Treatment of malarial access, simple (uncomplicated) to Plasmodium, falciparum.

Prophylaxis of Plasmodium falciparum malaria especially in travelers to endemic areas where resistant strains of amino-4-quinolines (chloroquine, amodiaquine, etc.) are present.
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Oral use.

The tablets should be administered with a meal or a milk drink to promote absorption of atovaquone

Treatment of access, Plasmodium falciparum malaria

Adults and children over 40 kg of body weight (about 12 years of age)

4 tablets in a single dose per day for 3 consecutive days at 24 hours, interval

Subjects of 11 to 40 kg of body weight

· From 31 to 40 kg: 3 tablets in a single dose per day for 3 consecutive days at 24 hours at intervals.
· From 21 to 30 kg: 2 tablets in a single dose per day for 3 consecutive days at 24 hours at intervals

· 11 to 20 kg: 1 tablet per day for 3 days, consecutively 24 hours apart

In children weighing less than 11 kg body weight the lowest dose should be used ATOVAQUONE / PROGUANIL ZENTIVA.
Prophylaxis of malaria with Plasmodium falciparum

Treatment will begin on or before the day of departure in endemic areas. It will be continued for the duration of the risk of malaria and 7 days after leaving the endemic area.
The duration of administration of ATOVAQUONE / PROGUANIL ZENTIVA in this indication should be limited to 3 months.
Adult and child over 40 kg of body weight (about 12 years of age)

1 tablet per day per hour, fixed.

In subjects less than 40 kg, the lower dosage of ATOVAQUONE / PROGUANIL ZENTIVA should be used.
Elderly subject

There is no need for special precautions or dosage adjustments in the elderly.

Hepatic impairment

There is no need to plan for dose adjustment in subjects with hepatic insufficiency. The absence of studies in subjects with severe hepatic impairment does not, however, make it possible to determine the efficacy and tolerance in these cases. >
Renal insufficiency

Dosage adjustment in patients with mild to moderate renal insufficiency should not be expected.

Pharmacotherapeutic group: Antimalarial

ATC code: P01BB51.

Atovaquone and proguanil hydrochloride exert an inhibitory action at 2 levels, different from the synthesis of pyrimidines and thus lead to an inhibition of the replication of plasmodium deoxyribonucleic acid.

Atovaquone inhibits electron transport at the cytochrome bc1 complex of the parasite mitochondria and decreases the membrane potential of the mitochondrion. Proguanil hydrochloride acts primarily through its hepatic metabolite, cycloguanil, a dihydrofolate reductase inhibitor, and the inhibition of dihydrofolate reductase interferes with the synthesis of deoxythymidilate inhibiting the metabolism of folate. Proguanil also has a mechanism of action independent of cycloguanil metabolism. Proguanil alone can potentiate the action of atovaquone to decrease the membrane potential of the parasite's mitochondria. These mechanisms of action lead to a schizonticidal synergy of the proguanil / atovaquone combination.

The effects on the ability to drive or use machines have not been evaluated.
History of hypersensitivity to atovaquone or hydrochloride proguanil or to another component of the specialty

Renal impairment, severe (creatinine clearance

Clinically, no malformative or fetotoxic effects have so far occurred with each of the active ingredients taken alone. However, the monitoring of pregnancies exposed to this association is insufficient to exclude any risk.

Therefore, the use of atovaquone / proguanil may be considered in pregnant women if necessary.

In women, the excretion of atovaquone in milk is not known, low amounts of proguanil are found there, so breast-feeding is not recommended during treatment (see section on safety data; Preclinical).

The adverse reactions are listed below by organ system and frequency. Frequencies are defined as very common (≥1 / 10), frequent (≥1 / 100, and