Artemether & Lumefantrine Tablets RAVMAL80/480
COMPOSITION:
Each film coated tablet contains:
Artemether 80 mg
Lumefantrine USP 480 mg
Excipients q.s.
Colour : Tartrazine Yellow
DESCRIPTION:
Artemether / Lumefantrine is a new treatment of malaria. It is the fixed combination of Artemether
(Methyl-ether derivative of Artemisinin) & Lumefantrine (fluorene derivative belonging to aminoalcohol
class).
THERAPEUTIC INDICATION:
Artemether / Lumefantrine are indicated for the treatment of uncomplicated P.falciparum malaria
including multi-drug resistant strains of P.falciparum. Artemether / Lumefantrine is also effective against the blood stage of P.vivax but not active against hypnozoites Artemether / Lumefantrine must be used for the malaria infections acquired in areas where the parasites may be resistant to other anti-malarial drugs. World Health Organization recommends Artemether / Lumefantrine as a first line treatment for the acute uncomplicated P.falciparum malaria for both multi-drug resistant areas & drugs sensitive areas.
PHARMACODYNAMICS:
Artemether / Lumefantrine comprises a fixed combination of 1 part of Artemether and 6 parts of
Lumefantrine, Artemether has quick onset of action while Lumefantrine has longer duration of action. Both exert their anti-parasitic action at the blood stage of malarial parasite, where they convert the haem(a toxic metabolite produced during haemoglobin breakdown) to nontoxic haemozoin(malaria pigment).Lumefantrine interfere with the polymerization process, while Artemether generates reactive metabolites as a result of interaction between its peroxide bridge & haem iron. Both components also have a secondary action involving inhibition of nucleic acid and protein synthesis within the malarial parasite.
There is a synergism of independent actions of both Artemether and Lumefantrine, which has been
shown to potentiate the blood schizontocidal effects. It is also effective against drug resistant strains of P.falciparum malaria. Comprehensive in vitro studies using laboratory maintained and fresh field parasite isolates from different malaria endemic areas have shown marked synergic effect of these two components Results of comparative clinical trials indicate that this Artemether and Lumefantrine combination also clears gametocytes more rapidly than other conventional antimalarials.
PRECAUTION:
Pregnancy: There are no adequate data from the use of Artemether / Lumefantrine in pregnant women. Artemether / Lumefantrine treatment should only be considered if the expected benefit to the mother outweighs the risk to the fetus.
Lactation: Artemether / Lumefantrine excrete into breast milk. It should not be taken by breast-feeding women.
STORAGE:
Store in a cool & dry place below 30°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.
