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P - Caution when used during pregnancy
L - Contraindicated in lactation
FI - Food *
Terbinafine is used for treating fungal infections of the fingernails and toenails.
In India, Terbinafine hydrochloride is available in topical form under the brand name Sebifin (Ranbaxy Labs) and Zimig (GSK Pharma).
Terbinafine causes fungal cell death by inhibiting squalene epoxidase, the main enzyme in sterol biosynthesis, resulting in ergosterol deficiency within fungal cell walls. It has fungicidal activity against dermatophytes and some yeast.
Absorbed well from the GI tract with 40% bioavailability (oral), minimal absorption (topical); peak plasma concentrations after 2 hours (oral).
Distributed into stratum corneum of the skin, nail plate, hair (concentrations higher than plasma) and breastmilk. Protein-binding: Extensive.
Hepatic; converted to inactive metabolites.
Via urine; 17-36 hours (plasma elimination half-life); up to 400 hours (terminal elimination half-life) in prolonged therapy.
Information Not Available
Anorexia, nausea, abdominal pain, taste disturbances, diarrhoea, rash, urticaria.
Potentially Fatal: Liver failure, Stevens-Johnson syndrome, neutropaenia.
Terbinafine Hydrochloride tablets are not recommended for patients with chronic or active liver disease. Before prescribing Terbinafine Hydrochloride Tablets, pre-existing liver disease should be assessed. Hepatotoxicity may occur in patients with and without pre-existing liver disease. Pretreatment serum transaminase (ALT and AST) tests are advised for all patients before taking Terbinafine Hydrochloride Tablets. Patients prescribed Terbinafine Hydrochloride Tablets should be warned to report immediately to their physician any symptoms of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain or jaundice, dark urine or pale stools. Patients with these symptoms should discontinue taking oral Terbinafine, and the patient's liver function should be immediately evaluated.
Preexisting liver or renal impairment, pregnancy. Perform liver function tests prior to oral therapy.
Possible increase in levels in drugs metabolised by CYP450 2D6. Decreased terbinafine concentration with rifampicin; increased terbinafine concentration with cimetidine.
Oral bioavailability increased when administered with food.
Adult: 250 mg once daily for 2-4 weeks in tinea cruris, 6 weeks for tinea pedis, 4 weeks for tinea corporis and 6-12 weeks for nail infections.
Child: 10-20 kg: 62.5 mg; 20-40 kg: 125 mg; >40 kg: 250 mg. Doses to be taken once daily. Treatment is usually given for 2 weeks for tinea capitis; 2-4 weeks for tinea cruris; 4 weeks for tinea corporis; 6 weeks in tinea pedis; 6-12 weeks for nail infections.
CrCl (ml/min) Dosage Recommendation
<50 Half the usual oral dose.
Adult: Apply a 1% cream/solution once or bid. 1-2 weeks to treat tinea corporis and tinea cruris; 1-week course is for tinea pedis; 2-weeks course in cutaneous candidiasis and pityriasis versicolor
May be taken with or without food.
Caution when used during pregnancy
Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
Contraindicated in lactation
Safety and efficacy not established (tablets).
Safety and efficacy not established in children younger than 4 years of age.
Safety and efficacy not established in children younger than 12 years of age.
Use of oral granules have not been studied in elderly patients.
Hypersensitivity, active or chronic liver disease, lactation.
Store below 25°C. Protect from light.
Store below 25°C. Protect from light.