BNF for Children (BNFC) 2018-2019

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lINTERACTIONS→Appendix 1 : statins


lSIDE-EFFECTS
▶Rare or very rareAngioedema.face oedema.lupus-like
syndrome.muscle weakness.sensation abnormal.
vasculitis


lBREAST FEEDINGManufacturer advises avoid—no
information available.


lRENAL IMPAIRMENT
Dose adjustmentsManufacturer advises doses above 40 mg
daily should be initiated with caution if estimated
glomerularfiltration rate less than 30 mL/minute/ 1. 73 m^2.


lPATIENT AND CARER ADVICEPatient counselling is advised
forfluvastatin tablets/capsules (muscle effects).


lNATIONAL FUNDING/ACCESS DECISIONS


Scottish Medicines Consortium (SMC) Decisions
TheScottish Medicines Consortiumhas advised (February
2004 ) thatfluvastatin is accepted for restricted use for the
secondary prevention of coronary events after
percutaneous coronary angioplasty; if the patient has
previously been receiving another statin, then there is no
need to change the statin.

lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Modified-release tablet
CAUTIONARY AND ADVISORY LABELS 25
▶Fluvastatin (Non-proprietary)
Fluvastatin (as Fluvastatin sodium) 80 mgFluvastatin 80 mg
modified-release tablets| 28 tabletPsDT = £ 19. 20
▶Dorisin XL(Aspire Pharma Ltd)
Fluvastatin (as Fluvastatin sodium) 80 mgDorisin XL 80 mg
tablets| 28 tabletP£ 19. 20 DT = £ 19. 20
▶Lescol XL(Novartis Pharmaceuticals UK Ltd)
Fluvastatin (as Fluvastatin sodium) 80 mgLescol XL 80 mg tablets
| 28 tabletP£ 19. 20 DT = £ 19. 20
▶Nandovar XL(Sandoz Ltd)
Fluvastatin (as Fluvastatin sodium) 80 mgNandovar XL 80 mg
tablets| 28 tabletP£ 16. 32 DT = £ 19. 20
Capsule
▶Fluvastatin (Non-proprietary)
Fluvastatin (as Fluvastatin sodium) 20 mgFluvastatin 20 mg
capsules| 28 capsuleP£ 6. 96 DT = £ 2. 01
Fluvastatin (as Fluvastatin sodium) 40 mgFluvastatin 40 mg
capsules| 28 capsuleP£ 7. 42 DT = £ 2. 22


eiiiiF 131

Pravastatin sodium 04-Jun-2017


lINDICATIONS AND DOSE
Hyperlipidaemia including familial hypercholesterolaemia
▶BY MOUTH
▶Child 8–13 years: 10 mg daily, then increased if
necessary up to 20 mg daily, dose to be taken at night,
dose to be adjusted at intervals of at least 4 weeks
▶Child 14–17 years: 10 mg daily, then increased if
necessary up to 40 mg daily, dose to be taken at night,
dose to be adjusted at intervals of at least 4 weeks

lINTERACTIONS→Appendix 1 : statins


lSIDE-EFFECTS
▶UncommonFatigue.hair abnormal.scalp abnormal.
urinary disorders.vision disorders
▶Rare or very rareFulminant hepatic necrosis.polymyositis


lBREAST FEEDINGManufacturer advises avoid—small
amount of drug present in breast milk.


lRENAL IMPAIRMENT
Dose adjustmentsStart with lower doses in moderate to
severe impairment.


lPATIENT AND CARER ADVICEPatient counselling is advised
for pravastatin tablets (muscle effects).


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
Tablet
▶Pravastatin sodium (Non-proprietary)
Pravastatin sodium 10 mgPravastatin 10 mg tablets|
28 tabletP£ 16. 10 DT = £ 0. 55
Pravastatin sodium 20 mgPravastatin 20 mg tablets|
28 tabletP£ 29. 60 DT = £ 0. 87
Pravastatin sodium 40 mgPravastatin 40 mg tablets|
28 tabletP£ 29. 60 DT = £ 1. 10

eiiiiF 131

Rosuvastatin 05-Feb-2018


lINDICATIONS AND DOSE
Heterozygous familial hypercholesterolaemia (specialist
use only)
▶BY MOUTH
▶Child 6–9 years:Initially 5 mg once daily, then
increased if necessary up to 10 mg once daily, dose to
be increased gradually at intervals of at least 4 weeks
▶Child 10–17 years:Initially 5 mg once daily, then
increased if necessary up to 20 mg once daily, dose to
be increased gradually at intervals of at least 4 weeks,
use lower max. dose in children with risk factors for
myopathy or rhabdomyolysis (including personal or
family history of muscular disorders or toxicity)
Homozygous familial hypercholesterolaemia (specialist
use only)
▶BY MOUTH
▶Child 6–17 years:Initially 5 – 10 mg once daily, then
increased if necessary up to 20 mg once daily, dose to
be increased gradually at intervals of at least 4 weeks,
use lower max. dose in children with risk factors for
myopathy or rhabdomyolysis (including personal or
family history of muscular disorders or toxicity)
▶Child 6–17 years (patients of Asian origin):Initially 5 mg
once daily, then increased if necessary up to 20 mg
once daily, dose to be increased gradually at intervals
of at least 4 weeks, use lower max. dose in children
with risk factors for myopathy or rhabdomyolysis
(including personal or family history of muscular
disorders or toxicity)

lCAUTIONSKnown genetic polymorphisms—consult
product literature.patients of Asian origin
lINTERACTIONS→Appendix 1 : statins
lSIDE-EFFECTS
▶Rare or very rareArthralgia.gynaecomastia.haematuria.
polyneuropathy
▶Frequency not knownCough.dyspnoea.oedema.
proteinuria.Stevens-Johnson syndrome.tendon disorders
lBREAST FEEDINGManufacturer advises avoid—no
information available.
lRENAL IMPAIRMENTAvoid if estimated glomerular
filtration rate less than 30 mL/minute/ 1. 73 m^2.
Dose adjustmentsReduce dose if estimated glomerular
filtration rate less than 60 mL/minute/ 1. 73 m^2.
lMONITORING REQUIREMENTSManufacturer advises
consider routine monitoring of renal function when using
40 mg daily dose.
lPATIENT AND CARER ADVICEPatient counselling is advised
for rosuvastatin tablets (muscle effects).

BNFC 2018 – 2019 Hyperlipidaemia 133


Cardiovascular system

2

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