Exiter - Instructions For Use Of Tablets And Cream, Analogs, Price

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Exeter

Exiter: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. In case of impaired renal function
11. 11. In case of impaired liver function
12. 12. Use in the elderly
13. 13. Drug interactions
14. 14. Analogs
15. 15. Terms and conditions of storage
16. 16. Terms of dispensing from pharmacies
17. 17. Reviews
18. 18. Price in pharmacies

Latin name: Exiter

ATX code: D01AE15

Active ingredient: terbinafine (terbinafine)

Manufacturer: Ozone LLC (Russia)

Description and photo update: 2018-25-10

Prices in pharmacies: from 227 rubles.

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Exiter is an antifungal drug for local and systemic use.

Release form and composition

Exiter's dosage form:

• tablets 250 mg: white or almost white, flat-cylindrical, with a chamfer on both sides and a risk on one side (7, 10 or 14 pcs. in blister contour packs, in a cardboard box 1-6, 8 or 10 packs; 10, 14, 20, 28, 30, 40, 50 or 100 pcs. In containers, 1 container in a cardboard box);
• cream for external use 1%: homogeneous, white or almost white, has a faint smell (10, 15, 20 or 30 g in a tube or 10, 15, 20, 25, 30 or 50 g in a jar, in a cardboard box 1 tube or jar).

Composition of 1 tablet:

• active substance: terbinafine hydrochloride - 281 mg, equivalent to 250 mg terbinafine;
• auxiliary components: croscarmellose sodium, potato starch, povidone (polyvinylpyrrolidone), magnesium stearate, purified water.

Composition of 100 g cream:

• active substance: terbinafine hydrochloride - 1 g;
• excipients: benzyl alcohol, polysorbate-60, sorbitan stearate, cetyl alcohol, isopropyl myristate, cetyl palmitate, sodium hydroxide, water.

Pharmacological properties

Pharmacodynamics

Exiter is an antifungal drug, its active ingredient is terbinafine hydrochloride, belongs to the group of allylamines. Pharmacological activity is due to the suppression of the enzyme squalene epoxidase contained in the cell membrane of the fungus, which leads to a deficiency of ergosterol and intracellular accumulation of squalene, and then leads to cell death of the pathogen.

The fungicidal action of the drug is directed to molds and certain types of dimorphic fungi, yeast-like and yeast fungi (in relation to the latter, fungistatic action is also possible), as well as dermatophytes.

Pharmacokinetics

Exiter in tablet form is absorbed from the gastrointestinal tract (GIT). The connection with plasma proteins is 99%. When applied topically, terbinafine diffuses through the dermal layer and accumulates in the stratum corneum of the lipophilic type, where it is secreted into subcutaneous fat, as a result of which high concentrations of the substance are found not only in the hair follicles, but also in the nails.

In the liver, the drug is metabolized to inactive metabolites. The half-life is 17 hours. It is excreted in the urine as metabolites.

Indications for use

According to the instructions, Exiter in pill form is recommended for the following diseases:

• mycoses of the scalp (trichophytosis, microsporia);
• fungal diseases of the skin and nails caused by Trychophyton spp. (T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum spp. (M. canis, M. gypseum) and Epidermophyton floccosum;
• candidiasis of the skin;
• dermatomycosis of the smooth skin of the trunk and extremities, requiring systemic therapy.

The cream is indicated for the treatment of candidiasis, fungal skin lesions caused by pathogens sensitive to terbinafine (microsporia, trichophytosis, epidermophytosis, rubrophytosis) and versicolor lichen.

Contraindications

Absolute contraindications:

• age up to 3 years (for tablets) and up to 12 years (for cream);
• lactation period;
• increased sensitivity to Exiter's components.

Additional absolute contraindications for tablets:

• liver disease;
• chronic renal failure (creatinine clearance ˂ 50 ml / min);
• pregnancy.

Relative contraindications for systemic use (tablets):

• renal failure (creatinine clearance ˃ 50 ml / min);
• liver failure;
• alcoholism;
• oppression of bone marrow hematopoiesis;
• metabolic diseases;
• tumors;
• occlusive vascular disease of the extremities.

Instructions for use of the Exiter: method and dosage

Pills

Exiter tablets are taken orally, after meals.

The usual dose is 250 mg once a day. the duration of Exiter's use and the dosage regimen are set individually depending on the severity and localization of the lesion, as well as on the condition of the nails with onychomycosis and the presence of concomitant diseases.

Duration of therapy:

• onychomycosis - the average duration of treatment is 6-12 weeks. In case of damage to the nails of the feet (except for the thumbnail) and hands or in the case of a young patient's age, a course of less than 12 weeks is possible. In case of damage to the big toe, the duration of use is 3 months. Longer therapy may be required in patients with delayed nail growth;
• fungal infections of the skin: when the infection is localized on the legs and trunk, the recommended duration of treatment is 2–4 weeks, with interdigital localization, or localization by the type of socks - 2–6 weeks. Mycoses caused by fungi of the genus Candida require 2–4 weeks of treatment, mycoses of the scalp caused by fungi of the genus Microsporum - more than a month.

The use of the Exiter tablet form in children, the recommended dosage:

• body weight 20–40 kg: 125 mg once a day;
• body weight ˃ 40 kg: 250 mg once a day.

Cream for external use

Exiter cream is applied externally.

The skin to be treated should be cleaned and dried. The cream is applied in a thin layer, lightly rubbing on the affected and adjacent skin 1-2 times a day. When applied to diaper rash, the cream can be covered with gauze, especially at night.

The duration and frequency of Exiter's use depend on the severity of the lesion and are on average:

• dermatomycosis of the trunk: 1 week, 1 time per day;
• dermatomycosis of the feet, candidiasis of the skin, versicolor versicolor: 1-2 weeks, 1-2 times a day.

An improvement in the condition is usually noted in the first days of treatment, if there is no effect after 7 days of using the drug, you should consult a doctor to clarify the diagnosis. With irregular use or premature discontinuation of the drug, there is a risk of re-infection.

Exiter should not be used more than 2 times a day.

Side effects

Possible side reactions with systemic use of Exiter (tablets):

• digestive system: decreased appetite, feeling of full stomach, nausea, dyspepsia, abdominal pain, diarrhea;
• hematopoietic organs: neutropenia, pancytopenia, agranulocytosis (the development of these undesirable effects may cause a decrease in the dose of the drug or its cancellation);
• immune system: anaphylactoid reactions, including angioedema, cutaneous and systemic lupus erythematosus;
• nervous system: headache, violation of taste sensations (including their loss), passing on their own within several weeks after discontinuation of the drug, leading to significant weight loss, decreased food intake, dizziness, paresthesia;
• hepatobiliary system: hepatobiliary dysfunction, mainly of cholestatic nature, up to severe liver failure, requiring liver transplantation and sometimes fatal;
• skin: rash, urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis, exacerbation of psoriasis, psoriasis-like rashes, alopecia;
• musculoskeletal system: arthralgia, myalgia;
• other reactions: feeling tired.

Possible side reactions with topical application of Exiter (cream for external use):

• sensory organs: eye irritation;
• skin: pigmentation disorders, peeling, erythema, burning sensation, dry skin, eczema, contact dermatitis, rash;
• local reactions: pain and irritation at the site of application;
• allergic reactions: papules, redness, blisters.

Overdose

Overdose symptoms when taking Exiter pills: nausea, vomiting, headache, dizziness, pain in the epigastric region, lower abdomen, frequent urination.

Gastric lavage, the appointment of activated charcoal, symptomatic therapy are recommended.

When used externally, Exiter is unlikely to overdose.

special instructions

In the case when, after 2 weeks of using the drug, there is no improvement in the patient's condition, it is recommended to consult a doctor to re-determine the pathogen.

With onychomycosis, the systemic use of Exiter is required only in case of damage to most of the nails at the same time, with severe subungual hyperkeratosis, as well as with ineffectiveness of local therapy.

Removal of the nail plates is not required in the treatment of onychomycosis of the hands for 3 weeks and onychomycosis of the feet within 6 weeks.

During the period of Exiter therapy, it is recommended to monitor the activity of hepatic transaminases in the blood serum, since in rare cases, after 3 months of using the drug, cholestasis and hepatitis develop. Treatment should be discontinued immediately if the following symptoms occur: persistent nausea, weakness, loss of appetite, excessive abdominal pain, jaundice, discolored stools, dark urine, and the development of allergic reactions.

To prevent re-infection, general hygiene rules should be observed, and also 2 weeks after the start of therapy, it is recommended to carry out antifungal treatment of shoes, socks and stockings.

Avoid getting Exiter cream on the mucous membrane of the eyes, nose and mouth, in case of accidental contact, immediately rinse the mucous membrane with running water, if irritation occurs, consult a doctor.

Influence on the ability to drive vehicles and complex mechanisms

In case of dizziness while taking the Exeter orally, you should refrain from driving vehicles and other complex mechanisms that require the speed of psychomotor reactions.

Application during pregnancy and lactation

Taking Exiter by mouth during pregnancy is contraindicated due to the lack of sufficient data from clinical studies on safety and efficacy.

Topical application of Exiter cream during pregnancy is allowed only in cases where the expected benefit to the mother outweighs the potential risk to the fetus.

If it is necessary to use the drug during lactation, breastfeeding should be discontinued.

With impaired renal function

Patients with renal insufficiency, with creatinine clearance ˃ 50 ml / min, are prescribed a reduced dose of Exiter (125 mg / day).

If liver function is impaired

Liver disease can cause a decrease in terbinafine clearance.

Use in the elderly

Elderly patients do not need Exiter's dose adjustment.

Drug interactions

• metabolism inducers: accelerate the plasma clearance of terbinafine, its dose may need to be adjusted;
• inhibitors of cytochrome P450: suppress the plasma clearance of terbinafine, which may require a dose adjustment;
• cimetidine: decreases the plasma clearance of terbinafine and increases its concentration in plasma, which increases its toxicity;
• rifampicin: reduces the effectiveness of terbinafine by decreasing plasma concentrations and increasing its clearance;
• oral contraceptives: risk of menstrual irregularities;
• caffeine: its clearance (with intravenous administration) decreases by 19%, plasma concentration and toxicity of caffeine increase;
• desipramine: its clearance decreases by 82%;
• cyclosporine: its effect decreases and plasma concentration decreases, clearance increases by 15%.

In vitro and in vivo studies have shown that terbinafine inhibits metabolism mediated by the enzyme 2D6 (CYP2D6), which may be clinically significant for drugs metabolized primarily by this enzyme, such as: beta-blockers, tricyclic antidepressants, selective serotonin reuptake inhibitors, antiarrhythmic Class I drugs, monoamine oxidase inhibitors type B, in the case when the drug used simultaneously has a small range of therapeutic concentration.

The exiter has no effect on the clearance of digoxin and antipyrine. It has a negligible potential to suppress or enhance the clearance of most drugs that are metabolized with the participation of the cytochrome P450 system, except for those that are metabolized with the participation of CYP2D6.

Analogs

Exiter's analogs are Atifin, Binafin, Terbinafin, Lamisil, Fungoterbin.

Terms and conditions of storage

Store away from light, at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Shelf life is 3 years.

Terms of dispensing from pharmacies

Available without a prescription.

Reviews about the Exeter

Reviews about the Exeter are mostly positive. Patients pay attention to its effectiveness in combating dermatological problems. The disadvantage of the drug is the relatively high cost and risk of side effects.

Exiter price in pharmacies

Estimated price for Exeter is 730 rubles. per pack containing 14 tablets.

Exeter: prices in online pharmacies

Drug name Price Pharmacy

Exiter cream for outdoor use approx. 1% tube 15g 227 r Buy

Exiter 1% cream for external use 15 g 1 pc. 227 r Buy

Exiter 1% cream for external use combination packaging 1 + 1 15 g 1 pc. 279 r Buy

Exiter 250 mg tablets 14 pcs. 324 r Buy

Exiter 250 mg tablets combi-pack 2 + 1 14 pcs. 331 r Buy

Exiter 250 mg tablets combi-pack 1 + 1 42 pcs. 865 RUB Buy

Exiter 250 mg tablets 42 pcs. 1099 RUB Buy

Exiter tablets 250mg 42 pcs. combi packaging 1 + 1 1344 RUB Buy

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Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!