Clinical Pharmacology Details


ARTESUNATE+MEFLOQUINE


View Drug Forms

Indications & Dose:

Severe malaria including erebral malaria and as a second line treatment in chloroquineresistant falciparum malaria.



Adults: Four tablets as a single dose at the time of intiail diagnosis, and then 8, 24 and 48 hours thereafter (total course comprises 16 tablets).


Children : 5-15 kg bodyweight: One tablet at the time of initial diagnosis, and then 8, 24 and 48 hours thereafter (total course comprises 4 tablets). 15-25 kg bodyweight: Two tablets as a single dose at the time of initial diagnosis, and then 8, 24 and 48 hours thereafter (total course comprises 8 tablets). 25-35 bodyweight: Three tablets as a single dose at the time of initial diagnosis, and then 8, 24 and 48 hours thereafter (total course comprises 12 tablets).


Elderly: Although no studies have been carried out in the elderly, no special precautions or dosage adjustments are considered necessary in such patients. 

Contraindications:

Hypersensitivity to the active substances or to any of the excipients.


Patients with renal or hepatic impairments: Although no specific studies have been carried out, no special precautions or dosage adjustment are considered necessary for these conditions. Most patients with acute malaria present with some degree of related hepatic impairment. The adverse event profile did not differ in patients with and those without hepatic impairment. Moreover, baseline abnormalities in liver function tests improved in nearly all patients after treatment with this treatment

Side Effects:

Similar to or lower than that of other antimalarial drugs

Cautions:

Precautions:

Has not been evaluated for the treatment of cerebral malaria or other severe manifestations of complicated malaria, pulmonary edema or renal failure. Several antimalarials are knwon to cause QTc-prolongation and a slight QTcprolongation without clinical symptoms has been observed in a few patients treated with the drug, mainly in cases where concomitant dehydration or electrolyte imbalance was present. No correlation was found between QTc prolongation and peak plasma concentration in individual patients. Patients who remain averse to food during treatment should be closely monitored as the risk of recrudescence may be greater. 

Interaction:

Drugs


No specific drug interaction studies 

Warnings:

Adverse Effects:

Lactations:

The safe use of artemether and lumefantrine during pregnancy has not been established.


Lactation: No data are available on the excertion of either of the two components in breast milk. 


 

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: