BNF for Children (BNFC) 2018-2019

(singke) #1
treatment should be discontinued. If symptoms resolve
and creatine kinase concentrations return to normal, the
statin should be reintroduced at a lower dose and the
patient monitored closely.
Interstitial lung diseaseIf patients develop symptoms
such as dyspnoea, cough, and weight loss, they should
seek medical attention.
lCONCEPTION AND CONTRACEPTIONAdequate
contraception is required during treatment and for
1 month afterwards.
lPREGNANCYStatins should be avoided in pregnancy
(discontinue 3 months before attempting to conceive) as
congenital anomalies have been reported and the
decreased synthesis of cholesterol possibly affects fetal
development.
lHEPATIC IMPAIRMENTStatins should be used with caution
in those with a history of liver disease. Avoid in active liver
disease or when there are unexplained persistent
elevations in serum transaminases.
lMONITORING REQUIREMENTS
▶Before starting treatment with statins, at least one full
lipid profile (non-fasting) should be measured, including
total cholesterol, HDL-cholesterol, non-HDL-cholesterol
(calculated as total cholesterol minus HDL-cholesterol),
and triglyceride concentrations, thyroid-stimulating
hormone, and renal function should also be assessed.
▶Liver functionThere is little information available on a
rational approach to liver-function monitoring; however,
NICE suggests that liver enzymes should be measured
before treatment, and repeated within 3 months and at
12 months of starting treatment, unless indicated at other
times by signs or symptoms suggestive of hepatotoxicity
(NICE clinical guideline 181 (July 2014 ). Lipid
Modification—Cardiovascular risk assessment and the
modification of blood lipids for the primary and secondary
prevention of cardiovascular disease).
Those with serum transaminases that are raised, but less
than^3 times the upper limit of the reference range, should
notbe routinely excluded from statin therapy. Those with
serum transaminases of more than 3 times the upper limit
of the reference range should discontinue statin therapy.
▶Creatine kinaseCreatine kinase concentration should be
measured in children before treatment and if unexplained
muscle pain occurs.
lPATIENT AND CARER ADVICEAdvise patients to report
promptly unexplained muscle pain, tenderness, or
weakness.

eiiiiF 131

Atorvastatin 07-Jun-2017


lINDICATIONS AND DOSE
Hyperlipidaemia including familial hypercholesterolaemia
▶BY MOUTH
▶Child 10–17 years:Initially 10 mg once daily, then
increased if necessary up to 20 mg once daily, dose to
be adjusted at intervals of at least 4 weeks
Homozygous familial hypercholestrolaemia
▶BY MOUTH
▶Child 10–17 years:Initially 10 mg once daily, then
increased if necessary up to 80 mg once daily, dose to
be adjusted at intervals of at least 4 weeks
DOSE ADJUSTMENTS DUE TO INTERACTIONS
▶Manufacturer advises if concurrent use of ciclosporin is
unavoidable, max. dose cannot exceed 10 mg daily.

lCAUTIONSHaemorrhagic stroke
lINTERACTIONS→Appendix 1 : statins

lSIDE-EFFECTS
▶Common or very commonEpistaxis.hyperglycaemia.
hypersensitivity.joint disorders.laryngeal pain.
nasopharyngitis.pain
▶UncommonAppetite decreased.burping.chest pain.
fatigue.fever.hearing impairment.hypoglycaemia.
malaise.numbness.peripheral oedema.taste altered.
vision disorders.weight increased
▶Rare or very rareAngioedema.gynaecomastia.severe
cutaneous adverse reactions (SCARs).skin reactions
lBREAST FEEDINGManufacturer advises avoid—no
information available.
lPATIENT AND CARER ADVICEPatient counselling is advised
for atorvastatin tablets (muscle effects).
Medicines for Children leaflet: Atorvastatin for high cholesterol
http://www.medicinesforchildren.org.uk/atorvastatin-high-
cholesterol- 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, oral solution
Tablet
▶Atorvastatin (Non-proprietary)
Atorvastatin (as Atorvastatin calcium trihydrate)
10 mgAtorvastatin 10 mg tablets| 28 tabletP£ 13. 00 DT = £ 0. 57
| 90 tabletP£ 41. 78
Atorvastatin (as Atorvastatin calcium trihydrate)
20 mgAtorvastatin 20 mg tablets| 28 tabletP£ 24. 64 DT = £ 0. 70
| 90 tabletP£ 79. 20
Atorvastatin (as Atorvastatin calcium trihydrate)
30 mgAtorvastatin 30 mg tablets| 28 tabletP£ 24. 76 DT =
£ 24. 63
Atorvastatin (as Atorvastatin calcium trihydrate)
40 mgAtorvastatin 40 mg tablets| 28 tabletP£ 24. 64 DT = £ 0. 98
| 90 tabletP£ 79. 20
Atorvastatin (as Atorvastatin calcium trihydrate)
60 mgAtorvastatin 60 mg tablets| 28 tabletP£ 28. 39 DT =
£ 28. 20
Atorvastatin (as Atorvastatin calcium trihydrate)
80 mgAtorvastatin 80 mg tablets| 28 tabletP£ 28. 21 DT = £ 2. 06
| 90 tabletP£ 90. 67
▶Lipitor(Pfizer Ltd)
Atorvastatin (as Atorvastatin calcium trihydrate) 10 mgLipitor
10 mg tablets| 28 tabletP£ 13. 00 DT = £ 0. 57
Atorvastatin (as Atorvastatin calcium trihydrate) 20 mgLipitor
20 mg tablets| 28 tabletP£ 24. 64 DT = £ 0. 70
Atorvastatin (as Atorvastatin calcium trihydrate) 40 mgLipitor
40 mg tablets| 28 tabletP£ 24. 64 DT = £ 0. 98
Atorvastatin (as Atorvastatin calcium trihydrate) 80 mgLipitor
80 mg tablets| 28 tabletP£ 28. 21 DT = £ 2. 06
Chewable tablet
CAUTIONARY AND ADVISORY LABELS 24
▶Lipitor(Pfizer Ltd)
Atorvastatin (as Atorvastatin calcium trihydrate) 10 mgLipitor
10 mg chewable tablets sugar-free| 30 tabletP£ 13. 80 DT =
£ 13. 80
Atorvastatin (as Atorvastatin calcium trihydrate) 20 mgLipitor
20 mg chewable tablets sugar-free| 30 tabletP£ 26. 40 DT =
£ 26. 40

eiiiiF 131

Fluvastatin 12-Apr-2017


lINDICATIONS AND DOSE
Heterozygous familial hypercholesterolaemia
▶INITIALLY BY MOUTH USING IMMEDIATE-RELEASE MEDICINES
▶Child 9–17 years:Initially 20 mg daily, dose to be taken
in the evening, then (by mouth) adjusted in steps of
20 mg daily (max. per dose 40 mg twice daily), adjusted
at intervals of at least 6 weeks; maximum 80 mg per
day
▶BY MOUTH USING MODIFIED-RELEASE MEDICINES
▶Child 9–17 years: 80 mg daily, dose form is not
appropriate for initial dose titration

132 Hyperlipidaemia BNFC 2018 – 2019


Cardiovascular system

2

Free download pdf