COARTEM artemether and lumefantrine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ARTEMETHER (UNII: C7D6T3H22J) (ARTEMETHER - UNII:C7D6T3H22J)

Available from:

Department of State Health Services, Pharmacy Branch

INN (International Name):

ARTEMETHER

Composition:

ARTEMETHER 20 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

COARTEM- ARTEMETHER AND LUMEFANTRINE TABLET
DEPARTMENT OF STATE HEALTH SERVICES, PHARMACY BRANCH
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
COARTEM TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR COARTEM TABLETS.
COARTEM (ARTEMETHER/LUMEFANTRINE) TABLETS
INITIAL U.S. APPROVAL: 2009
INDICATIONS AND USAGE
Coartem (artemether and lumefantrine) Tablets are indicated for
treatment of acute, uncomplicated malaria infections
due to _Plasmodium falciparum_ in patients of 5 kg bodyweight and
above. ( 1)
Coartem Tablets have been shown to be effective in geographical
regions where resistance to chloroquine has been
reported. ( 1)
Coartem Tablets should not be used to treat severe malaria or to
prevent malaria. ( 1)
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
DOSAGE FORMS AND STRENGTHS
Tablets are scored and contain 20 mg artemether and 120 mg
lumefantrine. ( 3)
CONTRAINDICATIONS
Known hypersensitivity to artemether, lumefantrine, or to any of the
excipients. ( 4)
Coadministration of strong inducers of CYP3A4 such as rifampin,
carbamazepine, phenytoin, and St. John’s wort with
Coartem Tablets. ( 4, 7.1, 12.3)
WARNINGS AND PRECAUTIONS
Avoid use in patients with known QT prolongation, those