- 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 |
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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
| Gastro-oesophageal reflux disease |
|---|
| Reflux oesophagitis |
|---|
|
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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
One case of acute pancreatitis has been reported
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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
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).
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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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| H2-receptor antagonists | ||
|---|---|---|
| A02BA02 | ||
| Proton pump inhibitors | ||
|---|---|---|
| A02BC05 | ||
| A02BC01 | ||
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References
- Das S et al, Oral pantoprazole-induced acute pancreatitis in an 11-year-old child, Ther Drug Monit, 2012, Jun;34(3), 242-4
- 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
- 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
- Pfizer, Prescribing information Protonix, Sept 2013, http://labeling.pfizer.com/showlabeling.aspx?id=135
- Takeda Nederland bv, SPC Pantozol 20-09-2012, www.cbg-meb.nl
- 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
- 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
- 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
- Pettersen, G. et al, Population pharmacokinetics of intravenous pantoprazole in paediatric intensive care patients, Br J Clin Pharmacol, 2009, 67 (2), 216-27
- 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
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Changes
Changes
