Release form, composition and packing
Of white or nearly white, round, biconvex, with a notch on one side and a facet.
1 tab. terbinafine (as hydrochloride) 125 mg.
Excipients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone, talc (magnesium hydrosilicates), colloidal anhydrous silica, magnesium stearate.
Of white or nearly white, round, biconvex, with a notch on one side and a facet.
1 tab. terbinafine (as hydrochloride) 250 mg.
Excipients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone, talc (magnesium hydrosilicates), colloidal anhydrous silica, magnesium stearate.
Clinico-pharmacological group: antifungal drugs.
Pharmacological action
Antifungal drug, belonging to the group allylamines. Terbinafine has a broad spectrum antifungal action. At low concentrations, exhibits fungicidal activity against dermatophytes: Trychophyton rubrum, Trychophyton mentagrophytes, Trychophyton tonsurans, Trychophyton verrucosum, Trychophyton violaceum, Microsporum canis, Epidermophyton floccosum; fungi: Aspergillus, Cladosporium, Scopulariopsis brevicalius; some dimorphic fungi and yeasts: mostly , Candida albicans. On fungi and filamentous forms of Candida terbinafine has depending on the type of fungus fungicidal or fungistatic action. Terbinafine breaks early stage of the biosynthesis of ergosterol - the main component of the cell membrane of the fungus by inhibiting the enzyme squalene-epoksidazu.
Squalene-epoksidaza not associated with cytochrome P450 (SYR450), so terbinafine does not affect the hormones and medications, metabolism of which is associated with SYR450.
When applied inside accumulates in the skin, nails and hair in an amount providing fungicidal action. Systemic treatment of multi-colored lichen, caused by Malassezia furfur ineffective.
Pharmacokinetics
Suction
After oral administration, is well absorbed: over 0.8 hours sucked 1 / 2 the dose. Food intake did not affect the bioavailability of terbinafine. After 1-2 h after a single oral 250 mg Cmax of terbinafine in plasma reaches 0.97 mg / ml. Bioavailability of 80%.
Distribution
In 4.6 h after intake 1 / 2 of the dose is distributed in the body. Terbinafine binds extensively to plasma proteins - 99%. Spreading rapidly in tissues, penetrates into the dermal layer of skin, nail plate and the secretion of sebaceous glands. Accumulates in high concentrations in the hair follicles in hair, skin and subcutaneous tissue. After several weeks of treatment, accumulating in nails in concentrations that provide the fungicidal effect.
Metabolism
Terbinafine biotransformed in the liver to inactive metabolites. Not accumulates in the body.
Breeding
T1 / 2 of terbinafine is 16-18 h, T1 / 2 terminal phase - 200-400 hours is displayed in the form of metabolites in urine - 80%, with a stool - 20% of the dose. Released together with breast milk.
Pharmacokinetics in special clinical situations
The patient's age does not affect the pharmacokinetics of terbinafine, however, elimination may be reduced in lesions of the kidney or liver, leading to high concentrations of terbinafine in the blood.
Statement
fungal infections of the scalp (trichophytosis, mikrosporiya);
fungal skin and nail (trichophytosis, mikosporiya, athlete);
onychomycosis;
severe widespread dermatomycoses smooth leather trunk and extremities, requiring systemic treatment;
candidiasis of skin and mucous membranes.
Dosing regimen
The drug is taken orally after meal. The duration of treatment and dosing regimen is established on an individual basis and depends on the localization process and the severity of the disease.
Adult drug is prescribed to 250 mg 1 time per day (1 tab.). In patients with slow-growing nails require prolonged treatment (more than 3 months).
The clinical effect may be noticeable in a few months after treatment, depending on the time required for the regeneration of the nail tissue. Patients with severe liver dysfunction and / or renal function (creatinine clearance <50> 300 umol / L) should take the drug to 125 mg 1 time per day.
Side effect
Adverse reactions are usually moderate and mild and temporary.
Common adverse drug reactions
On the part of the digestive system: the feeling of fullness, indigestion, nausea, loss of appetite, abdominal pain, diarrhea, and sometimes - a violation of gustatory perception (including its loss, which is restored in a few weeks after cessation of treatment), rarely - cholestatic jaundice , hepatitis, asymptomatic increase in liver transaminases.
Despite the failure to prove causation of these disorders with the use of terbinafine in the case of hepatobiliary dysfunction Atifinom treatment should be discontinued.
CNS and peripheral nervous system: rarely - paresthesia, giposteziya, dizziness, very rarely - depression, feelings of increased anxiety.
From the musculoskeletal system: often - arthralgia, myalgia.
From the hematopoietic system: very rarely - neutropenia, agranulocytosis, thrombocytopenia.
Allergic reactions: often - urticaria, erythema multiforme, rare - systemic allergic reaction (such as serum sickness reaction, angioedema), very rarely - severe skin reactions (toxic epidermal necrolysis, Stevens-Johnson syndrome, photosensitivity).
With the progression of skin rash treatment terbinafine should be discontinued.
Other: often - headache, malaise, fatigue, very rarely - exacerbation of psoriasis, increased hair loss.
Contraindications
pregnancy;
lactation;
Children under 2 years of age (not enough data on the use of the drug in children with body weight <12 kg);
Hypersensitivity to terbinafine and other ingredients.
With caution should use the drug in hepatic and / or renal failure, alcoholism, blood diseases, tumors, metabolic diseases, vascular pathology limbs psoriasis.
Pregnancy and lactation
Use of the drug is contraindicated in pregnancy due to lack of sufficient data about the safety of terbinafine in pregnant women. Use of the drug is contraindicated during breastfeeding, as terbinafine is excreted in breast milk.
Use in hepatic dysfunction
Precautions should be used in the preparation for liver failure.
Use in renal impairment
Precautions should be used in the preparation of renal failure.
Cautions
Irregular use Atifina or premature termination of treatment leads to relapse. The duration of therapy may influence the presence of concomitant diseases and the state of nails in the early course of treatment.
If after 2 weeks of treatment of skin infection is not marked improvement, it is necessary to re-identify the causative agent and its sensitivity to the drug. System application in onychomycosis is justified only in case of total destruction of the majority of nails, having pronounced subungual hyperkeratosis, inefficiency prior local therapy.
In the treatment of onychomycosis clinical response usually occurs several months after mycological cure and cessation of treatment because of the rate of regrowth of healthy nail. Removal of nail plates in the treatment of onychomycosis of brushes for 3 weeks and onychomycosis stop for 6 weeks is required. In the presence of severe renal insufficiency (creatinine clearance <50> 300 umol / L), and abnormal liver function the dose of terbinafine should be halved.
In the presence of liver disease, clearance of terbinafine may be reduced.
With reduced liver function prescribed 1 / 2 adult dose. During the treatment necessary to control the level of liver transaminases in the serum. In rare cases, after 3 months of treatment, there is cholestasis and hepatitis. If signs of liver dysfunction (fatigue, persistent nausea, loss of appetite, abdominal pain, jaundice, dark urine or colorless chair), the medication should be discontinued.
Appointment Atifina patients with psoriasis requires more caution, because in very rare cases, terbinafine may cause exacerbation of psoriasis.
When treating Atifinom should follow the general rules of hygiene to prevent the possibility of re-infection through clothes and shoes. In the course of treatment (after 2 weeks.) And at the end of antifungal treatment should be carried out shoes, socks and stockings.
Effects on ability to drive vehicles and management mechanisms
Atifin not affect the ability to drive and perform work requiring a high concentration.
Of white or nearly white, round, biconvex, with a notch on one side and a facet.
1 tab. terbinafine (as hydrochloride) 125 mg.
Excipients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone, talc (magnesium hydrosilicates), colloidal anhydrous silica, magnesium stearate.
Of white or nearly white, round, biconvex, with a notch on one side and a facet.
1 tab. terbinafine (as hydrochloride) 250 mg.
Excipients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone, talc (magnesium hydrosilicates), colloidal anhydrous silica, magnesium stearate.
Clinico-pharmacological group: antifungal drugs.
Pharmacological action
Antifungal drug, belonging to the group allylamines. Terbinafine has a broad spectrum antifungal action. At low concentrations, exhibits fungicidal activity against dermatophytes: Trychophyton rubrum, Trychophyton mentagrophytes, Trychophyton tonsurans, Trychophyton verrucosum, Trychophyton violaceum, Microsporum canis, Epidermophyton floccosum; fungi: Aspergillus, Cladosporium, Scopulariopsis brevicalius; some dimorphic fungi and yeasts: mostly , Candida albicans. On fungi and filamentous forms of Candida terbinafine has depending on the type of fungus fungicidal or fungistatic action. Terbinafine breaks early stage of the biosynthesis of ergosterol - the main component of the cell membrane of the fungus by inhibiting the enzyme squalene-epoksidazu.
Squalene-epoksidaza not associated with cytochrome P450 (SYR450), so terbinafine does not affect the hormones and medications, metabolism of which is associated with SYR450.
When applied inside accumulates in the skin, nails and hair in an amount providing fungicidal action. Systemic treatment of multi-colored lichen, caused by Malassezia furfur ineffective.
Pharmacokinetics
Suction
After oral administration, is well absorbed: over 0.8 hours sucked 1 / 2 the dose. Food intake did not affect the bioavailability of terbinafine. After 1-2 h after a single oral 250 mg Cmax of terbinafine in plasma reaches 0.97 mg / ml. Bioavailability of 80%.
Distribution
In 4.6 h after intake 1 / 2 of the dose is distributed in the body. Terbinafine binds extensively to plasma proteins - 99%. Spreading rapidly in tissues, penetrates into the dermal layer of skin, nail plate and the secretion of sebaceous glands. Accumulates in high concentrations in the hair follicles in hair, skin and subcutaneous tissue. After several weeks of treatment, accumulating in nails in concentrations that provide the fungicidal effect.
Metabolism
Terbinafine biotransformed in the liver to inactive metabolites. Not accumulates in the body.
Breeding
T1 / 2 of terbinafine is 16-18 h, T1 / 2 terminal phase - 200-400 hours is displayed in the form of metabolites in urine - 80%, with a stool - 20% of the dose. Released together with breast milk.
Pharmacokinetics in special clinical situations
The patient's age does not affect the pharmacokinetics of terbinafine, however, elimination may be reduced in lesions of the kidney or liver, leading to high concentrations of terbinafine in the blood.
Statement
fungal infections of the scalp (trichophytosis, mikrosporiya);
fungal skin and nail (trichophytosis, mikosporiya, athlete);
onychomycosis;
severe widespread dermatomycoses smooth leather trunk and extremities, requiring systemic treatment;
candidiasis of skin and mucous membranes.
Dosing regimen
The drug is taken orally after meal. The duration of treatment and dosing regimen is established on an individual basis and depends on the localization process and the severity of the disease.
Adult drug is prescribed to 250 mg 1 time per day (1 tab.). In patients with slow-growing nails require prolonged treatment (more than 3 months).
The clinical effect may be noticeable in a few months after treatment, depending on the time required for the regeneration of the nail tissue. Patients with severe liver dysfunction and / or renal function (creatinine clearance <50> 300 umol / L) should take the drug to 125 mg 1 time per day.
Side effect
Adverse reactions are usually moderate and mild and temporary.
Common adverse drug reactions
On the part of the digestive system: the feeling of fullness, indigestion, nausea, loss of appetite, abdominal pain, diarrhea, and sometimes - a violation of gustatory perception (including its loss, which is restored in a few weeks after cessation of treatment), rarely - cholestatic jaundice , hepatitis, asymptomatic increase in liver transaminases.
Despite the failure to prove causation of these disorders with the use of terbinafine in the case of hepatobiliary dysfunction Atifinom treatment should be discontinued.
CNS and peripheral nervous system: rarely - paresthesia, giposteziya, dizziness, very rarely - depression, feelings of increased anxiety.
From the musculoskeletal system: often - arthralgia, myalgia.
From the hematopoietic system: very rarely - neutropenia, agranulocytosis, thrombocytopenia.
Allergic reactions: often - urticaria, erythema multiforme, rare - systemic allergic reaction (such as serum sickness reaction, angioedema), very rarely - severe skin reactions (toxic epidermal necrolysis, Stevens-Johnson syndrome, photosensitivity).
With the progression of skin rash treatment terbinafine should be discontinued.
Other: often - headache, malaise, fatigue, very rarely - exacerbation of psoriasis, increased hair loss.
Contraindications
pregnancy;
lactation;
Children under 2 years of age (not enough data on the use of the drug in children with body weight <12 kg);
Hypersensitivity to terbinafine and other ingredients.
With caution should use the drug in hepatic and / or renal failure, alcoholism, blood diseases, tumors, metabolic diseases, vascular pathology limbs psoriasis.
Pregnancy and lactation
Use of the drug is contraindicated in pregnancy due to lack of sufficient data about the safety of terbinafine in pregnant women. Use of the drug is contraindicated during breastfeeding, as terbinafine is excreted in breast milk.
Use in hepatic dysfunction
Precautions should be used in the preparation for liver failure.
Use in renal impairment
Precautions should be used in the preparation of renal failure.
Cautions
Irregular use Atifina or premature termination of treatment leads to relapse. The duration of therapy may influence the presence of concomitant diseases and the state of nails in the early course of treatment.
If after 2 weeks of treatment of skin infection is not marked improvement, it is necessary to re-identify the causative agent and its sensitivity to the drug. System application in onychomycosis is justified only in case of total destruction of the majority of nails, having pronounced subungual hyperkeratosis, inefficiency prior local therapy.
In the treatment of onychomycosis clinical response usually occurs several months after mycological cure and cessation of treatment because of the rate of regrowth of healthy nail. Removal of nail plates in the treatment of onychomycosis of brushes for 3 weeks and onychomycosis stop for 6 weeks is required. In the presence of severe renal insufficiency (creatinine clearance <50> 300 umol / L), and abnormal liver function the dose of terbinafine should be halved.
In the presence of liver disease, clearance of terbinafine may be reduced.
With reduced liver function prescribed 1 / 2 adult dose. During the treatment necessary to control the level of liver transaminases in the serum. In rare cases, after 3 months of treatment, there is cholestasis and hepatitis. If signs of liver dysfunction (fatigue, persistent nausea, loss of appetite, abdominal pain, jaundice, dark urine or colorless chair), the medication should be discontinued.
Appointment Atifina patients with psoriasis requires more caution, because in very rare cases, terbinafine may cause exacerbation of psoriasis.
When treating Atifinom should follow the general rules of hygiene to prevent the possibility of re-infection through clothes and shoes. In the course of treatment (after 2 weeks.) And at the end of antifungal treatment should be carried out shoes, socks and stockings.
Effects on ability to drive vehicles and management mechanisms
Atifin not affect the ability to drive and perform work requiring a high concentration.
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