MonitoringManufacturer advises monitor ECG and
plasma-potassium concentration in moderate to severe
renal impairment.
lMONITORING REQUIREMENTS
▶Consider obtaining ECG in all patients before third dose
and 4 – 6 hours after third dose. If QTCinterval more than
500 milliseconds, discontinue treatment and monitor ECG
for a further 24 – 48 hours.
▶Obtain ECG as soon as possible after starting treatment
then continue monitoring in those taking medicines that
increase plasma-piperaquine concentration, in children
who are vomiting or in females.
lDIRECTIONS FOR ADMINISTRATIONTablets to be taken at
least 3 hours before and at least 3 hours after food. Tablets
may be crushed and mixed with water immediately before
administration.
lPATIENT AND CARER ADVICEPatients or carers should be
given advice on how to administer tablets containing
piperaquine phosphate with artenimol.lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Tablet
▶Eurartesim(Logixx Pharma Solutions Ltd)A
Artenimol 40 mg, Piperaquine phosphate 320 mgEurartesim
320 mg/ 40 mg tablets| 12 tabletP£ 40. 00Atovaquone with proguanil
hydrochloride
lINDICATIONS AND DOSE
MALARONE®250 MG/100 MG
Prophylaxis of falciparum malaria, particularly where
resistance to other antimalarial drugs suspected
▶BY MOUTH
▶Child (body-weight 41 kg and above): 1 tablet daily, to be
started 1 – 2 days before entering endemic area and
continued for 1 week after leaving
Treatment of acute uncomplicated falciparum malaria|
Treatment of non-falciparum malaria
▶BY MOUTH
▶Child (body-weight 11–20 kg): 1 tablet once daily for
3 days
▶Child (body-weight 21–30 kg): 2 tablets once daily for
3 days
▶Child (body-weight 31–40 kg): 3 tablets once daily for
3 days
▶Child (body-weight 41 kg and above): 4 tablets once daily
for 3 days
MALARONE®PAEDIATRIC
Prophylaxis of falciparum malaria, particularly where
resistance to other antimalarial drugs suspected
▶BY MOUTH
▶Child (body-weight 5–8kg): 0. 5 tablet once daily, to be
started 1 – 2 days before entering endemic area and
continued for 1 week after leaving
▶Child (body-weight 9–10 kg): 0. 75 tablet once daily, to be
started 1 – 2 days before entering endemic area and
continued for 1 week after leaving
▶Child (body-weight 11–20 kg): 1 tablet once daily, to be
started 1 – 2 days before entering endemic area and
continued for 1 week after leaving
▶Child (body-weight 21–30 kg): 2 tablets once daily, to be
started 1 – 2 days before entering endemic area and
continued for 1 week after leaving
▶Child (body-weight 31–40 kg): 3 tablets once daily, to be
started 1 – 2 days before entering endemic area and
continued for 1 week after leaving▶Child (body-weight 41 kg and above):UseMalarone®
(standard) tablets.
Treatment of acute uncomplicated falciparum malaria|
Treatment of non-falciparum malaria
▶BY MOUTH
▶Child (body-weight 5–8 kg): 2 tablets once daily for 3 days
▶Child (body-weight 9–10 kg): 3 tablets once daily for
3 days
▶Child (body-weight 11 kg and above):UseMalarone®
(standard) tablets.lUNLICENSED USENot licensed for treatment of non-
falciparum malaria. Not licensed for prophylaxis of malaria
in children under 11 kg.
lCAUTIONSDiarrhoea or vomiting (reduced absorption of
atovaquone).efficacy not evaluated in cerebral or
complicated malaria (including hyperparasitaemia,
pulmonary oedema or renal failure)
lINTERACTIONS→Appendix 1 : antimalarials
lSIDE-EFFECTS
▶Common or very commonAbdominal pain.appetite
decreased.cough.depression.diarrhoea.dizziness.fever
.headache.nausea.skin reactions.sleep disorders.
vomiting
▶UncommonAlopecia.anxiety.blood disorder.
hyponatraemia.oral disorders.palpitations
▶Frequency not knownHallucinations.hepatic disorders.
photosensitivity reaction.seizure.Stevens-Johnson
syndrome.tachycardia.vasculitis
lPREGNANCYManufacturer advises avoid unless essential.
lBREAST FEEDINGUse only if no suitable alternative
available.
lRENAL IMPAIRMENTAvoid for malaria prophylaxis and, if
possible, for treatment if estimated glomerularfiltration
rate less than 30 mL/minute/ 1. 73 m^2.
lDIRECTIONS FOR ADMINISTRATION
MALARONE®PAEDIATRICTablets may be crushed and
mixed with food or milky drink just before administration.
lPATIENT AND CARER ADVICEWarn travellers about
importanceof avoiding mosquito bites,importanceof
taking prophylaxis regularly, andimportanceof
immediate visit to doctor if ill within 1 year andespecially
within 3 months of return.
Medicines for Children leaflet: Malarone for prevention of
malariawww.medicinesforchildren.org.uk/malarone-for-
prevention-of-malaria
lNATIONAL FUNDING/ACCESS DECISIONS
NHS restrictionsDrugs for malaria prophylaxis are not
prescribable in NHS primary care; health authorities may
investigate circumstances under which antimalarials are
prescribed.lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Tablet
CAUTIONARY AND ADVISORY LABELS 21
▶Malarone(GlaxoSmithKline UK Ltd)
Proguanil hydrochloride 25 mg, Atovaquone 62.5 mgMalarone
Paediatric 62. 5 mg/ 25 mg tablets| 12 tabletP£ 6. 26
Proguanil hydrochloride 100 mg, Atovaquone 250 mgMalarone
250 mg/ 100 mg tablets| 12 tabletP£ 25. 21 DT = £ 25. 21394 Protozoal infection BNFC 2018 – 2019
Infection5