Atovaquone proguanil side effects

Atovaquone/Proguanil  

A – Be Aware When There is a Risk However Small

  • Find out if there is a malaria risk in the area you are visiting.
  • Aspects of travel may increase the risk e.g. rural travel, rainy season or unscreened accommodation.

B – Keep Mosquito Bites to a Minimum

  • Use clothing to protect the skin, particularly between dusk and dawn when mosquitoes feed.
  • Use DEET- based insect repellent on exposed areas of skin.
  • Sleep under a mosquito net that is impregnated with insecticide.
  • Use air conditioning (if available) and plug in vapourisers to protect your room.

C – Use Antimalarials Correctly

  • The antimalarial tablets recommended for you will depend not only on effectiveness but also on suitability, side effects, cost and which regime suits you best.
  • Tablets must be taken regularly according to the manufacturer’s instructions.
  • Delayed illnesses – the incubation period of the less severe form of malaria may be long (up to a year or more).

D – Report any Feverish Illness Promptly to a Doctor

(Particularly within 3 months of return but even up to 1 year and say you have been to a malarious area.)

  • You may need to take a supply of personal emergency treatment abroad with you if you are going to be remote from medical facilities since treatment should always be started promptly. Discuss this option with a Travel Advisor or other healthcare professional.

Atovaquone/Proguanil

Patient Information Leaflet (PIL) for atovaquone/proguanil

Licensed for prophylaxis in UK.

  • Adult dose is one tablet daily – each tablet contains 250mg atovaquone plus 100mg proguanil. It is licensed for children over 11kg of weight at a lower dosage and a children’s tablet is available.
  • Should be taken to 1 or 2 days before entering the malarious area, throughout exposure, and continued for 7 days after leaving the infected area. Licensed for stays in malarious areas for periods of up to 28 days but can be used safely for up to 1 year (and possibly longer).
  • Take your tablets with food at the same time each day. If you miss a dose or vomit within one hour of taking your tablets, take another dose and carry on as before (you may have to get more tablets). If you have diarrhoea, continue taking your tablets as normal. It is very important to complete the course.
  • Side effects may include: rashes, abdominal pain, headache, anorexia, nausea, diarrhoea, dizziness, change in sleep pattern, coughing and mouth ulcers can occur.
  • Absorption of this medicine may be reduced by diarrhoea and vomiting.
  • Atovaquone/proguanil may interact with other medicines if taken at the same time. These include: tetracyclines, metoclopramide, rifampicin, rifabutin or indinavir.
  • Proguanil can affect the anticoagulant, warfarin, which may result in bleeding. If it has to be used, re-stabilising the prothrombin time before departure is advised. It may be necessary to monitor blood levels whilst overseas and on return.
  • Those with kidney disease should be assessed carefully before taking this medication. Should be avoided in pregnancy and breast feeding unless there is no suitable alternative.
  • Pregnancy should be avoided for 2 weeks after stopping the medication.

back to top

Malarone

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Because MALARONE contains atovaquone and proguanil hydrochloride, the type and severity of adverse reactions associated with each of the compounds may be expected. The lower prophylactic doses of MALARONE were better tolerated than the higher treatment doses.

Prophylaxis of P. falciparum Malaria

In 3 clinical trials (2 of which were placebo-controlled) 381 adults (mean age 31 years) received MALARONE for the prophylaxis of malaria; the majority of adults were black (90%) and 79% were male. In a clinical trial for the prophylaxis of malaria, 125 pediatric patients (mean age 9 years) received MALARONE; all subjects were black and 52% were male. Adverse experiences reported in adults and pediatric patients, considered attributable to therapy, occurred in similar proportions of subjects receiving MALARONE or placebo in all studies. Prophylaxis with MALARONE was discontinued prematurely due to a treatment-related adverse experience in 3 of 381 (0.8%) adults and 0 of 125 pediatric patients.

In a placebo-controlled study of malaria prophylaxis with MALARONE involving 330 pediatric patients (aged 4 to 14 years) in Gabon, a malaria-endemic area, the safety profile of MALARONE was consistent with that observed in the earlier prophylactic studies in adults and pediatric patients. The most common treatment-emergent adverse events with MALARONE were abdominal pain (13%), headache (13%), and cough (10%). Abdominal pain (13% vs. 8%) and vomiting (5% vs. 3%) were reported more often with MALARONE than with placebo. No patient withdrew from the study due to an adverse experience with MALARONE. No routine laboratory data were obtained during this study.

Non-immune travelers visiting a malaria-endemic area received MALARONE (n = 1,004) for prophylaxis of malaria in 2 active-controlled clinical trials. In one study (n = 493), the mean age of subjects was 33 years and 53% were male; 90% of subjects were white, 6% of subjects were black and the remaining were of other racial/ethnic groups. In the other study (n = 511), the mean age of subjects was 36 years and 51% were female; the majority of subjects (97%) were white. Adverse experiences occurred in a similar or lower proportion of subjects receiving MALARONE than an active comparator (Table 3). Fewer neuropsychiatric adverse experiences occurred in subjects who received MALARONE than mefloquine. Fewer gastrointestinal adverse experiences occurred in subjects receiving MALARONE than chloroquine/proguanil. Compared with active comparator drugs, subjects receiving MALARONE had fewer adverse experiences overall that were attributed to prophylactic therapy (Table 3). Prophylaxis with MALARONE was discontinued prematurely due to a treatment-related adverse experience in 7 of 1,004 travelers.

Table 3: Adverse Experiences in Active-Controlled Clinical Trials of MALARONE for Prophylaxis of P. falciparum Malaria

In a third active-controlled study, MALARONE (n = 110) was compared with chloroquine/proguanil (n = 111) for the prophylaxis of malaria in 221 non-immune pediatric patients (2 to 17 years of age). The mean duration of exposure was 23 days for MALARONE, 46 days for chloroquine, and 43 days for proguanil, reflecting the different recommended dosage regimens for these products. Fewer patients treated with MALARONE reported abdominal pain (2% vs. 7%) or nausea ( < 1% vs. 7%) than children who received chloroquine/proguanil. Oral ulceration (2% vs. 2%), vivid dreams (2% vs. < 1%), and blurred vision (0% vs. 2%) occurred in similar proportions of patients receiving either MALARONE or chloroquine/proguanil, respectively. Two patients discontinued prophylaxis with chloroquine/proguanil due to adverse events, while none of those receiving MALARONE discontinued due to adverse events.

Treatment of Acute, Uncomplicated P. falciparum Malaria

In 7 controlled trials, 436 adolescents and adults received MALARONE for treatment of acute, uncomplicated P. falciparum malaria. The range of mean ages of subjects was 26 to 29 years; 79% of subjects were male. In these studies, 48% of subjects were classified as other racial/ethnic groups, primarily Asian; 42% of subjects were black and the remaining subjects were white. Attributable adverse experiences that occurred in ≥ 5% of patients were abdominal pain (17%), nausea (12%), vomiting (12%), headache (10%), diarrhea (8%), asthenia (8%), anorexia (5%), and dizziness (5%). Treatment was discontinued prematurely due to an adverse experience in 4 of 436 (0.9%) adolescents and adults treated with MALARONE.

In 2 controlled trials, 116 pediatric patients (weighing 11 to 40 kg) (mean age 7 years) received MALARONE for the treatment of malaria. The majority of subjects were black (72%); 28% were of other racial/ethnic groups, primarily Asian. Attributable adverse experiences that occurred in ≥ 5% of patients were vomiting (10%) and pruritus (6%). Vomiting occurred in 43 of 319 (13%) pediatric patients who did not have symptomatic malaria but were given treatment doses of MALARONE for 3 days in a clinical trial. The design of this clinical trial required that any patient who vomited be withdrawn from the trial. Among pediatric patients with symptomatic malaria treated with MALARONE, treatment was discontinued prematurely due to an adverse experience in 1 of 116 (0.9%).

In a study of 100 pediatric patients (5 to < 11 kg body weight) who received MALARONE for the treatment of uncomplicated P. falciparum malaria, only diarrhea (6%) occurred in ≥ 5% of patients as an adverse experience attributable to MALARONE. In 3 patients (3%), treatment was discontinued prematurely due to an adverse experience.

Abnormalities in laboratory tests reported in clinical trials were limited to elevations of transaminases in malaria patients being treated with MALARONE. The frequency of these abnormalities varied substantially across trials of treatment and were not observed in the randomized portions of the prophylaxis trials.

One active-controlled trial evaluated the treatment of malaria in Thai adults (n = 182); the mean age of subjects was 26 years (range 15 to 63 years); 80% of subjects were male. Early elevations of ALT and AST occurred more frequently in patients treated with MALARONE (n = 91) compared to patients treated with an active control, mefloquine (n = 91). On Day 7, rates of elevated ALT and AST with MALARONE and mefloquine (for patients who had normal baseline levels of these clinical laboratory parameters) were ALT 26.7% vs. 15.6%; AST 16.9% vs. 8.6%, respectively. By Day 14 of this 28-day study, the frequency of transaminase elevations equalized across the 2 groups.

Postmarketing Experience

In addition to adverse events reported from clinical trials, the following events have been identified during postmarketing use of MALARONE. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to MALARONE.

Blood and Lymphatic System Disorders: Neutropenia and anemia. Pancytopenia in patients with severe renal impairment treated with proguanil .

Immune System Disorders: Allergic reactions including anaphylaxis, angioedema, and urticaria, and vasculitis.

Nervous System Disorders: Seizures and psychotic events (such as hallucinations); however, a causal relationship has not been established.

Gastrointestinal Disorders: Stomatitis.

Hepatobiliary Disorders: Elevated liver laboratory tests, hepatitis, cholestasis; hepatic failure requiring transplant has been reported.

Skin and Subcutaneous Tissue Disorders: Photosensitivity, rash, erythema multiforme, and Stevens-Johnson syndrome.

Read the entire FDA prescribing information for Malarone (Atovaquone and Proguanil Hcl)

Taking antimalarial medication is vital in some parts of the world where malaria is endemic. Furthermore, different regions require different medication to be effective. You’ll find out which medication is recommended for the areas you’re travelling to during your travel health consultation with a Nomad expert, or you can find out using the NHS Fit for Travel website. The most commonly taken antimalarial is Atovaquone/Proguanil, but we often get asked what’s the difference between this and Malarone which may also be recommended.

The Differences Between Atovaquone/Proguanil & Malarone

Simply put, there are no differences! Malarone Is a brand name, where as Atovaquone/Proguanil is the generic name of the combination of medicines used to produce both versions of the antimalarial. In recent years, the exclusive license for the sale of Atovaquone/Proguanil as Malarone expired and the medication could be produced by other pharmaceutical manufacturers under the generic names. This is why we often refer to the combination of Atovaquone/Proguanil as Generic Malarone – same ingredients, no brand name.

Malarone vs Atovquone/Proguanil: Which Should I Choose?

It’s really up to you. Some people prefer to use Malarone as they’ve used it before and it works for them. Others prefer Atovaquone/Proguanil as it is more affordable. The generic and branded versions both follow the same schedule, both are a combined pill you take once a day.

Whichever malaria medication you choose, it’s important to remember that none give you 100% protection against malaria. It’s vital that you keep using DEET insect repellents & mosquito nets and cover up at dusk when mosquitoes are most active.

How to Buy Atovaquone/Proguanil or Malarone

It’s super easy to purchase your antimalarials safely online through the Nomad pharmacy. Simply choose your preferred medication and follow the instructions to complete your simple free online consultation. Your order will be reviewed by the Nomad pharmacists, prescribed and shipped to your home or work. If you need help, for a step by step guide to ordering malaria tablets online.

Atovaquone-Proguanil

Atovaquone and proguanil are medications to treat malaria, a disease caused by parasites. These medicines work by interfering with the growth of parasites in the red blood cells of the human body.

psites that cause malaria typically enter the body through the bite of a mosquito. Malaria is common in areas such as Africa, South America, and Southern Asia.

The combination of atovaquone and proguanil is used to treat or prevent malaria.

Atovaquone and proguanil may also be used for purposes not listed in this medication guide.

You should not use this medication if you are allergic to atovaquone or proguanil. You should not use this medication to prevent malaria if you have severe kidney disease.

Before using this medication, tell your doctor if you have liver or kidney disease, severe complications from infection with malaria, or uncontrolled vomiting or diarrhea.

Take atovaquone and proguanil at the same time each day with food or a milky drink.

If you vomit within 1 hour after taking this medication, take another dose. If your vomiting continues, call your doctor.

If you are taking this medicine to prevent malaria, start taking it 1 or 2 days before entering an area where malaria is common. Take the medication every day during your stay and for at least 7 days after you leave. If you stop taking the medicine early for any reason, contact a healthcare professional about another form of malaria prevention.

If you are taking this medicine to treat malaria, take the medication every day for 3 days in a row.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

In addition to taking atovaquone and proguanil, use protective clothing, insect repellents, and mosquito netting around your bed to further prevent mosquito bites that could cause malaria.

Contact your doctor as soon as possible if you have been exposed to malaria, or if you have a fever or other symptoms of illness during or after a stay in an area where malaria is common.

No medication is 100% effective in treating or preventing malaria. For best results, keep using the medication as directed. Talk with your doctor if you have fever, vomiting, or diarrhea during your treatment.

You should not use this medication if you are allergic to atovaquone or proguanil. You should not use this medication to prevent malaria if you have severe kidney disease.

To make sure you can safely take atovaquone and proguanil, tell your doctor if you have any of these other conditions:

  • kidney disease;
  • liver disease;
  • severe complications from malaria; or
  • uncontrolled vomiting or diarrhea.

FDA pregnancy category C. It is not known whether atovaquone and proguanil will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Malaria is more likely to cause death in a pregnant woman. If you are pregnant, talk with your doctor about the risks of traveling to areas where malaria is common.

Atovaquone and proguanil can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Atovaquone and proguanil should not be used to treat malaria in a child who weighs less than 11 pounds, and should not be used to prevent malaria in a child who weighs less than 24 pounds.

About the author

Leave a Reply

Your email address will not be published. Required fields are marked *