Pays: Afrique du Sud
Langue: anglais
Source: South African Health Products Regulatory Authority (SAHPRA)
Bm_squib
PROZEF 125 mg/5 mL Suspension PROZEF 250 mg/5 mL Suspension PROZEF 250 mg Tablets PROZEF 500 mg Tablets SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): PROZEF 125 mg/5 mL Suspension PROZEF 250 mg/5 mL Suspension PROZEF 250 mg Tablets PROZEF 500 mg Tablets COMPOSITION PROZEF ( Cefprozil ) is a semi-synthetic broad-spectrum cephalosporin antibiotic intended for oral administration. PROZEF tablets contain Cefprozil monohydrate equivalent to 250 mg or 500 mg of anhydrous Cefprozil. PROZEF for oral suspension contains Cefprozil monohydrate equivalent to 125 mg or 250 mg Cefprozil per 5 mL reconstituted suspension and sodium benzoate 0,1% w/v as preservative. Phenylketonurics: PROZEF for oral suspension contains phenylalanine (from aspartame) 28 mg per 5 mL reconstituted suspension for both the 125 mg/5 mL and 250 mg/5 mL dosage forms. PHARMACOLOGICAL CLASSIFICATION Category A 20.1.1 Broad and Medium Spectrum Antibiotics. PHARMACOLOGICAL ACTION Cefprozil is approximately 96% absorbed following oral administration in both fasting and non-fasting subjects. Average plasma concentrations after administrations of Cefprozil to fasting subjects are shown in the following table. Urinary recovery accounts for approximately 60% of the administration dose. Dosage Mean Plasma Cefprozil Concentrations (mcg/mL) 8-hour Urinary Excretion Peak approx. 1.5 hour 4 hour 8 hour Percentage 250 mg 500 mg 1g 6.1 10.5 18.3 1.7 3.2 8.4 0.2 0.4 1.0 60% 62% 54% During the first four-hour period after drug administration, the average urine concentrations following the 250 mg, 500 mg and 1g doses are approximately 700 mcg/mL, 1000 mcg/mL and 2900 mcg/mL. Plasma protein binding is approximately 36% and is independent of concentration in the range of 2 mcg/mL to 20 mcg/mL. The average plasma half-life in normal subjects Lire le document complet