Страна: ЮАР
Язык: английский
Источник: South African Health Products Regulatory Authority (SAHPRA)
Lennon
LENOCEF™-250 CAPSULES LENOCEF™-500 CAPSULES LENOCEF™-125 SUSPENSION LENOCEF™-250 SUSPENSION SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): LENOCEF™-250 CAPSULES LENOCEF™-500 CAPSULES LENOCEF™-125 SUSPENSION LENOCEF™-250 SUSPENSION COMPOSITION: (a) Capsules Capsules containing cephalexin monohydrate equivalent to 250 mg cephalexin. Capsules containing cephalexin monohydrate equivalent to 500 mg cephalexin. (b) Suspension Powder for preparing flavoured suspension. When dispensed as directed, each 5 mL contains cephalexin monohydrate equivalent to 125 mg or 250 mg cephalexin. The suspension contains 0,1% m/v sodium benzoate as a preservative. PHARMACOLOGICAL CLASSIFICATION: A 20.1.1 Broad and medium spectrum antibiotics. PHARMACOLOGICAL ACTION: Cephalexin is an acid-stable cephalosporin and is well absorbed from the gastro-intestinal tract. Peak plasma concentrations, reached at about 1 hour after ingestion of the drug, are approximately 9 and 18 ug/mL after oral doses of 250 and 500 mg, respectively. Cephalexin inhibits bacterial cell-wall synthesis in a manner similar to that of penicillin. In-vitro sensitivity does not necessarily indicate in-vivo efficacy. Cephalexin is active in vitro against both gram-positive and gram-negative micro- organisms. Group A Strep. pyogenes, the viridans group, and non-hemolytic streptococci, Strep. (D.) pneumoniae, penicillin-resistant and penicillin-sensitive Staph. aureus, Staph. epidermis, Cl. perfringens, List. monocytogenes, B. subtilis, C. diphtheriae, N. gonorrhoeae, N. meningitides, and A. israelii are highly sensitive to this agent, many being suppressed by concentrations of 0,004 to 1 ug/mL. Gram-negative bacteria are generally less susceptible, but the majority strains of Salmonella, including S. typhi, most Shigella, all Pr. mirabilis, and Прочитать полный документ