Artemether

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 should be taken with food
• Tablets may be crushed and mixed with 1 to 2 teaspoons of water immediately prior to administration to patients, including children
• 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
• The adult dosage for patients with bodyweight of 35 kg and above is 4 tablets per dose for a total of 6 doses
• The number of tablets per dose for children is determined by bodyweight, as shown in the chart below
• 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 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). …

Coartem Tablets contain 20 mg of artemether and 120 mg of lumefantrine. Coartem Tablets are supplied as yellow, round, flat tablets with beveled edges and scored on one side. Tablets are imprinted with “N/C” on one side and “CG” on the other side. Tablets are scored and contain 20 mg artemether and 120 mg lumefantrine. ( 3 )

• The safety and effectiveness of Coartem Tablets have been established
• In pediatric patients aged 2 months and older with a bodyweight of 5 kg and above
• For the treatment of acute, uncomplicated malaria [see Clinical Studies ]
• The safety and effectiveness of Coartem Tablets have not been established
• In pediatric patients younger than 2 months old or who weigh less than 5 kg
• Pediatric patients from non-endemic countries were not included in clinical trials

Clinical studies of Coartem Tablets did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. In general, the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients should be considered when prescribing Coartem Tablets.

• Advise patients to read the FDA-Approved Patient Labeling (Patient Information)
• Administration Instructions Instruct patients to take Coartem Tablets with food
• Patients who do not have an adequate intake of food are at risk for recrudescence of malaria [see Dosage and Administration ]
• Hypersensitivity Patients with known hypersensitivity to artemether, lumefantrine, or to any of the excipients should not receive Coartem Tablets [see Contraindications ] . …

• Hypersensitivity Known hypersensitivity to artemether, lumefantrine, or to any of the excipients of Coartem Tablets [see Adverse Reactions ]
• Strong CYP3A4 Inducers Coadministration of strong inducers of CYP3A4 such as rifampin, carbamazepine, phenytoin, and St. …

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. ( 2.1 , 7.4 , 12.3 ) Hormonal Contraceptives: Effectiveness may be reduced; use an additional method of birth control. …

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. …

The following serious and otherwise important adverse reactions are discussed in greater detail in other sections of labeling: Hypersensitivity Reactions [see Contraindications (4)] Prolongation of the QT Interval [see Warnings and Precautions (5.1)] Use of QT Prolonging Drugs and Other Antimalarials [see Warnings and Precautions (5.2)] Drug Interactions with CYP3A4 [see Warnings and Precautions (5.3)] Drug Interactions with CYP2D6 [see Warnings and Precautions (5.4)] The most common adverse reactions in adults (greater than 30%) are headache, anorexia, dizziness, asthenia, arthralgia, and myalgia. …

8.1 Pregnancy Risk Summary Published data from clinical studies and pharmacovigilance data have not established an association with artemether/lumefantrine use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. …

There is no information on overdoses of Coartem Tablets higher than the doses recommended for treatment. In cases of suspected overdosage, symptomatic and supportive therapy, which would include ECG and blood electrolyte monitoring, should be given as appropriate.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.