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.

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

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

Oedema, fatigue, dizziness, headaches, flushing, nausea, abdominal pain and gingival recession. In peritoneal dialysis, leukocytosis can occur in the effluent.

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.

Interactions

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

• CARDIOVASCULAR SYSTEM
• CALCIUM CHANNEL BLOCKERS

SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS

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

References

1. Tallian KB, et al., Efficacy of amlodipine in pediatric patients with hypertension, Pediatr Nephrol, 1999, 13, 304-10
2. Flynn JT., Efficacy and safety of prolonged amlodipine treatment in hypertensive children, Pediatr Nephrol, 2005, 20, 631-5
3. Flynn JT, et al, Population pharmacokinetics of amlodipine in hypertensive children and adolescents., J Clin Pharmacol, 2006, 46, 905-16
4. Andersen J, et al,, Preliminary experience with amlodipine in the pediatric population, Am J Ther, 2006, 13, 198-204
5. Von Vigier RO, et al, Antihypertensive efficacy of amlodipine in children with chronic kidney diseases., J Hum Hypertens, 2001, 15, 387-91
6. Lee F et al. , Association between peritoneal dialysate effluent leukocytosis and amlodipine besylate. , Am J Kidney Dis, 2009, Mar;53(3):, e1-3.
7. Pfizer BV, SPC Norvasc 5, 10 mg tablet (RVG 13348) 08-02-13, www.cbg-meb.nl
8. Lee F et al., Association between peritoneal dialysate effluent leukocytosis and amlodipine besylate., Am J Kidney Dis, 2009, Mar;53(3):, e1-3.

Changes

Therapeutic Drug Monitoring

Overdose