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

Interactions
PK
Renal impairment
References

Ranitidine

Generic name
Ranitidine
Brand name
ATC Code
A02BA02

Pharmacokinetics in children

The study by Orenstein et al. (N=29, 4–11 years) shows that the pharmacokinetics of ranitidine in children are similar to those in adults. Various studies have shown a half-life of approximately 2 hours, a clearance of 10–27 ml/min/kg and a volume of distribution between 1 and 2.5 l/kg. The average half-life in neonates is 3.5 hours and the clearance is 5 ml/min/kg; the volume of distribution if 1.5 l/kg (Fontana et al.). In neonates who are on ECMO, the half-life is on average 6.6 hours, the clearance is 4.1 ml/min/kg [Wells et al.].
Blumer et al. (N=12, 3.5–16 years) state that the half-life and the volume of distribution of ranitidine after one bolus injection are comparable to those after oral administration. The oral bioavailability averages 48%.

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

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Available formulations

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Dosages

Prevention of stress ulcers and as support in the treatment of gastrointestinal bleeding
  • Intravenous
    • Term neonate
      [1]
      • 2.5 mg/kg/day in 2 doses.

      • WARNING! When ranitidine is used in premature neonates with very low birthweights, a significantly higher level of mortality and an increased incidence of infections have been observed, in particular at somewhat higher doses (2.43 mg/kg/day intravenously, 11.44 mg/kg/day orally). An elevated incidence of necrotizing enterocolitis and longer durations of hospital admissions have also been noted.

        Only limited clinical research has been carried out into the use of ranitidine in neonates.

        ...read more
    • 1 month up to 18 years
      • 3 - 6 mg/kg/day in 3 - 4 doses. Max single dose: 50 mg/dose.  .

      • Alternative: 3, 6 mg/kg/day as a continuous infusion.
Gastro-oesophageal reflux, duodenal ulcers and peptic ulcers
  • Oral
    • Term neonate
      [1]
      • 5 mg/kg/day in 2 doses.

      • NOTE:When ranitidine is used in premature neonates with very low birthweights, a significantly higher level of mortality and an increased incidence of infections have been observed, in particular at somewhat higher doses (2.43 mg/kg/day intravenously, 11.44 mg/kg/day orally). An elevated incidence of necrotizing enterocolitis and longer durations of hospital admissions have also been noted.

        Only limited clinical research has been carried out into the use of ranitidine in neonates.

    • 1 month up to 18 years
      • 6 - 10 mg/kg/day in 2 doses. Max: 300 mg/day.
  • Intravenous
    • Term neonate
      [1]
      • 2.5 mg/kg/day in 2 doses.

      • NOTE:When ranitidine is used in premature neonates with very low birthweights, a significantly higher level of mortality and an increased incidence of infections have been observed, in particular at somewhat higher doses (2.43 mg/kg/day intravenously, 11.44 mg/kg/day orally). An elevated incidence of necrotizing enterocolitis and longer durations of hospital admissions have also been noted.

        Only limited clinical research has been carried out into the use of ranitidine in neonates.

    • 1 month up to 18 years
      • 4.5 - 6 mg/kg/day in 3 - 4 doses. Max single dose: 50 mg/dose.

      • Alternative: 3.6 mg/kg/day as a continuous infusion

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Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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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

Increased risk of sepsis, gastroenteritis and pneumonia. Additionally: bradycardia, headaches, dizziness, abnormal blood counts and impaired liver function. Hemiballism has been reported. Ranitidine use in premature neonate is associated with a greater risk of infection and elevated mortality (Santana 2017).

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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 in children

The effervescent tablets of 150 mg and 300 mg contain 30 mg and 45 mg of aspartame respectively (16.8 and 25.3 mg phenylalanine respectively). If no alternative route of administration can be used, the diet of patients with phenylketonuria should be modified accordingly.

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

When ranitidine is used in premature neonates with very low birthweights, a significantly higher level of mortality and an increased incidence of infections have been observed, in particular at somewhat higher doses (2.43 mg/kg/day intravenously, 11.44 mg/kg/day orally), as well as an increased incidence of necrotizing enterocolitis and longer duration of hospitalization. [Terrin 2012]
An increased incidence of infections has been observed in young children (up to 36 months) when ranitidine is used. [Bianconi S 2007; Canani RB 2006]

Zantac syrup contains 8% alcohol. The maximum dose of 300 mg/day corresponds to 1.6 grams of alcohol per day. This is comparable to 32 ml beer (one eighth of a glass) or 13 ml wine (one tenth of a glass). This should be taken into account when given to children or in patients with epilepsy, liver damage, brain damage or brain disease. An alcohol-free version of ranitidine syrup is also available.
Patients with peptic ulcers being treated at the same time with prostaglandin synthetase inhibitors (NSAIDs) should be monitored regularly by a doctor, preferably by endoscopic or X-ray examination.

Treatment with ranitidine in children of ≤ 18 months is according to the NVK (Dutch Association for Paediatric Medicine) guideline “Gastroesophageal reflux and reflux disease in children aged 0-18 years” and is only indicated for complaints that indicate reflux disease and in cases where treatment or trial treatment with medication is indicated.

Method of administration: There is no need to take the tablets with meals. Dissolve Zantac 150 mg and 300 mg effervescent tablets completely in at least 75 ml and 150 ml water respectively.
 

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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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Proton pump inhibitors
A02BC05
A02BC01
A02BC02

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References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. Bianconi S, et al, Ranitidine and late-onset sepsis in the neonatal intensive care unit., J Perinat Med, 2007, 35, 147-50
  3. Blumer JL, et al, Pharmacokinetic determination of ranitidine pharmacodynamics in pediatric ulcer disease, J Pediatr., 1985, 107, 301-6
  4. Canani RB, et al, Therapy with gastric acidity inhibitors increases the risk of acute gastroenteritis and community-acquired pneumonia in children, Pediatrics, 2006, 117, e817-20
  5. Fontana M, et al, Ranitidine pharmacokinetics in newborn infants, Arch Dis Child, 1993, 68, 602-3
  6. Harrison AM, et al, Gastric pH control in critically ill children receiving intravenous ranitidine, Crit Care Med., 1998, 26, 1433-6
  7. Kelly DA, Do H2 receptor antagonists have a therapeutic role in childhood?, J Pediatr Gastroenterol Nutr, 1994, 19, 270-6
  8. Kuusela AL, Long-term gastric pH monitoring for determining optimal dose of ranitidine for critically ill preterm and term neonates, Arch Dis Child Fetal Neonatal Ed, 1998, 78, F151-3
  9. Lopez-Herce Cid J, et al, Ranitidine prophylaxis in acute gastric mucosal damage in critically ill pediatric patients, Crit Care Med, 1988, Jun;16(6), 591-3
  10. Lopriore E, et al, Ventilator-associated pneumonia and upper airway colonisation with Gram negative bacilli: the role of stress ulcer prophylaxis in children, Intensive Care Med, 2002, 28, 763-7
  11. Lugo RA, et al, Pharmacokinetics and pharmacodynamics of ranitidine in critically ill children., Crit Care Med., 2001, 29, 759-64
  12. Mallet E, et al, Use of ranitidine in young infants with gastro-oesophageal reflux., Eur J Clin Pharmacol., 1989, 36, 641-2
  13. Orenstein SR, et al, Ranitidine, 75 mg, over-the-counter dose: pharmacokinetic and pharmacodynamic effects in children with symptoms of gastro-oesophageal reflux, Aliment Pharmacol Ther, 2002, 16, 899-907
  14. Osteyee JL, et al, Effects of two dosing regimens of intravenous ranitidine on gastric pH in critically ill children, Am J Crit Care, 1994, 3, 267-72
  15. Wells TG, et al, Pharmacokinetics and pharmacodynamics of ranitidine in neonates treated with extracorporeal membrane oxygenation, J Clin Pharmacol., 1998, 38, 402-7
  16. Wheatley E, et al, Cross-over trial of treatment for bradycardia attributed to gastroesophageal reflux in preterm infants, J Pediatr, 2009, 155, 516-21
  17. Wiest DB, et al, Pharmacokinetics of ranitidine in critically ill infants, Dev Pharmacol Ther, 1989, 12, 7-12
  18. Terrin G, et al, Ranitidine is Associated With Infections, Necrotizing Enterocolitis, and Fatal Outcome in Newborns, Pediatrics, 2012, 129 (1), e40-5
  19. Elzinga-Huttenga J, et al, Movement disorders induced by gastrointestinal drugs: two paediatric cases, Neuropediatrics, 2006, Apr;37(2), 102-6
  20. GlaxoSmithKline B.V., SPC Zantac 150, tabletten 150 mg (RVG 09265). , www.cbg-meb.nl, Geraadpleegd 26 april 2013, http://db.cbg-meb.nl/IB-teksten/h09265.pdf
  21. Nederlandse Vereniging voor Kindergeneeskunde. , Richtlijn gastro-oesfageale reflux(ziekte) bij kinderen van 0-18 jaar. , April 2012.
  22. Santana RNS et al., Use of ranitidine is associated with infections in newborns hospitalized in a neonatal intensive care unit: a cohort study, BMC Infect Dis., 2017, May 30;17(1), 375

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Changes

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