País: República de Sud-àfrica
Idioma: anglès
Font: South African Health Products Regulatory Authority (SAHPRA)
Adcock
ADCO-CEFACLOR 250 Capsules SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form) : ADCO-CEFACLOR 250 Capsules COMPOSITION: Each ADCO-CEFACLOR 250 Capsule contains 250 mg cefaclor . Cefaclor is chemically designated as 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate. PHARMACOLOGICAL CLASSIFICATION: A 20.1.1 Broad and Medium Spectrum Antibiotics PHARMACOLOGICAL ACTION: Cefaclor is a semi-synthetic cephalosporin antibiotic with a broad spectrum of bactericidal activity against certain Gram- positive and Gram-negative micro-organisms. Human pharmacology: Cefacloris absorbed after oral administration whether taken with food or while fasting. Following single doses of 250 mg, 500 mg, and 1g, to fasting subjects, average peak serum levels of approximately 7 ug/mL, 13 ug/mL, and 23 ug/mL respectively, were obtained at 30 to 60 minutes. Approximately 60% of the agent is excreted unchanged in the urine within 8 hours. Peak urine concentrations following the 250 mg, 500 mg, and 1g doses were approximately 600 ug/mL, 900 ug/mL, and 1 900 ug/mL respectively during the first 2 hours after a single dose. Cefacloris not appreciably metabolised. The presence of food in the gastro-intestinal tract delays absorption and lowers peak serum levels, but does not alter the total amount of cefaclorabsorbed. Microbiology: In vitro tests demonstrate that the bactericidal action of the cephalosporins results from inhibition of cell- wall synthesis. Cefaclor is active against the following organisms in vitro: Strains of staphylococci, including coagulase-positive, coagulase-negative and penicillinase-producing strains, are moderately sensitive. Streptococcus pyogenes (group A beta-haemolytic streptococci). Streptococcus pneumoniae. Escherichia coli. Proteus mirabilis. Klebsiella sp. Haemophilus influen Llegiu el document complet