Uses of Maltrine: - Malaria Oral Adults (weighing 35 kg and above): Administer 24 tablets over 3 days; use a 3-day treatment schedule with total of 6 doses. Day 1: 4 tablets initially and 4 tablets again after 8 hours. Days 2 & 3: 4 tablets BID (morning & evening). Oral Children (weighing 35 kg and above or more than 12 years of age): Administer 24 tablets over 3 days; use a 3-day treatment schedule with total of 6 doses. Day 1: 4 tablets initially and 4 tablets again after 8 hours. Days 2 & 3: 4 tablets BID (morning & evening). Children: < 12 years 5 to <15 kg: Administer 6 tablets over 3 days; 1 tablet initially and again after 8 hours on first day; follow by 1 tablet BID (morning & evening) for the next 2 days. 15 to <25 kg: Administer 12 tablets over 3 days; 2 tablets initially and again after 8 hours on first day; follow by 2 tablets BID (morning & evening) for the next 2 days. 25 to <35 kg: Administer 18 tablets over 3 days; 3 tablets initially and again after 8 hr on 1st day; follow by 3 tablets BID (morning & evening) for the next 2 days.

Anti-malarial drugs

This preparation contains a fixed ratio of 1:6 parts of Artemether and Lumefantrine respectively. Artemether is a derivative of naturally occurring substance Artemisinin. Lumefantrine is a synthetic racemic fluorine mixture belonging to the aryl amino alcohol family like other anti-malarials (e.g. Quinine, mafloquine, halofantrine). Both components act in the food vacuoles of malarial parasites, where they are thought to interfere with the conversion of haem, a toxic intermediate formed during haemoglobin breakdown, to the non-toxic haemozin (a malaria pigment). Lumefantrine is thought to interfere with the polymerization process, while Artemether generates reactive metabolites as a result of interaction between the peroxide bridge and haem iron. Both Artemether and Lumefantrine have a secondary action involving inhibition of nucleic acid - protein synthesis within the malarial parasites. This tablet did not induce resistance. This tablet is active against blood stages of Plasmodium vivax, but it is not active against hypnozoites. Therefore, sequential treatment with premaquine should be used to achieve hypnozoite eradication.

How to use Artemether + Lumefantrine: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Artemether + Lumefantrine is to be taken with food. Administration: Artemether causes QT prolongation in some patients. Thus concomitant use of erythromycin, terfenadine, procainamide, quinidine, disopyramide, amiodarone, bretylium, bepridil, sotalol, astemizole, probucol, tricyclic antidepressants, phenothiazines may be avoided. Adult Dose: Pregnancy and lactation. Avoid concomitant use of drugs known to prolong QT interval or monitor such patients. Lactation: not known if either component enters breast milk, use caution Renal Dose: Artemether is a potent and rapidly acting blood schizontocide. Artemether and active metabolite (DHA): via endoperoxide. Lumefantrine: unknown; possibly inhibits beta-hematin formation Both artemether and lumentantrine inhibit nucleic acid and protein synthesis

Hypersensitivity.

Oral Children (weighing 35 kg and above or more than 12 years of age): Administer 24 tablets over 3 days; use a 3-day treatment schedule with total of 6 doses. Day 1: 4 tablets initially and 4 tablets again after 8 hours. Days 2 & 3: 4 tablets BID (morning & evening). Children: < 12 years 5 to <15 kg: Administer 6 tablets over 3 days; 1 tablet initially and again after 8 hours on first day; follow by 1 tablet BID (morning & evening) for the next 2 days. 15 to <25 kg: Administer 12 tablets over 3 days; 2 tablets initially and again after 8 hours on first day; follow by 2 tablets BID (morning & evening) for the next 2 days. 25 to <35 kg: Administer 18 tablets over 3 days; 3 tablets initially and again after 8 hr on 1st day; follow by 3 tablets BID (morning & evening) for the next 2 days.

Common - Headache - Loss of appetite - Dizziness - Weakness - Joint pain - Muscle pain

Use in pregnancy & lactation is contraindicated; especially in the first trimester of pregnancy. Breast feeding women should not take this preparation. Due to the long elimination half-life of Lumefantrine (4-6 days), it is recommended that breast feeding should not resume before day 28 unless potential benefits to the mother and child outweigh the risk of treatment.

Precaution: Acute uncomplicated malaria, Falciparum malaria

In cases of suspected over dosage, symptomatic and supportive therapy should be given as appropriate. ECG and blood potassium level should be monitored.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Anti-malarial drugs

Should be taken with food.

>10% Abdominal pain (17%),Anorexia (40%),Arthralgia (34%),Asthenia (38%),Chills (23%),Dizziness (39%),Fatigue (17%),Headache (56%),Myalgia (32%),Nausea (26%),Palpitations (18%),Pyrexia (25%),Sleep disorder (22%),Vomiting(17%) 1-10% Anemia (4%),Cough (6%),Diarrhea (7%),Hepatomegaly (9%),Malaise (3%),Nasopharyngitis (3%),Pruritus (4%),Rash (3%),Splenomegaly (9%),Vertigo (3%)