Terbinafine-MFF - Instructions For Use, Ointment, Tablets, Reviews, Price

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

Terbinafine-MFF

Terbinafin-MFF: 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. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Terbinafine-MFF

ATX code: D01AE15

Active ingredient: terbinafine (Terbinafine)

Producer: Moscow Pharmaceutical Factory, CJSC (Russia)

Description and photo update: 2020-06-02

Prices in pharmacies: from 47 rubles.

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Terbinafine-MFF is an antifungal agent.

Release form and composition

• tablets (250 mg): flat-cylindrical, scored and chamfered, almost white or white, with a weak specific odor (10 or 14 pcs. in a blister strip, 1 or 2 packs in a cardboard box);
• ointment for external use 1%: white with a characteristic odor (10 or 15 g in an aluminum tube, 1 tube in a cardboard box).

Each pack also contains instructions for the use of Terbinafine-MFF.

1 tablet contains:

• active substance: terbinafine hydrochloride - 281 mg, which corresponds to terbinafine base in an amount of 250 mg;
• additional components: potato starch, colloidal silicon dioxide, microcrystalline cellulose (MKTs-200), calcium stearate monohydrate (calcium stearic acid 1-aqueous), lactose monohydrate, povidone K90 (plasdon K-90), crospovidone (polyplasdone XL) (polyplasdone XL), crosspovidone XL-10).

1 g of ointment contains:

• active substance: terbinafine hydrochloride - 10 mg;
• additional components: carbomer (lightly crosslinked polyacrylic acid MARS-06), vaseline oil, methyl parahydroxybenzoate (methylparaben), polysorbate 80 (tween 80), sodium hydroxide (sodium hydroxide), propylene glycol, purified water.

Pharmacological properties

Pharmacodynamics

Terbinafine is an allylamine antifungal agent with a broad spectrum of antifungal activity. In low concentrations, the substance has a fungicidal effect on dermatophytes Trichophyton spp. (T. tonsurans, T. rubrum, T. mentagrophytes, T. violaceum, T. verrucosum), Epidermophyton floccosum, Microsporum canis; molds (including Scopulariopsis brevicaulis) and yeasts, mainly Candida albicans, in the form of an ointment - on some dimorphic fungi (Pityrosporum orbiculare). In relation to the fungi Candida spp. and their mycelial forms, depending on their type, the drug exhibits fungicidal or fungistatic activity.

Terbinafine leads to disruption of the early stage of biosynthesis of the main structural component of the fungal cell membrane - ergosterol, as well as to the accumulation of squalene in the cell, as a result of which it dies. The action of the active substance is realized by suppressing the enzyme squalene epoxidase, which is located on the wall of the fungal cell.

In the case of oral use, Terbinafine-MPF is not effective in the treatment of varicoloured lichen, excited by Pityrosporum orbiculare, Pityrosporum ovale (Malassezia furfur).

Pharmacokinetics

When taken orally, terbinafine is well absorbed from the gastrointestinal tract - more than 70%. Due to the first pass effect, the absolute bioavailability is reduced by 40%. After a single oral administration of the drug in a dose of 250 mg, it takes about 2 hours to reach a maximum concentration (C _max) of 1 μg / ml. It binds to plasma proteins almost completely - by 99%. The area under the concentration-time curve (AUC) is 4.56 μg × h / ml, in the case of taking the drug with food, it increases by 20%. With prolonged use of terbinafine, its C _max increases by 25%, and AUC - 2.5 times. Effective half-life (T _1/2) of the drug averages 36 hours, terminal - 200-400 hours, which indicates its prolonged excretion from adipose tissue and skin.

Age does not affect the equilibrium concentration (C _ss) of terbinafine, its plasma content does not depend on the patient's sex. The drug is actively distributed in tissues, passes into the nail plate and the dermal layer of the skin. It is found in the secretion of the sebaceous glands and accumulates in high concentrations in the skin and subcutaneous tissue, hair follicles, hair. Terbinafine is metabolized in the liver, in the process, inactive metabolites are formed. Eliminated in the urine, mostly in the form of metabolites. In the body, the agent does not cumulate, it is excreted with breast milk.

In patients with liver / kidney disease, the clearance of terbinafine may be reduced and, as a result, its concentration in the blood may be increased.

With local use, the absorption of the active substance does not exceed 5%, the systemic effect is insignificant.

Indications for use

Pills

• fungal infections of the skin and nails (onychomycosis), excited by Microsporum spp. (M. canis, M. gypseum), Trichophyton spp. (T. rubrum, T. verrucosum, T. mentagrophytes, T. violaceum), Epidermophyton floccosum;
• mycoses of the scalp (microsporia, trichophytosis);
• common, severe dermatomycosis of smooth skin of the trunk and extremities, which require systemic treatment;
• candidiasis of the mucous membranes and skin.

Ointment

• fungal infections of the skin, including fungal infections of the smooth skin of the body (tinea corporis), mycoses of the feet (foot fungus), inguinal epidermophytosis (tinea cruris), excited by dermatophytes such as Trichophyton (T. verrucosum, T. rubrum, T. violaceum, T. mentagrophytes), Epidermophyton floccosum and Microsporum canis (treatment and prevention);
• versicolor versicolor (Pityriasis versicolor) caused by Pityrosporum orbiculare (Malassezia furfur);
• yeast infections of the skin, mainly caused by the genus Candida (Candida albicans), in particular diaper rash.

Contraindications

Absolute:

• chronic / active liver disease;
• chronic renal failure (CRF) with creatinine clearance (CC) ≤ 50 ml / min;
• age up to 3 years and body weight up to 20 kg - for tablets, age up to 12 years - for ointment;
• glucose-galactose malabsorption, lactase deficiency, lactose intolerance - for tablets;
• pregnancy - for pills;
• lactation period;
• hypersensitivity to any component of the drug.

Relative (Terbinafine-MFF is used with extreme caution):

• metabolic diseases;
• alcoholism;
• hepatic and / or renal failure;
• occlusive vascular lesions of the extremities;
• oppression of bone marrow hematopoiesis;
• tumors.

Terbinafine-MFF, instructions for use: method and dosage

Pills

Terbinafine-MFF tablets are taken orally after meals 1 time per day.

The duration of therapy and the dosage regimen are determined for each patient individually, depending on the severity of the disease and the localization of the fungal infection. The daily dose for adults is usually 250 mg.

Recommended duration of treatment in adults:

• fungal infections of the skin: with interdigital, plantar or sock-like localization of the infection - 2–6 weeks; with mycoses of the legs or trunk, mycoses caused by fungi of the genus Candida - 2–4 weeks;
• Onychomycosis: 6 to 12 weeks on average in young patients or in case of damage to the nails of the fingers of the hands, nails of the toes (except for the thumb), the course can be less than 12 weeks; with an infection of the big toe - usually 3 months, however, with a reduced rate of nail growth, longer therapy may be necessary;
• mycoses of the scalp, excited by Microsporum, over 4 weeks.

The daily dose of Terbinafine-MFF for children with a body weight of 20-40 kg is 125 mg, with a weight over 40 kg - 250 mg, the frequency of administration is 1 time per day. The duration of therapy for mycoses of the scalp in children is about 4 weeks, with damage to Microsporum canis, a longer course is possible.

In the presence of hepatic and / or renal insufficiency, the drug is taken at a dose of 125 mg 1 time per day.

Ointment

Terbinafin-MFF ointment is used externally. Before applying the drug, it is required to clean and dry the infected skin areas. It is recommended to apply the ointment 1-2 times a day in a thin layer to problem areas and adjacent skin areas, rubbing slightly. When treating the areas in the interdigital spaces, under the mammary glands, in the groin area, between the buttocks (with lesions accompanied by diaper rash), it is allowed to cover the place of application with gauze, especially at night.

Recommended course of therapy and frequency of use in adolescents over 12 years old and adults:

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

The severity of clinical manifestations of the disease usually decreases in the first days of the course.

If treatment with the drug is carried out irregularly or canceled prematurely, the risk of recurrence of an infectious disease is aggravated. If after 2 weeks of therapy with Terbinafine-MFF there is no improvement in the condition, the causative agent of the disease and the degree of its sensitivity to the drug should be re-established.

Side effects

With oral administration of Terbinafine-MFF, the following side effects may occur:

• skin and subcutaneous tissues: rarely - exacerbation of psoriasis, psoriasis-like skin rashes, toxic epidermal necrolysis (Lyell's syndrome), malignant exudative erythema (Stevens-Johnson syndrome);
• immune system: rash, urticaria, anaphylactoid reactions, worsening of systemic lupus erythematosus;
• blood and lymphatic system: rarely - thrombocytopenia, agranulocytosis, neutropenia, lymphopenia;
• musculoskeletal system: myalgia, arthralgia;
• digestive system: disturbances or loss of taste (after stopping therapy, recovery occurs within a few weeks), decreased appetite, feeling of fullness in the stomach, nausea, diarrhea, abdominal pain; rarely - increased activity of hepatic transaminases, hepatic failure.

With external application of the drug at the site of application, redness, burning or itching may occur. Allergic reactions may also occur.

Overdose

When using the tablet form of an antifungal agent, symptoms of an overdose may be dizziness, headache, frequent urination, nausea, vomiting, epigastric pain, pain in the lower abdomen.

There are no reports of an overdose of Terbinafine-MFF ointment; with its accidental oral administration, the same adverse reactions can be expected as with an overdose of tablets.

In this condition, gastric lavage and intake of activated charcoal and / or symptomatic treatment are prescribed.

special instructions

Pills

Concomitant diseases and condition of the nails at the beginning of the course with onychomycosis can affect the duration of treatment.

Systemic use of Terbinafine-MFF in onychomycosis is permissible only against the background of total damage to most of the nail plates, pronounced subungual hyperkeratosis, or in the absence of the effect of previous local treatment.

Complete elimination of the clinical manifestations of infection, confirmed by laboratory, during the treatment of onychomycosis is usually noted several months after the mycological cure and completion of the course of treatment, which is associated with the rate of regrowth of a healthy nail. When treating onychomycosis of the hands for 3 weeks and feet for 6 weeks, it is not required to remove the nail plates.

During the period of use of Terbinafine-MPF, serum levels of hepatic transaminases in the blood should be monitored. After 3 months of admission, rare cases of cholestasis and hepatitis were recorded. If there are signs of liver dysfunction, such as decreased appetite, weakness, persistent nausea, severe abdominal pain, dark urine, discolored stools, jaundice, the drug should be discontinued.

Patients with psoriasis should use antifungal agent with caution, as there are reports of extremely rare cases of exacerbation of psoriasis due to terbinafine.

During therapy with Terbinafine-MFF, general hygiene rules must be observed to prevent reinfection through underwear and shoes. 2 weeks after the start of the course and at the end of it, it is necessary to perform antifungal treatment of shoes, stockings and socks.

Ointment

Terbinafine-MFF ointment is intended exclusively for external use.

It is necessary to beware of getting the ointment in the eyes, since it can provoke irritation. If this still cannot be avoided, you should immediately rinse your eyes with running water, and in the event of persistent manifestations of irritation, consult a specialist.

If, during treatment, the development of allergic reactions is observed, it is necessary to stop using the drug.

Application during pregnancy and lactation

In the course of experimental studies, the teratogenic properties of terbinafine were not found.

During pregnancy, the use of the drug in the form of tablets is contraindicated, since there is not enough information about the safety of its oral administration during this period. The use of ointment in pregnant women is allowed only if the expected benefit to the woman outweighs the possible threat to the fetus.

If it is necessary to prescribe Terbinafine-MFF during lactation, it is necessary to resolve the issue of stopping breastfeeding, since the drug is excreted in breast milk.

Pediatric use

For children under 3 years of age and with a body weight of less than 20 kg, Terbinafine-MFF tablets are contraindicated, for children under 12 years of age, the use of the ointment is not recommended due to the lack of sufficient clinical experience.

With impaired renal function

Patients with chronic renal failure (CC ≤ 50 ml / min) are not prescribed the drug, with renal insufficiency (CC> 50 ml / min) - it is recommended to use it with caution.

The recommended dosing regimen for patients with impaired renal function is 125 mg once a day.

For violations of liver function

In the presence of chronic / active liver diseases, drug therapy is contraindicated.

With liver failure, treatment is carried out with caution.

The recommended dosage regimen of Terbinafine-MFF for patients with impaired liver function is 125 mg 1 time per day.

Use in the elderly

For the elderly, both dosage forms of the drug are recommended in the same doses as for younger patients.

Drug interactions

Possible interaction reactions with systemic use of Terbinafine-MPF with the following drugs / agents:

• selective serotonin reuptake inhibitors (SSRIs) (fluvoxamine, desipramine), tricyclic antidepressants, antiarrhythmics (propafenone, flecainide), monoamine oxidase B (MAO B) inhibitors (selegiline), antipsychotics (β-adrenergicol), chlorpromazinobol metoprolol): the metabolism of these drugs is disrupted, since the drug suppresses the CYP2D6 isoenzyme;
• oral contraceptives: the likelihood of menstrual irregularities increases;
• inducers of cytochrome P ₄₅₀ isoenzymes (rifampicin): the rate of metabolism and elimination of terbinafine from the body increases;
• inhibitors of cytochrome P ₄₅₀ isoenzymes (cimetidine): biotransformation and excretion of terbinafine slows down, a change in the dose of the latter may be required;
• caffeine: its clearance decreases by 21%, and T _1/2 increases by 31%;
• digoxin, phenazone, warfarin: the clearance of these substances does not change;
• ethanol; drugs with a hepatotoxic effect: possible drug damage to the liver.

For the drug in the form of an ointment, drug interactions with other drugs have not been established.

Analogs

Analogs of Terbinafin-MFF are Binafin, Lamisil, Lamifungin, Mikonorm, Tebikur, Terbized-Ajio, Terbinafin, Terbifin, Fungoterbin, Exifin, etc.

Terms and conditions of storage

Store out of the reach of children, for tablets - protected from light, at a temperature not exceeding 25 ° C.

Shelf life is 2 years.

Terms of dispensing from pharmacies

The tablets are prescription, and the topical ointment is available without a prescription.

Reviews about Terbinafine-MFF

Reviews of Terbinafine-MFF are mostly positive. Patients classify both forms of the drug as effective antifungal agents. Separately, the budget cost and the availability of the drug in pharmacies are noted. However, in some cases, the desired result can be achieved only with the combined use of both dosage forms of the drug. In the treatment of mycosis of the feet, only an ointment for external use is often also successfully used.

The disadvantages of the drug include the need for long-term treatment, in particular for onychomycosis - up to 3 months, as well as the presence of contraindications and the possible appearance of undesirable effects.

Price for Terbinafine-MFF in pharmacies

The price for Terbinafin-MFF can be:

• tablets (250 mg): 110–130 rubles. for 10 pcs. packaged;
• ointment for external use 1%: 50–70 rubles. per tube 15 g.

Terbinafine-MFF: prices in online pharmacies

Drug name Price Pharmacy

Terbinafine-MFF 1% ointment for external use 15 g 1 pc. RUB 47 Buy

Terbinafine-mff ointment for narcotics. approx. 1% tube 15g RUB 61 Buy

Terbinafine-MFF 250 mg tablets 10 pcs. 108 RUB Buy

Terbinafine-mff tablets 250mg 10 pcs. RUB 111 Buy

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, 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!