Universal reference book for medicines
Product name: TIGAL-SANOVEL (TIGAL-SANOVEL)

Active substance: terbinafine

Type: Antifungal medication

Manufacturer: SANOVEL PHARMACEUTICAL PRODUCTS Ind.
(Turkey)
Composition, form of production and packaging
Tablets
from white to white with a yellowish shade of color, round, biconcave, with a facet, with a risk and the inscription "LAMISIL 250" (in a circle) on one side;with a smooth or slightly rough surface.

1 tab.

terbinafine (in the form of hydrochloride) 250 mg

[PRING] magnesium stearate, silicon dioxide colloidal anhydrous, methylhydroxypropylcellulose, microcrystalline cellulose, sodium starch glycolate.

7 pcs.
- blisters (1) - packs of cardboard.
14 pcs.
- blisters (1) - packs of cardboard.
14 pcs.
- blisters (2) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2010.

PHARMACHOLOGIC EFFECT

Terbinafine belongs to the group of allylamines, it has a wide spectrum of antifungal action.
At low concentrations, it has a fungicidal effect on Tryphophytonspp dermatophytes. (T. rubrum, T. mentagrophytes, T. tonsurans, T. verrucosum, T. violaceum), Microsporum canis, Epidermophyton floccosum, mold fungi (eg, Scopulariopsis brevicalius), yeast-like fungi, mainly Candida albicans, and some dimorphic fungi. On fungi Candida spp. and their filamentous forms, depending on the type of fungus, have a fungicidal and fungistatic effect.
Terbinafine disrupts the early stage of biosynthesis of the main component of the cell membrane of the fungus (ergosterol) by inhibiting the enzyme squalene epoxidase.

When administered orally, it is not effective in treating multicolored lichen caused by Pityrosporum ovale, Pityrosporum orbiculare (Malasseria furfur).

PHARMACOKINETICS

When taken orally, it is absorbed well;
absolute bioavailability due to the effect of the first passage of about 40%. After a single oral intake at a dose of 250 mg, the time to reach C max is 1.67 h; C max 0.99 Ојg / ml. AUC - 4.34 Ојg h / ml, with simultaneous intake with food AUC increases by approximately 20%.
Terbinafine binds intensely to plasma proteins (99%).
High concentrations are created in the hair follicles and hair. After a few weeks, the treatment also penetrates the nail plate, accumulates in the stratum corneum and nails in concentrations that provide fungicidal action.
Subject to significant biotransformation, the resulting metabolites do not have antifungal activity.

Effective T 1/2 - about 36 hours, terminal T 1/2 200-400 h (indicates a prolonged excretion of skin and adipose tissue).
It is excreted through the skin, by the kidneys (70%) in the form of metabolites.
Do not cum in the body.
The age of the patients does not affect the pharmacokinetics of terbinafine, however, elimination may decrease with kidney or liver damage, leading to high concentrations of terbinafine in the blood.
It is excreted together with breast milk.

INDICATIONS

- mycoses of the scalp (trichophytosis, microsporia);

- fungal diseases of the skin and nails (onychomycosis), caused by Trychophytonspp.
(T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum spp.(M. canis, M. gypseum) and Epidermophytom floccosum;
- severe, common dermatomycosis of the smooth skin of the trunk and extremities, requiring systemic treatment;

Candidiasis of the skin and mucous membranes.

DOSING MODE

Inside, after eating.

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

Adults : 250 mg (1 tab.) 1 time / day.

Onychomycosis: the duration of therapy is about 6-12 weeks.
If the fingers and toes of the hands and feet (with the exception of the thumb of the foot) are damaged or the patient is young, the duration of the treatment may be less than 12 weeks. In case of infection of the thumb, usually a three-month course of therapy is usually sufficient. In rare cases, with a slower rate of nail growth, longer treatment may be required up to 6 months or more.
Fungal skin infections : the duration of treatment with interdigital, plantar or socks-like infection localization is 2-6 weeks;
with myosides shins - 2-4 weeks, trunks - 2-4 weeks; with mycoses caused by Candida fungi 2-4 weeks; with mycosis of the scalp caused by fungi of the genus Microsporum, more than 4 weeks.
Elderly patients do not need dose adjustment.

Patients with hepatic and / or renal insufficiency (creatinine clearance <50 ml / min or a creatinine concentration in the blood of more than 300 Ојmol / l):125 mg 1 time / day.

For children :

Usually prescribe 125 mg / day (1/2 tab.).
The duration of treatment of mycosis of the scalp is about 4 weeks, with infection of Microsporumcanis - may be longer.
Body weight of the child

20-40 kg 125 mg (1/2 tab.) 1 time / day

More than 40 kg 250 mg (1 tab.) 1 time / day

SIDE EFFECT

Frequency: very often more than 1/10, often more than 1/100 and less than 1/10, infrequently more than 1/1000 and less than 1/100, rarely more than 1/10 000 and less than 1/1000, very rarely - less than 1/10 000, including individual cases.

On the part of the digestive system: very often - a feeling of overflow of the stomach, a decrease in appetite, dyspepsia, nausea, abdominal pain, diarrhea;
rarely - a violation of liver function; very rarely - liver failure, up to a lethal outcome.
On the part of the organs of hematopoiesis: very rarely - neutropenia, agranulocytosis, thrombocytopenia, pancytopenia.

Allergic reactions: very rarely anaphylactoid reactions (including angioedema).

From the nervous system: often - headache;
infrequently - a violation of taste, including agevziyu.
From the skin: very often - skin reactions (including rash, urticaria);
very rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis, psoriasis-like rash, exacerbation of existing psoriasis, alopecia.
From the osteomuscular system: very often - arthralgia, myalgia.

Other: very rarely - fatigue;
cutaneous lupus erythematosus, systemic lupus erythematosus or their exacerbation.
CONTRAINDICATIONS

- Children's age up to 3 years and with a body weight of less than 20 kg (for this dosage form);

- chronic renal failure (CC less than 50 ml / min);

- Pregnancy;

- lactation period;

- hypersensitivity to terbinafine and other components of the drug.

With caution: renal failure (CC greater than 50 ml / min);
alcoholism; oppression of bone marrow hematopoiesis; tumors; metabolic diseases; occlusive diseases of the vessels of the extremities, cutaneous lupus erythematosus or systemic lupus erythematosus.
PREGNANCY AND LACTATION

The intake of terbinafine during pregnancy is contraindicated because of the lack of sufficient data on its safety during pregnancy.

Terbinafine is excreted in breast milk, so its use is contraindicated during lactation.

APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindicated: chronic renal failure (CC less than 50 ml / min).
With caution: renal failure (CC greater than 50 ml / min);
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

In the presence of liver disease, the terbinafine clearance can be reduced.

During treatment, it is necessary to monitor the activity of hepatic transaminases in the blood serum.
In rare cases, after 3 months of treatment, there is cholestasis and hepatitis. If there are signs of impaired liver function (weakness, persistent nausea, decreased appetite, excessive abdominal pain, jaundice, darkening of the urine, or discolored stools), the drug should be discontinued.
APPLICATION FOR CHILDREN

Contraindicated for children under 3 years and children with a body weight of less than 20 kg (for this dosage form).

Children older than 3 years and with a body weight of more than 20 kg are prescribed 125 mg / day (1/2 tab.).
The duration of treatment of mycosis of the scalp is about 4 weeks, with infection of Microsporum canis - may be longer.
Body weight of the child

20-40 kg 125 mg (1/2 tab.) 1 time / day

More than 40 kg 250 mg (1 tab.) 1 time / day

APPLICATION IN ELDERLY PATIENTS

Elderly patients do not need dose adjustment.

SPECIAL INSTRUCTIONS

Irregular application of terbinafine or premature termination of treatment can lead to a relapse of the disease.

The duration of therapy can be influenced by factors such as the presence of concomitant diseases, the condition of the nails with onychomycosis at the beginning of the course of treatment.

If after two weeks of treatment for a skin infection there is no improvement, it is necessary to repeatedly identify the pathogen and its sensitivity to the drug.

Systemic use in onychomycosis is justified only in case of total defeat of most nails, the presence of pronounced subungual hyperkeratosis, ineffectiveness of previous local therapy.
In the treatment of onychomycosis, a clinical response, confirmed laboratoryally, is usually observed a few months after mycological recovery and discontinuation of treatment, which is due to the rate of regrowth of a healthy nail. Removal of nail plates during treatment of onychomycosis of brushes for 3 weeks and onychomycosis of the feet for 6 weeks is not required.
In the presence of liver disease, the terbinafine clearance can be reduced.

During treatment, it is necessary to monitor the activity of hepatic transaminases in the blood serum.
In rare cases, after 3 months of treatment, there is cholestasis and hepatitis. If there are signs of impaired liver function (weakness, persistent nausea, decreased appetite, excessive abdominal pain, jaundice, darkening of the urine, or discolored stools), the drug should be discontinued.
The appointment of Tigal-sanovel with psoriasis requires increased circumspection;
In very rare cases, terbinafine can provoke an exacerbation of psoriasis.
When treating terbinafine, general hygiene rules should be followed to prevent the possibility of re-infection through linen and shoes.
In the process of treatment (after 2 weeks) and at the end of it, it is necessary to produce antifungal treatment of shoes, socks and stockings.
Impact on the ability to drive vehicles and manage mechanisms

Tigal-sanovel does not affect the ability to drive a car and perform work that requires increased concentration.

OVERDOSE

Symptoms: dizziness, nausea, vomiting, headache, pain in the lower abdomen, in the epigastric region, frequent urination.

Treatment: gastric lavage followed by the use of activated charcoal and / or symptomatic treatment.

DRUG INTERACTION

Inducers or inhibitors of microsomal liver enzymes may decrease or increase the concentration of terbinafine in the plasma, which may require correction of the dosage regimen of the latter.

Cimetidine reduces the plasma clearance of terbinafine by 33% and increases its plasma concentration (increased toxicity of the latter).

Rifampicin increases terbinafine clearance by 100% and reduces its plasma concentration (decreased terbinafine efficacy).

With simultaneous administration with oral contraceptives, a menstrual cycle disorder is possible.

Reduces caffeine clearance by 19% and increases its plasma concentration (increased caffeine toxicity).

It inhibits the isoenzyme CYP2D6, which can increase the toxicity of substrates of this isoenzyme (tricyclic antidepressants, beta adrenoblockers, selective serotonin reuptake inhibitors, class I antiarrhythmics, MAO B inhibitors) with a narrow therapeutic range.

Increased C max and AUC of desipramine by 2 and 5 times, respectively, in healthy volunteers with normal activity of the isoenzyme CYP2D6.

It can relax the action of cyclosporine and reduce its concentration in the plasma;
increases the clearance of cyclosporine by 15%.
Reduces prothrombin time while taking with warfarin (cause-effect relationship not established).

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

Keep the drug in a dark place at a temperature of no higher than 30 В° C.
Keep out of the reach of children. Shelf life - 2 years. Do not use after the time specified on the package.

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