DOSAGE AND 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.
Prevention of Malaria
Prophylactic treatment with MALARONE should be started 1 or 2 days before entering a malaria-endemic area and continued daily during the stay and for 7 days after return.
Adults
One MALARONE Tablet (adult strength = 250 mg atovaquone/100 mg proguanil hydrochloride) per day.
Pediatric Patients
The dosage for prevention of malaria in pediatric patients is based upon body weight (Table 5).
Table 5. Dosage for Prevention of Malaria in Pediatric Patients |
Weight
(kg)
|
Atovaquone/
Proguanil HCl
Total Daily Dose
|
Dosage Regimen
|
|
11-20
|
62.5 mg/25 mg
|
1 MALARONE Pediatric Tablet daily
|
|
21-30
|
125 mg/50 mg
|
2 MALARONE Pediatric Tablets as a single dose daily
|
|
31-40
|
187.5 mg/75 mg
|
3 MALARONE Pediatric Tablets as a single dose daily
|
|
>40
|
250 mg/100 mg
|
1 MALARONE Tablet (adult strength) as a single dose daily
|
Treatment of Acute Malaria
Adults
Four MALARONE Tablets (adult strength; total daily dose 1 g atovaquone/400 mg proguanil hydrochloride) as a single dose daily for 3 consecutive days.
Pediatric Patients
The dosage for treatment of acute malaria in pediatric patients is based upon body weight (Table 6).
Table 6. Dosage for Treatment of Acute Malaria in Pediatric Patients |
Weight
(kg)
|
Atovaquone/
Proguanil HCl
Total Daily Dose
|
Dosage Regimen
|
|
5-8
|
125 mg/50 mg
|
2 MALARONE Pediatric Tablets daily for 3 consecutive days
|
|
9-10
|
187.5 mg/75 mg
|
3 MALARONE Pediatric Tablets daily for 3 consecutive days
|
|
11-20
|
250 mg/100 mg
|
1 MALARONE Tablet (adult strength) daily for 3 consecutive days
|
|
21-30
|
500 mg/200 mg
|
2 MALARONE Tablets (adult strength) as a single dose daily for 3 consecutive days
|
|
31-40
|
750 mg/300 mg
|
3 MALARONE Tablets (adult strength) as a single dose daily for 3 consecutive days
|
|
>40
|
1 g/400 mg
|
4 MALARONE Tablets (adult strength) as a single dose daily for 3 consecutive days
|
MALARONE Tablets may be crushed and mixed with condensed milk just prior to administration for children who may have difficulty swallowing tablets.
Patients With Renal Impairment
MALARONE should not be used for malaria prophylaxis in patients with severe renal impairment (creatinine clearance <30 mL/min). MALARONE may be used with caution for the treatment of malaria in patients with severe renal impairment (creatinine clearance <30 mL/min), only if the benefits of the 3-day treatment regimen outweigh the potential risks associated with increased drug exposure (see CLINICAL PHARMACOLOGY: Special Populations: Renal Impairment). No dosage adjustments are needed in patients with mild (creatinine clearance 50 to 80 mL/min) and moderate (creatinine clearance 30 to 50 mL/min) renal impairment (see CLINICAL PHARMACOLOGY: Special Populations).
Patients With Hepatic Impairment
No dosage adjustments are needed in patients with mild to moderate hepatic impairment. No studies have been conducted in patients with severe hepatic impairment (see CLINICAL PHARMACOLOGY: Special Populations: Hepatic Impairment).
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