Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Terbinafine Hydrochloride
AVERROES PHARMACEUTICALS SDN. BHD.
Terbinafine Hydrochloride
20gm mcg/mL
SIU GUAN CHEM. IND.CO.,LTD.
TERBISIL CREAM 1% W/W TERBINAFINE HYDROCHLORIDE 10MG (1%) PRODUCT DESCRIPTION A white cream has a slight pear-like and peppermint odor. COMPOSITION Each gram of Terbisil Cream contains 10mg of Terbinafine hydrochloride. PHARMACODYNAMICS Terbinafine is an allylamine which has a broad spectrum of antifungal activity in fungal infections of the skin. It’s action being fungicidal against dermatophytes, moulds and certain dimorphous fungi. It has a fungicidal or fungistatic action on yeasts depending on the species involved. Terbinafine interferes with fungal ergosterol biosynthesis at an early stage. This leads to a deficiency in ergosterol and to intracellular accumulation of squalene, resulting in fungal cell death. Terbinafine acts by inhibiting squalene epoxidase in the fungal cell membrane. The squalene epoxidase is not dependent on the cytochrome P450 system. Terbinafine does not have any influence on the metabolism of hormones or of other medicines. PHARMACOKINETICS Less than 5% of the dose is absorbed after topical application in humans; systemic exposure is thus very slight. Biotransformation results in metabolites with no antifungal activity, which is excreted predominantly in the urine and the faeces. The elimination half life is 17 hours. There is no evidence of accumulation. At the level of the stratum corneum, fungicidal concentrations of terbinafine can be measured up to 7 days after the last administration. INDICATIONS Terbisil Cream is used for the treatment of - Fungal infections of the skin caused by _Trichophyton_ (eg. _T. _ _Rubrum_, _T.Mentagrophytes, _ _T. _ _Verrucosum, T. Violaceum), Microsporum canis_ and _Epidermophyton floccosum_. - Yeast infections of the skin, principally those caused by the genus _Candida_ (eg. _C. albicans_). - Pityriasis (tinea) versicolor due to _Pityrosporum orbiculare_ (also known as _Malassezia furfur_). MODE OF ADMINISTRATION Terbisil Cream is administered by topically. RECOMMENDED DOSAGE _Adults and children from 12 years: _ Cleanse and dry the affected areas Baca dokumen lengkap