Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Buprenorphine

Generic name
Buprenorphine
Brand name
ATC Code
N02AE01

Pharmacokinetics in children

The following pharmacokinetic parameters have been found (Olkkola 1989, Barret 1993, Ng 2015):

  Administration route t½ (hours) Cl (l/hour/kg) Vd (l/kg)
Premature infants Intravenous 20±8 0.23 ± 0.07 6.2 ± 2.1
Neonates Sublingual 11 3.5 -
4-7 years Intravenous 1 ± 0.2 3.6 ± 1.14 3.2 ± 2.0

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

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

Neonatal abstinence syndrome (NAS)
  • Sublingual
    • 0 months up to 1 month
      • Initial dose: 15 microg./kg/day in 3 doses.
      • Maintenance dose:
          15 - 60         microg./kg/day in 3 doses.
      • Directions for administration:

        After 48 hours on an unchanged dose: reduce. Give 10% less of this ‘unchanged 48-hour dose’ every day until the initial dose is reached. After this, the administration can be stopped.

      • If there is insufficient effect, a rescue dose can be given (50% of the last dose) and the maintenance dose can be increased in steps of 25% per dose 
Moderate to severe pain
  • Transdermal
    • 2 years up to 18 years and < 30 kg
      • 5 microg./hour continuous release. Max: 140 microg./hour. If there is insufficient effect after 24 hours, double the dose to a maximum of 140 mcg/hour..
    • 2 years up to 18 years and ≥ 30 kg
      • 10 microg./hour continuous release. Max: 140 microg./hour. If there is insufficient effect after 24 hours, double the dose to a maximum of 140 mcg/hour.
Severe pain
  • Sublingual
    • ≥ 6 years and ≥ 45 kg
      • 0.2 - 0.4 mg/dose, as required 3-4 dd.

      • Interval between two doses: 6 hours. 

    • ≥ 6 years and 35 up to 45 kg
      • 5 microg./kg/dose, as required 3-4 times daily.

      • Interval between two doses: 6 hours. 

  • Intramuscular
    • ≥ 1 year
      • 3 - 6 microg./kg/dose, as required 3-4 times daily. Max: 9 microg./kg/dose.
  • Intravenous
    • ≥ 1 year
      • 3 - 6 microg./kg/dose, as required 3-4 times daily. Max: 9 microg./kg/dose.

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Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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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

Neonatal opioid withdrawal syndrome.

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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

The patches sometimes become empty more rapidly in children; it is thought that this may be caused by a somewhat higher body temperature. The result of this is that the patches may have to be changed sooner than the manufacturer recommends.

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Interactions

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

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Natural opium alkaloids
N02AA03
N02AA01
N02AA05
N02AA59
Phenylpiperidine derivatives
N02AB03
N02AB03
N02AB02
Diphenylpropylamine derivatives
N02AC06
N02AC03
Morphinan derivatives
N02AF02
Other opioids
N02AX06
N02AX01
N02AX02
Opioids in combination with non-opioid analgesics
N02AJ13

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References

  1. Barrett, D.A., et al, The pharmacokinetics and physiological effects of buprenorphine infusion in premature neonates. , Br J Clin Pharmacol, 1993, 36(3), 215-9.
  2. Ng, C.M., et al, Population Pharmacokinetic Model of Sublingual Buprenorphine in Neonatal Abstinence Syndrome., Pharmacotherapy, 2015, 35(7), 670-80
  3. Kraft, W.K., et al, Buprenorphine for the Treatment of the Neonatal Abstinence Syndrome., N Engl J Med, 2017, 376(24), 2341-2348
  4. Kraft, W.K., et al, Revised dose schema of sublingual buprenorphine in the treatment of the neonatal opioid abstinence syndrome. , Addiction, 2011, 106(3), 574-80
  5. Kraft, W.K., et al, Sublingual buprenorphine for treatment of neonatal abstinence syndrome: a randomized trial. , Pediatrics, 2008, 122(3), e601-7
  6. Olkkola, K.T., et al, Pharmacokinetics of intravenous buprenorphine in children., Br J Clin Pharmacol, 1989, 28(2), 202-4
  7. Ruggiero, A., et al., Efficacy and safety of transdermal buprenorphine in the management of children with cancer-related pain., Pediatr Blood Cancer, 2013, 60(3), 433-7
  8. Indivior UK Limited, SmPC Temgesic SL (RVG 11872) 15-05-2016, www.geneesmiddelinformatiebank.nl
  9. Disher T et al., Pharmacological Treatments for Neonatal Abstinence Syndrome: A Systematic Review and Network Meta-analysis, JAMA Pediatr, 2019, 173(3), 234-243
  10. Hall ES et al., Comparison of Neonatal Abstinence Syndrome Treatment with Sublingual Buprenorphine versus Conventional Opioids., Am J Perinatol, 2018, 35(4), 405-412
  11. Indivior Europe Limited, SmPC, Temgesic® sublingual/sublingual forte 0,2/0,4 mg Sublingualtablette (997.00.01/27138.00.00)
  12. Indivior Europe Limited, SmPC, Temgesic® Ampullen 0,3 mg Injektionslösung (997.00.00), 01/2019
  13. Barrett, D.A., et al, The pharmacokinetics and physiological effects of buprenorphine infusion in premature neonates., Br J Clin Pharmacol, 1993, 36(3), 215-9.
  14. Kraft, W.K., et al, Sublingual buprenorphine for treatment of neonatal abstinence syndrome: a randomized trial., Pediatrics, 2008, 122(3), e601-7
  15. Kraft, W.K., et al, Revised dose schema of sublingual buprenorphine in the treatment of the neonatal opioid abstinence syndrome., Addiction, 2011, 106(3), 574-80

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Changes

Changes