General MedicationsORALHigh Alert

COARTEM

ARTEMETHER AND LUMEFANTRINE

Standard Dose

2 DOSAGE AND ADMINISTRATION Coartem Tablets should be taken with food. ( 2.1 , 5.2 ) Tablets may be crushed and mixed with 1 to 2 teaspoons of water immediately prior to administration to patients, including children. ( 2.1 ) Coartem Tablets should be administered over 3 days for a total of 6 doses: an initial dose, second dose after 8 hours, and then twice-daily (morning and evening) for the following 2 days. ( 2.2 , 2.3 ) The adult dosage for patients with bodyweight of 35 kg and above is 4 tablets per dose for a total of 6 doses. ( 2.2 ) The number of tablets per dose for children is determined by bodyweight, as shown in the chart below. ( 2.3 ) Tablets per dose by bodyweight; total of 6 doses over 3 days 5 to < 15 kg 1 tablet 15 to < 25 kg 2 tablets 25 to < 35 kg 3 tablets 35 kg and over 4 tablets 2.1 Administration Instructions Coartem Tablets should be taken with food. Patients with acute malaria are frequently averse to food. Patients should be encouraged to resume normal eating as soon as food can be tolerated since this improves absorption of artemether and lumefantrine. For patients who are unable to swallow the tablets such as infants and children, Coartem Tablets may be crushed and mixed with a small amount of water (1 to 2 teaspoons) in a clean container for administration immediately prior to use. The container can be rinsed with more water and the contents swallowed by the patient. The crushed tablet preparation should be followed whenever possible by food/drink (e.g., milk, formula, pudding, broth, and porridge). In the event of vomiting within 1 to 2 hours after administration, a repeat dose should be taken. If the repeat dose is vomited, the patient should be given an alternative antimalarial for treatment. 2.2 Dosage in Adult Patients (greater than 16 years of age) A 3-day treatment schedule with a total of 6 doses is recommended for adult patients with a bodyweight of 35 kg and above: Four tablets as a single initial dose, 4 tablets again after 8 hours, and then 4 tablets twice-daily (morning and evening) for the following 2 days (total course of 24 tablets). For patients weighing less than 35 kg, [see Dosage and Administration (2.3)] . 2.3 Dosage in Pediatric Patients A 3-day treatment schedule with a total of 6 doses is recommended as below: 5 kg to less than 15 kg bodyweight : One tablet as an initial dose, 1 tablet again after 8 hours, and then 1 tablet twice daily (morning and evening) for the following 2 days (total course of 6 tablets). 15 kg to less than 25 kg bodyweight : Two tablets as an initial dose, 2 tablets again after 8 hours, and then 2 tablets twice daily (morning and evening) for the following 2 days (total course of 12 tablets). 25 kg to less than 35 kg bodyweight : Three tablets as an initial dose, 3 tablets again after 8 hours, and then 3 tablets twice daily (morning and evening) for the following 2 days (total course of 18 tablets). 35 kg bodyweight and above : Four tablets as a single initial dose, 4 tablets again after 8 hours, and then 4 tablets twice daily (morning and evening) for the following 2 days (total course of 24 tablets). 2.4 Dosage in Patients With Hepatic or Renal Impairment No specific pharmacokinetic studies have been carried out in patients with hepatic or renal impairment. Most patients with acute malaria present with some degree of related hepatic and/or renal impairment. In clinical studies, the adverse event profile did not differ in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function. No specific dose adjustments are needed for patients with mild or moderate hepatic impairment. In clinical studies, the adverse event profile did not differ in patients with mild or moderate renal impairment compared to patients with normal renal function. There were few patients with severe renal impairment in clinical studies. There is no significant renal excretion of lumefantrine, artemether, and dihydroartemisinin (DHA) in healthy volunteers and while clinical experience in this population is limited, no dose adjustment is recommended. Caution should be exercised when administering Coartem Tablets in patients with severe hepatic or renal impairment [see Warnings and Precautions (5.6)] .

Max Dose

See official label

Primary Use

1 INDICATIONS AND USAGE Coartem Tablets are indicated for treatment of acute, uncomplicated malaria infections due to Plasmodium falciparum (P.

Summary

Coartem Tablets have been shown to be effective in geographical regions where resistance to chloroquine has been reported [see Clinical Studies (14.1)] .

Structured Monograph

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE Coartem Tablets are indicated for treatment of acute, uncomplicated malaria infections due to Plasmodium falciparum (P. falciparum) in patients 2 months of age and older with a bodyweight of 5 kg and above. Coartem Tablets have been shown to be effective in geographical regions where resistance to chloroquine has been reported [see Clinical Studies (14.1)] . Limitations of Use : Coartem Tablets are not approved for patients with severe or complicated P. falciparum malaria. Coartem Tablets are not approved for the prevention of malaria. Coartem Tablets are a combination of artemether and lumefantrine, both antimalarials, indicated for treatment of acute, uncomplicated malaria infections due to Plasmodium falciparum (P. falciparum) in patients 2 months of age and older with a bodyweight of 5 kg and above. ( 1 ) Coartem Tablets have been shown to be effective in geographical regions where resistance to chloroquine has been reported. ( 1 ) Limitations of Use: ( 1 ) Coartem Tablets are not approved for patients with severe or complicated P. falciparum malaria . Coartem Tablets are not approved for the prevention of malaria. Dosage and administration 2 DOSAGE AND ADMINISTRATION Coartem Tablets should be taken with food. ( 2.1 , 5.2 ) Tablets may be crushed and mixed with 1 to 2 teaspoons of water immediately prior to administration to patients, including children. ( 2.1 ) Coartem Tablets should be administered over 3 days for a total of 6 doses: an initial dose, second dose after 8 hours, and then twice-daily (morning and evening) for the following 2 days. ( 2.2 , 2.3 ) The adult dosage for patients with bodyweight of 35 kg and above is 4 tablets per dose for a total of 6 doses. ( 2.2 ) The number of tablets per dose for children is determined by bodyweight, as shown in the chart below. ( 2.3 ) Tablets per dose by bodyweight; total of 6 doses over 3 days 5 to < 15 kg 1 tablet 15 to < 25 kg 2 tablets 25 to < 35 kg 3 tablets 35 kg and over 4 tablets 2.1 Administration Instructions Coartem Tablets should be taken with food. Patients with acute malaria are frequently averse to food. Patients should be encouraged to resume normal eating as soon as food can be tolerated since this improves absorption of artemether and lumefantrine. For patients who are unable to swallow the tablets such as infants and children, Coartem Tablets may be crushed and mixed with a small amount of water (1 to 2 teaspoons) in a clean container for administration immediately prior to use. The container can be rinsed with more water and the contents swallowed by the patient. The crushed tablet preparation should be followed whenever possible by food/drink (e.g., milk, formula, pudding, broth, and porridge). In the event of vomiting within 1 to 2 hours after administration, a repeat dose should be taken. If the repeat dose is vomited, the patient should be given an alternative antimalarial for treatment. 2.2 Dosage in Adult Patients (greater than 16 years of age) A 3-day treatment schedule with a total of 6 doses is recommended for adult patients with a bodyweight of 35 kg and above: Four tablets as a single initial dose, 4 tablets again after 8 hours, and then 4 tablets twice-daily (morning and evening) for the following 2 days (total course of 24 tablets). For patients weighing less than 35 kg, [see Dosage and Administration (2.3)] . 2.3 Dosage in Pediatric Patients A 3-day treatment schedule with a total of 6 doses is recommended as below: 5 kg to less than 15 kg bodyweight : One tablet as an initial dose, 1 tablet again after 8 hours, and then 1 tablet twice daily (morning and evening) for the following 2 days (total course of 6 tablets). 15 kg to less than 25 kg bodyweight : Two tablets as an initial dose, 2 tablets again after 8 hours, and then 2 tablets twice daily (morning and evening) for the following 2 days (total course of 12 tablets). 25 kg to less than 35 kg bodyweight : Three tablets as an initial dose, 3 tablets again after 8 hours, and then 3 tablets twice daily (morning and evening) for the following 2 days (total course of 18 tablets). 35 kg bodyweight and above : Four tablets as a single initial dose, 4 tablets again after 8 hours, and then 4 tablets twice daily (morning and evening) for the following 2 days (total course of 24 tablets). 2.4 Dosage in Patients With Hepatic or Renal Impairment No specific pharmacokinetic studies have been carried out in patients with hepatic or renal impairment. Most patients with acute malaria present with some degree of related hepatic and/or renal impairment. In clinical studies, the adverse event profile did not differ in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function. No specific dose adjustments are needed for patients with mild or moderate hepatic impairment. In clinical studies, the adverse event profile did not differ in patients with mild or moderate renal impairment compared to patient

Monitoring

• 5 WARNINGS AND PRECAUTIONS Avoid use in patients with known QT prolongation, those with hypokalemia or hypomagnesemia, and those taking other drugs that prolong the QT interval.
• ( 5.1 , 12.6 ) Halofantrine and Coartem Tablets should not be administered within one month of each other due to potential additive effects on the QT interval.
• ( 5.1 , 5.2 , 12.3 ) Antimalarials should not be given concomitantly, unless there is no other treatment option, due to limited safety data.
• ( 5.2 ) QT prolonging drugs, including quinine and quinidine, should be used cautiously following Coartem Tablets.

Interaction Notes

• 7 DRUG INTERACTIONS CYP3A4 Inducers: Potential for loss of antimalarial efficacy.
• ( 4 , 5.3 , 7.1 , 12.3 ) CYP3A4 Inhibitors: Use cautiously due to potential for QT prolongation.
• ( 5.3 , 7.2 , 12.3 ) Antiretrovirals: Use cautiously due to potential for QT prolongation, loss of antiviral efficacy, or loss of antimalarial efficacy of Coartem Tablets.
• ( 5.3 , 7.3 , 12.3 ) Mefloquine: If used immediately before treatment, monitor for decreased efficacy of Coartem Tablets and encourage food consumption.