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TERBINAFINE is a brand name for Terbinafine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of fungal infections of the skin caused by terbinafine sensitive dermatophytes in cases of tinea corporis, tinea cruris and tinea pedis, when oral therapy is considered appropriate due to the site, severity or extent of the infection. Treatment of onychomycosis caused by terbinafine sensitive dermatophytes.…
Verbatim from this product's MHRA label. Tap a section to expand.
Adults The usual dose is 250 mg once daily, however, the duration of treatment will vary according to the indication and the severity of the infection. Skin infections Duration of the treatment The likely durations of treatments 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 usually between 6 weeks and 3 months.
Treatment of 6 weeks for onychomycosis of the finger nails is generally sufficient. Regarding onychomycosis of the toe nails, a 12 week treatment is usually sufficient, although a few patients with poor nail outgrowth may require a longer treatment duration (6 months or longer).
Complete resolution of the signs and symptoms of infection may not occur until several months after cessation of the treatment. This corresponds to the time needed for a healthy nail growth. Complete resolution of the signs and symptoms of infection may not occur until several weeks after mycological cure.
Additional information on special population Liver impairment Terbinafine tablets are contraindicated for patients with chronic or active hepatic disease (see sections
). Patients prescribed Terbinafine tablets should be instructed to report immediately any signs or symptoms suggestive of liver dysfunction such as pruritus, unexplained persistent nausea, decreased appetite, anorexia, jaundice, vomiting, fatigue, right upper abdominal pain, dark urine, or pale stools.
Patients with these symptoms should discontinue taking oral terbinafine and the patient’s liver function should be immediately evaluated. g. Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms) have been very rarely reported in patients taking Terbinafine tablets.
If progressive skin rash occurs, Terbinafine tablets treatment should be discontinued. Terbinafine should be used with caution in patients with pre-existing psoriasis, as very rare cases of exacerbation of psoriasis have been reported.
Haematological effects Very rare cases of blood dyscrasias (neutropenia, agranulocytosis, thrombocytopenia, pancytopenia) have been reported in patients treated with Terbinafine tablets. Aetiology of any blood dyscrasias that occur in patients treated with Terbinafine tablets should be evaluated and consideration should be given for a possible change in medication regimen, including discontinuation of treatment with Terbinafine tablets.
2 Pharmacokinetic properties). Other Terbinafine tablets should be used with caution in patients with lupus erythematosus as very rare cases of lupus erythematosus have been reported. 5 Interaction with other medicinal products and other forms of interaction Effect of other medicinal products on terbinafine The plasma clearance of terbinafine may be accelerated by drugs, which induce metabolism (such as rifampicin) and may be inhibited by drugs, which inhibit cytochrome P450 (such as cimetidine).
Where co-administration of such agents is necessary, the dosage of terbinafine may need to be adjusted accordingly. The following medicinal products may increase the effect or plasma concentration of terbinafine: Cimetidine decreased the clearance of terbinafine by 30%.
). 2 Pharmacokinetic properties). Children A review of safety experience with oral TERBINAFINE in children, which includes 314 patients involved in the UK TERBINAFINE Post Marketing Surveillance study, has shown that the adverse event profile in children is similar to that seen in adults.
No evidence of any new, unusual or more severe reactions to those seen in the adult population have been noted. However, as data is still limited its use is not recommended. Elderly There is no evidence to suggest that elderly patients (aged 65 years or above) require different dosages or experience side-effects different to those of younger patients.
The possible impairment of liver or kidney function should be considered in this age group (see Precautions). Method of administration The scored tablets are taken orally with water. They should preferably be taken at the same time each day and can be taken on any empty stomach or after a meal.
1.. • severe renal impairment (creatinine clearance < 30 ml/min). • severe hepatic impairment. 4 Special warnings and precautions for use Liver Function Terbinafine tablets are contraindicated for patients with chronic or active hepatic disease.
Before prescribing Terbinafine tablets, a liver function test should be performed and any pre-existing liver disease should be assessed. Hepatotoxicity may occur in patients with and without pre-existing liver disease therefore periodic monitoring (after 4-6 weeks of treatment) of liver function test is recommended.
Terbinafine tablets should be immediately discontinued in case of elevation of liver function test. Very rare cases of serious liver failure (some with a fatal outcome, or requiring liver transplant) have been reported in patients treated with Terbinafine tablets.
8 Undesirable effects). Patients prescribed Terbinafine tablets should be instructed to report immediately any signs or symptoms suggestive of liver dysfunction such as pruritus, unexplained persistent nausea, decreased appetite, anorexia, jaundice, vomiting, fatigue, right upper abdominal pain, dark urine, or pale stools.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Fluconazole increased the Cmax and AUC of terbinafine by 52% and 69% respectively, due to inhibition of both CYP2C9 and CYP3A4 enzymes. Similar increase in exposure may occur when other drugs which inhibit both CYP2C9 and CYP3A4 such as ketoconazole and amiodarone are concomitantly administered with terbinafine.
The following medicinal products may decrease the effect or plasma concentration of terbinafine: Rifampicin increased the clearance of terbinafine by 100%. Effect of terbinafine on other medicinal products Terbinafine may increase the effect or plasma concentration of the following medicinal products: Caffeine – Terbinafine decreased the clearance of caffeine administered intravenously by 21%.
Compounds predominantly metabolised by CYP2D6 – In vitro and in vivo studies have shown that terbinafine inhibits the CYP2D6-mediated metabolism. g. 4). Terbinafine decreased the clearance of desipramine by 82%. In studies in healthy subjects characterized as extensive metabolisers of dextromethorphan (antitussive drug and CYP2D6 probe substrate), terbinafine increased the dextromethorphan/dextrorphan metabolic ratio in urine by 16- to 97-fold on average.
Thus, terbinafine may convert extensive CYP2D6 metabolisers (genotype) to poor metaboliser (phenotype) status. g. tolbutamine, terfenadine, triazolam, oral contraceptives) with exception of those metabolised through CYP2D6 (see below).
Terbinafine does not interfere with the clearance of antipyrine or digoxin. There was no effect of terbinafine on the pharmacokinetics of fluconazole. Further there was no clinically relevant interaction between terbinafine and the potential comedications cotrimoxazole (trimethoprim and sulfamethoxazole), zidovudine or theophylline.
Some cases of menstrual disturbance (breakthrough bleeding and irregular cycle) have been reported in patients taking Terbinafine tablets concomitantly with oral contraceptives, although the incidence of these disorders remains within the background incidence of patients taking oral contraceptives alone.
Terbinafine may decrease the effect or plasma concentration of the following medicinal products: Terbinafine increased the clearance of ciclosporin by 15%. Rare cases of changes in INR and/or prothrombin time have been reported in patients receiving terbinafine concomitantly with warfarin.
6 Fertility, Pregnancy and lactation Pregnancy Foetal toxicity and fertility studies in animals suggest no adverse effects. Since clinical experience in pregnant women is very limited, terbinafine tablets should not be used during pregnancy unless clinical condition of the woman requires treatment with oral terbinafine and the potential benefits for the mother outweigh any potential risks for the foetus.
Lactation Terbinafine is excreted in breast milk and therefore nursing mothers should not receive terbinafine whilst […]
Patients with these symptoms should discontinue taking oral terbinafine and the patient’s liver function should be immediately evaluated. g. Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms) have been very rarely reported in patients taking Terbinafine tablets.
If progressive skin rash occurs, Terbinafine tablets treatment should be discontinued. Terbinafine should be used with caution in patients with pre-existing psoriasis, as very rare cases of exacerbation of psoriasis have been reported.
Haematological effects Very rare cases of blood dyscrasias (neutropenia, agranulocytosis, thrombocytopenia, pancytopenia) have been reported in patients treated with Terbinafine tablets. Aetiology of any blood dyscrasias that occur in patients treated with Terbinafine tablets should be evaluated and consideration should be given for a possible change in medication regimen, including discontinuation of treatment with Terbinafine tablets.
2 Pharmacokinetic properties). Other Terbinafine tablets should be used with caution in patients with lupus erythematosus as very rare cases of lupus erythematosus have been reported.