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Art-Luf (Artemether/Lumenfantrine)

Posted by : admin / On : Aug 06, 2019 /

ArtLuf Tablets contain a fixed combination of 2 antimalarial active ingredients, artemether, an artemisinin derivative, and lumefantrine. Both components are blood schizontocides. The chemical name of artemether is (3R,5aS,6R,8aS,9R,10S,12R,12aR)-10-methoxy-3,6,9-trimethyldecahydro-3,12-epoxypyrano[4,3-j]-1,2- benzodioxepine. Artemether is a white, crystalline powder that is freely soluble in acetone, soluble in methanol and ethanol, and practically insoluble in water. 

INDICATIONS
ArtLuf (artemether/lumefantrine) Tablets are indicated for treatment of acute, uncomplicated malaria infections due to Plasmodium falciparum in patients of 5 kg bodyweight and above. ArtLuf Tablets have been shown to be effective in geographical regions where resistance to chloroquine has been reported [see Clinical Studies].

Limitations Of Use
ArtLuf Tablets are not approved for patients with severe or complicated P. falciparum malaria.  ArtLuf Tablets are not approved for the prevention of malaria.

DOSAGE AND ADMINISTRATION
Administration Instructions

ArtLuf 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, 
ArtLuf 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 of administration, a repeat dose should be taken. If the repeat dose is vomited, the patient should be given an alternative antimalarial for treatment.

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 In Pediatric Patients.

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).


Caution should be exercised when administering ArtLuf Tablets in patients with severe hepatic or renal impairment [see WARNINGS AND PRECAUTIONS].

HOW SUPPLIED
Dosage Forms And Strengths

ArtLuf Tablets contain 20 mg of artemether and 120 mg of lumefantrine. ArtLuf 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.

Storage And Handling

ArtLuf (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 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]

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