Posology : מינונים

4.2    Posology and method of administration
The daily dose should be taken at the same time each day with food or a milky drink. In the event of vomiting within 1 hour after dosing, a repeat dose should be taken.

Malarone Paediatric Tablets:
Malarone may be crushed and mixed with condensed milk just prior to administration to patients who may have difficulty swallowing tablets.

Malarone Tablets for adults:
There is no data regarding crush/divide/chew

Prevention of Malaria


Start prophylactic treatment with Malarone 1 or 2 days before entering a malaria-endemic area and continue daily during the stay and for 7 days after return.
Adults: One tablet of Malarone Tablets For Adults (250 mg atovaquone/100 mg proguanil hydrochloride) per day.
Paediatric Patients: The dosage for prevention of malaria in paediatric patients is based upon body weight (Table 1).

Table 1. Dosage for Prevention of Malaria in Paediatric Patients
Atovaquone/
Weight Proguanil HCl
(kg)      Total Daily Dose        Dosage Regimen
11-20     62.5 mg/25 mg           1 Malarone Paediatric Tablet daily
21-30     125 mg/50 mg            2 Malarone Paediatric Tablets as a single daily dose
31-40     187.5 mg/75 mg          3 Malarone Paediatric Tablets as a single daily dose >40       250 mg/100 mg           1 Malarone Tablets For Adults as a single daily dose 
Treatment of Acute Malaria
Adults: Four Malarone Tablets For Adults (total daily dose 1 g atovaquone/400 mg proguanil hydrochloride) as a single daily dose for 3 consecutive days.
Paediatric Patients: The dosage for treatment of acute malaria in paediatric patients is based upon body weight (Table 2).

Table 2. Dosage for Treatment of Acute Malaria in Paediatric Patients Atovaquone/
Weight Proguanil HCl
(kg)      Total Daily Dose       Dosage Regimen
5-8       125 mg/50 mg           2 Malarone Paediatric Tablets daily for 3 consecutive days.
9-10      187.5 mg/75 mg         3 Malarone Paediatric Tablets daily for 3 consecutive days.
11-20     250 mg/100 mg          1 Malarone Tablet For Adults daily for 3 consecutive days  21-30     500 mg/200 mg          2 Malarone Tablets For Adults as a single daily dose for
3 consecutive days
31-40     750 mg/300 mg          3 Malarone Tablets For Adults as a single daily dose for 3 consecutive days
>40       1 g/400 mg             4 Malarone Tablets For Adults as a single daily dose for 3 consecutive days

Renal Impairment
Do not use Malarone for malaria prophylaxis in patients with severe renal impairment (creatinine clearance <30 mL/min) [see Contraindications (4.2)]. Use with caution for the treatment of malaria in patients with severe renal impairment, only if the benefits of the 3-day treatment regimen outweigh the potential risks associated with increased drug exposure. No dosage adjustments are needed in patients with mild (creatinine clearance 50 to 80 mL/min) or moderate (creatinine clearance 30 to 50 mL/min) renal impairment. [See Clinical Pharmacology (12.3).]

Hepatic Impairment
No dosage adjustments are needed in patients with mild or moderate hepatic impairment. No trials have been conducted in patients with severe hepatic impairment.


Paediatric Use

Prophylaxis of Malaria
Malarone is not indicated for the prophylaxis of malaria in paediatric patients who weigh less than 11 kg.
Safety and effectiveness have not been established in paediatric patients who weigh less than 11 kg.
The efficacy and safety of Malarone have been established for the prophylaxis of malaria in controlled trials involving paediatric patients weighing 11 kg or more.

Treatment of Malaria
Malarone is not indicated for the Treatment of Malaria in paediatric patients who weigh less than 5 kg.
Safety and effectiveness have not been established in paediatric patients who weigh less than 5 kg. The efficacy and safety of Malarone for the treatment of malaria have been established in controlled trials involving paediatric patients weighing 5 kg or more.

Geriatric Use
Clinical trials of Malarone did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, the higher systemic exposure to cycloguanil, and the greater frequency of concomitant disease or other drug therapy.