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 paediatric tablets contain a fixed dose combination of atovaquone and proguanil hydrochloride, which acts as a blood schizontocide and also has activity against hepatic schizonts of Plasmodium falciparum. They are indicated for:
Prophylaxis of P. falciparum malaria in individuals weighing 11-40 kg.
Treatment of acute, uncomplicated P. falciparum malaria in children weighing ≥5 kg and <11 kg.
For treatment of acute, uncomplicated P. falciparum malaria in individuals weighing 11-40 kg please refer to the Summary of Product Characteristics for Malarone tablets.
Malarone may be active against P. falciparum that are resistant to one or more other antimalarial agents. Therefore, Malarone may be particularly suitable for prophylaxis and treatment against P. falciparum infections in areas where this species is known to be commonly resistant to one or more other antimalarial agents and also for treatment of patients infected with P. falciparum malaria whilst in these areas.
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 once daily with food or a milky drink (to ensure maximum absorption) at the same time each day.
If patients are unable to tolerate food Malarone paediatric tablets 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.
Malarone paediatric tablets should preferably be swallowed whole. If difficulties are encountered when dosing young children, the tablets may be crushed and mixed with food or a milky drink just prior to administration.
The dosage for the prophylaxis and treatment of acute, uncomplicated P. falciparum malaria in children is based on body weight.
| Dosage/day | |||
|---|---|---|---|
| Body Weight Range (kg) | Atovaquone (mg) | Proguanil (mg) | No of Tablets |
| 11-20 | 62.5 | 25 | One Malarone paediatric tablet |
| 21-30 | 125 | 50 | Two Malarone paediatric tablets |
| 31-40 | 187.5 | 75 | Three Malarone paediatric tablet |
| >40 | 250 | 100 | Subjects of >40 kg should receive ONE Malarone 250/100 mg tablet daily Refer to Malarone 250/100 mg Tablets SmPC |
The safety and effectiveness of Malarone paediatric tablets for prophylaxis of malaria in children who weigh less than 11 kg has not been established.
Prophylaxis should
The safety and effectiveness of Malarone paediatric tablets have been established in studies of up to 12 weeks in residents (semi-immune) of endemic areas (see section 5.1).
In non-immune subjects, the average duration of exposure in clinical studies was 27 days.
| Dosage/day | |||
|---|---|---|---|
| Body Weight Range (kg) | Atovaquone (mg) | Proguanil (mg) | Dosage Regimen |
| 5-8 | 125 | 50 | Two Malarone paediatric tablets daily for 3 consecutive days |
| 9-10 | 187.5 | 75 | Three Malarone paediatric tablets daily for 3 consecutive days. |
| ≥11 | Refer to Malarone 250/100 mg Tablets SmPC | ||
The safety and effectiveness of Malarone paediatric tablets for the treatment of malaria in children who weigh less than 5 kg has not been established.
For individuals who weigh 11 kg or more, the first choice for the treatment of acute, uncomplicated P. falciparum malaria is Malarone tablets (250/100 mg). Please consult the Malarone tablets SmPC for the recommended dosage for this weight range. Malarone tablets are four-times the strength of Malarone paediatric tablets.
In circumstances when sufficient Malarone tablets are not available, then Malarone paediatric tablets may be used.
There are no studies in children with hepatic impairment. However, a pharmacokinetic study in adults 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).
There are no studies in children with renal impairment. However, pharmacokinetic studies in adults indicate that no dosage adjustments are needed in those with mild to moderate renal impairment. Due to the lack of information regarding appropriate dosing, Malarone is contraindicated for the prophylaxis of malaria in adults and children with severe renal impairment (creatinine clearance <30 mL/min; see sections 4.3 and 5.2).
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 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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