BNF for Children (BNFC) 2018-2019

BETA-ADRENOCEPTOR BLOCKERS›

ALPHA- AND BETA-ADRENOCEPTOR

BLOCKERS

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Labetalol hydrochloride

lINDICATIONS AND DOSE

Hypertensive emergencies

▶BY INTRAVENOUS INFUSION

▶Neonate:Initially 0. 5 mg/kg/hour (max. per dose

4 mg/kg/hour), dose to be adjusted according to

response at intervals of at least 15 minutes.

▶Child 1 month–11 years:Initially 0. 5 – 1 mg/kg/hour (max.

per dose 3 mg/kg/hour), dose to be adjusted according

to response at intervals of at least 15 minutes

▶Child 12–17 years:Initially 30 – 120 mg/hour, dose to be

adjusted according to response at intervals of at least

15 minutes

Hypertension

▶BY MOUTH

▶Child 1 month–11 years: 1 – 2 mg/kg 3 – 4 times a day

▶Child 12–17 years:Initially 50 – 100 mg twice daily, dose

to be increased if required at intervals of 3 – 14 days;

usual dose 200 – 400 mg twice daily, higher doses to be

given in 3 – 4 divided doses; maximum 2. 4 g per day

▶BY INTRAVENOUS INJECTION

▶Child 1 month–11 years: 250 – 500 micrograms/kg (max.

per dose 20 mg) for 1 dose

▶Child 12–17 years: 50 mg, dose to be given over at least

1 minute, then 50 mg after 5 minutes if required;

maximum 200 mg per course

lUNLICENSED USENot licensed for use in children.

IMPORTANT SAFETY INFORMATION

▶With intravenous use

Consult local guidelines. In hypertensive

encephalopathy reduce blood pressure to normotensive

level over 24 – 48 hours (more rapid reduction may lead

to cerebral infarction, blindness, and death). If child

fitting, reduce blood pressure rapidly, but not to normal

levels.

lCAUTIONSLiver damage

lINTERACTIONS→Appendix 1 : beta blockers, non-selective

lSIDE-EFFECTS

▶Common or very commonDrug fever.hypersensitivity.

urinary disorders

▶Rare or very rareHepatic disorders.systemic lupus

erythematosus (SLE).toxic myopathy.tremor

▶Frequency not knownCyanosis.hyperkalaemia.interstitial

lung.lethargy.lichenoid keratosis.muscle cramps.nasal

congestion.peripheral oedema.photosensititivy reaction

.postural hypotension.psychosis

lPREGNANCYThe use of labetalol in maternal hypertension

is not known to be harmful, except possibly in thefirst

trimester. If labetalol is used close to delivery, infants

should be monitored for signs of alpha-blockade (as well as

beta blockade).

lBREAST FEEDINGInfants should be monitored as there is a

risk of possible toxicity due to alpha-blockade (in addition

to beta-blockade).

lHEPATIC IMPAIRMENTAvoid—severe hepatocellular injury

reported.

lRENAL IMPAIRMENT

Dose adjustmentsDose reduction may be required.

lMONITORING REQUIREMENTS

▶Liver damageSevere hepatocellular damage reported after

both short-term and long-term treatment. Appropriate

laboratory testing needed atfirst symptom of liver

dysfunction and if laboratory evidence of damage (or if

jaundice) labetalol should be stopped and not restarted.

lEFFECT ON LABORATORY TESTSInterferes with laboratory

tests for catecholamines.

lDIRECTIONS FOR ADMINISTRATION

▶With intravenous useForintravenous infusion, dilute to a

concentration of 1 mg/mL in Glucose 5 % or Sodium

Chloride and Glucose 5 %; iffluid restricted may be given

undiluted, preferably through a central venous catheter.

Avoid upright position during and for 3 hours after

intravenous administration.

▶With oral useFor administrationby mouth, injection may be

given orally with squash or juice.

lPATIENT AND CARER ADVICE

Medicines for Children leaflet: Labetalol hydrochloride for

hypertensionwww.medicinesforchildren.org.uk/labetalol-

hydrochloride-for-hypertension

lMEDICINAL FORMS

There can be variation in the licensing of different medicines

containing the same drug. Forms available from special-order

manufacturers include: oral suspension, oral solution

Solution for injection

▶Labetalol hydrochloride (Non-proprietary)

Labetalol hydrochloride 5 mg per 1 mlLabetalol 100 mg/ 20 ml

solution for injection ampoules| 5 ampouleP£ 61. 34 DT = £ 57. 06

Tablet

CAUTIONARY AND ADVISORY LABELS8, 21

▶Labetalol hydrochloride (Non-proprietary)

Labetalol hydrochloride 100 mgLabetalol 100 mg tablets|

56 tabletP£ 7. 21 DT = £ 5. 73

Labetalol hydrochloride 200 mgLabetalol 200 mg tablets|

56 tabletP£ 9. 97 DT = £ 9. 48

Labetalol hydrochloride 400 mgLabetalol 400 mg tablets|

56 tabletP£ 21. 12 DT = £ 15. 41

▶Trandate(RPH Pharmaceuticals AB)

Labetalol hydrochloride 50 mgTrandate 50 mg tablets|

56 tabletP£ 3. 79 DT = £ 3. 79

Labetalol hydrochloride 100 mgTrandate 100 mg tablets|

56 tabletP£ 4. 64 DT = £ 5. 73 | 250 tabletP£ 15. 62

Labetalol hydrochloride 200 mgTrandate 200 mg tablets|

56 tabletP£ 7. 41 DT = £ 9. 48 | 250 tabletP£ 24. 76

Labetalol hydrochloride 400 mgTrandate 400 mg tablets|

56 tabletP£ 10. 15 DT = £ 15. 41

BETA-ADRENOCEPTOR BLOCKERS›

NON-SELECTIVE

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Propranolol hydrochloride 07-Feb-2018

lINDICATIONS AND DOSE

Hyperthyroidism with autonomic symptoms

▶BY MOUTH

▶Neonate:Initially 250 – 500 micrograms/kg every

6 – 8 hours, adjusted according to response.

▶Child:Initially 250 – 500 micrograms/kg every 8 hours,

adjusted according to response; increased if necessary

up to 1 mg/kg every 8 hours (max. per dose 40 mg every

8 hours)

▶BY INTRAVENOUS INJECTION

▶Neonate:Initially 20 – 50 micrograms/kg every 6 – 8 hours,

adjusted according to response, to be given over

10 minutes.

▶Child:Initially 25 – 50 micrograms/kg every 6 – 8 hours

(max. per dose 5 mg), adjusted according to response,

to be given over 10 minutes

104 Blood pressure conditions BNFC 2018 – 2019

Cardiovascular system

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