OTCConsult

Atovaquone and Proguanil

Deregulated medicines

Indications for use
  • Chemoprophylaxis of Plasmodium falciparum (P. Falciparum) malaria in adults. It is especially recommended where the pathogen may be resistant to other antimalarials
  • The manufacturer states that “official guidelines and local information on the prevalence of resistance to antimalarial drugs should be taken into consideration. Official guidelines will normally include World Health Organisation (WHO) and public health authorities' guidelines.”
Age
  • 18 years +
Dose/Directions
  • One tablet daily, with food or a milky drink (to ensure maximum absorption) at the same time each day. If patients are unable to tolerate food, Maloff Protect® should be administered (but systemic exposure of atovaquone will be reduced
  • In the event of vomiting within one hour of taking the tablet, a repeat dose should be taken
  • The tablets should preferably not be crushed
Duration
  • The tablets should be commenced one to two days prior to entering a malaria-endemic area, during the period of the stay and continued for seven days after leaving the area
  • The maximum duration of travel for which Maloff Protect® can be supplied without prescription is 12 weeks (93 tablets). For longer durations of travel, advice should be sought from a doctor or other qualified prescriber
Contra-indications/referral criteria
  • Not recommended for malaria chemoprophylaxis in persons under 40 kg bodyweight
  • Hypersensitivity to the active substances or to any of the excipients
  • Renal or hepatic impairment of any severity
  • Children and adolescents
  • Maloff Protect® should not be used unless advised by a doctor or other qualified prescriber in the following circumstances:
    • In patients taking etoposide, rifampicin or rifabutin, metoclopramide, warfarin or other oral anticoagulant, tetracycline, indinavir, efavirenz, zidovudine or boosted protease inhibitors (see SmPC for further guidance)
  • In patients with a history of depression or seizures
  • In patients with tuberculosis
  • Patients who are pregnant, planning to become pregnant, or breastfeeding
Examples of drug interactions

  • See above (etoposide, rifampicin or rifabutin, metoclopramide, warfarin or other oral anticoagulant, tetracycline, indinavir, efavirenz, zidovudine or boosted protease inhibitors)

Side-effects
  • Dizziness has been reported, therefore patients should be warned that if affected they should not drive, operate machinery or take part in activities where this may put themselves or others at risk
  • In clinical trials the most commonly reported adverse reactions were headache, abdominal pain and diarrhoea
Other pertinent information
  • Advise to take a repeat dose if patients vomit within one hour of dosing; in the event of diarrhoea, normal dosing should be continued
  • The manufacturer states that absorption of atovaquone may be reduced in patients with diarrhoea or vomiting (but diarrhoea or vomiting was not associated with reduced efficacy in clinical trials of Maloff Protect for malaria chemoprophylaxis)
  • Patients with diarrhoea or vomiting should be advised to continue with malaria prevention measures by complying with other personal protection/bite avoidance measures (repellents, bed nets)
  • NB: malaria prophylaxis is only one aspects of pre-travel advice; travellers should be reminded about the need to receive a full travel consultation (including vaccination advice and guidance on traveller’s diarrhoea and other country-specific risks). See Travel Health Pro website for further information
  • Reclassified POM→P: 2017

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