Artemether + Lumefantrine
Indications
This preparation is indicated for:
Treatment and stand by emergency treatment of adults, children and
infants with acute, uncomplicated infection due to Plasmodium falciparum
or mixed infections including P. falciparum. Because Artemether and
Lumefantrine is effective against both drug sensitive and drug
resistance P. falciparum. This preparation is also recommended for
malaria infections acquired in areas where the parasites may be
resistant to other antimalarials. Stand by emergency treatment: Most
tourists and business travelers, considered to be non-immune, will be
able to obtain prompt medical attention if malaria is suspected. However
a minority at risk of infection may be unable to obtain such care
within 24 hours of onset of symptoms, particularly if they are in an
isolated location far from medical services. In such case, prescribers
are advised to issue Artemether and Lumefantrine to be carried by the
traveler for self-administration (stand by emergency treatment).
Consideration should be given to official guidance regarding the
appropriate use of the anti-malarial agents.
Pharmacology
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.
Dosage & Administration
Patients with acute malaria are frequently
averse to food. The dose should be taken with high fat food or drinks
such as milk. In the event of vomiting within 1 hour of administration a
repeat dose should be taken.
Adults and children weighing 35 kg and above: A standard 3 days treatment schedule with a total of 6 doses is recommended dosage is 4 tablets as a single dose at the time of initial diagnosis, again 4 tablets after eight hours, and then 4 tablets twice daily (morning and evening) on each of the following two days (Total course comprises 24 tablets).
5 to <15 kg body weight: 1 tablet at the time of initial diagnosis, 1 tablet again after 8 hours and then 1 tablet twice daily (morning and evening) on each of the following two days (Total course comprises of 6 tablets).
15 to <25 kg body weight: 2 tablets as a single dose at the time of initial diagnosis , 2 tablets again after 8 hours and then 2 tablets twice daily (morning and evening) on each of the following two days (Total course comprises 12 tablets).
25 to <35 kg body weight: 3 tablets as a single dose at the time of initial diagnosis, 3 tablets again after 8 hours and then 3 tablets twice daily (morning and evening) on each of the following two days (Total courses comprises 18 tablets).
Adults and children weighing 35 kg and above: A standard 3 days treatment schedule with a total of 6 doses is recommended dosage is 4 tablets as a single dose at the time of initial diagnosis, again 4 tablets after eight hours, and then 4 tablets twice daily (morning and evening) on each of the following two days (Total course comprises 24 tablets).
5 to <15 kg body weight: 1 tablet at the time of initial diagnosis, 1 tablet again after 8 hours and then 1 tablet twice daily (morning and evening) on each of the following two days (Total course comprises of 6 tablets).
15 to <25 kg body weight: 2 tablets as a single dose at the time of initial diagnosis , 2 tablets again after 8 hours and then 2 tablets twice daily (morning and evening) on each of the following two days (Total course comprises 12 tablets).
25 to <35 kg body weight: 3 tablets as a single dose at the time of initial diagnosis, 3 tablets again after 8 hours and then 3 tablets twice daily (morning and evening) on each of the following two days (Total courses comprises 18 tablets).
Interaction
No such result is available.
Contraindications
Hypersensitivity to any of the ingredients
or excipients; 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 known to prolong the QTc interval such as
patients with a history of symptomatic cardiac arrythmias with
clinically relevant bradycardia or with severe cardiac disease; Patients
with known disturbance of electrolyte balance e.g. hypokalaemia or
hypomagnesemia; Patients taking any drug which is metabolized by the
cytochrome enzyme CYP2D6 (e.g. flecainide, metoprolol, imipramine,
amitriptyline, clomipramine).
Side Effects
It is generally very well tolerated by
children and adults, with most adverse effects are of mild to moderate
severity and duration. Hypersensitivity, headache, dizziness, sleep
disorder, somnolence, involuntary muscle contractions, paraesthesia,
hypoesthesia, abnormal gait, ataxia, palpitation, cough, abdominal pain,
anorexia, diarrhoea, vomiting, nausea, pruritus, rash, arthralgia,
myalgia, asthenia, fatigue.
Pregnancy & Lactation
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.
Precautions & Warnings
This has not been evaluated for prophylaxis
and is therefore not indicated. This is also not evaluated for the
treatment of cerebral malaria or other severe manifestations of severe
malaria including pulmonary oedema or renal failure.
Overdose Effects
In cases of suspected over dosage,
symptomatic and supportive therapy should be given as appropriate. ECG
and blood potassium level should be monitored.
Therapeutic Class
Anti-malarial drugs
Storage Conditions
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
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