Lamican^® (Tablets) Instructions for Use

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

ATC Code

D01BA02 (Terbinafine)

Active Substance

Terbinafine (Rec.INN registered by WHO)

Dosage Forms

	Lamican®	Tablets 125 mg: 7, 10, 14, 20, 21, 28, 30 or 40 pcs.
		Tablets 250 mg: 7, 10, 14, 20, 21, 28, 30 or 40 pcs.

Dosage Form, Packaging, and Composition

Tablets white or white with a yellowish tint, flat-cylindrical, with a score and a bevel.

Excipients: hydroxypropylcellulose, hypromellose, microcrystalline cellulose, silicon dioxide, calcium stearate.

7 pcs. – contour cell packs (1) – cardboard packs.
7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (3) – cardboard packs.
7 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.

Clinical-Pharmacological Group

Antifungal drug

Pharmacotherapeutic Group

Antifungal agent

Pharmacological Action

Antifungal drug, allylamine. It has a broad spectrum of antifungal action. Active against dermatophytes Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Trichophyton verrucosum, Trichophyton violaceum, Microsporum canis, Epidermophyton floccosum. In low concentrations, it has a fungicidal effect against dermatophytes, molds (Aspergillus, Cladosporium, Scopulariopsis brevicaulis) and some dimorphic fungi. Activity against yeast fungi of the genus Candida and their mycelial forms, depending on the species, can be fungicidal or fungistatic.

Terbinafine is also active against Pityrosporum ovale – the causative agent of pityriasis versicolor.

Terbinafine disrupts the synthesis of ergosterol occurring in fungi by inhibiting the enzyme squalene epoxidase located on the fungal cell membrane. This leads to a deficiency of ergosterol and intracellular accumulation of squalene, which causes the death of the fungal cell.

Pharmacokinetics

Absorption

After a single oral administration of the drug, C_max of terbinafine in blood plasma is reached after 2 hours. The drug is well absorbed (about 70%), bioavailability is 40%.

Distribution

Binding to plasma proteins is 99%. The drug quickly penetrates into the dermal layer of the skin and accumulates in the stratum corneum of the skin and nail plates, providing a fungicidal effect. It quickly penetrates into the secretion of the sebaceous glands, creating high concentrations in the hair follicles, hair, skin, and subcutaneous tissue. Does not accumulate in the body.

Metabolism and excretion

It is biotransformed in the liver with the formation of inactive metabolites; about 70% of the taken dose is excreted in the urine. T_1/2 in the α-phase is about 17 hours. T_1/2 in the terminal phase is 200-400 hours.

Pharmacokinetics in special clinical cases

No changes in the equilibrium concentration of terbinafine depending on age were detected. In renal failure or liver cirrhosis, the rate of drug elimination may be slowed, which leads to higher concentrations of terbinafine in the blood plasma.

Indications

• Onychomycosis;
• Mycoses of the scalp (trichophytosis, microsporia);
• Treatment of widespread dermatomycoses of the trunk and extremities;
• Candidiasis of the skin and mucous membranes caused by fungi of the genus Candida (in cases where the localization or prevalence of the process makes oral therapy appropriate).

ICD codes

Dosage Regimen

The duration of the course of treatment and the dosage regimen are set individually and depend on the localization of the process and the severity of the disease.

In children over 2 years of age, a single dose depends on the child’s body weight.

There are no data on the use of the drug in children under 2 years of age with a body weight of less than 12 kg.

Adults are prescribed the drug at a dose of 250 mg once a day (after meals).

Patients with hepatic and/or renal insufficiency – 125 mg once a day.

The recommended duration of treatment for dermatomycosis of the foot (interdigital, plantar or sock-type) is 2-6 weeks; for dermatomycosis of the trunk, extremities – 2-4 weeks; for candidiasis of the skin and mucous membranes – 2-4 weeks.

The complete disappearance of the clinical manifestations of the disease is usually observed several weeks after mycological cure.

The recommended duration of treatment for scalp mycosis is 4 weeks. Scalp mycoses are observed mainly in children.

For onychomycosis, the duration of treatment in most patients is 6-12 weeks. For onychomycosis of the hands, the course of treatment in most cases is 6 weeks, for onychomycosis of the feet – 12 weeks. Some patients who have a reduced rate of nail growth may require longer treatment. The optimal clinical effect is observed several months after mycological cure and cessation of therapy. This is determined by the period of time required for the regrowth of a healthy nail.

Adverse Reactions

Lamican^® is generally well tolerated. Side effects are usually mild or moderate and are transient.

From the digestive system dyspepsia, abdominal pain, feeling of stomach fullness, nausea, loss of appetite, diarrhea; sometimes – taste disturbance, including loss of taste (recovers a few weeks after stopping treatment).

From the musculoskeletal system muscle pain, joint pain.

From the hematopoietic system neutropenia, agranulocytosis, thrombocytopenia; rarely – lymphopenia.

Allergic reactions skin rash in the form of spots, blisters; rarely – toxic epidermal necrolysis, Stevens-Johnson syndrome, anaphylactoid reactions.

Contraindications

• Hypersensitivity to terbinafine or any other component that is part of the drug.

With caution the drug should be prescribed for alcoholism, blood diseases, tumors, metabolic diseases, pathology of the vessels of the extremities, children under 2 years of age.

Use in Pregnancy and Lactation

Experience with the use of the drug Lamican^® during pregnancy is limited, so the drug should not be used during pregnancy. Terbinafine is excreted in breast milk, so if it is necessary to prescribe the drug, the issue of stopping breastfeeding should be decided.

Use in Hepatic Impairment

Patients with hepatic insufficiency – 125 mg once a day.

Use in Renal Impairment

Patients with renal insufficiency – 125 mg once a day.

Pediatric Use

In children over 2 years of age, a single dose depends on the child’s body weight.

There are no data on the use of the drug in children under 2 years of age with a body weight of less than 12 kg.

Special Precautions

It should be taken into account that irregular use or premature termination of treatment increases the risk of relapse.

If after 2 weeks of treatment there is no improvement in the condition, it is necessary to re-determine the causative agent of the disease and its sensitivity to the drug.

Caution should be exercised when prescribing Lamican^® to patients with impaired liver and/or kidney function. If symptoms suggesting impaired liver function (loss of appetite, fatigue, persistent nausea, jaundice, dark urine) are detected, the drug should be discontinued. Patients with chronic liver and kidney dysfunction should be prescribed half the usual recommended dose of the drug and monitor liver and kidney function indicators during treatment.

During and at the end of treatment, antifungal treatment of shoes, socks and stockings should be carried out.

Overdose

To date, no cases of terbinafine overdose when taken orally in recommended doses have been described. With an acute overdose of the drug, the development of symptoms nausea, vomiting, pain in the epigastric region is possible.

Treatment gastric lavage followed by the appointment of activated charcoal; if necessary – symptomatic supportive therapy.

Drug Interactions

Terbinafine in vitro has an extremely low ability to change the clearance of most drugs that are metabolized with the participation of cytochrome P₄₅₀ enzymes (for example, cyclosporine, terfenadine, tolbutamide, triazolam or oral contraceptives).

In women simultaneously taking Lamican^® and oral contraceptives, menstrual irregularities may be observed.

The total clearance of terbinafine may be accelerated by drugs that cause induction of cytochrome P₄₅₀ enzymes (for example, rifampicin) and may be slowed down by drugs – inhibitors of cytochrome P₄₅₀ enzymes (for example, cimetidine). If it is necessary to use these drugs simultaneously, dose adjustment may be required.

Terbinafine reduces the clearance of caffeine by 20%.

Terbinafine does not affect the clearance of antipyrine, digoxin, warfarin.

Ethanol and other hepatotoxic drugs, when used simultaneously with Lamican^®, increase the risk of hepatotoxicity.

Storage Conditions

List B. The drug should be stored in a dry, light-protected place, out of the reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.