Artemether and Lumefantrine
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Description & Indication(s)
Each tablet contains Artemether INN 20 mg and Lumefantrine INN 120 mg.
Artemether and lumefantrine are anti-malaria medications
that interfere with the growth of parasites in the red blood cells of the human body. Malaria is caused by parasites that enter the body through the bite of
a mosquito. Malaria is common in areas such as Africa, South America, and Southern Asia. This combination is used to
treat non-severe malaria.
Artemether & Lumefantrine combination 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 â€“ protein synthesis within the malarial parasites. Artemether & Lumefantrine combination did not induce resistance. Artemether & Lumefantrine combination 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.
Artemether & Lumefantrine combination acts as a blood schizontocide. This combination 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. Artemether & Lumefantrine combination 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 attentin 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 & Lumefantrine combination 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.
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. A standard 3 days treatment schedule with a total of 6 doses is recommended.
Dosage in adults and children weighing 35 kg and above: 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).
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.
Hypersensitivity to any of the ingredients or excipients; Patients with severe malaria ccording 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).
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.
Overdose & Precautions
In cases of suspected over dosage, symptomatic and supportive therapy should be given as appropriate. ECG and blood potassium level should be monitored.
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.
|Brand Name||Manufacturer/Marketer||Composition||Dosage Form||Pack Size & Price|
|AREXEL||Jayson Pharmaceuticals Ltd.||Artemether 20mg+ Lumefantrine 120mg||Tablet||24's: 409.44 IP|
|ARTEM||Aexim Pharmaceutical Ltd.||Artemether 20mg+ Lumefantrine 120mg||Tablet||16's: 320.00 MRP|
|ARTEM Syrup||Aexim Pharmaceutical Ltd.||Artemether 15mg+ Lumefantrine 90mg/5ml (Dry Syrup)||Syrup||60ml: 220.00 MRP|
|Artemet||Incepta Pharmaceuticals Limited||Artemether INN 20 mg and Lumefantrine INN 120 mg||Tablet||4x6's:MRP 480 Tk|
|COARTEM||Novartis (Bangladesh) Ltd.||Artemether INN 20mg+ Lumefantrine INN 120mg||Tablet||16's MRP 346.40; 24's: MRP 519.60|
|COAVLON||ACI Ltd.||Artemether 20mg+ Lumefantrine 120mg||Tablet||24's: 481.92 MRP|
|LUMERTAM||Square Pharmaceuticals Ltd.||Artemether 20mg + Lumefantrine 120mg||Tablet||6x4's: 483.12 MRP|
Why is Artemether/Lumefantrine prescribed?
The combination of artemether and lumefantrine is used to treat certain kinds of malaria infections (a serious infection that is spread by mosquitoes in certain parts of the world and can cause death). Artemether and lumefantrine should not be used to prevent malaria. Artemether and lumefantrine is in a class of medications called antimalarials. It works by killing the organisms that cause malaria.
How should Artemether/Lumefantrine be used?
The combination of artemether and lumefantrine comes as a tablet to take by mouth. It is usually taken twice a day for 3 days as instructed by your doctor. Always take artemether and lumefantrine with food. If you are not able to eat, contact your doctor. Follow the directions on your prescription label carefully, and ask your doctor to explain any part you do not understand. Take artemether and lumefantrine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
If you have trouble swallowing the tablets, they may be crushed and mixed with 1 or 2 teaspoons (5 or 10 mL) of water in a clean container. Drink the mixture right away. Rinse the glass with more water and swallow the entire contents.
You may vomit soon after you take the medication. If you vomit less than 1 hour after you take artemether and lumefantrine, you should take another full dose of artemether and lumefantrine. If you vomit again after taking the extra dose, call your doctor.
You should begin to feel better during the first few days of treatment with artemether and lumefantrine. If your symptoms do not improve or get worse, call your doctor. Also call your doctor if you have a fever, chills, muscle pain, or headache soon after you finish your treatment. This could be a sign that you still are infected with malaria.
Take artemether and lumefantrine until you finish the prescription, even if you feel better. If you stop taking artemether and lumefantrine too soon or skip doses, your infection may not be completely treated and the organisms may become resistant to antimalarials.
Other uses for Artemether/Lumefantrine
- tell your doctor if you are allergic to artemether and lumefantrine, any other medications, or any of the ingredients in artemether and lumefantrine tablets. Ask your pharmacist for a list of the ingredients.
- tell your doctor what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: certain antidepressants such as amitriptyline, clomipramine, imipramine, and nefazodone; certain antifungals such as itraconazole and ketoconazole; antimalarials such as mefloquine and quinine; carbamazepine; cisapride ; fluoroquinolone antibiotics such as ciprofloxacin, gatifloxacin , gemifloxacin, levofloxacin, lomefloxacin , moxifloxacin, nalidixic acid, norfloxacin, ofloxacin, and sparfloxacin ; macrolide antibiotics such as clarithromycin; certain medications for human immunodeficiency virus or acquired immunodeficiency syndrome such as indinavir, nelfinavir, and ritonavir; medications for irregular heartbeat including amiodarone, disopyramide, flecainide, procainamide, quinidine, and sotalol; medications for mental illness such as pimozide and ziprasidone; and rifampin . Also tell your doctor if you are taking or have stopped taking halofantrine within the past month. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with artemether and lumefantrine, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
- tell your doctor if you or anyone in your family has had a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death); or if you have or have ever had a slow, fast, or irregular heartbeat; a recent heart attack; a low level of magnesium or potassium in your blood; kidney, heart, or liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking artemether and lumefantrine, call your doctor.
- you should know that artemether and lumefantrine may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, implants, and injections). Talk to your doctor about methods of birth control that will work for you while you are taking artemether and lumefantrine.
What special dietary instructions need to follow?
Do not drink grapefruit juice while taking Artemether/Lumefantrine.
What need to do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can Artemether/Lumefantrine cause?Artemether and lumefantrine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
mus cle or joint pain
difficulty falling asleep or staying asleep
loss of appetite
abnormal or fast heartbeat
difficulty breathing or swallowing
swelling of the lips, tongue, face, or throat
Artemether and lumefantrine may cause other side effects. Consult your doctor if you have any unusual problems while taking Artemether/Lumefantrine.
What need to know about storage and disposal of Artemether/Lumefantrine?
Keep Artemether/Lumefantrine in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed.
In case of emergency/overdose
Keep all appointments with your doctor.
Do not let anyone else take your medication. Your prescription is probably not refillable. If you still have symptoms of infection after you finish the artemether and lumefantrine, call your doctor.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Ref: MedlinePlus, U.S. Natl. Library of Medicine
This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.
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| | Latest mph edition: 26 Dec 2013 |
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