Clavospey

Composition

Each vial contains: Sterile Amoxicillin Sodium BP equivalent to Amoxicillin – 1.0 g

Sterile Potassium Clavulanate BP equivalent to Clavulanic  Acid – 0.2 g

Indications for use

Clavospey is indicated for the treatment of infections caused by all organisms sensitive to amoxicillin, as well as those organisms which produce beta-lactamases that are sensitive to clavulanic acid.

This includes:

• Acute bacterial sinusitis (adequately diagnosed)
• Acute otitis media
• Acute exacerbations of chronic bronchitis (adequately diagnosed)
• Community acquired pneumonia
• Cystitis
• Pyelonephritis
• Skin  and  soft  tissue  infections  in  particular  cellulitis,  animal  bites,  severe  dental  abscess  with  spreading  cellulitis
• Bone and joint infections, in particular osteomyelitis.

Mode of application

Doses are expressed throughout in terms of Clavospey acid content except when doses are stated in terms of an individual component. The dose of Clavospey that is selected to treat an individual infection should take into account: The expected pathogens and their likely susceptibility to antibacterial agents. 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 Clavospey (e.g. those that provide higher doses of amoxicillin and/or different ratios of amoxicillin to clavulanic acid) should be considered as necessary. The duration of therapy should be determined by the response of the patient. Some infections (e.g. osteomyelitis) require longer periods of treatment. Treatment should not be extended beyond 14 days without review. Consideration should be given to local guidelines on appropriate dosing frequencies for amoxicillin/clavulanic acid.

Adults and children ≥ 40kg: For treatment of infections as indicated in section Indication: 1g/ 0.2 g every 8 hours.

For surgical prophylaxis: For procedures less than 1 hour in duration, the recommended dose of Clavospey is 1g/0.2 g to 2g/0.2g given at induction of anaesthesia. For procedures greater than 1 hour in duration, the recommended dose of Clavospey is 1g/0.2g to 2g/0.2g given at induction of anesthesia, with up to 3 doses of 1g/0.2g in 24 hours. Clear clinical signs of infection at operation will require a normal course of intravenous or oral therapy post-operatively.

Children < 40 kg: Recommended doses: Children aged 3 months and over: 25 mg/5 mg per kg every 8 hours Children aged less than 3 months or weighing less than 4 kg: 25 mg/5 mg per kg every 12 hours.

Elderly: No dose adjustment is considered necessary. Renal impairment: Dose adjustments are based on the maximum recommended level of amoxicillin. No dose adjustment is required in patients with creatinine clearance (CrCl) greater than 30 ml/min.

Adults and children ≥ 40kg CrCl: 10-30 ml/min: Initial dose of 1000 mg/200 mg and then 500 mg/100 mg given twice daily CrCl < 10 ml /min: Initial dose of 1000 mg/200 mg and then 500 mg/100 mg given every 24 hours Haemodialysis: Initial dose of 1000 mg/200 mg and then followed by 500 mg/100 mg every 24 hours, plus a dose of 500 mg/100 mg at the end of dialysis (as serum concentrations of both amoxicillin and clavulanic acid are decreased)

Children < 40 kg: CrCl: 10 to 30 ml/min: 25 mg/5 mg per kg given every 12 hours CrCl < 10 ml /min: 25 mg/5 mg per kg given every 24 hours Haemodialysis: 25 mg/5 mg per kg given every 24 hours, plus a dose of 12.5 mg/2.5 mg per kg at the end of dialysis (as serum concentrations of both amoxicillin and clavulanic acid are decreased). Hepatic impairment: Dose with caution and monitor hepatic function at regular intervals. Method of administration: Clavospey is for intravenous use. Clavospey may be administered either by slow intravenous injection over a period of 3 to 4 min directly into a vein or via a drip tube or by infusion over 30 to 40 min. Clavospey is not suitable for intramuscular administration. Children aged less than 3 months should be administered Clavospey by infusion only. Treatment with Clavospey may be initiated by the use of an intravenous preparation and completed with an appropriate oral presentation as considered appropriate for the individual patient.