Negara: Armenia
Bahasa: Inggris
Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
metronidazole
Arpimed LLC
metronidazole
10mg/g
gel
Prescription
SUMMARY PRODUCT CHARACTERISTIC (SPC) METRONIDAZOLE 1% GEL BRAND NAME – Metronidazole 1% gel INTERNATIONAL NON-PROPERTY NAME - Metronidazole COMPOSITION Each gram contents: _ACTIVE INGREDIENTS_: metronidazole - 10 mg; _NON ACTIVE INGREDIENTS_: propylene glycol, carbomer-940, methylparaben, triethanolamine, disodium EDTA, purified water. CHEMICAL NAME AND CAS NUMBER 2-(2-Methyl-5-nitro-1_H_-imidazol-1-yl)ethanol; 443-48-1. PHARMACOLOGICAL GROUP AND ATC CODE Metronidazole is a 5-nitroimidazole derivative with antibacterial activity. ATC Code: J01X D01. PHARMACOLOGICAL ACTION Metronidazole is an antiprotozoal and antibacterial agent which is active against a wide range of pathogenic micro-organisms. The mechanisms of action of metronidazole in rosacea are unknown but available evidence suggests that the effects may be antibacterial and/or anti-inflammatory. PHARMACOKINETICS The systemic concentration of Metronidazole following the topical administration of 1 g Metronidazole gel to 10 patients with rosacea ranged from 25 ng/ml (limit of detection), to 66 mg/ml with a mean Cmax of 40.6 ng/ml. The corresponding mean Cmax following the oral administration of a solution containing 30 mg of metronidazole was 850 ng/ml (equivalent to 212 ng/ml if dose corrected. The mean Tmax for the topical formulation was 6.0 hours compared to 0.97 hours for the oral solution. USES Indicated in the treatment of inflammatory papules, pustules and erythema of rosacea. DOSAGE AND ADMINISTRATION _FOR TOPICAL ADMINISTRATION ONLY. _ The average period of treatment is three to four months. The recommended duration of treatment should not be exceeded. However, if a clear benefit has been demonstrated, continued therapy for a further three to four months period may be considered by the prescribing physician depending on the severity of the condition. In clinical studies, topical metronidazole therapy for rosacea has been continued for up to 2 years. In the absence of a clear clinical improvement, therapy should be stopped. _ADULTS:_ Metronidazol Baca dokumen lengkapnya