Artemether Lumefantrine

Artemether/Lumefantrine is a prescription medication used to treat Malaria.

• Artemether/Lumefantrine is available under the following different brand names: Coartem

Adult and pediatric dosage

Tablet

• 20mg/120mg

Malaria

Pediatric dosage

• Children younger than 2 years of age or weighing less than 5 kg: Safety and efficacy not established
• 5 to less than 15 kg: Administer 6 tablets over 3 days; 1 tablet initially and again after 8 hours on first day; follow by 1 tablet twice daily (morning and evening) for the next 2 days
• 15 to less than 25 kg: Administer 12 tablets over 3 days; 2 tablets initially and again after 8 hours on first day; follow by 2 tablets twice daily (morning and evening) for the next 2 days
• 25 kg to less than 35 kg: Administer 18 tablets over 3 days; 3 tablets initially and again after 8 hours on first day; follow by 3 tablets twice daily (morning and evening) for the next 2 days
• 35 kg or greater: As in adults; administer 24 tablets over 3 days; 4 tablets initially and again after 8 hours on the first day; follow by 4 tablets twice daily (morning and evening) for the next 2 days

Adult dosage

• 35 kg or greater: 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
• Day 2 and 3: 4 tablets twice per day (morning and evening)

Dosage Considerations – Should be Given as Follows: 

• See "Dosages"

Common side effects of Artemether/Lumefantrine include:

• headache, 
• dizziness, 
• fever, 
• cough, 
• weakness, 
• tiredness, 
• muscle pain, 
• tenderness, 
• weakness, 
• joint pain, 
• vomiting, and 
• loss of appetite

Serious side effects of Artemether/Lumefantrine include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, and
• fast heart rate, 
• fever, 
• chills, 
• body aches, 
• severe headache, 
• flu symptoms after finishing all doses of the medication, 
• worsening malaria symptoms, 
• severe vomiting, 
• loss of appetite, 
• being unable to eat, 
• fast or pounding heartbeats, 
• lightheadedness, and
• first sign on any skin rash, no matter how mild

Rare side effects of Artemether/Lumefantrine include:

• none 

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them.  Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first

• Artemether/Lumefantrine has severe interactions with at least 31 other drugs. 
• Artemether/Lumefantrine has serious interactions with at least 123 other drugs.
• Artemether/Lumefantrine has moderate interactions with at least 180 other drugs.
• Artemether/Lumefantrine has minor interactions with at least 56 other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drugs interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use.  Keep a list of all your medications with you, and share this information with your doctor and pharmacist.  Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity
• Coadministration with strong CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin, St. John’s wort) can result in decreased artemether and/or lumefantrine serum concentrations and loss of antimalarial efficacy

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Artemether/Lumefantrine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Artemether/Lumefantrine?”

Cautions

• Not approved for severe/complicated P. falciparum infections
• Not approved for prevention
• Concurrent CYP3A4 or CYP2D6 inhibitors / inducers
• May render hormonal contraceptives ineffective
• If patient vomits out drug repeatedly, use alternative treatment
• Avoid with conditions that prolong QT
• Long QT syndrome, history of symptomatic cardiac disease, clinically relevant bradycardia, or severe cardiac disease
• Family history of congenital QT prolongation or sudden death
• Electrolyte imbalance (eg, hypokalemia, hypomagnesemia)
• Coadministration with other drugs that prolong QT interval (eg, class IA antiarrhythmics [quinidine, procainamide, disopyramide], or class III antiarrhythmics [amiodarone, sotalol] antiarrhythmic agents, antipsychotics [pimozide, ziprasidone], antidepressants; certain antibiotics [macrolide, fluoroquinolones], antiretrovirals [eg, ritonavir], cisapride
• CYP3A4 and CYP2D6 inhibitors may increase serum levels by inhibiting metabolism, and therefore risk for QT prolongation
• QT prolongation with other antimalarials; duplicate antimalarials should not be given concomitantly, unless there is no other treatment option, due to limited safety data
• Not for concomitant administration with halofantrine within one month of each other due to potential additive effects on QT interval
• Cautiously use quinine and quinidine for malaria following Coartem due to long half-life of Coartem and potential additive QT prolongation

Pregnancy and Lactation

• Published data from clinical studies and pharmacovigilance data have not established an association between drug use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Malaria during and after pregnancy increases risk for adverse pregnancy and neonatal outcomes, including maternal anemia, severe malaria, spontaneous abortion, stillbirths, preterm delivery, low birth weight, intrauterine growth restriction, congenital malaria, and maternal and neonatal mortality
  • Contraception
    • May reduce efficacy of hormonal contraceptives; advise patients using hormonal contraceptives to use an alternative non-hormonal contraceptive method or add a barrier method of contraception during treatment
  •   Infertility
    • In animal fertility studies, administration of repeated doses to female rats (for 2 to 4 weeks) resulted in pregnancy rates that were reduced by one half
    • Male rats dosed for approximately 3 months, abnormal sperm cells, showed decreased sperm motility, and increased testes weight
    • There are no data on presence of drug in human milk, effects on breastfed infant or on milk production; drug components are transferred into rat milk; when a drug is transferred into animal milk, it is likely that the drug will also be transferred into human milk
• The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition