Instructions for Terbinafine
Composition Terbinafine Cream:
1 g of Cream for external use contains:
active substances Terbinafine Cream:
terbinafine hydrochloride 10 mg;
pharmachologic effect Terbinafine Cream:
Terbinafine Cream belongs to the group of allylamines, has a wide spectrum of antifungal action. At low concentrations, it has a fungicidal effect on Trychophyton dermatophytes (T. rubrum, T. mentagrophytes, T. tonsurans, T.verrusosum, T.violaceum), Microsporum canis, Epidermophyton floccosum, molds (e.g. Scopulariopsis brevicaulis), yeast image of Candida albicans. On Candida spp. and their mycelial forms, depending on the type of fungus, have a fungicidal or fungistatic effect.
Terbinafine Cream disrupts the early stage of biosynthesis of the main component of the cell membrane of the ergosterol fungus by inhibiting the squalene epoxidase enzyme.
When administered orally, it is not effective in treating multi-colored lichen caused by Pityrosrorum ovale, Pityrosporum orbiculare, Malassezia furfur.
Pharmacokinetics Terbinafine Cream:
When taken orally, it is well absorbed, after 0.8 hours, half the dose taken is absorbed; after 4.6 hours, half 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 μg / ml. Bioavailability is 80%. Eating does not affect the bioavailability of Terbinafine Cream.
Terbinafine Cream intensively binds to plasma proteins (99%), is rapidly distributed in tissues, penetrates the dermal layer of the skin and nail plates. It 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 half-life of the terminal phase is 200–400 hours.
Biotransformed in the liver to inactive metabolites. 80% of the accepted dose is excreted by the kidneys in the form of metabolites, the rest (20%) is excreted through the intestines.
Does not cumulate in the body. The age of patients does not affect the pharmacokinetics of Terbinafine Cream, however, elimination may decrease with damage to the kidneys or liver, leading to high concentrations of antifungal agent in the blood.
Excreted in breast milk.
Indications Terbinafine Cream:
- Prevention and treatment of fungal infections of the skin
- including foot mycoses (foot fungus), inguinal epidermophytosis (tinea cruris)
- fungal infections of smooth body skin (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 genus Candida (e.g. Candida albicans), in particular diaper rash.
- Multi-colored lichen (Pityriasis versicolor) caused by Pityrosporum orbiculare (also known as Malassezia furfur).
- Pregnancy and lactation
- In experimental studies
- teratogenic properties of antifungal agent were not detected.
- The use of the drug during pregnancy is possible in cases where the intended benefits to the mother outweigh the possible risk to the fetus.
- Antifungal agent is excreted in breast milk.
- If necessary, the use of the drug during lactation should decide on the termination of breastfeeding.
Contraindications Terbinafine Cream:
chronic or active liver disease;
chronic renal failure (CC less than 50 ml / min);
children's age (up to 12 years) and with a body weight of up to 20 kg (for this dosage form);
lactation period;
lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
hypersensitivity or other components of the drug.
Caution should be exercised when:
renal failure (with CC more than 50 ml / min);
alcoholism;
inhibition of bone marrow hematopoiesis;
tumors;
metabolic diseases;
occlusive vascular disease of the limbs;
cutaneous lupus erythematosus or systemic lupus erythematosus.
Side effects
For external use: itching and burning of the skin, flushing at the site of application, allergic reactions are possible.
Interaction Terbinafine Cream:
No drug interactions for Terbinafine Cream ointment / cream are known.
How to take Terbinafine Cream:
Adults and children over 12 years of age: Apply to the affected areas of the skin and adjacent areas with a thin layer, rubbing slightly, 1 or 2 times a day.
The duration of treatment depends on the indication and severity of the disease.
The course of treatment is an average of 2-4 weeks.
Duration and frequency of use: dermatomycosis of the trunk, legs, feet - 1 time per day for 1 week; skin candidiasis - 1-2 times a day for 1-2 weeks; multi-colored lichen - 1-2 times a day for 2 weeks.
Overdose Terbinafine Cream:
Symptoms: headache, dizziness, nausea, vomiting, pain in the epigastric region, frequent urination, rash.
Treatment: measures to remove the drug (gastric lavage, taking activated charcoal); if necessary, symptomatic maintenance therapy.
