Usual Adult Dose for Malaria

Less than 35 kg: Usual pediatric dose

At least 35 kg: 4 tablets orally as a single initial dose, followed by 4 tablets after 8 hours, and then 4 tablets twice a day (morning and evening) for the following 2 days

• Total course: 24 tablets

• A 3-day treatment regimen, with a total of 6 doses

Usual Pediatric Dose for Malaria

2 months or older:

• Weight 5 to less than 15 kg: 1 tablet orally as a single initial dose, followed by 1 tablet after 8 hours, and then 1 tablet twice a day (morning and evening) for the following 2 days
• Total course: 6 tablets
• Weight 15 to less than 25 kg: 2 tablets orally as a single initial dose, followed by 2 tablets after 8 hours, and then 2 tablets twice a day (morning and evening) for the following 2 days
• Total course: 12 tablets
• Weight 25 to less than 35 kg: 3 tablets orally as a single initial dose, followed by 3 tablets after 8 hours, and then 3 tablets twice a day (morning and evening) for the following 2 days
• Total course: 18 tablets
• Weight At least 35 kg: 4 tablets orally as a single initial dose, followed by 4 tablets after 8 hours, and then 4 tablets twice a day (morning and evening) for the following 2 days
• Total course: 24 tablets

• A 3-day treatment regimen, with a total of 6 doses

Renal Dose Adjustments

Renal dysfunction: No adjustment recommended.

• Severe renal dysfunction: Caution recommended.

Liver Dose Adjustments

Mild to moderate liver dysfunction: No adjustment recommended.
Severe liver dysfunction: Caution recommended.

Precautions

CONTRAINDICATIONS:

• Known hypersensitivity to either active component or to any of the ingredients
• Coadministration with strong CYP450 3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's wort)

Dialysis

Data not available

Other Comments

Administration advice:

• Administer with food; although patients with acute malaria are often averse to food, encourage patients to resume normal eating as soon as food can be tolerated as this improves absorption of each component.
• For patients unable to swallow the tablets (e.g., infants, children), crush tablet(s) and mix with a small amount of water (1 to 2 teaspoons) in a clean container for administration immediately prior to use; rinse the container with more water and swallow the contents; whenever possible, follow this crushed tablet preparation with food/drink (e.g., milk, formula, pudding, broth, porridge).
• If vomiting occurs within 1 to 2 hours after dosing, administer a repeat dose; if the repeat dose is vomited, use an alternative antimalarial for treatment.

• Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).

• Limitations of Use: This drug is not approved for patients with severe or complicated P falciparum malaria; this drug is not approved for prevention of malaria.
• This drug has shown efficacy in geographical regions where chloroquine resistance has occurred.

• Cardiovascular: ECG in patients using medically-required drugs that prolong QT interval

• Read the US FDA-approved patient labeling (Patient Information).
• Take with food.
• Notify physician if any symptoms of QT interval prolongation (including prolonged heart palpitations, loss of consciousness) occur.
• If using hormonal contraceptive, use an alternative nonhormonal contraceptive method or add a barrier method of contraception during therapy.
• Stop this drug at first sign of skin rash, hives/other skin reactions, rapid heartbeat, difficult swallowing/breathing, any swelling suggesting angioedema (e.g., swelling of lips/tongue/face, tightness of throat, hoarseness), or other symptoms of allergic reaction.