Labetalol

Generic name
Labetalol
Brand name
ATC Code
C07AG01
Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

Kinetic data determined in case studies:
T½ = 3.1-6.8 hours and t½ up to 24 hours if premature (1 case, via the mother)
Clearance ~28 ml/min/kg
 

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

Hypertensive crisis
  • Intravenous
    • 1 year up to 18 years
      • 0.25 - 3 mg/kg/hour, continuous infusion.

      • Starting with a low dosage. Under OR/IC monitoring.

        Not many good studies have been carried out. The stated dose is primarily based on case studies. Make sure the blood pressure drops gradually, by not more than 25% in two hours. Thomas et al. state however that doses of greater than approximately 0.59 mg/kg/hour have little added value in terms of lowering the blood pressure.
Hypertension
  • Oral
    • 1 year up to 18 years
      • Initial dose: 1 mg/kg/day in 2 doses.
      • Maintenance dose: Depending on the clinical response, the Initial dose can be raised to a maximum of 1.200 mg/day in 2 doses.

      • Not many good studies have been carried out. The stated dose is primarily based on case studies. Always start with a low dosage and make sure there is a gradual drop in the blood pressure. Doses of up to 10-20 mg/kg/day have been described and in one case study even of 40 mg/kg/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

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

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

Caution is needed in children with ischemic or traumatic brain injury because of the association with a greater risk of hypotension. Great caution is needed in concomitant use of verapamil (Isoptin®) because of the risk of severe arrhythmia. Do not administer in peripheral blood perfusion disorders.

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
C07AG02

References

  1. Haraldsson A, et al, Half-life of maternal labetalol in a premature infant., Pharm Weekbl Sci, 1989, Dec 15;11(6), 229-31
  2. Thorsteinsson A, et al, Severe labetalol overdose in an 8-month-old infant., Paediatr Anaesth, 2008, May;18(5), 435-8
  3. Porto I, Hypertensive emergencies in children, J Pediatr Health Care, 2000, Nov-Dec;14(6), 312-7; quiz 8-9
  4. Bunchman TE, et al, Intravenously administered labetalol for treatment of hypertension in children, J Pediatr, 1992, Jan;120(1), 140-4
  5. Deal JE, et al, Management of hypertensive emergencies, Arch Dis Child, 1992, Sep;67(9), 1089-92
  6. Grubb BP. , The use of oral labetalol in the treatment of arrhythmias associated with the long QT syndrome. , Chest., 1991, Dec;100(6), 1724-5
  7. Willis JK, et al, Reversible myopathy due to labetalol, Pediatr Neurol, 1990, Jul-Aug;6(4):, 275-6
  8. Thomas CA\, et al., Safety and efficacy of intravenous labetalol for hypertensive crisis in infants and small children., Pediatr Crit Care Med, 2011, Jan;12(1), 28-32
  9. Lurbe E, et al, Management of high blood pressure in children and adolescents: recommendations of the European Society of Hypertension, J Hypertens, 2009, Sep;27(9),, 1719-42
  10. Grubb BP., The use of oral labetalol in the treatment of arrhythmias associated with the long QT syndrome., Chest., 1991, Dec;100(6), 1724-5

Changes

Therapeutic Drug Monitoring


Overdose