BNF for Children (BNFC) 2018-2019

(singke) #1
Treatment of venous thromboembolism in pregnancy
▶BY SUBCUTANEOUS INJECTION
▶Child 12–17 years (body-weight up to 50 kg): 40 mg twice
daily, dose based on early pregnancy body-weight
▶Child 12–17 years (body-weight 50–69 kg): 60 mg twice
daily, dose based on early pregnancy body-weight
▶Child 12–17 years (body-weight 70–89 kg): 80 mg twice
daily, dose based on early pregnancy body-weight
▶Child 12–17 years (body-weight 90 kg and above): 100 mg
twice daily, dose based on early pregnancy body-
weight
Prophylaxis of thrombotic episodes
▶BY SUBCUTANEOUS INJECTION
▶Neonate: 750 micrograms/kg twice daily.

▶Child 1 month: 750 micrograms/kg twice daily
▶Child 2 months–17 years: 500 micrograms/kg twice daily;
maximum 40 mg per day
DOSE EQUIVALENCE AND CONVERSION
▶ 1 mg equivalent to 100 units.

lUNLICENSED USENot licensed for treatment of venous
thromboembolism in pregnancy.
Not licensed for use in children.
lINTERACTIONS→Appendix 1 : low molecular-weight
heparins


lSIDE-EFFECTS
▶Common or very commonHypersensitivity
▶Frequency not knownCutaneous vasculitis.eosinophilia.
haemorrhagic anaemia.headache.hepatic disorders


lPREGNANCYNot known to be harmful, low molecular
weight heparins do not cross the placenta. Multidose vial
contains benzyl alcohol—avoid.


lBREAST FEEDINGDue to the relatively high molecular
weight of enoxaparin and inactivation in the gastro-
intestinal tract, passage into breast-milk and absorption
by the nursing infant are likely to be negligible; however
manufacturers advise avoid.


lHEPATIC IMPAIRMENT
Dose adjustmentsReduce dose in severe impairment—risk
of bleeding may be increased.


lRENAL IMPAIRMENTRisk of bleeding increased; use of
unfractionated heparin may be preferable. Consult
specialist sources.


lMONITORING REQUIREMENTSRoutine monitoring of anti-
Factor Xa activity is not usually required during treatment
with enoxaparin, except in neonates; monitoring may also
be necessary in severely ill children and those with renal or
hepatic impairment.


lPRESCRIBING AND DISPENSING INFORMATIONEnoxaparin
sodium is a biological medicine. Biological medicines must
be prescribed and dispensed by brand name, seeBiological
medicinesandBiosimilar medicines, under Guidance on
prescribing p. 1.


lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Solution for injection
EXCIPIENTS:May contain Benzyl alcohol
▶Clexane(Sanofi)
Enoxaparin sodium 100 mg per 1 mlClexane 60 mg/ 0. 6 ml solution
for injection pre-filled syringes| 10 pre-filled disposable
injectionP£ 39. 26 DT = £ 39. 26
Clexane 300 mg/ 3 ml solution for injection multidose vials|
1 vialP£ 21. 33 DT = £ 21. 33
Clexane 80 mg/ 0. 8 ml solution for injection pre-filled syringes| 10 pre-
filled disposable injectionP£ 55. 13 DT = £ 55. 13
Clexane 40 mg/ 0. 4 ml solution for injection pre-filled syringes| 10 pre-
filled disposable injectionP£ 30. 27 DT = £ 30. 27
Clexane 100 mg/ 1 ml solution for injection pre-filled syringes| 10 pre-
filled disposable injectionP£ 72. 30 DT = £ 72. 30


Clexane 20 mg/ 0. 2 ml solution for injection pre-filled syringes| 10 pre-
filled disposable injectionP£ 20. 86 DT = £ 20. 86
Enoxaparin sodium 150 mg per 1 mlClexane Forte 120 mg/ 0. 8 ml
solution for injection pre-filled syringes| 10 pre-filled disposable
injectionP£ 87. 93 DT = £ 87. 93
Clexane Forte 150 mg/ 1 ml solution for injection pre-filled syringes|
10 pre-filled disposable injectionP£ 99. 91 DT = £ 99. 91
▶Enoxaparin Becat(ROVI Biotech Ltd)A
Enoxaparin sodium 100 mg per 1 mlEnoxaparin Becat 40 mg/ 0. 4 ml
solution for injection pre-filled syringes| 10 pre-filled disposable
injectionP£ 30. 27 DT = £ 30. 27
Enoxaparin Becat 60 mg/ 0. 6 ml solution for injection pre-filled syringes
| 10 pre-filled disposable injectionP£ 39. 26 DT = £ 39. 26
Enoxaparin Becat 100 mg/ 1 ml solution for injection pre-filled syringes
| 10 pre-filled disposable injectionP£ 72. 30 DT = £ 72. 30
Enoxaparin Becat 20 mg/ 0. 2 ml solution for injection pre-filled syringes
| 10 pre-filled disposable injectionP£ 20. 86 DT = £ 20. 86
Enoxaparin Becat 80 mg/ 0. 8 ml solution for injection pre-filled syringes
| 10 pre-filled disposable injectionP£ 55. 13 DT = £ 55. 13
▶Inhixa(Techdow Pharma England Ltd)A
Enoxaparin sodium 100 mg per 1 mlInhixa 40 mg/ 0. 4 ml solution
for injection pre-filled syringes| 10 pre-filled disposable
injectionP£ 24. 22 DT = £ 30. 27
Inhixa 80 mg/ 0. 8 ml solution for injection pre-filled syringes| 10 pre-
filled disposable injectionP£ 44. 10 DT = £ 55. 13
Inhixa 60 mg/ 0. 6 ml solution for injection pre-filled syringes| 10 pre-
filled disposable injectionP£ 31. 41 DT = £ 39. 26
Inhixa 100 mg/ 1 ml solution for injection pre-filled syringes| 10 pre-
filled disposable injectionP£ 57. 84 DT = £ 72. 30
Inhixa 20 mg/ 0. 2 ml solution for injection pre-filled syringes| 10 pre-
filled disposable injectionP£ 16. 69 DT = £ 20. 86
eiiiiF 93

Heparin (unfractionated)


lINDICATIONS AND DOSE
Prevention of clotting in extracorporeal circuits
▶TO THE DEVICE AS A FLUSH
▶Child:(consult product literature)
Maintenance of neonatal umbilical arterial catheter
▶BY INTRAVENOUS INFUSION
▶Neonate: 0. 5 unit/hour.

Treatment of thombotic episodes
▶INITIALLY BY INTRAVENOUS INJECTION
▶Neonate up to 35 weeks corrected gestational age:Initially
50 units/kg, then (by continuous intravenous infusion)
25 units/kg/hour, adjusted according to APTT.

▶Neonate:Initially 75 units/kg, then (by continuous
intravenous infusion) 25 units/kg/hour, adjusted
according to APTT.

▶Child 1–11 months:Initially 75 units/kg, then (by
continuous intravenous infusion) 25 units/kg/hour,
adjusted according to APTT
▶Child 1–17 years:Initially 75 units/kg, then (by
continuous intravenous infusion) 20 units/kg/hour,
adjusted according to APTT
▶BY SUBCUTANEOUS INJECTION
▶Child: 250 units/kg twice daily, adjusted according to
APTT
Prophylaxis of thrombotic episodes
▶BY SUBCUTANEOUS INJECTION
▶Child: 100 units/kg twice daily (max. per dose
5000 units), adjusted according to APTT
Maintenance of cardiac shunts and critical stents
▶TO THE DEVICE AS A FLUSH
▶Child:(consult local protocol)

lUNLICENSED USECheck product literature for licensed use
in children.
lINTERACTIONS→Appendix 1 : heparin (unfractionated)
lSIDE-EFFECTSAdrenal insufficiency.hypokalaemia.
rebound hyperlipidaemia

BNFC 2018 – 2019 Thromboembolism 95


Cardiovascular system

2

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