Teicoplanin

eMC §4.2 (Teicoplanin 200 mg powder and solvent for solution for injection/infusion or oral solution). Dose and duration should be adjusted according to the underlying type and severity of infection, the clinical response, and patient factors such as age and renal function. The dose is to be adjusted on bodyweight whatever the weight of the patient. THERAPEUTIC DRUG MONITORING: trough serum concentrations should be monitored at steady state after completion of the loading dose regimen. For most Gram-positive infections, trough levels of at least 10 mg/L by HPLC, or at least 15 mg/L by FPIA. For endocarditis and other severe infections, trough levels of 15-30 mg/L by HPLC, or 30-40 mg/L by FPIA. Targeted trough concentrations at day 3-5 (FPIA): above 15 mg/L for skin/soft tissue, pneumonia and complicated UTI; above 20 mg/L for bone and joint infections; 30-40 mg/L for infective endocarditis. During maintenance, monitor trough concentrations at least once a week to ensure they are stable (above 15, above 20 and above 30 mg/L respectively by FPIA). DURATION: decided on clinical response; for infective endocarditis a minimum of 21 days is usually considered appropriate; treatment should NOT exceed 4 months. CLOSTRIDIUM DIFFICILE INFECTION-ASSOCIATED DIARRHOEA AND COLITIS: the recommended dose is 100-200 mg administered ORALLY twice a day for 7 to 14 days. CAPD PATIENTS: after a single intravenous loading dose of 6 mg/kg bodyweight, 20 mg/L is administered in the bag of the dialysis solution in the first week, 20 mg/L in different bags the second week, then 20 mg/L in the overnight bag in the third week. ELDERLY: no dose adjustment required unless there is renal impairment. COMBINATION THERAPY: teicoplanin has a limited (Gram-positive) spectrum and is not suitable as a single agent for some types of infection unless the pathogen is documented and known to be susceptible, or there is high suspicion that the likely pathogens would be suitable for teicoplanin. §4.4: caution in patients with known vancomycin hypersensitivity because of cross-hypersensitivity including fatal anaphylactic shock (a prior history of 'red man syndrome' with vancomycin is not a contraindication); infusion-related reactions can be limited by infusing the daily dose over 30 minutes rather than giving it as a bolus; periodic haematological examinations including complete blood count are recommended; monitor renal function and perform auditory tests in patients with renal insufficiency, on the high loading dose regimen, or receiving concurrent or sequential nephrotoxic medicinal products.

eMC §4.2 paediatric population, quoted faithfully. NEONATES AND INFANTS UP TO THE AGE OF 2 MONTHS: loading dose one single dose of 16 mg/kg body weight administered intravenously by infusion on the first day; maintenance dose one single dose of 8 mg/kg body weight administered intravenously by infusion once a day. CHILDREN 2 MONTHS TO 12 YEARS: loading dose one single dose of 10 mg/kg body weight administered intravenously every 12 hours, repeated 3 times; maintenance dose one single dose of 6-10 mg/kg body weight administered intravenously once a day (the dosePerKg field records the LOWER bound of this maintenance range). CHILDREN ABOVE 12 YEARS: the dose recommendations are the same as in adults. Only the infusion method should be used in neonates. Trough serum concentration monitoring applies as for adults, and in paediatric patients with severe renal impairment the adult renal adjustment principles in the SPC apply. Verify all under-18 dosing against a children's formulary before prescribing.