Pharmacokinetics in children

When administered orally Teicoplanin is not absorbed from gastrointestinal tract [SmPC].

The studies by Reed et al. and Dufort et al. show that the clearance of teicoplanin in children younger than 12 years is higher than in adults. Clearance in children aged < 12 years is very variable; range 29-51 ml/hour/kg.

Lukas et al. suggest that teicoplanin in children < 1 year (N = 4) possibly has a lower clearance and volume of distribution than in children: > 1 year (N = 16). These values in children aged < 1 year are 0.09 l/hour and 1.05 litres respectively. In children aged > 1 year, these values are 0.29 l/hour and 3.9 litres respectively.

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Bacterial infections
Intravenous 1 month up to 2 months Initial dose: 16 mg/kg/day in 1 dose Maintenance dose: 8 mg/kg/day in 1 dose 2 months up to 12 years Initial dose: 10 mg/kg/dose every 12 hours for the first 3 doses. Maintenance dose: 6 - 10 mg/kg/day in 1 dose Term neonate Initial dose: 16 mg/kg/day in 1 dose Maintenance dose: 8 mg/kg/day in 1 dose

Clostridium difficile infection
Oral ≥ 12 years 200 - 400 mg/day in 2 doses. Duration of treatment: 7-14 days ≥ 12 years 200 - 400 mg/day in 2 doses. Duration of treatment: 7-14 days

Therapeutic Drug Monitoring (TDM) directive

Route of administration not applicable 0 years up to 18 years Serum concentration: First through level before first maintenance dose, after 3-4 days of maintenance therapy and after every dose adjustment and weekly until steady state.  Target trough level:  Complicated infections of skin and soft tissue, pneumonia and complicated urinart tract infections ≥ 15 mg/L Bone and joint infections, Intensive care patients and patients with burns ≥ 20 mg/L Infectious endocarditis ≥ 30 mg/L

Renal impaiment in children > 3 months

GFR 50-80 ml/min/1.73 m2
Dose adjustment is not required

GFR 30-50 ml/min/1.73 m2
Day 1: no dose adjustment: normal starting dose (1st and 2nd dose of the starting dose series): 
Day 2: no dose adjustment: normal starting dose (3rd dose of the starting dose series).
Day 3: no dosage adjustment: normal maintenance dosage 
Day 4: 50% of normal maintenance dose once daily

GFR 10-30 ml/min/1.73 m2
Day 1: no dose adjustment: normal starting dose (1st and 2nd dose of the starting dose series): 
Day 2: no dose adjustment: normal starting dose (3rd dose of the starting dose series).
Day 3: no dosage adjustment: normal maintenance dosage 
Day 4: 33% of normal maintenance dose once daily

GFR < 10 ml/min/1.73 m2
A general recommendation cannot be given. A trade-off between the intended effect, the risks of side effects in case of overdose and therapy failure in case of underdose must be made for each patient.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Pain at the injection site, thrombophlebitis, allergic reactions, haematological reactions.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Teicoplanin is a ‘reserves’ antimicrobial drug and should only be prescribed after consulting an infectiologist/bacteriologist. Caution is needed in cases of hypersensitivity to vancomycin. In long-term use, in renal insufficiency and in simultaneous treatment with neurotoxic or nephrotoxic drugs it is recommended that the blood, liver, kidney and hearing functions should be checked regularly.
A case of a complete atrioventricular blockage has been described [Sharif-Yakan 2013]

 

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

• ANTIINFECTIVES FOR SYSTEMIC USE
• ANTIBACTERIALS FOR SYSTEMIC USE

OTHER ANTIBACTERIALS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Glycopeptide antibacterials
	Dalbavancine Related Medicines Menu">	J01XA04
	Vancomycin Related Medicines Menu">	J01XA01

Polymyxins
	Colistin Related Medicines Menu">	J01XB01

Steroid antibacterials
	Fusidic acid Related Medicines Menu">	J01XC01

Nitrofuran derivatives
	Nitrofurantoin Related Medicines Menu">	J01XE01

Other antibacterials
	Daptomycin Related Medicines Menu">	J01XX09
	Linezolid Related Medicines Menu">	J01XX08
	Phosphomycin Related Medicines Menu">	J01XX01

References

1. Degraeuwe PL, et al, Use of teicoplanin in preterm neonates with staphylococcal late-onset neonatal sepsis., Biol Neonate, 1998, 73, 287-94
2. Dufort G, et al, Teicoplanin pharmacokinetics in pediatric patients., Pediatr Infect Dis J, 1996, 15, 494-8
3. Fanos V, et al, A review of teicoplanin in the treatment of serious neonatal infections, Eur J Pediatr, 1997, 156, 423-7
4. Lukas JC, et al, Pharmacokinetics of teicoplanin in an ICU population of children and infants., Pharm Res, 2004, 21, 2064-71
5. Möller JC, et al, Comparison of vancomycin and teicoplanin for prophylaxis of sepsis with coagulase negative staphylococci (CONS) in very low birth weight (VLBW) infants., J Perinat Med., 1997, 25, 361-7
6. Reed MD, et al, The pharmacokinetics of teicoplanin in infants and children., J Antimicrob Chemother, 1997, 39, 789-96
7. Tarral E, et al, Pharmacokinetics of teicoplanin in children., J Antimicrob Chemother., 1988, Jan;21 Suppl A, 47-51
8. Yalaz M, et al, Experience with teicoplanin in the treatment of neonatal staphylococcal sepsis, J Int Med Res, 2004, 32, 540-8
9. Sanofi-aventis Netherlands B.V, SmPC Targocid (RVG 13473) 02-05-2023, www.geneesmiddeleninformatiebank.nl
10. Sharif-Yakan A et al., Complete heart block in a patient with acute lymphoblastic leukaemia: teicoplanin as a possible cause and review of literature, J Clin Pharm Ther, 2013, Apr;38(2), 156-8
11. HEXAL®, SmPC Teicoplanin 100/200/400 mg Pulver zur Injektion (84895.00.00 / 84896.00.00 / 84897.00.00), 11/15
12. Sanofi, SmPC Targocid 100/200/400 mg Pulver für Injektion (27257.00.00 / 27257.01.00 / 27257.02.00), 10/17

Changes

Therapeutic Drug Monitoring

Overdose