Pantoprazole

Generic name
Pantoprazole
Brand name
ATC Code
A02BC02
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Pantoprazole

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

The kinetics in children aged 2-16 years do not differ from those of adults, nor is there a difference between oral and IV administration. The following (mean ± SD) parameters have been found (Kearns 2008):

  Oral
(n=24)		 IV
(n=18)
Tmax (hours) 2.54 ± 0.72 0.34 ± 0.12
Cmax (mg/l) 2.97 ± 1.51 8.04 ± 3.21
T½ (hours) 1.27 ± 1.29 1.22 ± 0.68
Cl/F, Cl (l/hour/kg) 0.26 ± 0.2 0.20 ± 0.23
Vd/F, Vd (l/kg) 0.24 ± 0.09 0.22 ± 0.14

 

 

 

 


 

 

 

 

The following median (range) PK parameters were found in 20 children 1 month to 5 years after intravenous administration (Pettersen et al. 2009):

t½ (hour) 2,0 (0,7-11,8)
Cl (L/hour/kg) 0,14 (0,01-0,26)
Vss (L/kg) 0,22 (0,09-0,52)

 

The following mean ± SD (range) pharmacokinetic parameters were found in 40 predominantly preterm neonates (3 term neonates) after oral administration (Ward et al. 2010):

  1,25 mg 2,5 mg
GA (weeks), median (range) 29 (23,5-40) 28 (23-41)
PNA (Wochen), median (range) 7,7 (1,3-17,7) 8 (1,3-19,6)
t½ (h) 3,1 ± 1,5 2,7 ± 1,1
Cl/F (l/h/kg) 0,21 ± 0,12 (0,04-0,42) 0,23 ± 0,21 (0,03-0,92)

Vd (l/kg) (calculated)

 0,94 0,90

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

Gastro-oesophageal reflux disease
  • Oral
    • 12 years up to 18 years
      • 20 mg/day in 1 dose
  • Intravenous
    • 1 month up to 18 years
      [2] [8]
      • 0.4 - 0.6 mg/kg/day in 1 dose. Max: 20 mg/day.
Reflux oesophagitis
  • Oral
    • 5 years up to 12 years and 15 up to 40 kg
      • 20 mg/day in 1 dose
    • 5 years up to 12 years and ≥ 40 kg
      • 40 mg/day in 1 dose
    • 12 years up to 18 years
      • 20 - 40 mg/day in 1 dose. Max: 80 mg/day.

      • Maintenance dose to prevent relapses: 20 mg/day in a single dose.

  • Intravenous
    • 1 month up to 18 years
      • 0.4 - 1.2 mg/kg/day in 1 dose. Max: 80 mg/day.

      • Maintenance dose to prevent relapses: 0.4-0.6 mg/kg/day in 1 dose, max 20 mg/day

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.

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

One case of acute pancreatitis has been reported

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

In obese children, dosing based on total body weight is recommended based on limited data. Dividing the dose into 2 doses per day may be considered (Ross et al. 2015).

Interactions

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

DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)

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

H2-receptor antagonists
A02BA02
Proton pump inhibitors
A02BC05
A02BC01

References

  1. Das S et al, Oral pantoprazole-induced acute pancreatitis in an 11-year-old child, Ther Drug Monit, 2012, Jun;34(3), 242-4
  2. Kearns GL et al , Single-dose pharmacokinetics of oral and intravenous pantoprazole in children and adolescents, J Clin Pharmacol, 2008, Nov;48(11), 1356-65
  3. Madrazo-de la Garza A et al, Efficacy and safety of oral pantoprazole 20 mg given once daily for reflux esophagitis in children, J Pediatr Gastroenterol Nutr, 2003, Feb;36(2), 261-5
  4. Pfizer, Prescribing information Protonix, Sept 2013, http://labeling.pfizer.com/showlabeling.aspx?id=135
  5. Takeda Nederland bv, SPC Pantozol 20-09-2012, www.cbg-meb.nl
  6. Tolia V et al, Multicenter, randomized, double-blind study comparing 10, 20 and 40 mg pantoprazole in children (5-11 years) with symptomatic gastroesophageal reflux disease, J Pediatr Gastroenterol Nutr, 2006, Apr;42(4), 384-91
  7. Ward, RM, et al., Single-dose, multiple-dose, and population pharmacokinetics of pantoprazole in neonates and preterm infants with a clinical diagnosis of gastroesophageal reflux disease (GERD), Eur J Clin Pharmacol, 2010, 66, 555–561
  8. Knebel, W., et al , Population pharmacokinetic modeling of pantoprazole in pediatric patients from birth to 16 years., J Clin Pharmacol , 2011, 51 (3), 333-45
  9. Pettersen, G. et al, Population pharmacokinetics of intravenous pantoprazole in paediatric intensive care patients, Br J Clin Pharmacol, 2009, 67 (2), 216-27
  10. Ross, E. L., et al, Development of recommendations for dosing of commonly prescribed medications in critically ill obese children., Am J Health Syst Pharm, 2015, 72 (7), 542-56

Changes

Therapeutic Drug Monitoring


Overdose