País: África do Sul
Língua: inglês
Origem: South African Health Products Regulatory Authority (SAHPRA)
Aspen-p
AUGMAXCIL INJECTION (Injection) SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): AUGMAXCIL INJECTION (Injection) COMPOSITION: Each vial contains: Amoxicillin Sodium equivalent to Amoxicillin 1000 mg and Potassium Clavulanate (sterile) equivalent to Clavulanic Acid 200 mg. PHARMACOLOGICAL CLASSIFICATION: A 20.1.2 - Penicillins PHARMACOLOGICAL ACTION: AUGMAXCIL INJECTION is a combination of amoxicillin and clavulanic acid. Amoxicillin is a semisynthetic beta-lactamase-susceptible penicillin, which has in vitro bactericidal activity against a broad spectrum of non beta-lactamase-producing Gram-positive and Gram-negative organisms. The spectrum of activity does not include those organisms that produce lactamase, namely resistant staphylococci, and all strains of Pseudomonas, Klebsiella and Enterobacter. Clavulanic acid has been shown in vitro to be an irreversible inhibitor of beta-lactamases produced by: Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Haemophilus influenzae, Neisseria gonorrhoea and Bacteroides fragilis. Clavulanic acid does not inactivate the chromosomally mediated (Sykes Type 1 Cephalosporinase) beta-lactamases produced by Acinetobacter species, Citrobacter species, Enterobacter, Indole positive Proteus, Providencia species and Serratia marcescens. In vitro the formulation showed synergism against Amoxicillin-resistant organisms, with no evidence of antagonism and the activity was not reduced in the presence of serum. (In vitro activity does not necessarily imply in vivo efficacy). The clavulanic acid component has very little bactericidal activity. Pharmacokinetics: Absorption: Amoxicillin is stable in the presence of acidic gastric secretions. Peak blood levels are achieved 1-2 hours after administration. There is a linear dose res Leia o documento completo