This is a summary of the most important information about Atovaquone-Proguanil. For details, talk to your healthcare professional.
Atovaquone-Proguanil has been shown to be effective in regions where resistance to other anti-malarial drugs has developed. Malaria is transmitted from person to person by the bite of an infected Anopheles mosquito. These mosquitoes are present in almost all tropical countries.
Persons contemplating travel to certain endemic tropical areas should see their doctor and ask about malaria prevention. The early symptoms of malaria include fever, chills, headache, muscle ache, and malaise. Without prompt treatment complications such as coma, kidney failure, and respiratory distress may occur resulting in death. Travelers who become ill with a fever during or after travel in an area of malaria transmission should seek prompt medical attention and inform their physician of their recent travel history. Atovaquone-Proguanil was evaluated for the treatment of malaria in adults, children, partially immune, and non-immune individuals. Eight active- controlled clinical trials were conducted in countries in Africa, Asia, South America, and Europe. Overall efficacy in 521 evaluable patients was 98.7 percent. Malaria can be prevented by the use of prophylactic antimalarial drugs and protection against mosquito bites through the use of protective clothing, insect repellents, and bednets.
Atovaquone-Proguanil was evaluated for the prophylaxis (prevention) of malaria due toP. falciparum in four clinical trials in Africa. Over a period of approximately 3 months, malaria occurred in 2 out of 279 patients who received Atovaquone-Proguanil. For those patients who were given a placebo, 92 out of 297 patients contracted malaria. Additional information from challenge studies indicated that Atovaquone-Proguanil was effective against the early liver stage of malaria as well as the blood stage. The early liver stage is the form of the parasite before it appears in the blood and before symptoms, such as fever and chills, occur. A challenge study showed that Atovaquone-Proguanil is active against the early liver as well as the blood stage. Among adults who received Atovaquone-Proguanil for treatment of malaria, the side effects included abdominal pain, nausea, vomiting and headache. Among pediatric patients, vomiting and itching were reported adverse reactions. In subjects given Atovaquone-Proguanil for prevention of malaria, the most commonly reported side effects were headache and abdominal pain.
Atovaquone-Proguanil should be taken at the same time each day with food or milk. In the event of vomiting, a repeat dose should be taken within 1 hour of dosing. For the treatment of adults with malaria, Atovaquone-Proguanil is given as a single dose of four tablets (total daily dose 1 g atovaquone/400 mg proguanil hydrochloride)for three consecutive days. The dose for prophylactic treatment with Atovaquone-Proguanil is one tablet (250 mg atovaquone/100 mg proguanil hydrochloride) per day for adults. Prophylactic treatment with Atovaquone-Proguanil should be started 1 or 2 days before entering a malaria-endemic area and continued daily during the stay and for 7 days after return. Body weight determines the dose for malaria treatment and prevention in children.