AMBEN Powder for oral suspension Ref.[28106] Active ingredients: Cefadroxil

Source: Υπουργείο Υγείας (CY)  Revision Year: 2018  Publisher: Medochemie Ltd, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Other beta-lactam antibacterials, First-generation cephalosporins
ATC code: J01DB05

Amben is a cephalosporin antibiotic, bactericidal in vitro against a wide range of Gram-positive and Gram-negative micro-organisms. Amben inhibits mucopeptide synthesis in the bacterial cell wall, making it defective and osmotically unstable.

The action in vivo is usually bactericidal, depending on organism susceptibility, dose, tissue concentrations and the rate at which organisms are multiplying. It is more effective against rapidly growing organisms forming cell walls.

In vitro, cefadroxil is bactericidal against a wide range of organisms. Sensitive Gram-positive organisms include: penicillinase and non-penicillinase-producing Staphylococci, beta-haemolytic Streptococci, Streptococcus pneumoniae and Streptococcus pyogenes. Sensitive Gram-negative organisms include Escherichia coli, Klebsiella species, Proteus mirabilis, Moraxella (Branhamella) catarrhalis and Bacteroides spp. (excluding Bacteroides fragilis) and some strains of Haemophilus influenzae.

5.2. Pharmacokinetic properties

Amben is rapidly absorbed after oral administration. The bioavailability is unaffected by food. Following single doses of 500 and 1,000mg, average peak serum levels were approximately 16 and 28 µg/ml, respectively. Measurable levels were present 12 hours after administration. Over 90% of the drug is excreted unchanged in the urine within 24 hours. Peak urine concentrations are approximately 1,800 µg/ml after a 500mg dose. Increases in dose generally produce a proportionate increase in Amben urinary concentration. Oral dosing produces effective tissue penetration in lungs, tonsils, liver, gall bladder, bile duct, prostate, bone, muscle and synovial capsule as well as saliva, sputum, pleural exudate, bile and synovial fluid. The half-life is approximately 80-120 minutes and protein binding is approximately 20%. In addition, Amben is soluble in lipids (0.19 mg/ml ether) and in water (12.79 mg/ml).

5.3. Preclinical safety data

No additional relevant data.

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