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    Therapeutic indications Malarone is a fixed dose combination of atovaquone and proguanil hydrochloride which acts as a blood schizonticide and also has activity against hepatic schizonts of Plasmodium falciparum. It is indicated for: Prophylaxis of Plasmodium falciparum malaria. Treatment of acute, uncomplicated Plasmodium falciparum malaria. Because Malarone is effective against drug sensitive and drug resistant P. falciparum it is especially recommended for prophylaxis and treatment of P. falciparum malaria where the pathogen may be resistant to other antimalarials. Official guidelines and local information on the prevalence of resistance to antimalarial drugs should be taken into consideration. Official guidelines will normally include WHO and public health authorities\' guidelines. Posology and method of administration Method of administration The daily dose should be taken with food or a milky drink (to ensure maximum absorption) at the same time each day. If patients are unable to tolerate food, Malarone should be administered, but systemic exposure of atovaquone will be reduced. In the event of vomiting within 1 hour of dosing a repeat dose should be taken. Posology Prophylaxis: Prophylaxis should �� commence 24 or 48 hours prior to entering a malaria-endemic area, �� continue during the period of the stay, which should not exceed 28 days, �� continue for 7 days after leaving the area. In residents (semi-immune subjects) of endemic areas, the safety and effectiveness of Malarone has been established in studies of up to 12 weeks. Dosage in Adults One Malarone tablet daily. Malarone tablets are not recommended for malaria prophylaxis in persons under 40kg bodyweight. Treatment Dosage in Adults Four Malarone tablets as a single dose for three consecutive days. Dosage in Children 11-20 kg bodyweight. One tablet daily for three consecutive days. 21-30 kg bodyweight. Two tablets as a single dose for three consecutive days. 31-40 kg bodyweight. Three tablets as a single dose for three consecutive days. >40 kg bodyweight. Dose as for adults. Dosage in the Elderly A pharmacokinetic study indicates that no dosage adjustments are needed in the elderly (See Section 5.2). Dosage in Hepatic Impairment A pharmacokinetic study indicates that no dosage adjustments are needed in patients with mild to moderate hepatic impairment. Although no studies have been conducted in patients with severe hepatic impairment, no special precautions or dosage adjustment are anticipated (See Section 5.2). Dosage in Renal Impairment Pharmacokinetic studies indicate that no dosage adjustments are needed in patients with mild to moderate renal impairment. In patients with severe renal impairment (creatine clearance <30 mL/min) alternatives to Malarone for treatment of acute P. falciparum malaria should be recommended whenever possible (See Sections 4.4 and 5.2). For prophylaxis of P. falciparum malaria in patients with several renal impairments Contraindications Hypersensitivity to the active substances or to any of the excipients. Malarone is contraindicated for prophylaxis of P. falciparum malaria in patients with severe renal impairment (creatine clearance <30 mL/min). Special warnings and precautions for use The safety and effectiveness of Malarone (atovaquone 250 mg/proguanil hydrochloride 100 mg tablets) for prophylaxis of malaria in patients who weigh less than 40kg has not been established. Persons taking Malarone for prophylaxis or treatment of malaria should take a repeat dose if they vomit within 1 hour of dosing. In the event of diarrhoea, normal dosing should be continued. Absorption of atovaquone may be reduced in patients with diarrhoea or vomiting, but diarrhoea or vomiting was not associated with reduced efficacy in clinical trials of Malarone for malaria prophylaxis. However, as with other antimalarial agents, subjects with diarrhoea or vomiting should be advised to continue to comply with personal protection measures (repellants, bednets). In patients with acute malaria who present with diarrhoea or vomiting, alternative therapy should be considered. If Malarone is used to treat malaria in these patients, parasitaemia should be closely monitored. The safety and effectiveness of Malarone (atovaquone 250 mg/proguanil hydrochloride 100 mg tablets) for treatment of malaria in paediatric patients who weigh less than 11 kg has not been established. Malarone has not been evaluated for the treatment of cerebral malaria or other severe manifestations of complicated malaria including hyperparasitaemia, pulmonary oedema or renal failure. Occasionally, severe allergic reactions (including anaphylaxis) have been reported in patients taking Malarone. If patients experience an allergic reaction (see section 4.8) Malarone should be discontinued promptly and appropriate treatment initiated. Parasite relapse occurred commonly when P. vivax malaria was treated with Malarone alone. Travellers with intense exposure to P. vivax or P. ovale, and those who develop malaria caused by either of these parasites, will require additional treatment with a drug that is active against hypnozoites. In the event of recrudescent infections due to P. falciparum after treatment with Malarone, or failure of chemoprophylaxis, patients should be treated with a different blood schizonticide. Parasitaemia should be closely monitored in patients receiving concurrent metoclopramide or tetracycline (see section 4.5). The concomitant administration of Malarone and rifampicin or rifabutin is not recommended (see section 4.5). In patients with severe renal impairment (creatinine clearance <30 mL/min) alternatives to Malarone for treatment of acute P. falciparum malaria should be recommended whenever possible Interaction with other medicinal products and other forms of interaction Proguanil may potentiate the anticoagulant effect of warfarin and other coumarin based anticoagulants. The mechanism of this potential drug interaction has not been established. Caution is advised when initiating or withdrawing malaria prophylaxis or treatment with atovaquone-proguanil in patients on continuous treatment with coumarin based anticoagulants. Concomitant treatment with metoclopramide and tetracycline has been associated with significant decreases in plasma concentrations of atovaquone (see section 4.4). Concomitant administration of atovaquone and indinavir results in a decrease in the Cmin of indinavir (23% decrease; 90% CI 8-35%). Caution should be exercised when prescribing atovaquone with indinavir due to the decrease in the trough levels of indinavir. Concomitant administration of rifampicin or rifabutin is known to reduce atovaquone levels by approximately 50% and 34%, respectively. (see section 4.4). Atovaquone is highly protein bound (>99%) but does not displace other highly protein bound drugs in vitro, indicating significant drug interactions arising from displacement are unlikely. Pregnancy and lactation The safety of atovaquone and proguanil hydrochloride when administered concurrently for use in human pregnancy has not been established and the potential risk is unknown. Animal studies showed no evidence for teratogenicity of the combination. The individual components have shown no effects on parturition or pre- and post-natal development. Maternal toxicity was seen in pregnant rabbits during a teratogenicity study (see section 5.3). The use of Malarone in pregnancy should only be considered if the expected benefit to the mother outweighs any potential risk to the foetus. The proguanil component of Malarone acts by inhibiting parasitic dihydrofolate reductase. There are no clinical data indicating that folate supplementation diminishes drug efficacy. For women of childbearing age receiving folate supplements to prevent neural tube birth defects, such supplements should be continued while taking Malarone. Lactation The atovaquone concentrations in milk, in a rat study, were 30% of the concurrent atovaquone concentrations in maternal plasma. It is not known whether atovaquone is excreted in human milk. Proguanil is excreted in human milk in small quantities. Malarone should not be taken by breast-feeding women. Effects on ability to drive and use machines Dizziness has been reported. Patients should be warned that if affected they should not drive, operate machinery or take part in activities where this may put themselves or others at risk
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