Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2023 Publisher: Glaxo Wellcome UK Ltd, trading as GlaxoSmithKline UK, GSK Medicines Research Centre, Gunnels Wood Road, Stevenage, Hertfordshire, SG1 2NY, UK
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.
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.
Prophylaxis should
In residents (semi-immune subjects) of endemic areas, the safety and effectiveness of Malarone has been established in studies of up to 12 weeks.
In non-immune subjects, the average duration of exposure in clinical studies was 27 days.
One Malarone tablet daily.
Malarone tablets are not recommended for malaria prophylaxis in persons under 40 kg bodyweight.
Malarone paediatric tablets are recommended for malaria prophylaxis in persons weighing <40 kg.
Four Malarone tablets as a single dose for three consecutive days.
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.
A pharmacokinetic study indicates that no dosage adjustments are needed in the elderly (see section 5.2).
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).
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 (see section 4.3).
There is insufficient experience to predict the consequences or suggest specific management of Malarone overdose. However, in the reported cases of atovaquone overdose, the observed effects were consistent with known undesirable effects of the drug. If overdose occurs, the patient should be monitored and standard supportive treatment applied.
5 years.
This medicinal product does not require any special storage conditions.
PVC-aluminium/paper child-resistant foil blister pack/s containing 12 tablets.
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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