Carvedilol

Generic name
Carvedilol
Brand name
ATC Code
C07AG02
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Carvedilol

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

The elimination half-life is shorter in children than in adults, at 2.9 hours and 5.7 hours respectively. This increases with the age (Laer et al.).
The clearance of carvedilol is greater in young children, namely 2.7 l/h/kg at the age of 1 year and 0.7 l/h/kg at age 19 years [Albers et al.].
 

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

Adjuvant treatment to the standard therapy for moderate to severe stable chronic cardiac failure, and heart failure in Duchenne muscular dystrophy
  • Oral
    • 1 month up to 18 years
      • Initial dose: 0.1 mg/kg/day in 2 doses.
      • Maintenance dose: Increase every 2 weeks by 0.1 mg/kg/day to 0.2 - 0.8 mg/kg/day in 2 doses. Max: 0.8mg/kg/day, but not exceeding 50 mg/day.

      • A very low oral dose is used at first; carefully increase every 2 weeks to the maximum dose unless clinical side effects (symptoms of congestion, dizziness, symptomatic hypotension) or worsening occurs.
        In children aged up to 3 years, higher doses (max. 1-1.5 mg/kg/day in 2-3 doses) may be needed

        Only use in consultation with a paediatric cardiologist

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

Dyspnoea, cold extremities, provocation of congestive heart failure or hypoglycaemia (without symptoms: take care with diabetes patients) and nightmares.

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

Contra-indications in children

Sinus bradycardia, AV block, hypotension, asthma and congestive heart failure.

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

Great caution is needed in concomitant use of verapamil (Isoptin) because of the risk of severe arrhythmia. The clearance of orally administered digoxin halves when carvedilol is used (Ratnapalan et al.). Be careful: digoxin intoxication.


 

Interactions

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

BETA BLOCKING AGENTS

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

Beta blocking agents, non-selective
C07AA05
C07AA07
Beta blocking agents, selective
C07AB03
C07AB07
C07AB09
C07AB02
Alpha and beta blocking agents
C07AG01

References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. Erdo&#287;an I, et al, Treatment of dilated cardiomyopathy with carvedilol in children, Turk J Pediatr, 2009, Jul-Aug;51(4), 354-60
  3. Askari H, et al, Carvedilol therapy in pediatric patients with dilated cardiomyopathy, Turk J Pediatr, 2009, Jan-Feb;51(1), 22-7
  4. Albers S, et al, Population pharmacokinetics and dose simulation of carvedilol in paediatric patients with congestive heart failure, Br J Clin Pharmacol, 2008, Apr;65(4), 511-22
  5. Bajcetic M, et al, Effects of carvedilol on left ventricular function and oxidative stress in infants and children with idiopathic dilated cardiomyopathy: a 12-month, two-center, open-label study, Clin Ther., 2008, Apr;30(4), 702-14
  6. Shaddy RE, et al, : Carvedilol for children and adolescents with heart failure: a randomized controlled trial, JAMA, 2007, Sep 12;298(10), 1171-9
  7. Blume ED, et al, Prospective single-arm protocol of carvedilol in children with ventricular dysfunction, Pediatr Cardiol, 2006, May-Jun;27(3), 336-42
  8. Giardini A, et al, Modulation of neurohormonal activity after treatment of children in heart failure with carvedilol, Cardiol Young, 2003, Aug;13(4), 333-6
  9. Ratnapalan S, et al, Digoxin-carvedilol interactions in children, J Pediatr, 2003, May;142(5), 572-4
  10. Azeka E, et al, Delisting of infants and children from the heart transplantation waiting list after carvedilol treatment., J Am Coll Cardiol, 2002, Dec 4;40(11), 2034-8
  11. Williams RV, et al, Intermediate effects of treatment with metoprolol or carvedilol in children with left ventricular systolic dysfunction, J Heart Lung Transplant, 2002, Aug;21(8):, 906-9
  12. Läer S, et al, Carvedilol therapy in pediatric patients with congestive heart failure: a study investigating clinical and pharmacokinetic parameters., Am Heart J., 2002, May;143(5), 916-22
  13. Matsumura T, et al, Carvedilol can prevent cardiac events in Duchenne muscular dystrophy, Intern Med, 2010, 49(14), 1357-63. Epub 2010 Jul 15.

Changes

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Overdose