Terbinafin-MFF, ointment 1% 15 g

Terbinafine belongs to the group of allilamines and has a broad spectrum of antifungal action. In low concentrations it has fungicidal effect on dermatophytes Trychophyton (T. rubrum, T. mentagrophytes, T. tonsurans, T.verrucosum, T.violaceum), Microsporum canis, Epidermophyton floccosum, mold fungi (e.g. Scopulariopsis brevicaulis), yeasts, mainly Candida albicans. Candida spp. fungi and their mycelial forms have fungicidal or fungistatic effect depending on the fungus species.

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.

In oral administration it is not effective in the treatment of variegated herpes caused by Pityrosporum ovale, Pityrosporum orbiculare, Malassezia furfur.

Pharmacokinetics

In oral administration it is well absorbed, after 0.8 hours half of the taken dose is absorbed; after 4.6 hours half of the taken dose is distributed in the body. One to two hours after a single oral dose of 250 mg, maximum blood plasma concentration reaches 0.97 mcg/ml. Bioavailability is 80%.
Terbinafine binds intensively with blood plasma proteins (99%), is rapidly distributed in the tissues, penetrates the dermal layer of the skin and nail plates. It penetrates into the secretion of sebaceous glands and accumulates in high concentrations in the hair follicles, hair, skin and subcutaneous tissue.

The elimination half-life is 16-18 hours, the terminal phase elimination half-life is 200-400 hours.
It is biotransformed in the liver to inactive metabolites. The kidneys excrete 80% of the taken dose as metabolites, the rest (20%) is excreted through the intestines.

It does not cumulate in the body. The age of patients does not affect the pharmacokinetics of terbinafine, but elimination may be reduced with renal or hepatic damage, leading to high concentrations of terbinafine in the blood.
Excreted with breast milk.

Indications

Active ingredient

Composition

1 g of ointment for external use contains:

acting substances:

terbinafine hydrochloride 10 mg;

excipients:

methylparahydroxybenzoate (methylparaben),

carbomer (rare crosslinked polyacrylic acid mARS- 06),

polysorbate, vaseline oil,

propylene glycol,

sodium hydroxide (sodium caustic),

purified water

How to take, the dosage

Adults and children over 12 years of age: Apply a thin layer, rubbing gently, 1 or 2 times a day on the affected skin and the surrounding area.

The duration of treatment depends on the indication and the severity of the disease.

The course of treatment is on the average 2-4 weeks.

Duration and number of times of application: dermatomycosis of the trunk, shins, feet – once a day for 1 week; cutaneous candidiasis – once or twice a day for 1-2 weeks; varicolored lichen – once or twice a day for 2 weeks.

Interaction

There are no known drug interactions for terbinafine ointment/cream.

Special Instructions

Avoid getting it in the eyes as it may cause irritation.

In case of accidental contact of the drug in the eyes, they should be immediately rinsed with running water, and if persistent irritation develops, consult a doctor.

If allergic reactions develop, the drug should be discontinued.

Contraindications

Caution should be exercised when:

Side effects

For external use: itching and burning of the skin, hyperemia at the application site, allergic reactions possible.

Overdose

Symptoms:headache, dizziness, nausea, vomiting, pain in the epigastric region, rapid urination, rash.

treatment: measures to eliminate the drug (gastric lavage, taking activated charcoal); if necessary – symptomatic supportive therapy.

Pregnancy use

Terbinafine has not been found to have teratogenic properties in experimental studies.

The use of the drug in pregnancy is possible in cases where the estimated benefit to the mother exceeds the possible risk to the fetus. Terbinafine is excreted with the breast milk.

If it is necessary to use the drug during lactation, the question of stopping breastfeeding should be addressed.

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