ATIFIN

Active material: Terʙinafin
When ATH: D01BA02
CCF: Antifungal agent
ICD-10 codes (testimony): B35.0, B35.1, B35.2, B35.3, B35.4, B35.6, B37.2, B37.3, B37.4
When CSF: 08.01.02
Manufacturer: KRKA d.d. (Slovenia)

Pharmaceutical form, composition and packaging

Pills white or nearly white, round, lenticular, with a notch on one side and a facet.

Excipients: lactose monohydrate, microcrystalline cellulose, Croscarmellose sodium, povidone, talc (magnesium hydrosilicate), silica colloidal anhydrous, magnesium stearate.

7 PC. – blisters (2) – packs cardboard.
7 PC. – blisters (4) – packs cardboard.

Pills white or nearly white, round, lenticular, with a notch on one side and a facet.

Excipients: lactose monohydrate, microcrystalline cellulose, Croscarmellose sodium, povidone, talc (magnesium hydrosilicate), silica colloidal anhydrous, magnesium stearate.

7 PC. – blisters (2) – packs cardboard.
7 PC. – blisters (4) – packs cardboard.

Pharmacological action

Antifungal agent, belonging to the Group allilaminov. Terbinafine has a broad spectrum antifungal action.

In low concentrations is showing fungicidnuju active against dermophytes: Red Trychophyton, Trychophyton mentagrophytes, Trychophyton tonsurans, Trychophyton verrucosum, Trychophyton violet, Microspores dog, Epidermophyton floccosum; molds: Aspergillus, Cladosporium, Scopulariopsis brevicalius; some dimorphic fungi and yeasts: primarily, Candida albicans. On mushrooms and Mycelial forms of Candida terbinafine has, depending on the type of fungus fungicidal fungistaticescoe or.

Terbinafine violates early biosynthesis ergosterola – a major component of cell membranes fungus, inhibiting enzyme squalene-jepoksidazu. Squalene-jepoksidaza is not associated with the cytochrome P450 system (SYR450), terbinafine is therefore does not affect hormones and pharmaceuticals, metabolism which is associated with SYR450.

When applying inside accumulates in the skin, nails and hair in quantity, provides fungicidal effect.

Systemic treatment of multicolored depriving, caused by Malassezia furfur is inefficient.

Pharmacokinetics

Absorption

After intake of a well-absorbed: through 0.8 h sucked 1/2 the dose. Eating does not affect the bioavailability of terbinafine. Through 1-2 h after a single reception inside 250 mg C_max terbinafine in plasma reaches 0.97 ug / ml. Bioavailability 80%.

Distribution

Through 4.6 hours after ingestion 1/2 the dose distributed in the body.

Terbinafine is intensively associated with blood plasma proteins – 99%. Spreads rapidly in tissues, penetrates into the dermal layer of the skin, nail plate and the secret of the sebaceous glands. Accumulate in high concentrations in hair follicles, hair, skin and subcutaneous tissue. After a few weeks of treatment concentrations in nails accumulates, providing fungicidal action.

Metabolism

Terbinafine biotransformiroetsa in the liver to inactive metabolites. Not accumulates in the body.

Deduction

T_1/2 terbinafine is 16-18 no, T_1/2 terminal phase – 200-400 no.

Appears in the form of metabolites in urine – 80%, with stool – 20% the dose. Is highlighted, together with the breast milk.

Pharmacokinetics in special clinical situations

The patient's age does not affect the farmakokinetiku terbinafine, However, elimination can decrease when kidney or liver lesions, resulting in high concentrations of terbinafine blood.

Testimony

- Fungal infections of the scalp (ringworm, microsporia);

- Fungal infections of the skin and nails (ringworm, mikosporija, athlete);

- Onychomycosis;

- Heavy common ringworm smooth skin of the trunk and extremities, requiring systemic treatment;

- Candidiasis of the skin and mucous membranes.

Dosage regimen

The drug should be taken inside after eating.

The duration of treatment and the dosage is set individually and depends on the location and severity of the disease process.

Adults the drug is prescribed for 250 mg 1 time / day (1 tab.).

The dosage at children

Duration of treatment depending on the localization process and the severity of the disease

Patients with expressed human liver and/or kidney disease (CC<50 mL/min or concentration of creatinine in the blood >300 mmol / l) the drug should be taken 125 mg 1 time / day.

Side effect

Adverse reactions usually medium and light gravity and are of a temporary nature.

Common adverse reactions

On the part of the digestive system: feeling crowded stomach, dyspepsia, nausea, loss of appetite, stomach ache, diarrhea; sometimes – violation of taste perception (incl. the loss of his, which restored a few weeks after cessation of treatment); rarely – cholestatic jaundice, hepatitis, asymptomatic increase in transaminaz liver. Despite the proof of causation of these violations with the use of terbinafine, in the case of Hepatobiliary dysfunction treatment Atifinom should be discontinued.

From the central and peripheral nervous system: rarely – paraesthesia, giposteziya, dizziness; rarely – depression, feeling increased anxiety.

On the part of the musculoskeletal system: often – arthralgia, myalgia.

From the hematopoietic system: rarely – neutropenia, agranulocytosis, thrombocytopenia.

Allergic reactions: often – hives, erythema multiforme, rarely – systemic allergic reactions (reactions such as serum sickness, angioedema), rarely – severe skin reactions (toxic epidermal necrolysis, Stevens-Johnson syndrome, photosensitivity). With the progression of the skin vsapani terbinafine therapy should be discontinued.

Other: often – headache, bad feeling, feeling tired; rarely – exacerbation of psoriasis, increased hair loss.

Contraindications

- Pregnancy;

- Breastfeeding;

- Children under the age of 2 years (There is not enough information available on the use of drugs in infants weighing <12 kg);

-hypersensitivity to terbinafinu and other components of the drug.

FROM caution use in patients with hepatic and / or renal insufficiency, alcoholism, blood diseases, tumors, metabolic diseases, Pathology receptacles limbs, psoriaze.

Pregnancy and lactation

Drug use in pregnancy is contraindicated because of the lack of sufficient data on the safety of terbinafine in pregnant women.

The drug is contraindicated during breastfeeding, because terbinafine is excreted in breast milk.

Cautions

Irregular use of Atifina or premature termination of treatment leads to relapse of the disease.

The duration of therapy can influence the presence of concomitant diseases and condition of nails at the beginning of the course of treatment.

If after 2 weeks of treatment skin infection does not improve the condition notes, must re-determine the causative agent and its sensitivity to the drug.

Systemic application in onychomycosis justified only in the case of total destruction of the majority of nail, availability expressed subungual hyperkeratosis, ineffectiveness of previous local therapy. In the treatment of onychomycosis clinical response is usually seen after a few months after mycological cure and cessation of treatment, due to the speed of regrowth of healthy nails. Removal of the nail plate in the treatment of onychomycosis of brushes for 3 weeks and stop for onychomycosis 6 weeks is not required.

In the presence of severe renal failure (CC<50 ml / min, creatinine in the blood >300 mmol / l), If any of the liver dose should be halved terbinafine. If there is liver disease klirens terbinafine may be reduced. With reduced liver appoint 1/2 the adult dose. During treatment, it is necessary to monitor the level transaminaz liver in serum. In rare cases, through 3 months of treatment occurs cholestasis and hepatitis. If signs of liver dysfunction (weakness, persistant nausea, loss of appetite, stomach ache, jaundice, dark urine or colourless stool) the drug should be discontinued.

Appointment Atifina patients with psoriasis requires greater diligence, because very rarely terbinafine can cause exacerbation of psoriasis.

When treating Atifinom should follow the General rules of hygiene to prevent reinfection through underwear and shoes. During treatment (through 2 Sun.) and at the end should be held protivogribkovu shoe processing, socks and stockings.

Effects on ability to drive vehicles and management mechanisms

Atifin does not affect your ability to drive and perform the work, requiring high concentration.

Overdose

Symptoms: nausea, vomiting, Pain in the lower abdomen, in epigastralna area.

Treatment: gastric lavage, followed by the appointment of activated carbon and / or symptomatic therapy.

Drug Interactions

Terbinafine has virtually no effect on the clearance of drugs, metaboliziruthan involving izofermentov zitohroma r450 (incl. cyclosporine, terfenadine, tolbutamid, triazolam, oral contraceptives).

Terbinafine is not also affects the clearance of antipyrine, digoxin and warfarin.

Terbinafine inhibits CYP2D6 metabolism and inhibits the CYP tricyclic antidepressants, selective inhibitors of reverse takeover Catecholamines (incl. desipramine, fluvoxamine), beta-blockers (incl. metoprolol, propranolol), complications (incl. flekainid, propafenone), MAO inhibitors in type (incl. selegiline) and antipsychotic (incl. chlorpromazine, haloperidol) means.

Drugs-inductors CYP450 Isoenzymes (incl. rifampicin) can accelerate the excretion from the body of terbinafine.

Drugs-inhibitors CYP450 Isoenzymes (incl. cimetidine) can slow metabolism and excretion from the body, terbinafine.

If you are applying to Atifina with inducers/inhibitors, izofermentov zitohroma r450 may require dose adjustment terbinafine.

While applying terbinafine with oral contraceptives may have menstrual cycle.

While applying terbinafine reduces the clearance of caffeine on 21% and increases T_1/2 kofeinana 31%.

While applying terbinafine with ethanol and other hepatotoxic drugs increases the risk of hepatotoxic effect.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored out of reach of children at or above 25 ° C. Shelf life – 3 year.