Terbin 250 mg 14 tablets
Global napi pharmaceuticals
Global napi pharmaceuticals
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.