- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
The study by Flynn (2006) shows that the weight-corrected clearance is higher in young children (ages < 6 years). Young children need higher doses than older children:
Cl (oral) 1-5 yrs: 1.0±0.33 l/kg/hour
Cl (oral) 6-12 yrs: 0.63±0.36 l/kg/hour
Cl (oral) 13-17 yrs: 0.40±0.16 l/kg/hour
Vd 1-5 yrs: 44.5±12.5 l/kg
Vd 6-12 yrs: 27±8.8 l/kg
Vd 12-17 yrs: 21.6±6.4 l/kg
High interindividual variability in exposure has been observed.
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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
| Hypertension |
|---|
|
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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
Oedema, fatigue, dizziness, headaches, flushing, nausea, abdominal pain and gingival recession. In peritoneal dialysis, leukocytosis can occur in the effluent.
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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
Caution is needed in hepatic insufficiency as t½ may then be lengthened. Dose adjustments should not be more often than once every 5 to 7 days.
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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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| Dihydropyridine derivatives | ||
|---|---|---|
| C08CA04 | ||
| C08CA05 | ||
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References
- Tallian KB, et al., Efficacy of amlodipine in pediatric patients with hypertension, Pediatr Nephrol, 1999, 13, 304-10
- Flynn JT., Efficacy and safety of prolonged amlodipine treatment in hypertensive children, Pediatr Nephrol, 2005, 20, 631-5
- Flynn JT, et al, Population pharmacokinetics of amlodipine in hypertensive children and adolescents., J Clin Pharmacol, 2006, 46, 905-16
- Andersen J, et al,, Preliminary experience with amlodipine in the pediatric population, Am J Ther, 2006, 13, 198-204
- Von Vigier RO, et al, Antihypertensive efficacy of amlodipine in children with chronic kidney diseases., J Hum Hypertens, 2001, 15, 387-91
- Lee F et al. , Association between peritoneal dialysate effluent leukocytosis and amlodipine besylate. , Am J Kidney Dis, 2009, Mar;53(3):, e1-3.
- Pfizer BV, SPC Norvasc 5, 10 mg tablet (RVG 13348) 08-02-13, www.cbg-meb.nl
- Lee F et al., Association between peritoneal dialysate effluent leukocytosis and amlodipine besylate., Am J Kidney Dis, 2009, Mar;53(3):, e1-3.
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Changes
Changes
