מדינה: דרום אפריקה
שפה: אנגלית
מקור: South African Health Products Regulatory Authority (SAHPRA)
Lennon
DACEF SUSPENSION 250 mg/5 mL DACEF SUSPENSION 500 mg/5 mL DACEF CAPSULES 500 mg SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): DACEF SUSPENSION 250 mg/5 mL DACEF SUSPENSION 500 mg/5 mL DACEF CAPSULES 500 mg COMPOSITION: POWDERS OF ORAL SUSPENSION : Powders providing cefadroxil monohydrate equivalent to 250 mg and 500 mg cefadroxil per 5 mL respectively when reconstituted, containing approximately 0,1% m/v sodium benzoate as preservative. CAPSULES: Capsules containing cefadroxil monohydrate equivalent to and 500 mg cefadroxil. PHARMACOLOGICAL CLASSIFICATION: A20.1.1 Broad spectrum antibiotic. PHARMACOLOGICAL ACTION: CLINICAL PHARMACOLOGY: DACEF (cefadroxil monohydrate) is a semisynthetic antibiotic with a broad spectrum of bactericidal activity. It is chemically designated as 7[[D-2-amino-2(4-hydroxyphenyl) acetyl] amino]-3-methyl-8-oxo-5-tia-1-azabicyclo [4.2.0]oct-2-ene-2-carboxylic acid monohydrate. DACEF is stable in the presence of acid and is rapidly absorbed after oral administration. Following single oral doses of 250, 500 and 1 000 mg, average peak serum concentrations are approximately 9, 16 and 28 µg/mL respectively. Measurable levels are present 12 hours after administration. DACEF is approximately 20% bound to serum proteins. DACEF has been shown to be widely distributed in most body tissues, including tonsils, bronchial secretions, pleural fluid, liver and bile and prostate. Approximately 80% of the medicine is excreted unchanged in the urine within eight hours. Peak urine concentrations reach approximately 1 800 µg/mL following a single 500 mg dose. Urine DACEF concentration was maintained well above minimum inhibitory concentration of susceptible urinary pathogens for 20 to 22 hours following a single one gram dose. Increases in dosage generally produce a proportional קרא את המסמך השלם