Alar™

[Artemether + Lumefantrine]

Alar

Description / Properties

Alar™ [Artemether + Lumefantrine] is a fixed combination of two active ingredients which act as blood schizontocides. Artemether, a sesquiterpene lactone derivative of naturally occurring substance, artemisinin. Chemically it is (3R, 5aS, 8As, 9r, 10s, 12r, 12Ar) - Decahydro - 10 - methoxy-3, 6, 9­trimethyl-3, 12-epoxy-12H-pyrano [4,3-j] 1, 2 - benzodioxepin. The empirical formula is C16H26O5. Lumefantrine, a synthetic racemic flourene mixture (1 R-S)-2­Dibutylamino-1-{2,7-dichloro-9-[(Z)(4-cholorobenzylidene)-9H-fluoren-4-yl}-ethanol. The empirical formula is C30H32C13NO.

Indications

ALAR is indicated for the treatment of uncomplicated infections with plasmodium falci­parum, including strains from multi-drug resistant areas in adult, children and infants of 5kg and above.

Drug Interactions

Mefloquine: Pre-treatment with mefloquine has no effect on plasma con­centrations of artemether or the artemether/dihydroartemisinin ratio but there was a significant reduction in plasma levels of lumefantrine. Patients should be encouraged to eat at dosing times to compensate for the decrease in bioavailability.

Quinine: Quinine alone caused a transient prolongation of the QTc interval, which was consistent with its known cardiotoxicity. Thus, prior administration of ALAR combi­nation appears to enhance the inherent risk of QTc prolongation from IV quinine.

Interaction with CYP450 3A4 inhibitors (Ketoconazole): The concurrent oral administration of ketoconazole with ALAR combination led to a modest increase (~2-fold) in artemether, DHA, and lumefantrine exposure in healthy subjects. Dose adjustment of ALAR is considered unnecessary in falciparum malaria patients when administered in association with ketoconazole or other potent CYP3A4 inhibitors.

Warning and Precautions

Alar™ should not be given concurrently with any other anti-malarial agent unless there is no other treatment option. Caution is advised when administering ALAR tablets to patients with severe renal, hepatic or cardiac problems. In these patients, ECG and blood potassium monitoring is advised. Patients receiving ALAR combination should be warned that dizziness or fatigue / asthenia might occur in which they should not drive or use machines.

Dosage & Administration

Alar™ should be taken with food or a milky drink. Patients who vomit within 1 hour of taking the medication should repeat the dose.

Adult dose: For patients of > 12 years of age and > 35kg body weight, a course of treatment comprises of six doses of four tablets i.e. total of 24 tablets, given over a period of 60 hours as follows: The first dose of four tablets, given at the time of initial diagnosis, should be followed by five further doses of four tablets given at 8, 24, 36, 48 and 60 hours thereafter.

Children and infants weighing 5kg to less than 35kg:

  • 5 to < 15kg body weight: The first dose of one tablet, given at the time of initial diagnosis, should be followed by five further doses of one tablet given at 8, 24, 36, 48 and 60 hours.
  • 15 to < 25kg body weight: The first dose of two tablets, given at the time of initial diagnosis, should be followed by five further doses of two tablets given at 8, 24, 36, 48 and 60 hours.
  • 25 to < 35kg body weight: The first dose of three tablets, given at the time of initial diagnosis, should be followed by five further doses of three tablets given at 8, 24, 36, 48 and 60 hours.

    Presentations Available

    Alar™ [Artemether 20mg + Lumefantrin 120mg] is available in blister pack of 16 tablets.

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