Atovaquone/Proguanil

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Atovaquone/Proguanil on Prescriptsy

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Atovaquone/proguanil is a combination antimalarial medicine prescribed for the prevention and treatment of Plasmodium falciparum malaria.

Known widely by the brand name Malarone, this fixed-dose combination contains atovaquone, a hydroxynaphthoquinone antiparasitic, and proguanil hydrochloride, a biguanide antimalarial.

Together they provide synergistic activity against the blood and liver stages of the malaria parasite, making atovaquone/proguanil one of the most effective prophylactic antimalarials available to UK travellers.

Malaria remains a significant global health threat.

Public Health England (now UKHSA) reports approximately 1,300-1,800 imported malaria cases in the UK annually, with 2 to 10 deaths per year.

The vast majority of cases occur in travellers who either took no prophylaxis or used it inconsistently.

Sub-Saharan Africa accounts for over 90% of UK-imported cases, predominantly caused by P. falciparum, the most dangerous species. Atovaquone/proguanil is active against chloroquine-resistant P.

falciparum strains that now predominate across Africa, South-East Asia and parts of South America.

This product information has been reviewed by Dr.

Claire Phipps, MBBS MRCGP (GMC 7014359), and provides a detailed clinical overview of atovaquone/proguanil covering its mechanism of action, prophylactic and treatment dosing, side effects, contraindications, travel health guidance and practical advice for UK patients.

Essential safety information about atovaquone/proguanil

No antimalarial provides 100% protection against malaria. Atovaquone/proguanil must be used alongside mosquito bite prevention measures including insect repellent containing DEET, permethrin-treated bed nets, and appropriate clothing. Three critical points for all users:

• Any fever during travel in a malarious area or within 12 months of return is a medical emergency until malaria is excluded, attend A&E immediately and state your travel history
• Take every dose with food or a milky drink, absorption of atovaquone approximately doubles with dietary fat, and subtherapeutic levels risk prophylaxis failure
• Complete the full 7-day post-travel course without fail, stopping early is the commonest cause of breakthrough malaria after prophylaxis

Atovaquone/proguanil is a prescription-only medicine. Before travelling, consult a travel health adviser, your GP, or a legitimate online travel health service to confirm the appropriate antimalarial for your destination, duration of travel, and individual medical circumstances.

How atovaquone/proguanil works

The combination exploits two distinct mechanisms against the malaria parasite.

Atovaquone selectively inhibits the mitochondrial electron transport chain of Plasmodium species by binding to the cytochrome bc1 complex (complex III) at the ubiquinol oxidation site.

This collapses the parasite's mitochondrial membrane potential, halting pyrimidine biosynthesis and ATP production, which kills the parasite.

Proguanil is a prodrug metabolised in the liver to cycloguanil, which inhibits parasite dihydrofolate reductase (DHFR), disrupting folate synthesis essential for DNA replication.

Importantly, proguanil also has an intrinsic synergistic effect with atovaquone independent of its conversion to cycloguanil: it enhances the collapse of mitochondrial membrane potential caused by atovaquone, even in parasites carrying DHFR resistance mutations.

This dual mechanism reduces the likelihood of resistance developing during treatment.

Atovaquone/proguanil has causal prophylactic activity, meaning it acts against the pre-erythrocytic (liver) stage parasites as well as the blood-stage parasites.

This is why the post-travel continuation period is only 7 days, compared with 4 weeks for suppressive prophylactics such as doxycycline and mefloquine that act primarily on blood-stage parasites.

The shorter post-travel course improves patient adherence and makes atovaquone/proguanil particularly convenient for short trips.

Who should use atovaquone/proguanil

Malaria prophylaxis for travellers

Atovaquone/proguanil is recommended as first-line malaria prophylaxis for UK travellers to areas with chloroquine-resistant P.

falciparum, which includes most of sub-Saharan Africa, parts of South and South-East Asia, and the Amazon basin.

The UK Advisory Committee on Malaria Prevention (ACMP) guidelines, published by UKHSA, recommend it alongside doxycycline and mefloquine as options for travellers to these regions.

Choice between these agents depends on individual factors including medical history, pregnancy status, duration of travel, cost preference, and tolerance of side effects.

Atovaquone/proguanil is particularly suitable for short trips (due to the short lead-in and post-travel course), last-minute travel (can be started just 1-2 days before departure), travellers who experience photosensitivity with doxycycline, and those who prefer to avoid the neuropsychiatric side effects occasionally associated with mefloquine.

Treatment of uncomplicated malaria

Atovaquone/proguanil is licensed for the treatment of acute uncomplicated P. falciparum malaria. The treatment dose is four standard tablets taken once daily for 3 days.

It is not suitable for severe or complicated malaria, which requires urgent hospital admission and intravenous artesunate.

In the UK, all confirmed malaria cases should be managed under specialist infectious disease or tropical medicine supervision, typically through the Hospital for Tropical Diseases or regional infectious disease units.

Dosing instructions

Prophylaxis (prevention): Adults take one standard tablet (250mg atovaquone / 100mg proguanil) once daily. Begin 1-2 days before entering the malarious area. Continue daily throughout the stay.

Continue for 7 days after leaving the malarious area. Take at the same time each day, with food.

For children, paediatric strength tablets (62.5mg atovaquone / 25mg proguanil) are used: children weighing 11-20kg take one paediatric tablet daily, 21-30kg take two, 31-40kg take three, and children over 40kg take one adult tablet daily.

Atovaquone/proguanil is not licensed for children under 11kg body weight.

Treatment: Adults take four standard tablets as a single dose once daily for 3 consecutive days, with food.

Paediatric treatment doses are weight-based: 11-20kg takes one adult tablet daily for 3 days, 21-30kg takes two, 31-40kg takes three, and over 40kg takes four (adult dose).

If vomiting occurs within 1 hour, the dose should be repeated.

No dose adjustment is needed in mild to moderate renal impairment.

Atovaquone/proguanil is contraindicated for prophylaxis in severe renal impairment (creatinine clearance below 30 ml/min) and should be used with caution for treatment in this group.

Hepatic impairment does not require dose adjustment but liver function should be monitored.

Side effects of atovaquone/proguanil

Common side effects

Atovaquone/proguanil is generally well tolerated, which is one reason for its popularity among travellers. The most common side effects, reported in prophylactic use, include:

• Gastrointestinal: nausea, abdominal pain, vomiting, and diarrhoea (reduced by taking with food)
• Neurological: headache, dizziness, and vivid or unusual dreams
• General: mouth ulcers, anorexia, and fatigue
• Skin: rash and pruritus (uncommon)

These side effects are generally mild and self-limiting.

In comparative trials, atovaquone/proguanil had a significantly lower rate of neuropsychiatric side effects than mefloquine and a lower rate of photosensitivity than doxycycline.

Gastrointestinal side effects often improve after the first 2-3 days of treatment.

Uncommon and serious side effects

Uncommonly, atovaquone/proguanil may cause insomnia, cough, transient elevation of liver enzymes, and hair loss.

Rare but serious reactions include hepatitis, cholestatic jaundice, pancytopenia, and severe skin reactions (Stevens-Johnson syndrome, erythema multiforme). Anaphylaxis is extremely rare.

Seek urgent medical attention for skin blistering, jaundice, persistent vomiting preventing further dosing, or signs of severe allergic reaction.

Contact your GP or call NHS 111 for advice on managing troublesome side effects. In an emergency, call 999. Report suspected adverse reactions to the MHRA via the Yellow Card Scheme at yellowcard.mhra.gov.uk.

Warnings, contraindications and interactions

Atovaquone/proguanil is contraindicated in patients with known hypersensitivity to atovaquone or proguanil, and for prophylactic use in patients with severe renal impairment (creatinine clearance below 30 ml/min). Key drug interactions that reduce atovaquone levels and may compromise efficacy include:

• Metoclopramide and tetracycline: reduce atovaquone bioavailability, avoid concurrent use if possible
• Rifampicin and rifabutin: reduce atovaquone plasma levels by approximately 50%, an alternative antimalarial should be chosen
• Warfarin: proguanil may enhance anticoagulant effect, INR monitoring is required
• Efavirenz and lopinavir/ritonavir: significant reduction in atovaquone levels reported

Persistent diarrhoea or vomiting during prophylaxis compromises absorption and therefore efficacy. If you experience gastrointestinal illness lasting more than 24 hours while in a malarious area, seek medical advice about supplementary protection or alternative arrangements.

Pregnancy, breastfeeding and special populations

Atovaquone/proguanil is not recommended in pregnancy due to insufficient human safety data. Animal reproductive studies with atovaquone have shown adverse developmental effects.

Proguanil alone has a longer safety record in pregnancy but the combination product should be avoided. Pregnant women should ideally avoid travel to malaria-endemic areas.

Where travel cannot be avoided, specialist advice should be sought from a travel medicine clinic or tropical disease unit.

Atovaquone is excreted in animal breast milk and likely passes into human breast milk. The manufacturer advises against use during breastfeeding.

The safety of the combination in infants below 11kg body weight (including those exposed through breast milk) has not been established.

Travel health advice for UK travellers

Before travelling to a malarious area, obtain up-to-date destination-specific advice from the UKHSA malaria prevention guidelines (available via TravelHealthPro at travelhealthpro.org.uk), a NHS travel health clinic, your GP surgery, or a legitimate online travel health consultation.

Antimalarial prophylaxis is just one component of malaria prevention. Effective bite prevention measures include:

• DEET-based insect repellent (50% concentration for tropical destinations) applied to exposed skin
• Sleeping under a long-lasting insecticide-treated net (LLIN), ensuring it is tucked in securely
• Wearing long-sleeved tops, long trousers, and socks during peak mosquito feeding times (dusk to dawn)
• Using air conditioning or mesh screens on windows and doors where available
• Permethrin treatment of clothing for additional protection in high-risk settings

Antimalarial prophylaxis is generally not available on the NHS and requires a private prescription. Cost varies between pharmacies.

Generic atovaquone/proguanil is substantially less expensive than the branded Malarone product and is clinically equivalent. Compare prices between high-street pharmacies, online pharmacies, and travel clinics.

Sources and further reading

• Electronic Medicines Compendium (EMC), Malarone SmPC: medicines.org.uk/emc
• British National Formulary (BNF), Atovaquone with proguanil: bnf.nice.org.uk
• UKHSA, Guidelines for malaria prevention in travellers from the UK: gov.uk
• TravelHealthPro, NaTHNaC country information: travelhealthpro.org.uk
• NHS, Malaria: nhs.uk/conditions/malaria
• MHRA Yellow Card Scheme: yellowcard.mhra.gov.uk