Terbin 250 mg, 14 tabs

Trade Name:

Terbin

Terbinafine 250 mg

14 tablets

Composition:

Each tablet contains:

Terbinafine hydrochloride 281.25 mg equivalent to 250 mg terbinafine

Inactive ingredients: 

Colloidal silicon dioxide, sodium starch glycolate, microcrystalline cellulose, magnesium stearate, hydroxypropylmethyl cellulose.

Properties: 

Oral antifungal agent

Terbinafine is an allylamine which has a broad spectrum of antifungal activity. At low concentrations terbinafine is fungicidal against dermatophytes, molds and certain dimorphic fungi. The activity versus yeasts is fungicidal or fungistatic depending on the species.

Terbinafine interferes specifically with fungal sterol biosynthesis at an early step. This leads to a deficiency in ergosterol and to an intracellular accumulation of squalene, resulting in fungal cell death. Terbinafine acts by inhibition of squalene epoxidase in the fungal cell membrane. The enzyme squalene epoxidase is not linked to the cytochrome P450 system.

When given orally, the drug concentrates in skin at levels associated with fungicidal activity.

Indications:

-Fungal infections of the skin and nails caused by Trichophyton (eg. T. rubrum, T Mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum.

-treatment of ringworm (tỉnea corporis, tinea cruris and tinea pedis) where oral therapy is considered appropriate due to the site, severity or extent of the infection.

-the treatment of onychomycosis.

Dosage and administration:

Orally

• Adults: 250 mg once daily. The duration of treatment varies according to the indication and the severity of the infection.

Skin infections

• Likely durations of treatment are as follows:

-Tinea pedis (interdigital, plantar/moccasin type): 2 to 6 weeks

-Tinea corporis: 4 weeks

-Tinea cruris: 2 to 4 weeks

• Onychomycosis

The duration of treatment for most patients is between 6 weeks and 3 months.  •Children:

Not recommended

• Elderly:

There is no evidence to suggest that elderly patients require different dosages or experience side-effects different to those of younger patients. The possibility of impairment of liver or kidney function should be considered in this age group.

Side effects:

-Blood and lymphatic system disorders:

Neutropenia, agranulocytosis, thrombocytopenia, Anaemia Pancytopenia

Immune system disorders, Anaphylactoid reactions (including angioedema), cutaneous and systemic lupus erythematosus.

-Metabolism and nutrition disorders:

Decreased appetite

-Psychiatric disorders:

Anxiety and depressive symptoms secondary to taste disturbances.

-Nervous system disorders:

Headache, Taste disturbances, including taste loss, Paraesthesia, hypoaesthesia, dizziness, insomnia including permanent insomnia, 

-Ear and labyrinth disorders:

Vertigo, Hypoacusis, impaired hearing, tinnitus, Vascular disorders, Vasculitis

-Gastrointestinal disorders:

Loss of appetite, dyspepsia, diarrhea 

-Hepatobiliary disorders:

Cases of serious hepatic disorders and insufficiency, including jaundice and hepatitis, cholestasis and hepatitis. 

-Skin and subcutaneous tissue disorders:

Rash, urticaria), Stevens- Johnson syndrome, toxic epidermal necrolysis, Photosensitivity,  Psoriasiform eruptions or exacerbation of psoriasis. 

-Musculoskeletal and connective tissue disorders:

Arthralgia

Contraindications:

Hypersensitivity to the active substance 

Warnings and precautions:

• Doctors prescribing oral terbinafine should first ensure that there is a clear indication for its use (use oral form only after adequate trial of topical therapy).
• Terbin tablets are not recommended for patients with chronic or active liver disease. Before prescribing Terbin tablets, any pre-existing liver disease should be assessed.

Hepatotoxicity may occur in patients with and without pre-existing liver disease therefore periodic monitoring (after 6 weeks of treatment) of liver function test is recommended.

Terbin tablets should be immediately disconunued in case of elevation of liver function test.

• The uses of Terbin tablets have not been adequately studied in patients with renal impairment and therefore not recommended in this population.
• Terbinafine tablets should not be used during pregnancy unless the clinical condition of the woman requires treatment with oral terbinafine and the potential benefits for the mother outweigh any potential risks for the fetus.
• Terbinafine is excreted in breast milk and therefore mothers should not receive Terbin treatment whilst breast-feeding.
• Effects on the ability to drive and use machines:

Patients who experience dizziness as an undesirable effect should avoid

driving vehicles or using machines.

Storage:

Store at a temperature not exceeding 30°C in a dry place.

Package:

Carton box holds 2 strips each of 7 tablets and an insert leaflet.