COARTEM- artemether and lumefantrine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ARTEMETHER (UNII: C7D6T3H22J) (ARTEMETHER - UNII:C7D6T3H22J), LUMEFANTRINE (UNII: F38R0JR742) (LUMEFANTRINE - UNII:F38R0JR742)

Available from:

Novartis Pharmaceuticals Corporation

INN (International Name):

ARTEMETHER

Composition:

ARTEMETHER 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Hypersensitivity Known hypersensitivity to artemether, lumefantrine, or to any of the excipients of Coartem Tablets [see Adverse Reactions (6.2)] . Strong CYP3A4 Inducers Coadministration of strong inducers of CYP3A4 such as rifampin, carbamazepine, phenytoin, and St. John’s wort with Coartem Tablets can result in decreased concentrations of artemether and/or lumefantrine and loss of antimalarial efficacy [see Warnings and Precautions (5.3), Drug Interactions (7.1), and Cl

Product summary:

Coartem (artemether/lumefantrine) Tablets 20 mg/120 mg Tablets - 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. Bottle of 24                         NDC 0078-0568-45 Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature ]. Dispense in tight container (USP).

Authorization status:

New Drug Application

Summary of Product characteristics

COARTEM- ARTEMETHER AND LUMEFANTRINE TABLET
NOVARTIS PHARMACEUTICALS CORPORATION
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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 AND LUMEFANTRINE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2009
INDICATIONS AND USAGE
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
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 over4 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