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When you cannot take ATOVAQUONE/ PROGUANIL
  • When you cannot take ATOVAQUONE/ PROGUANIL
  • Cautions
  • Interactions
  • Further Information on Malaria
  • Adverse reactions to ATOVAQUONE/ PROGUANIL
  • Not to be taken if you are:

    .• Hypersensitive to the active substance(s) or to any of the excipients or trace residuals in atovaquone/proguanil tablets.

    • an individual under 12 months of age.

    • Under 11kg in bodyweight.

    • Pregnant (Known or suspected) 

     • Breast-feeding .

     •a  patient with severe hepatic impairment.

    • a patient with severe renal impairment (creatinine clearance < 30mL/minute).

    • a patient receiving renal dialysis.

    •a  patients taking medications that would contraindicate the supply of atovaquone/proguanil (see Product Interactions)

     

  • Repeat dosing 

    • A repeat dose of atovaquone/proguanil should be taken if vomiting occurs within 1 hour of dosing.

    • In the event of diarrhoea, normal dosing should be continued.

    Lactose

    • Some atovaquone/proguanil medicinal products contains lactose monohydrate. If you have rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption you should not take this medicine .

    Planning a Pregnancy • Women of childbearing potential travelling to malarious areas in which multiple resistant P. falciparum is found and who are receiving atovaquone/proguanil for the treatment and prophylaxis of malaria should take reliable contraceptive precautions for the entire duration of therapy and for two weeks after the last dose of atovaquone/proguanil.

     

    Adults:

    • Adult and children weighing over 40 kg: One atovaquone/proguanil 250/100mg tablet daily .

    • Adult tablets are not recommended for malaria prophylaxis in persons 40kg or under.

    In adults weighing 40 kg or under, paediatric doses may be taken as per paediatric guidelines and available on prescription from your GP or travel clinic.

     

    Children:

    • Weight should be used for the purpose of children’s dosage calculation including children who are over or under-weight.

    Table of atovaquone/proguanil dose for 62.5/25mg (paediatric) and 250/100mg (Adult) tablets: 

    Weight         Number of tablets

    11-20 kg      1 paediatric tablet

    21-30 kg      2 paediatric tablets

    31-40 kg      3 paediatric tablets

    Over 40 kg   1 adult tablet

     

    • Children are at particular risk of severe and fatal malaria; therefore, parents should be advised against taking infants and young children to malarious areas without adequate precautions.

    • If travel is unavoidable, infants and children should be well protected against mosquito bites and receive appropriate malaria chemoprophylaxis.

    • It is important that if you are a child’s carer you understand the importance of trying to ensure that the child properly completes the full course of prophylactic medication.

    •You should supervise children’s chemoprophylaxis, as some regimens can be difficult whilst being cautious not to exceed maximum recommended doses, since antimalarials can be particularly toxic to children.

    Allergic reactions

    • Occasionally, severe allergic reactions (including anaphylaxis) have been reported in people taking atovaquone/proguanil tablets. If you experience an allergic reaction to atovaquone/proguanil, your treatment should be discontinued promptly, and medical advice should be sought immediately .

    Oral anticoagulants

    • Caution is advised when initiating or withdrawing malaria prophylaxis or treatment with atovaquone/proguanil if you are on continuous treatment with oral anticoagulants. The dose of the oral anticoagulant may need to be adjusted during treatment or after its withdrawal, based on your INR results.

     

  •  • Concomitant administration of rifampicin, rifabutin, metoclopramide, efavirenz or boosted protease-inhibitors and tetracycline is not recommended .

    • Proguanil may potentiate the effect of warfarin and other coumarin based anticoagulants which may lead to an increase in the risk of haemorrhage .

    • Proguanil is predicted to increase the risk of adverse effects when given with pyrimethamine 

  •  

    Malaria prevention

    •It is a good idea before you travel to make yourself  aware of the current guidelines on malaria prevention and how to recognise signs and symptoms of malaria infection. A useful tool is the widely recognised ABCD approach to malaria prophylaxis: ̵ Awareness of risk ̵ Bite prevention ̵ Chemoprophylaxis ̵ Diagnose malaria promptly and treat without delay.

    More information at Fit For Travel

    • The Advisory Committee on Malaria Prevention (ACMP) recommends the following repellents: ̵ 50% DEET based insect repellent as first choice̵  20% Picaridin based insect repellent ̵ Eucalyptus citriodora oil ̵ 3-ethylaminoproprionate containing repellent

    • Whilst no regime can provide total protection from becoming infected, taking sensible precautions will reduce risks. • If any illness occurs within 1 year and especially within 3 months of return from travelling to a risk area  then it might be malaria even if all recommended precautions against malaria were taken. You should go immediately to a doctor and specifically mention your exposure to malaria. Symptoms of malaria vary but typically include: fever, headache, fatigue, and muscle aches. Cough and diarrhoea may also occur.

    Malaria prevention guidelines for travellers from the UK

    Other useful resources 

    http://travelhealthpro.org.uk/country-information/

    http://www.travax.nhs.uk/

     

  • Very common side effects include (≥1/10): Headache, nausea, vomiting, diarrhoea and abdominal pain .

    Common side effects include (≥1/100 to <1/10): Anaemia, neutropenia, allergic reactions, hyponatraemia, anorexia, abnormal dreams, depression, insomnia, dizziness, elevated liver enzymes, pruritus, rash, fever and cough

    Uncommon side effects include (≥1/1,000 to <1/100): Elevated amylase levels, anxiety, palpitations, stomatitis, hair loss and urticaria .

    Rare side effects include (≥1/10,000 to <1/1,000): Hallucinations

    . • For a comprehensive list of all warnings, cautions and potential adverse reactions, refer to the current SPC 

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