This is a
summary of the most important information about Malarone. For details, talk to
your healthcare professional.
Malarone 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.
Malarone 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.
Malarone was evaluated for the prophylaxis
(prevention) of malaria due to P. falciparum in four clinical trials in
Africa. Over a period of approximately 3
months, malaria occurred in 2 out of 279 patients who received Malarone. For
those patients who were given a placebo, 92 out of 297 patients contracted
malaria.
Additional information from
challenge studies indicated that Malarone 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 Malarone is active
against the early liver as well as the blood stage.
Among adults who received
Malarone 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 Malarone for prevention of
malaria, the most commonly reported side effects were headache and abdominal
pain.
Malarone 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, Malarone 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 Malarone is one tablet (250 mg atovaquone/100 mg
proguanil hydrochloride) per day for adults. Prophylactic
treatment with Malarone 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.
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