Rx: RM CO-AMOXICLAV 1G TAB

Amoxicillin is a semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as penicillin binding proteins, BPs) in the biosynthetic pathway of bacterial peptidoglycan, which is an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to weakening of the cell wall, which is usually followed by cell lysis and death.

Amoxicillin is susceptible to degradation by beta-actamases produced by resistant bacteria and therefore the spectrum of activity of amoxicillin alone does not include organisms which produce these enzymes.
Clavulanic acid is a beta-lactam structurally related to penicillins. It inactivates some beta-lactamase enzymes thereby preventing inactivation of amoxicillin. Clavulanic acid alone does not exert a clinically useful antibacterial effect.

It is for the treatment of common bacterial infections where oral therapy is indicated, including:

• upper respiratory tract infections (including ENT): sinusitis, tonsillitis, otitis media
• skin and soft tissue infections: boils/abscesses, cellulits, wound infections, intra-abdominal Sepsis
• lower respiratory tract infections: acute and chronic bronchitis, pneumonia, lung abscess
• geniturinary tract infections: cystitis, urethritis, pyelonephritis, septic abortion, pelvic infection, gonorrhea
• other infections: osteomyelitis, septicemia, peritonitis, post-operative infections

DOSAGE AND METHOD OF ADMINISTRATION

Doses are expressed throughout in terms of amoxicillin/clavulanic acid content except when doses are stated in terms of an individual component.

The dose of amoxicillin/clavulanic acid that is selected to treat an individual infection should take into account:

The expected pathogens and their likely susceptibility to antibacterial agents (see section Special Warnings and Precautions for Use)
The severity and the site of the infection
The age, weight and renal function of the patient as shown below

The use of alternative presentations of amoxicillin/clavulanic acid (e.g. those that provide higher doses of amoxicillin and/or different ratios of amoxicillin to clavulanic acid) should be considered as necessary (see sections Special Warnings and Precautions for Use and Pharmacodynamic Properties).

For adults and children ≥40 kg, this formulation of co-amoxiclav provides a total daily dose of 1500 mg amoxicillin/375 mg clavulanic acid, when administered as recommended below. For children <40 kg, this formulation of co-amoxiclav provides a maximum daily dose of 2400 mg amoxicillin/600 mg clavulanic acid, when administered as recommended below. If it is considered that a higher daily dose of amoxicillin is required, it is recommended that another preparation of co-amoxiclav is selected in order to avoid administration of unnecessarily high daily doses of clavulanic acid (see sections Special Warnings and Precautions for Use and Pharmacodynamic Properties).

Adults and Children ≥40 kg
One 500 mg/125 mg dose taken three times a day.
Children <40 kg
20 mg/5 mg/kg/day to 60 mg/15 mg/kg/day, given in three divided doses.
Children May Be Treated with Co-amoxiclav Tablets, Suspensions or Pediatric Sachets

Children aged 6 years and below should preferably be treated with co-amoxiclav suspension or pediatric sachets.

No clinical data are available on doses of co-amoxiclav 4:1 formulations higher than 40 mg/10 mg/kg per day in children under 2 years.

Elderly

No dose adjustment is considered necessary.

Renal Impairment

Dose adjustments are based on the maximum recommended level of amoxicillin.

No adjustment in dose is required in patients with creatinine clearance (CrCl) greater than 30 mL/min.

Hepatic Impairment

Dose with caution and monitor hepatic function at regular intervals (see Contraindications and Special Warnings and Precautions for Use).