BNF for Children (BNFC) 2018-2019

postural hypotension.pulmonary oedema.renal

impairment.urinary disorders.weight increased

▶UncommonAlopecia.angina pectoris.hyperhidrosis.

presyncope.skin reactions

▶Rare or very rareDry mouth.hypersensitivity.leucopenia

.nasal congestion.severe cutaneous adverse reactions

(SCARs).thrombocytopenia

lPREGNANCYInformation on the safety of carvedilol during

pregnancy is lacking. If carvedilol 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 in hepatic impairment.

lMONITORING REQUIREMENTSMonitor renal function

during dose titration in patients with heart failure who

also have renal impairment, low blood pressure, ischaemic

heart disease, or diffuse vascular disease.

lPATIENT AND CARER ADVICE

Medicines for Children leaflet: Carvedilol for heart failure

http://www.medicinesforchildren.org.uk/carvedilol-heart-failure- 0

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

Tablet

CAUTIONARY AND ADVISORY LABELS 8

▶Carvedilol (Non-proprietary)

Carvedilol 3.125 mgCarvedilol 3. 125 mg tablets| 28 tabletP

£ 8. 00 DT = £ 0. 55

Carvedilol 6.25 mgCarvedilol 6. 25 mg tablets| 28 tabletP

£ 8. 99 DT = £ 0. 77

Carvedilol 12.5 mgCarvedilol 12. 5 mg tablets| 28 tabletP£ 9. 99

DT = £ 0. 57

Carvedilol 25 mgCarvedilol 25 mg tablets| 28 tabletP£ 12. 50

DT = £ 1. 01

DIURETICS›POTASSIUM-SPARING DIURETICS›

ALDOSTERONE ANTAGONISTS

Potassium canrenoate

lINDICATIONS AND DOSE

Short-term diuresis for oedema in heart failure and in

ascites

▶BY INTRAVENOUS INJECTION, OR BY INTRAVENOUS INFUSION

▶Neonate: 1 – 2 mg/kg twice daily.

▶Child 1 month–11 years: 1 – 2 mg/kg twice daily

▶Child 12–17 years: 1 – 2 mg/kg twice daily (max. per dose

200 mg)

DOSE EQUIVALENCE AND CONVERSION

▶To convert to equivalent oral spironolactone dose,

multiply potassium canrenoate dose by 0. 7.

lUNLICENSED USENot licensed for use in the UK.

lCONTRA-INDICATIONSHyperkalaemia.hyponatraemia

lCAUTIONSAcute porphyrias p. 603 .hypotension.

potential metabolic products carcinogenic inrodents

lINTERACTIONS→Appendix 1 : potassium canrenoate

lSIDE-EFFECTS

▶Common or very commonAtaxia.drowsiness.headache.

hyperuricaemia.injection site pain (on rapid

administration).menstruation irregular

▶UncommonElectrolyte imbalance.eosinophilia.

thrombocytopenia

▶Rare or very rareAgranulocytosis.alopecia.

hepatotoxicity.hypersensitivity.osteomalacia.skin

reactions.voice alteration

▶Frequency not knownAcidosis hyperchloraemic.breast

pain.confusion (transient; with high doses).

gastrointestinal disorder.gynaecomastia.hirsutism.

hypotension

lPREGNANCYCrosses placenta. Feminisation and

undescended testes in male fetus inanimalstudies—

manufacturer advises avoid.

lBREAST FEEDINGPresent in breast milk—manufacturer

advises avoid.

lRENAL IMPAIRMENTUse with caution if estimated

glomerularfiltration rate 30 – 60 mL/minute/ 1. 73 m^2. Avoid

if estimated glomerularfiltration rate less than

30 mL/minute/ 1. 73 m^2.

MonitoringMonitor plasma-potassium concentration if

estimated glomerularfiltration rate

30 – 60 mL/minute/ 1. 73 m^2.

lMONITORING REQUIREMENTSMonitor electrolytes

(discontinue if hyperkalaemia occurs).

lDIRECTIONS FOR ADMINISTRATIONConsult product

literature. Intravenous injection to be given over at least

3 minutes.

lPRESCRIBING AND DISPENSING INFORMATIONPotassium

canrenoate injection is available from‘special-order’

manufacturers or specialist importing companies.

lMEDICINAL FORMS

There can be variation in the licensing of different medicines

containing the same drug.

Solution for injection

▶Aldactone (Imported (Germany))

Potassium canrenoate 20 mg per 1 mlAldactone 200 mg/ 10 ml

solution for injection ampoules| 10 ampoulePs

Spironolactone 19-Mar-2018

lINDICATIONS AND DOSE

Oedema in heart failure and in ascites|Nephrotic

syndrome|Reduction of hypokalaemia induced by

diuretics or amphotericin

▶BY MOUTH

▶Neonate:Initially 1 – 2 mg/kg daily in 1 – 2 divided doses;

increased if necessary up to 7 mg/kg daily, in resistant

ascites.

▶Child 1 month–11 years:Initially 1 – 3 mg/kg daily in

1 – 2 divided doses; increased if necessary up to 9 mg/kg

daily, in resistant ascites

▶Child 12–17 years:Initially 50 – 100 mg daily in

1 – 2 divided doses; increased if necessary up to 9 mg/kg

daily, in resistant ascites; maximum 400 mg per day

lUNLICENSED USENot licensed for reduction of

hypokalaemia induced by diuretics or amphotericin.

lCONTRA-INDICATIONSAddison’s disease.anuria.

hyperkalaemia

lCAUTIONSAcute porphyrias p. 603 .potential metabolic

products carcinogenic inrodents

lINTERACTIONS→Appendix 1 : aldosterone antagonists

lSIDE-EFFECTSAcidosis hyperchloraemic.acute kidney

injury.agranulocytosis.alopecia.breast neoplasm benign

.breast pain.confusion.dizziness.electrolyte imbalance.

gastrointestinal disorder.gynaecomastia.hepatic

function abnormal.hyperkalaemia (discontinue).

hypertrichosis.leg cramps.leucopenia.libido disorder.

malaise.menstrual disorder.nausea.severe cutaneous

adverse reactions (SCARs).skin reactions.

thrombocytopenia

lPREGNANCYUse only if potential benefit outweighs risk—

feminisation of male fetus inanimalstudies.

126 Heart failure BNFC 2018 – 2019

Cardiovascular system

2