TEICOPLANIN

Posology The dose and duration of treatment should be adjusted according to the underlying type and severity of infection and clinical response of the patient, and patient factors such as age and renal function. Measurement of serum concentrations Teicoplanin trough serum concentrations should be monitored at steady state after completion of the loading dose regimen in order to ensure that a minimum trough serum concentration has been reached: • For most Gram-positive infections, teicoplanin trough levels of at least 10 mg/L when measured by High Performance Liquid Chromatography (HPLC), or at least 15 mg/L when measured by Fluorescence Polarization Immunoassay (FPIA) method.

• For endocarditis and other severe infections, teicoplanin trough levels of 15- 30 mg/L when measured by HPLC, or 30-40 mg/L when measured by FPIA method. During maintenance treatment, teicoplanin trough serum concentrations monitoring may be performed at least once a week to ensure that these concentrations are stable.

Adults and elderly patients with normal renal function Loading dose Maintenance doseIndications Loading dose regimen Targeted trough concentrations at day 3 to 5 Maintenance dose Targeted trough concentrations during maintenance - Complicated skin and soft tissue infections - Pneumonia - Complicated urinary tract infections 6 mg/kg body weight every 12 hours for 3 intravenous or intramuscular administrations >15 mg/L1 6 mg/kg body weight intravenous or intramuscular once a day >15 mg/L1 once a week - Bone and joint infections 12 mg/kg body weight every 12 hours for 3 to 5 intravenous administrations >20 mg/L1 12 mg/kg body weight intravenous or intramuscular once a day >20 mg/L1 - Infective endocarditis 12 mg/kg body weight every 12 hours for 3 to 5 intravenous 30-40 mg/L1 12 mg/kg body weight intravenous or intramuscular once a day >30 mg/L1 administrations 1Measured by FPIA The dose is to be adjusted on bodyweight, whatever the weight of the patient.

Duration of treatment The duration of treatment should be decided based on the clinical response. For infective endocarditis a minimum of 21 days is usually considered appropriate. Treatment should not exceed 4 months. Combination therapy Teicoplanin has a limited spectrum of antibacterial activity (Gram positive).

It is not suitable for use as a single agent for the treatment of some types of infections unless the pathogen is already documented and known to be susceptible or there is a high suspicion that the most likely pathogen(s) would be suitable for treatment with teicoplanin.

Clostridium difficile infection-associated diarrhoea and colitis The recommended dose is 100-200 mg administered orally twice a day for 7 to 14 days. Elderly population No dose adjustment is required, unless there is renal impairment (see below).

Adults and elderly patients with impaired renal function Dose adjustment is not required until the fourth day of treatment, at which time dosing should be adjusted to maintain a serum trough concentration of at least 10 mg/L when measured by HPLC, or at least 15 mg/L when measured by FPIA method.

After the fourth day of treatment: • In mild and moderate renal insufficiency (creatinine clearance 30-80 mL/min): maintenance dose should be halved, either by administering the dose every two days or by administering half of this dose once a day.

• In severe renal insufficiency (creatinine clearance less than 30 mL/min) and in haemodialysed patients: dose should be one-third the usual dose, either by administering the initial unit dose every third day or by administering one-third of this dose once a day.

Teicoplanin is not removed by haemodialysis. Patients in continuous ambulatory peritoneal dialysis (CAPD) 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 and then 20 mg/L in the overnight bag in the third week.

Paediatric population The dose recommendations are the same in adults and children above 12 years of age.

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. Method of administration Teicoplanin should be administered by the intravenous or intramuscular route.

The intravenous injection may be administered either as a bolus over 3 to 5 minutes or as a 30-minute infusion. Only the infusion method should be used in neonates. For Clostridium difficile infection-associated diarrhoea and colitis, the oral route is to be used.

6.

Tabulated list of adverse reactions In the table below all the adverse reactions, which occurred at an incidence greater than placebo and more than one patient are listed using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. g. 4). 4) Renal and Urinary disorders Blood creatinine increased Renal failure (including renal failure acute) (see below description of selected adverse reactions)* System organ class Common (≥1/100 to <1/10 ) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from available data) General disorders and administration site conditions Pain, pyrexia Injection site abscess, chills (rigors) Investigations Transaminases increased (transient abnormality of transaminases), blood alkaline phosphatase increased (transient abnormality of alkaline phosphatase) Description of selected adverse reactions *Based on literature reports, the estimated rate of nephrotoxicity in patients receiving low loading dose regimen of average 6 mg/kg twice a day, followed by a maintenance dose of average 6 mg/kg once daily, is around 2%.

5%]) over the first 10 days. 8%]). 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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Teicoplanin should not be administered by intraventricular use. g. anaphylactic shock). If an allergic reaction to teicoplanin occurs, treatment should be discontinued immediately, and appropriate emergency measures should be initiated.

Teicoplanin must be administered with caution in patients with known hypersensitivity to vancomycin, as crossed hypersensitivity reactions, including fatal anaphylactic shock, may occur. However, a prior history of "red man syndrome" with vancomycin is not a contraindication to the use of teicoplanin.

Infusion related reactions In rare cases (even at the first dose), red man syndrome (a complex of symptoms including pruritus, urticaria, erythema, angioneurotic oedema, tachycardia, hypotension, dyspnoea) has been observed. Stopping or slowing the infusion may result in cessation of these reactions.

Infusion related reactions can be limited if the daily dose is not given via bolus injection but infused over a 30-minute period. 8). 8). g. progressive skin rash often with blisters or mucosal lesions or pustular rash, or any other sign of skin hypersensitivity) and be closely monitored.

If signs and symptoms suggestive of severe skin reactions appear, teicoplanin should be withdrawn and alternative treatment should be considered. Spectrum of antibacterial activity Teicoplanin has a limited spectrum of antibacterial activity (Gram-positive).

It is not suitable for use as a single agent for the treatment of some types of infections unless the pathogen is already documented and known to be susceptible or there is a high suspicion that the most likely pathogen(s) would be suitable for treatment with teicoplanin.

The rational use of teicoplanin should take into account the bacterial spectrum of activity, the safety profile and the suitability of standard antibacterial therapy to treat the individual patient. On this basis it is expected that in most instances teicoplanin will be used to treat severe infections in patients for whom standard antibacterial activity is considered to be unsuitable.

8). Periodic haematological examinations, including complete blood count, are recommended during treatment. 8). g. aminoglycosides, colistin, amphotericin B, ciclosporin, and cisplatin) should be carefully monitored, and should get auditory tests (see “Ototoxicity” below).

2). 8). Patients who develop signs and symptoms of impaired hearing or disorders of the inner ear during treatment with teicoplanin should be carefully evaluated and monitored, especially in case of prolonged treatment and in patients with renal insufficiency.

g. aminoglycosides, colistin, amphotericin B, ciclosporin, cisplatin, furosemide and ethacrynic acid) should be carefully monitored and the benefit of teicoplanin evaluated if hearing deteriorates. Special precautions must be taken when administering teicoplanin in patients who require concomitant treatment with ototoxic and/or nephrotoxic medicinal products for which it is recommended that regular haematology, liver and kidney function tests are carried out.

Superinfection As with other antibiotics, the use of teicoplanin, especially if prolonged, may result in overgrowth of non-susceptible organisms. If superinfection occurs during therapy, appropriate measures should be taken.

Hypersensitivity to teicoplanin or to any of the excipients listed in section 6.