BNF for Children (BNFC) 2018-2019

(singke) #1

▶UncommonDry mouth.hyperhidrosis
▶Rare or very rareFatigue.hyperthyroidism.pallor
▶Frequency not knownAscites.pulmonary oedema (avoid
chronic use if occurs during dose titration).spleen
abnormalities


lPREGNANCYManufacturer advises caution—no
information available.


lBREAST FEEDINGManufacturer advises avoid—no
information available.


lMONITORING REQUIREMENTS
▶Anticoagulant monitoring required when given with
anticoagulants.
▶Monitor blood pressure.


lTREATMENT CESSATIONAvoid abrupt withdrawal (risk of
rebound pulmonary hypertension and pulmonary
hypertensive crisis).


lDIRECTIONS FOR ADMINISTRATIONReconstitute using the
glycine buffer diluent provided to make a concentrate (pH
10. 5 );filter the concentrate using thefilter provided. The
concentrate can be administered via a central venous
catheter, alternatively it may be diluted further either with
the glycine buffer diluentorto a minimum concentration
of 1. 43 micrograms/mL with Sodium Chloride 0. 9 %.
Solution stable for 12 hours at room temperature,
although some units use for 24 hours and allow for loss of
potency; solution stable for 24 hours if prepared in glycine
buffer diluent only and administered via an ambulatory
cold pouch system (to maintain solution at 2 – 8 °C).
Neonatal intensive care, prepare afiltered concentrate of
10 micrograms/mL using the 500 -microgram vial.Neonate
body-weight under 2 kg, using the concentrate, dilute
150 micrograms/kg body-weight to afinal volume of 50 mL
with Sodium Chloride 0. 9 %; an intravenous infusion rate
of 0. 1 mL/hour provides a dose of 5 nanograms/kg/minute.
Neonate body-weight over 2 kg, using the concentrate,
dilute 60 micrograms/kg body-weight to afinal volume of
50 mL with Sodium Chloride 0. 9 %; an intravenous infusion
rate of 0. 1 mL/hour provides a dose of
2 nanograms/kg/minute.


lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Powder for solution for infusion
▶Veletri(Actelion Pharmaceuticals UK Ltd)
Epoprostenol (as Epoprostenol sodium) 500 microgramVeletri
500 microgram powder for solution for infusion vials| 1 vialP
£ 24. 44
Epoprostenol (as Epoprostenol sodium) 1.5 mgVeletri 1. 5 mg
powder for solution for infusion vials| 1 vialP£ 49. 24
Powder and solvent for solution for infusion
▶Flolan(GlaxoSmithKline UK Ltd)
Epoprostenol (as Epoprostenol sodium) 500 microgramFlolan
500 microgram powder and solvent (pH 12 ) for solution for infusion
vials| 1 vialP£ 22. 22
Epoprostenol (as Epoprostenol sodium) 1.5 mgFlolan 1. 5 mg
powder and solvent (pH 12 ) for solution for infusion vials| 1 vialP
£ 44. 76


Iloprost


lINDICATIONS AND DOSE
Idiopathic or familial pulmonary arterial hypertension
(initiated under specialist supervision)
▶BY INHALATION OF NEBULISED SOLUTION
▶Child 8–17 years:Initially 2. 5 micrograms for 1 dose,
increased to 5 micrograms for 1 dose, increased if
tolerated to 5 micrograms 6 – 9 times a day, adjusted
according to response; reduced if not tolerated to
2. 5 micrograms 6 – 9 times a day, reduce to lower
maintenance dose if high dose not tolerated

Raynaud’s syndrome
▶BY INTRAVENOUS INFUSION
▶Child 12–17 years:Initially 30 nanograms/kg/hour,
increased to 60 – 120 nanograms/kg/hour daily for
3 – 5 days, dose to be given over 6 hours, dose increase
should be performed gradually

lUNLICENSED USENot licensed for use in children.
lCONTRA-INDICATIONSConditions which increase risk of
haemorrhage.congenital or acquired valvular defects of
the myocardium.decompensated cardiac failure (unless
under close medical supervision).pulmonary veno-
occlusive disease.severe arrhythmias.severe coronary
heart disease
lCAUTIONS
GENERAL CAUTIONSHypotension (do not initiate if systolic
blood pressure below 85 mmHg).unstable pulmonary
hypertension with advanced right heart failure
SPECIFIC CAUTIONS
▶When used by inhalationAcute pulmonary infection.severe
asthma
lINTERACTIONS→Appendix 1 : iloprost
lSIDE-EFFECTS
▶Common or very commonChest discomfort.cough.
diarrhoea.dizziness.dyspnoea.haemorrhage.headache.
hypotension.nausea.oral disorders.pain.palpitations.
rash.syncope.tachycardia.throat complaints.
vasodilation.vomiting
▶Frequency not knownRespiratory disorders.taste altered.
thrombocytopenia
lPREGNANCY
▶When used by inhalationUse if potential benefit outweighs
risk.
lBREAST FEEDING
▶When used by inhalationManufacturer advises avoid—no
information available.
lHEPATIC IMPAIRMENT
Dose adjustments▶When used by inhalationInitially
2. 5 micrograms at intervals of 3 – 4 hours (max. 6 times
daily), adjusted according to response (consult product
literature).
Dose may need to be halved in liver cirrhosis.
lDIRECTIONS FOR ADMINISTRATION
▶With intravenous useForintravenous infusiondilute to a
concentration of 200 nanograms/mL with Glucose 5 %or
Sodium Chloride 0. 9 %; alternatively, may be diluted to a
concentration of 2 micrograms/mL and given via syringe
driver.
▶When used by inhalationForinhaled treatment, to minimise
accidental exposure use only with nebulisers listed in
Ventavis®product literature in a well ventilated room.
lPRESCRIBING AND DISPENSING INFORMATION
▶When used by inhalationDelivery characteristics of nebuliser
devices may vary—only switch devices under medical
supervision.
▶With intravenous useConcentrate for infusion available on a
named patient basis from Bayer Schering in 0. 5 mL and
1 mL ampoules.

lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Solution for infusion
▶Iloprost (Non-proprietary)
Iloprost (as Iloprost trometamol) 100 microgram per
1mlIloprost 100 micrograms/ 1 ml solution for infusion ampoules|
1 ampoulePs
Iloprost 50 micrograms/ 0. 5 ml solution for infusion ampoules|
1 ampoulePs

BNFC 2018 – 2019 Pulmonary hypertension 119


Cardiovascular system

2

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