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Drug Details

Targocid 200mg & 400mg

• Drug Class Description
  Glycopeptides antibiotic
• Generic Name
  Teicoplanin
• Presentation
  Powder for Injection
• Description
  Teicoplanin 200mg Teicoplanin 400mg
• Indications
  

  Targocid is indicated in potentially serious Gram-positive infections including those which cannot be treated with other antimicrobial drugs, eg. penicillins and cephalosporins.

  Targocid is useful in the therapy of serious staphylococcal infections in patients who cannot receive or who have failed to respond to the penicillins and cephalosporins, or who have infections with staphylococci resistant to other antibiotics.

  The effectiveness of teicoplanin has been documented in the following infections:-

  Skin and soft tissue infections, urinary tract infections, lower respiratory tract infections, joint and bone infections, septicaemia, endocarditis and peritonitis related to continuous ambulatory peritoneal dialysis.

  Targocid may be used for antimicrobial prophylaxis in orthopaedic surgery at risk of Gram-positive infection.

• Adult Dosage
  

  Administration

  The reconstituted Targocid injection may be administered directly either intravenously or intramuscularly. The intravenous injection may be administered either as a bolus or as a 30 minute infusion. Only the infusion method must be used in neonates. Dosage is usually once daily but, in cases of severe infection, a second injection should be administered on the first day in order to reach more rapidly the required serum concentrations.

  The administration of teicoplanin by the intraventricular route is not indicated

  The majority of patients with infections caused by organisms sensitive to the antibiotic show a therapeutic response within 48-72 hours. The total duration of therapy is determined by the type and severity of the infection and the clinical response of the patient. In endocarditis and osteomyelitis, treatment for three weeks or longer is recommended.

  TARGOCID^®?must not be administered for more than 4 months.

  Determination of teicoplanin serum concentrations may optimise therapy. In severe infections, trough serum concentrations should not be less than 10mg/l. Peak concentrations measured one hour after a 400mg intravenous dose are usually in the range of 20-50mg/l; peak serum concentrations of up to 250mg/l have been reported after intravenous doses of 25mg/kg. A relationship between serum concentration and toxicity has not been established.

  Therapeutic dosage:

  Adult or elderly patients with normal renal function

  Prophylaxis:	400mg intravenously as a single dose at induction of anaesthesia
  Moderate infections:	Skin and soft tissue infection, urinary tract infection, lower respiratory tract infection
  Loading dose:	One single i.v. or i.m. injection of 400mg on the first day
  Maintenance dose:	A single i.v. or i.m. injection of 200mg daily
  Severe infections:	Joint and bone infection, septicaemia, endocarditis
  Loading dose:	Three 400mg i.v. injections, administered 12 hours apart
  Maintenance dose:	A single i.v. or i.m. injection of 400mg daily

  1. Standard doses of 200 and 400mg equate respectively to mean doses of 3 and 6mg/kg. In patients weighing more than 85kg it is recommended to adapt the dosage to the weight following the same therapeutic schedule: moderate infection 3mg/kg, severe infection 6mg/kg.

  2. In some clinical situations, such as infected, severely burned patients or Staphylococcus aureus endocarditis, unit maintenance doses of up to 12mg/kg have been administered (intravenously). In endocarditis caused by Staphylococcus aureus, satisfactory results have been achieved with teicoplanin in polytherapy. When serum concentrations are controlled in severe infections, the trough levels must be 10 times higher than the MIC or, generally, at least 10 mg/l.

  In the treatment of antibiotic-associated diarrhoea caused by Clostridium difficile: one oral dose of 200 mg twice a day.

  In continuous ambulatory periotoneal dialysis

  After a single loading IV dose of 400mg of the patient is febrile, the recommended dosage is 20mg/l per bag in the first week, 20mg/l in alternate bags in the second week and 20mg/l in the overnight dwell bag only during the third week, feverish patients must also take an I.V. loading dose of 400 mg of teicoplanin.

  Teicoplanin remains stable in solutions for peritoneal dialysis (1.36% or 3.86% dextrose). These solutions must not be kept for more than 24 hours.

  Combined treatment:

  It is recommended that the treatment be combined with an appropriate antibacterial agent when the infection requires a maximum antibacterial activity (e.g. staphylococcal endocarditis) and when it cannot be ruled out that there is a mixed infection with gram-negatives (e.g. empirical treatment of fever in a neutropenic patient).

  Prophylaxis of endocarditis caused by gram-positives in dental surgery and in patients with heart valve disease:

  To induce anaesthesia, 400 mg (6 mg/kg) of I.V. teicoplanin.

  Adults and elderly patients with renal insufficiency

  For patients with impaired renal function, reduction of dosage is not required until the fourth day of Targocid treatment. Measurement of the serum concentration of teicoplanin may optimise therapy (see section 'Administration').

  From the fourth day of treatment

  In mild renal insufficiency

  Creatinine clearance between 40 and 60ml/min, Targocid dose should be halved, either by administering the initial unit dose every two days, or by administering half of this dose once a day.

  In severe renal insufficiency

  Creatinine clearance less than 40ml/min and in haemodialysed patients, Targocid dose should be one third of the normal 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 dialysis.

• Child Dosage
  

  Teicoplanin can be used to treat Gram-positive infections in children from the age of 2 months. For severe infections and neutropenic patients the recommended dose is 10mg/kg every 12 hours for the first three doses; thereafter a dose of 10mg/kg should be administered by either intravenous or intramuscular injection as a single dose each day.

  For moderate infections the recommended dose is 10mg/kg every twelve hours for the first three doses; thereafter a dose of 6mg/kg should be administered by either intravenous or intramuscular injection as a single dose each day.

  The recommended dosage regimen for neonates is a loading dose of 16mg/kg followed by a daily dose of 8mg/kg.

  The I.V. dose must be infused over 30 minutes.

• Contra Indications
  

  Teicoplanin is contra-indicated in patients who have exhibited previous hypersensitivity to the drug.

• Special Precautions
  

  Warnings:

  Targocid should be administered with caution in patients known to be hypersensitive to vancomycin since cross hypersensitivity may occur. However, a history of the “Red Man Syndrome” that can occur with vancomycin is not a contra-indication to Targocid.

  Thrombocytopenia has been reported with teicoplanin, especially at higher doses than those usually recommended. It is advisable for periodic haematological studies to be performed during treatment. Liver and renal function tests are advised during treatment.

  Serial renal and auditory function tests should be undertaken in the following circumstances:

  Prolonged treatment in patients with renal insufficiency.

  Concurrent and sequential use of other drugs which may have neurotoxic and/or nephrotoxic properties. These include aminoglycosides, colistin, amphotericin B, ciclosporin, cisplatin, furosemide and etacrynic acid.

  However, there is no evidence of synergistic toxicity with combinations with Targocid.

  Dosage must be adapted in patients with renal impairment (see 'Dosage').

  Precautions:

  Superinfection: as with other antibiotics, the use of teicoplanin, especially if prolonged, may result in overgrowth of non-susceptible organisms. Repeated evaluation of the patient's condition is essential. If superinfection occurs during therapy, appropriate measures should be taken.

  In some cases of intraventricular use, seizures have been reported.

• Interactions
  

  Targocid should be used with care in conjunction with or sequentially with other drugs with known nephrotoxic or ototoxic potential. These include aminoglycosides, amphotericin B, ciclosporin, and furosemide. Of particular concern are streptomycin, neomycin, kanamycin, gentamicin, amikacin, tobramycin, cephaloridine, colistin.

  In clinical trials teicoplanin has been administered to many patients already receiving various medications including other antibiotics, antihypertensives, anaesthetic agents, cardiac drugs and antidiabetic agents without evidence of adverse interaction.

  Animal studies have shown lack of interaction with diazepam, thiopental, morphine, neuromuscular blocking agents or halothane.

• Adverse Drug Reactions
  

  Although causal relationships have not been established in every case, the following undesirable effects have been reported with the administration of teicoplanin:

  System organ class	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)	Frequency not known (cannot be estimated from available data)*
  Infections and infestations				Abscess		Injection site abscess, superinfection (overgrowth of non-susceptible organisms)
  Blood and the lymphatic system disorders			Eosinophilia, thrombocytopenia, leucopenia			Agranulocytosis, neutropenia
  Immune system disorders			Anaphylactic reaction (anaphylaxis)			Anaphylactic shock
  Nervous system disorders			Dizziness, headache			Seizures with intraventricular use
  Ear and labyrinth disorders			Deafness (mild hearing loss), tinnitus, vestibular disorder
  Vascular disorders			Phlebitis			Thrombophelebitis
  Respiratory, thoracic and mediastinal disorders			Bronchospasm
  Gastrointestinal disorders			Nausea, vomiting, diarrhoea
  Skin and subcutaneous tissue disorders		Erythema (redness), rash (skin rash), pruritus				Urticaria, angioedema, dermatitis exfoliative (exfoliative dermatitis), toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome
  Renal and urinary disorders						Renal failure
  General disorders and administration site conditions		Pain, pyrexia (fever),				Chills (rigors)
  Investigations			Transaminases abnormal (transient abnormality of transaminases), blood alkaline phosphatase abnormal (transient abnormality of alkaline phosphatase), blood creatinine increased (transient rise of serum creatinine)

  * postmarketing experience.