BNF for Children (BNFC) 2018-2019

(singke) #1

Abacavir with lamivudine and


zidovudine


The properties listed below are those particular to the
combination only. For the properties of the components
please consider, abacavir p. 416 , lamivudine p. 420 ,
zidovudine p. 422.


lINDICATIONS AND DOSE
HIV infection (use only if patient is stabilised for
6 – 8 weeks on the individual components in the same
proportions)
▶BY MOUTH
▶Child (body-weight 30 kg and above): 1 tablet twice daily

lUNLICENSED USETrizivir®not licensed for use in children.


lINTERACTIONS→Appendix 1 : abacavir.lamivudine.
zidovudine


lRENAL IMPAIRMENTAvoidTrizivir®if estimated
glomerularfiltration rate less than 50 mL/minute/ 1. 73 m^2.


lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Tablet
▶Trizivir(ViiV Healthcare UK Ltd)
Lamivudine 150 mg, Abacavir (as Abacavir sulfate) 300 mg,
Zidovudine 300 mgTrizivir tablets| 60 tabletP£ 509. 06


eiiiiF 415

Didanosine 01-Sep-2016


(ddI; DDI)


lINDICATIONS AND DOSE
HIV infection in combination with other antiretroviral
drugs
▶BY MOUTH
▶Child 1–7 months: 50 – 100 mg/m^2 twice daily
▶Child 8 months–17 years: 180 – 240 mg/m^2 once daily;
usual dose 200 mg/m^2 once daily; maximum 400 mg
per day

lUNLICENSED USETablets not licensed for use in children
under 3 months. EC capsules not licensed for use in
children under 6 years.


lCAUTIONSHistory of pancreatitis (preferably avoid,
otherwise extreme caution).hyperuricaemia.lactic
acidosis.peripheral neuropathy
CAUTIONS, FURTHER INFORMATION
▶Lactic acidosisLactic acidosis associated with hepatomegaly
and hepatic steatosis has been reported with didanosine.
Use with caution in patients with hepatomegaly, hepatitis,
or other risk factors for liver disease and hepatic steatosis
(including obesity and alcohol abuse). Discontinue
treatment if symptoms of hyperlactataemia, lactic
acidosis, progressive hepatomegaly or rapid deterioration
of liver function become apparent.


lINTERACTIONS→Appendix 1 : didanosine


lSIDE-EFFECTS
▶Common or very commonArthralgia.chills.dry mouth.
fever.flatulence.gynaecomastia.hepatic disorders.pain.
peripheral neuropathy (switch to another antiretroviral if
peripheral neuropathy develops)
▶UncommonAcute kidney injury.alopecia.diabetes
mellitus.dry eye.haemodialysis.hyperglycaemia.
hypoglycaemia.leucopenia.myopathy.optic neuritis.
retinal discolouration.sialadenitis
▶Rare or very rareParotid gland enlargement
▶Frequency not knownLipoatrophy


SIDE-EFFECTS, FURTHER INFORMATION

PancreatitisSuspend treatment if serum lipase raised or
if symptoms of pancreatitis develop; discontinue if
pancreatitis confirmed. Whenever possible avoid
concomitant treatment with other drugs known to cause
pancreatic toxicity; monitor closely if concomitant therapy
unavoidable. Since significant elevations of triglycerides
cause pancreatitis monitor closely if elevated.
Lipodystrophy syndromeMetabolic effects may occur
with didanosine: these include fat redistribution, insulin
resistance, and dyslipidaemia—collectively termed
lipodystrophy syndrome. Manufacturer advises monitoring
of plasma lipids and blood-glucose.
lPREGNANCYManufacturer advises use only if potential
benefit outweighs risk.
lHEPATIC IMPAIRMENT
MonitoringIn hepatic impairment, monitor for toxicity.
lRENAL IMPAIRMENT
Dose adjustmentsReduce dose if estimated glomerular
filtration rate less than 60 mL/minute/ 1. 73 m

2
; consult
product literature.
lMONITORING REQUIREMENTSOphthalmological
examination (including visual acuity, colour vision, and
dilated fundus examination) recommended annually or if
visual changes occur.
lDIRECTIONS FOR ADMINISTRATIONCapsules should be
swallowed whole and taken at least 2 hours before or
2 hours after food.
With chewable tablets, to ensure sufficient antacid, each
dose to be taken as at least 2 tablets (child under 1 year
1 tablet) chewed thoroughly, crushed or dispersed in
water; clear apple juice may be added forflavouring;
tablets to be taken 2 hours after lopinavir with ritonavir
capsules and oral solution or atazanavir with ritonavir.
lPATIENT AND CARER ADVICEPatients or carers should be
given advice on how to administer didanosine capsules
and chewable tablets.

lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Gastro-resistant capsule
CAUTIONARY AND ADVISORY LABELS 25
▶Videx EC(Bristol-Myers Squibb Pharmaceuticals Ltd)
Didanosine 125 mgVidex EC 125 mg capsules| 30 capsuleP
£ 48. 18 (Hospital only)
Didanosine 200 mgVidex EC 200 mg capsules| 30 capsuleP
£ 77. 09 (Hospital only)
Didanosine 250 mgVidex EC 250 mg capsules| 30 capsuleP
£ 96. 37 (Hospital only)
Didanosine 400 mgVidex EC 400 mg capsules| 30 capsuleP
£ 154. 19 (Hospital only)
Chewable tablet
CAUTIONARY AND ADVISORY LABELS 23
EXCIPIENTS:May contain Aspartame
▶Videx(Bristol-Myers Squibb Pharmaceuticals Ltd)
Didanosine 25 mgVidex 25 mg chewable dispersible tablets sugar-
free| 60 tabletP£ 25. 06 (Hospital only)

BNFC 2018 – 2019 HIV infection 417


Infection

5

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