Land: Sør-Afrika
Språk: engelsk
Kilde: South African Health Products Regulatory Authority (SAHPRA)
Bm_squib
CEFRIL 250 CAPSULES CEFRIL 500 CAPSULES CEFRIL 125 SUSPENSION CEFRIL 250 SUSPENSION SCHEDULING STATUS S4 PROPRIETARY NAME (and dosage form) CEFRIL 250 CAPSULES CEFRIL 500 CAPSULES CEFRIL 125 SUSPENSION CEFRIL 250 SUSPENSION COMPOSITION CEFRIL products contain Cephradine which is a semi-synthetic cephalosporin chemically designated as 7-[D-2-amino- 2-(1,4-cychlohexadien-1-yl) acetamido]-3-methyl-8-oxo- 5- thia-1- azabicyclo [4.2.0]oct-2-ene-2-carboxylic acid. CEFRIL 250 CAPSULES and CEFRIL 500 CAPSULES contain 250 mg and 500 mg cephradine respectively. CEFRIL 125 SUSPENSION and CEFRIL 250 SUSPENSION provide 125 mg and 250 mg cephradine per 5 mL respectively after reconstitution to 100 mL of suspension. PHARMACOLOGICAL CLASSIFICATION Category A 20.1.1 Broad Spectrum Antibiotics PHARMACOLOGICAL ACTION Cephradine is a broad spectrum, bactericidal antibiotic active against both Gram positive and Gram negative bacteria. Microbiology: The following organisms have shown in vitro sensitivity to cephradine. Gram positive: Staphylococci (both penicillin sensitive and resistant strains), Group A Beta-haemolytic Streptococci, and Streptococcus pneumoniae. Gram negative: Escherichia coli, Klebsiella species, Proteus mirabilis, Haemophilus influenzae and Neisseria species. Pseudomonads are uniformly resistant. Because cephradine is unaffected by penicillinase, many strains of E. coli and Staphylococcus aureus that produce this enzyme are susceptible to cephradine. Methicillin-resistant staphylococci are not sensitive to cephradine. Human Pharmacology: Cephradine is acid stable and is rapidly absorbed following oral administration in the fasting state. Following doses of 250 mg and 500 mg, average peak serum levels of approximately 9 and 16,5 micrograms/mL, respectively, were obtained at one hour in adult volunteers. The pre Les hele dokumentet