Terbinafine MFF, ointment 1%, 15g

Composition

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of 1 g of ointment for external use contains:

active substances:

terbinafine hydrochloride 10 mg;

excipients:

methylparahydroxybenzoate (methylparaben),

carbomer (rare cross – linked polyacrylic acid mARS-06),

polysorbate, petroleum jelly oil,

propylene glycol,

sodium hydroxide (sodium hydroxide),

purified water

Pharmacological action

Terbinafine belongs to the group of allylamines, has a wide spectrum of antifungal action. In low concentrations, it has a fungicidal effect on Trychophyton dermatophytes (T. rubrum, T. mentagrophytes, T. tonsurans, T. verrucosum, T. violaceum), Microsporum canis, Epidermophyton floccosum, mold fungi (for example. Scopulariopsis brevicaulis), yeast fungi, mainly Candida albicans. For fungi Candida spp. and their mycelial forms have a fungicidal or fungistatic effect, depending on the type of fungus.

Terbinafine disrupts the early stage of biosynthesis of the main component of the fungal cell membrane, ergosterol, by inhibiting the squalene oxidase enzyme.

When administered orally, it is not effective in the treatment of multicolored lichen caused by Pityrosporum ovale, Pityrosporum orbiculare, Malassezia furfur.

Pharmacokinetics

When taken orally, it is well absorbed, after 0.8 hours, half of the dose taken is absorbed; after 4.6 hours, half of the dose taken is distributed in the body. 1-2 hours after ingestion of a single dose of 250 mg, the maximum concentration of the drug in blood plasma reaches 0.97 mcg / ml. Bioavailability is 80%.

Food intake does not affect the bioavailability of terbinafine. Terbinafine binds intensively to plasma proteins (99%), is rapidly distributed in tissues, and penetrates the dermal layer of the skin and nail plates. Penetrates the secret of the sebaceous glands and accumulates in high concentrations in the hair follicles, hair, skin and subcutaneous tissue.

The half-life is 16-18 hours, the terminal phase half — life is 200-400 hours. Biotransformed in the liver to inactive metabolites. 80% of the dose is excreted by the kidneys in the form of metabolites, the rest (20%) is excreted through the intestine.

It does not accumulate in the body. The age of patients does not affect the pharmacokinetics of terbinafine, but elimination may decrease with kidney or liver damage, leading to high concentrations of terbinafine in the blood. It is excreted in breast milk.

Indications

• Prevention and treatment of fungal skin infections, including athlete’s foot (“fungus” of the foot), Jock itch (tinea cruris), fungal infections smooth skin of the body (tinea corporis), caused by dermatophytes such as Trichophyton (including T. rubrum, T. mentagrophytes, T. verruco-sum, T. violaceum), Microsporum canis and Epidermophyton floccosum.
• Yeast infections of the skin, mainly those caused by the Candida genus (for example, Candida albicans), in particular diaper rash.
• Multi-colored lichen (Pityriasis versicolor), caused by Pityrosporum orbiculare (also known as Malassezia furfur).

Use during pregnancy and lactation

No teratogenic properties of terbinafine were found in experimental studies.

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

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

Contraindications

• chronic or active liver disease;
• chronic renal failure (CC less than 50 ml/min);
• children’s age (up to 3 years) and weighing up to 20 kg (for this dosage form);
• lactation;
• lactase deficiency, lactose intolerance, malabsorption glucosegalactose;
• hypersensitivity to terbinafine or any other components of the drug.

Care should be taken when:

• renal failure (with creatinine clearance greater than 50 ml/min);
• alcoholism;
• suppression of bone marrow hematopoiesis;
• tumors;
• metabolic diseases;
• occlusive diseases of the vessels of the extremities;
• cutaneous lupus erythematosus or systemic lupus erythematosus.

Side effects

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

Interaction

No drug interactions are known for terbinafine ointment/cream.

How to take, course of use and dosage

Adults and children over 12 years of age: apply to the affected skin and adjacent areas in a thin layer, lightly rubbing,1 or 2 times a day.

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

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

Duration and frequency of application: dermatomycosis of the trunk, legs, feet-1 time a day for 1 week; candidiasis of the skin-1-2 times a day for 1-2 weeks; multi-colored lichen-1-2 times a day for 2 weeks.

Overdose

Symptoms: headache, dizziness, nausea, vomiting, epigastric pain, frequent urination, rash.

Treatment: measures to remove the drug (gastric lavage, taking activated charcoal); if necessary, symptomatic maintenance therapy.

Special instructions

Avoid getting it in your eyes, as it can cause irritation.

If the drug accidentally gets into the eyes, they should be immediately rinsed with running water, and in case of persistent irritation, consult a doctor.

If allergic reactions develop, the drug should be discontinued.

Form of production

Ointment for external use

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Terbinafine

Dosage form

ointment

Description

Nursing mothers as prescribed by a doctor, Children over 12 years of age, For adults, Pregnant women as prescribed by a doctor

Indications

Mushroom