effects
Often
- a headache
- dyspepsia, feeling of overflow of a stomach, loss of appetite, nausea,
a mild abdominal pain, diarrhea, a cholestasia, jaundice, hepatitis
- allergic reactions of skin (rash, an itching, urticaria)
- arthralgias, myalgias, an alopecia
- a neutropenia, an agranulocytosis, thrombocytopenia
Seldom
- disturbances of flavoring feelings, including their loss
Very seldom
- Stephens-Johnson's syndrome, a toxic epidermal necrolysis, an acute anaphylaxis
- psoriazopodobny rashes, exacerbation of psoriasis
- aggravation of a system lupus erythematosus
of the Contraindication
- hypersensitivity to active agent or others kompo-
to drug nenta
- a heavy renal failure (clearance of creatinine less than 50 ml/min.
or concentration of creatinine in blood serum of more than 300 µmol/l)
- pregnancy and the period of a lactation
- children's age up to 18 years
Medicinal interactions
Terbinafin does not inhibit metabolism of tolbutamide, ethinylestradiol, ethoxycoumarin and cyclosporine.
Terbinafin is CYP450 2D6 isoenzyme inhibitor. Combined use ТЕРФАЛИН® with medicines, mainly, metabolized by means of CYP450 2D6 isoenzyme (for example, tricyclic antidepressants, selective serotonin reuptake inhibitors, beta blockers and monoamine oxidase inhibitors of type B) has to be under careful observation and can demand reduction of a dose of the drugs which are metabolized by means of CYP450 2D6 isoenzyme.
Terbinafin does not affect clearance of antipyrine or digoxin.
Terbinafin lowers clearance of caffeine for 19%.
Terbinafin increases clearance of cyclosporine by 15%.
Drugs which cause induction of microsomal enzymes of a liver (rifampicin) can accelerate removal of a terbinafin. The drugs inhibiting P450 cytochrome (Cimetidinum) slow down removal of a terbinafin. Tsiklosproin does not affect clearance of a terfalin.
Special instructions
Patients with the accompanying chronic diseases of a liver should appoint a half of usually recommended dose ТЕРФАЛИН®, before an initiation of treatment it is recommended to estimate initial indicators of function of a liver and to provide their systematic control in the course of treatment. It is necessary to adhere to the same recommendations at appointment ТЕРФАЛИН® as the alcoholic, with dysfunctions baking. In case in the course of drug treatment the patients have symptoms allowing to assume an abnormal liver function, for example: persistent nausea, lack of appetite, feeling of fatigue, jaundice, dark coloring of urine, decolouration a calla, drug treatment it is necessary to cancel.
It was reported about separate cases of a heavy neutropenia. This state was reversible at the termination of reception ТЕРФАЛИН®, with use or without use of maintenance therapy. If clinical symptoms speak about accession of consecutive infection, then blood indicators have to be completely counted. If the quantity of neutrophils is also lt,/=1000 cells/mm3, reception ТЕРФАЛИН® has to be stopped and maintenance therapy has to be begun.
There are no bases to assume that patients of advanced age require change of a dosage or that they observe the side effects differing from those at patients of younger age.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous
TERFALIN® mechanisms in therapeutic doses does not affect ability to run the vehicle or potentially dangerous mechanisms.
Overdose
Symptoms - nausea, vomiting, pains in the lower part of a stomach.
Treatment - gastric lavage, use of activated carbon and/or symptomatic therapy.
Form of release and packing
On 14 tablets in blister strip packaging from a film of polyvinylchloride and printing aluminum foil.
On 1 or 2 planimetric packs together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions in the dry, protected from light place at a temperature not above 25 °C.
To protect from children!
2 years
not to apply a period of storage after an expiration date.
Prescription status
According to the prescription
Republic of Kazakhstan JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Producer,
Almaty, Shevchenko St. 162 E.
The owner of the registration certificate
of JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika
the Republic of Kazakhstan
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Republic of Kazakhstan, Almaty, Shevchenko St. 162 E. Phone number: (+7 727) 399-50-50Номер fax: (+7 727) 399-60-60Адрес e-mail nobel@nobel.kz
to Develop
of TERFALIN® medicine
Trade name
ТЕРФАЛИН®
the International unlicensed
name Terbinafin Lekarstvennaya a form
of the Tablet, 250 mg
Structure
One tablet contains
active agent – a terbinafin a hydrochloride of 281.250 mg (250 mg are equivalent to a terbinafin)
excipients: a hydroksipropilmetiltsellyuloza 15 sr, sodium of a kroskarmeloz, cellulose microcrystalline PH 101, cellulose microcrystalline PH 102, silicon dioxide colloidal, magnesium stearate
the Description
of the Tablet of white color of round shape with risky on one party.
Pharmacotherapeutic group
Antifungal drugs for system use. Terbinafin.
The ATH D01BA 02 code
the Pharmacological
Pharmacokinetics At properties intake terbinafin is well soaked up (& by gt, 70%) and the bioavailability of drug as a result of presistemny metabolism is about 40%. After reception of a terbinafin inside in a dose of 250 mg the maximum concentration in plasma is reached in 2 hours and makes 0.97 mkg/ml. The period of semi-absorption is 0.8 hour, the semi-distribution period - 4.6 hour. Meal can have insignificant impact on biological availability of drug, however it does not demand drug dose adjustment. Terbinafin substantially contacts proteins of blood plasma (99%), quickly gets through a thermal layer of skin and concentrates in a lipophilic corneal layer, gets into secretion of sebaceous glands that leads to creation of high concentrations in hair follicles, hair and in the skin rich with sebaceous glands. It is shown also what terbinafin gets into nail plates in the first several weeks after an initiation of treatment drug. As a result of biotransformation terbinafin it will be transformed to metabolites which have no antifungal activity, metabolites are removed mainly with urine. Elimination half-life makes 17 hours. Any signs of accumulation are not revealed. Long administration of drug at observance of conditions of an equilibrium state does not cause changes of concentration of a terbinafin in plasma depending on age of patients, nevertheless, at patients with a renal failure the clearance rate can be reduced that leads to increase in level of a terbinafin in blood.
Pharmacodynamics
ТЕРФАЛИН® is to synthetic derivatives of allylamine which has the broad antifungal spectrum of action. It is supposed what terbinafin works by skvalenepoksidaza inhibition, thus, blocking ergosterol biosynthesis, the being main component of a membrane of a fungal cell. With accumulation of squalene in fungal cell ТЕРФАЛИН® has the fungicide effect. As the skvalenepoksidaza does not belong to group of enzymes R-450 cytochrome, terbinafin does not inhibit any enzyme from this system of enzymes.
ТЕРФАЛИН® has the big range of therapeutic concentration. Any of metabolites of a terbinafin has no antifungal activity identical with terbinafiny.
ТЕРФАЛИН® shows activity against the majority of strains of following microorganisms: Trichophyton mentagrophytes, Trichophyton rubrum, Candida albicans, Epidermophyton floccosum, Microsporum canis, Scopulariopsis brevicaulis.
- the onychomycosis of feet and brushes caused by dermatophytes (tinea unguinum)
- the dermatomycosis caused by trikhofita, microspores,
epidermofita (mycosis of smooth skin, crotch, feet)
- the skin infections caused by barmy mushrooms, such as Candida
(for example, Candida albicans)
the Route of administration and doses
Adults
Usually appoint indications on 1 tablet (250 mg) of 1 times a day.
Onychomycoses
therapy Duration usually is 6-12 weeks. Duration of therapy can depend on associated diseases, a condition of nails. The clinical effect occurs usually in several months after mycologic treatment and the termination of a course of treatment.
Mycoses of smooth skin
treatment Duration in mycoses of feet - 2-6 weeks, in mycoses of other sites of skin - 2-4 weeks.
Duration of therapy is: mycoses of smooth skin-1-2 weeks, mycoses of feet - 2-4 weeks, candidiasis of skin of-1 - 2 week.
To patients of advanced age drug is appointed in the same doses, as the adult.
Side effects
Often
- a headache
- dyspepsia, feeling of overflow of a stomach, loss of appetite, nausea,
a mild abdominal pain, diarrhea, a cholestasia, jaundice, hepatitis
- allergic reactions of skin (rash, an itching, urticaria)
- arthralgias, myalgias, an alopecia
- a neutropenia, an agranulocytosis, thrombocytopenia
Seldom
- disturbances of flavoring feelings, including their loss
Very seldom
- Stephens-Johnson's syndrome, a toxic epidermal necrolysis, an acute anaphylaxis
- psoriazopodobny rashes, exacerbation of psoriasis
- aggravation of a system lupus erythematosus
of the Contraindication
- hypersensitivity to active agent or others kompo-
to drug nenta
- a heavy renal failure (clearance of creatinine less than 50 ml/min.
or concentration of creatinine in blood serum of more than 300 µmol/l)
- pregnancy and the period of a lactation
- children's age up to 18 years
Medicinal interactions
Terbinafin does not inhibit metabolism of tolbutamide, ethinylestradiol, ethoxycoumarin and cyclosporine.
Terbinafin is CYP450 2D6 isoenzyme inhibitor. Combined use ТЕРФАЛИН® with medicines, mainly, metabolized by means of CYP450 2D6 isoenzyme (for example, tricyclic antidepressants, selective serotonin reuptake inhibitors, beta blockers and monoamine oxidase inhibitors of type B) has to be under careful observation and can demand reduction of a dose of the drugs which are metabolized by means of CYP450 2D6 isoenzyme.
Terbinafin does not affect clearance of antipyrine or digoxin.
Terbinafin lowers clearance of caffeine for 19%.
Terbinafin increases clearance of cyclosporine by 15%.
Drugs which cause induction of microsomal enzymes of a liver (rifampicin) can accelerate removal of a terbinafin. The drugs inhibiting P450 cytochrome (Cimetidinum) slow down removal of a terbinafin. Tsiklosproin does not affect clearance of a terfalin.
Special instructions
Patients with the accompanying chronic diseases of a liver should appoint a half of usually recommended dose ТЕРФАЛИН®, before an initiation of treatment it is recommended to estimate initial indicators of function of a liver and to provide their systematic control in the course of treatment. It is necessary to adhere to the same recommendations at appointment ТЕРФАЛИН® as the alcoholic, with dysfunctions baking. In case in the course of drug treatment the patients have symptoms allowing to assume an abnormal liver function, for example: persistent nausea, lack of appetite, feeling of fatigue, jaundice, dark coloring of urine, decolouration a calla, drug treatment it is necessary to cancel.
It was reported about separate cases of a heavy neutropenia. This state was reversible at the termination of reception ТЕРФАЛИН®, with use or without use of maintenance therapy. If clinical symptoms speak about accession of consecutive infection, then blood indicators have to be completely counted. If the quantity of neutrophils is also lt,/=1000 cells/mm3, reception ТЕРФАЛИН® has to be stopped and maintenance therapy has to be begun.
There are no bases to assume that patients of advanced age require change of a dosage or that they observe the side effects differing from those at patients of younger age.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous
TERFALIN® mechanisms in therapeutic doses does not affect ability to run the vehicle or potentially dangerous mechanisms.
Overdose
Symptoms - nausea, vomiting, pains in the lower part of a stomach.
Treatment - gastric lavage, use of activated carbon and/or symptomatic therapy.
Form of release and packing
On 14 tablets in blister strip packaging from a film of polyvinylchloride and printing aluminum foil.
On 1 or 2 planimetric packs together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions in the dry, protected from light place at a temperature not above 25 °C.
To protect from children!
2 years
not to apply a period of storage after an expiration date.
Prescription status
According to the prescription
Republic of Kazakhstan JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Producer,
Almaty, Shevchenko St. 162 E.
The owner of the registration certificate
of JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika
the Republic of Kazakhstan
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Republic of Kazakhstan, Almaty, Shevchenko St. 162 E. Phone number: (+7 727) 399-50-50Номер fax: (+7 727) 399-60-60Адрес e-mail nobel@nobel.kz
to Develop
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