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PRODUCT DETAIL
 
   
 


ARENAX PLUS®


Composition.
One tablet or 7ml suspension after reconstitution contains: -
Artemether 20mg & Lumefantrine 120mg.

Arenax Plus® Forte
One tablet contains Artemether 80mg & Lumefantrin 480mg.
Artemether is a derivative of artemisinin, a sesquiterpene lactone isolated from the plan Artemisia annua.
Lumefantrine is a synthetic racemic fluorene mixture.

 Indication
 Arena Plus®  is a fixed combination of Artemether and Lumefantrine which acts as a blood schizonticide indicated for.
  –  Treatment of adult, children and infants with acute uncomplicated infections due to Plasmodium falciparium or mixed infection including
      P. falciparium.
  –  Arenax Plus®  is effective against drug-sensitive and drug-resistant P.falciparium.
  –  "stand-by emergency treatment" i.e. for non-immune travelers for self-administration.

Dosage & Administration
•  High fat food and drinks such as milk improves absorption of artemether and lumefantrine.
•  In the event of vomiting within lhr of administration a repeat dose should be taken.

Dosage in infants and children weighing 5 to less than 35kg.
•  A six dose regimen is recommended with 1 to 3 tabs/7ml Susp. per dose depending on body weight.
•  5kg to 14kg BW: 1 tab/7ml Susp. start, 1 tab/7ml Susp. after 8 hrs & then 1 tab/7ml Susp. twice daily on each of the following 2 days. (6 tabs)
•  15kg to 24kg BW: 2 tabs start, 2 tabs after 8 hrs & then 2 tabs twice daily on each of the following 2 days. (12 tabs)
•  25kg to 34kg BW: 3 tabs start, 3 tabs after 8 hrs & then 3 tabs twice daily on each of the following 2 days.(18 tabs)

Dosage in Adult and Children weighing 35kg and above
• A standard 3 days treatment schedule with a total of (6) six doses is recommended as follows.
  – 4 tabs of Arenax Plus® /1 tab of Arenax Plus®  Forte as a single dose at the time of initial diagnosis.
  – Again 4 tabs of Arenax Plus® /1 tab of Arenax Plus®  Forte after 8 hours
  – Then 4 tabs of Arenax Plus® /1 tab of Arenax Plus®  Forte twice daily (moving & evening) on each of the following two days.
     (Total course comprises 24 tablets for Arenax Plus®  or 6 tabs for Arenax Plus®  Forte)

Contraindications
•  Hypersasitivity to artemether, lumefantrine or to any of the excipients of Arenax Plus® .
•  Patients with severe malaria according to WHO definition.
•  First trimester of pregnancy.
•  Patients with a family history of congenital prolongation of the QTc interval or sudden death, or with any other clinical condition know to prolong
   QTc interval such as patients with a history of symptomatic cardiac arrhythmias
•  Clinically relevant brandycardia.
•  Severe cardiac disease.
•  Patients with known disturbances of electrolyte imbalance e.g hypokalaemia or hypomagnesaemia.
•  Patients taking any drug which is metabolized by enzyme CYP2D6 (e.g. flecainide, metoprolol;imipramine, amitriptyline, clomipramine)

Pregnancy & Lactation
•  Arenax Plus®  treatment is contraindicated during the first trimester of pregnancy. However, it should not be withheld in life-threatening
    situations where no other effective anti-malarials are available.
•  During the second and the third trimester, treatment should only be considered if the expected benefit to the mother outweighs the risk to the
    foetus.
•  Breast-feeding women should not take Arenax  Plus® . Due to the long elimination half-life of lumefantrine (4 to 6 days) it is recommended that
   breast-feeding should not resume before day 28 unless potential benefits to mother and child outweighs the risk of Arenax  Plus®  treatment.

Undesirable Effects
•  Arenax Plus®  is generally very well tolerated by children and adults with most adverse events being of mild to moderate severity and duration
•  N:B- Many of the reported events are likely to be related to the underlying malaria and / or to an unsatisfactory response to the treatment  rather than to Arenax Plus® .
 
Over dosage
•  In cases of suspected over dosage, symptomatic & supportive therapy should be given as appropriate. ECG and blood potassium levels should be monitored.