Version July 2025
Malaria, treatment: Oral: Artemether 80 mg/lumefantrine 480 mg twice daily for 3 days; ideally, the first 2 doses should be administered 8 hours apart (Ref). For P. vivax or P. ovale, use in combination with primaquine. If used for severe malaria (after completion of IV therapy), use full 3-day schedule in addition to IV therapy (Ref). Note: Treatment failure has been reported in patients weighing >65 kg (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Dosage adjustments are not recommended in mild or moderate impairment. Use caution in severe impairment (has not been studied).
Dosage adjustments are not recommended in mild or moderate impairment. Use caution in severe impairment (has not been studied).
Refer to adult dosing.
(For additional information see "Artemether and lumefantrine: Pediatric drug information")
Malaria, treatment: Note: Patients with Plasmodium vivax or Plasmodium ovale should receive concomitant therapy with an antimalarial agent active against Plasmodium liver hypnozoites (antirelapse treatment) (eg, primaquine). If used for severe malaria (after completion of IV therapy), use full 3-day schedule following IV therapy (Ref).
Infants, Children, and Adolescents: Limited data available in infants <2 months (Ref): Note: Additional tablet strengths may be available outside the US.
Artemether 20 mg/lumefantrine 120 mg per tablet:
5 kg to <15 kg: Oral: One tablet at hour 0 and at hour 8 on the first day and then one tablet twice daily on days 2 and 3 (total of 6 tablets per treatment course).
15 kg to <25 kg: Oral: Two tablets at hour 0 and at hour 8 on the first day and then two tablets twice daily on days 2 and 3 (total of 12 tablets per treatment course).
25 kg to <35 kg: Oral: Three tablets at hour 0 and at hour 8 on the first day and then three tablets twice daily on day 2 and 3 (total of 18 tablets per treatment course).
≥35 kg: Oral: Four tablets at hour 0 and at hour 8 on the first day and then four tablets twice daily on days 2 and 3 (total of 24 tablets per treatment course).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Infants ≥2 months, Children, and Adolescents:
Mild or moderate impairment: Dosage adjustment not necessary.
Severe impairment: No dosage adjustment is provided in the manufacturer's labeling; use caution.
Infants ≥2 months, Children, and Adolescents:
Mild or moderate impairment: Dosage adjustment not necessary.
Severe impairment: No dosage adjustment is provided in the manufacturer's labeling; use caution.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Cardiovascular: Palpitation (adults: 18%)
Central nervous system: Headache (adults 56%; children 13%), dizziness (adults 39%; children 4%), fever (25% to 29%), chills (adults 23%; children 5%), sleep disorder (adults: 22%), fatigue (adults 17%; children 3%)
Gastrointestinal: Anorexia (adults 40%; children 13%), nausea (adults 26%; children 5%), vomiting (17% to 18%), abdominal pain (8% to 17%)
Infection: Plasmodium falciparum (exacerbation: children: 17%)
Neuromuscular & skeletal: Weakness (adults 38%; children 5%), arthralgia (adults 34%; children 3%), myalgia (adults 32%; children 3%)
Respiratory: Cough (adults 6%; children 23%)
Miscellaneous: Fever (25% to 29%)
3% to 10%:
Central nervous system: Insomnia (adults: 5%), malaise (adults: 3%), vertigo (adults: 3%)
Dermatologic: Pruritus (adults: 4%), skin rash (3%)
Gastrointestinal: Diarrhea (7% to 8%)
Hematologic & oncologic: Anemia (4% to 9%)
Hepatic: Hepatomegaly (6% to 9%), increased serum AST (≤4%)
Infection: Malaria (≤3%)
Respiratory: Rhinitis (4%), nasopharyngitis (≤3%)
<3%, postmarketing, and/or case reports: Abnormal gait, abnormal lymphocytes, abscess, agitation, anaphylaxis, angioedema, asthma, ataxia, back pain, bronchitis, bullous dermatitis, change in platelet count (increased), clonus, conjunctivitis, constipation, decreased hematocrit, decreased platelet count, decreased white blood cell count, dermatitis (hands and feet), dyspepsia, dysphagia, emotional lability, eosinophilia, fine motor control disorder, gastroenteritis, helminthiasis, hematuria, hemolytic anemia (delayed), hookworm infection, hyper-reflexia, hypoesthesia, hypokalemia, impetigo, increased serum ALT, influenza, leukocytosis, leukopenia, lower respiratory tract infection, nystagmus, oral herpes, otic infection, peptic ulcer, pharyngolaryngeal pain, pneumonia, proteinuria, respiratory tract infection, subcutaneous abscess, tinnitus, tremor, upper respiratory tract infection, urinary tract infection, urticaria
Hypersensitivity to artemether, lumefantrine, or any component of the formulation; concurrent use with strong CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin, St John’s wort)
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Concerns related to adverse effects:
• QT prolongation: Use associated with prolonging the QT interval; avoid use in patients at risk for QT prolongation, including patients with a history of long QT syndrome, family history of congenital QT prolongation or sudden death, symptomatic arrhythmias, clinically relevant bradycardia, severe heart disease, known hypokalemia, hypomagnesemia or concurrent administration of antiarrhythmics (eg, Class Ia or III), drugs metabolized by CYP2D6 known to have cardiac effects (eg, flecainide, tricyclic antidepressants), or other drugs known to prolong the QT interval (eg, antipsychotics, antidepressants, macrolides, fluoroquinolones, triazole antifungals, or cisapride).
Disease-related concerns:
• Hepatic impairment: Use caution in patients with severe hepatic impairment; has not been adequately studied.
• Renal impairment: Use caution in patients with severe renal impairment; has not been adequately studied.
Concurrent drug therapy issues:
• Drugs that prolong the QT interval: Avoid use in patients receiving other agents that prolong the QT interval; consider alternative therapy. ECG monitoring is advised if concomitant use of agents that prolong the QT interval is medically required. In addition, do not use halofantrine (not available in the US) and artemether/lumefantrine within one month of one another due to the potential additive effects on the QT interval. After discontinuation of artemether/lumefantrine, drugs that prolong the QT interval, including quinidine and quinine, should be used with caution.
• Duplicate therapy: Antimalarials should not be given concomitantly unless there is no other treatment option.
Other warnings/precautions:
• Appropriate use: Not indicated for the prevention of malaria.
• Recrudescence: In the event of disease reappearance after a quiescent period, patients should be treated with a different antimalarial drug.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Coartem: Artemether 20 mg and lumefantrine 120 mg [scored; contains polysorbate 80]
No
Tablets (Coartem Oral)
20-120 mg (per each): $6.74
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Administer with a full meal for best absorption. For patients unable to swallow tablets: Crush tablet and mix with 5-10 mL of water. Administer to patient. Rinse container with water and administer contents to the patient. The crushed mixture should be followed with food/drink if possible. Repeat dose if vomiting occurs within 2 hours of administration; for persistent vomiting, explore alternative therapy.
Oral:
Tablets: Administer with a full meal for best absorption.
Patients unable to swallow tablets: Crush tablet and mix with 5 to 10 mL of water in a clean container; administer mixture immediately; rinse container with water and administer remaining contents. The crushed mixture should be followed with food/milk, infant formula, pudding, porridge, or broth if possible.
Vomiting: Repeat dose if vomiting occurs within 1 to 2 hours of administration; for persistent vomiting, explore alternative therapy (Ref). Other options for patients not tolerating oral therapy include administration via NG tube or following an antiemetic (Ref).
Malaria , treatment: Treatment of acute, uncomplicated malaria infections due to Plasmodium falciparum, including geographical regions where chloroquine resistance has been reported, in patients 2 months of age and older. Note: Guidelines also recommend artemether/lumefantrine for nonfalciparum malaria and as oral treatment for severe malaria after completion of IV therapy or as interim therapy pending IV therapy (CDC 2024a; WHO 2024).
Limitations of use: Not approved for the prevention of malaria.
Substrate of CYP3A4 (Major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Induces CYP3A4 (Weak);
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Antimalarial Agents: May increase adverse/toxic effects of Artemether and Lumefantrine. Management: Artemether/lumefantrine (combination product) should not be used with other antimalarials unless there is no other treatment option. If combined, monitor patients for increased toxicities of both agents, including QTc interval prolongation. Risk D: Consider Therapy Modification
Atogepant: CYP3A4 Inducers (Weak) may decrease serum concentration of Atogepant. Management: For treatment of episodic migraine, the recommended dose of atogepant is 30 mg once daily or 60 mg once daily when combined with CYP3A4 inducers. When used for treatment of chronic migraine, use of atogepant with CYP3A4 inducers should be avoided. Risk D: Consider Therapy Modification
Chlorprothixene: May increase QTc-prolonging effects of Antimalarial Agents. Risk X: Avoid
Clofazimine: May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor
CloZAPine: CYP3A4 Inducers (Weak) may decrease serum concentration of CloZAPine. Risk C: Monitor
CYP2D6 Substrates (High risk with Inhibitors): Artemether and Lumefantrine may increase serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor
CYP3A4 Inducers (Moderate): May decrease serum concentration of Artemether and Lumefantrine. CYP3A4 Inducers (Moderate) may decrease active metabolite exposure of Artemether and Lumefantrine. Specifically, concentrations of dihydroartemisinin (DHA), the active metabolite of artemether may be decreased. Risk C: Monitor
CYP3A4 Inducers (Strong): May decrease serum concentration of Artemether and Lumefantrine. CYP3A4 Inducers (Strong) may decrease active metabolite exposure of Artemether and Lumefantrine. Specifically, concentrations of dihydroartemisinin (DHA), the active metabolite of artemether may be decreased. Risk X: Avoid
CYP3A4 Inhibitors (Strong): May increase serum concentration of Artemether and Lumefantrine. CYP3A4 Inhibitors (Strong) may increase active metabolite exposure of Artemether and Lumefantrine. Specifically, concentrations of dihydroartemisinin (DHA), the active metabolite of artemether may be increased. Risk C: Monitor
Dapsone (Systemic): Antimalarial Agents may increase adverse/toxic effects of Dapsone (Systemic). Specifically, concomitant use of antimalarial agents with dapsone may increase the risk of hemolytic reactions. Dapsone (Systemic) may increase adverse/toxic effects of Antimalarial Agents. Specifically, concomitant use of dapsone with antimalarial agents may increase the risk for hemolytic reactions. Management: Closely monitor patients for signs/symptoms of hemolytic reactions with concomitant use of dapsone and antimalarial agents, particularly in patients deficient in glucose-6-phosphate dehydrogenase (G6PD), methemoglobin reductase, or with hemoglobin M. Risk D: Consider Therapy Modification
Dapsone (Topical): Antimalarial Agents may increase adverse/toxic effects of Dapsone (Topical). Specifically, the risk of hemolytic reactions may be increased. Management: Consider avoidance of this combination when possible. If combined, closely monitor for signs/symptoms of hemolytic reactions. Patients with glucose-6-phosphate dehydrogenase deficiency may be at particularly high risk for adverse hematologic effects. Risk D: Consider Therapy Modification
Efavirenz: May decrease serum concentration of Artemether and Lumefantrine. Efavirenz may decrease active metabolite exposure of Artemether and Lumefantrine. Specifically, concentrations of dihydroartemisinin (DHA), the active metabolite of artemether may be decreased. Risk C: Monitor
Fusidic Acid (Systemic): May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Consider avoiding this combination if possible. If required, monitor patients closely for increased adverse effects of the CYP3A4 substrate. Risk D: Consider Therapy Modification
Grapefruit Juice: May increase active metabolite exposure of Artemether and Lumefantrine. Specifically, concentrations of dihydroartemisinin (DHA), the active metabolite of artemether may be increased. Grapefruit Juice may increase serum concentration of Artemether and Lumefantrine. Risk C: Monitor
Halofantrine: Artemether and Lumefantrine may increase QTc-prolonging effects of Halofantrine. Management: Halofantrine and artemether/lumefantrine should not be used within 1 month of each other. Risk X: Avoid
Haloperidol: QT-prolonging Agents (Indeterminate Risk - Avoid) may increase QTc-prolonging effects of Haloperidol. Risk C: Monitor
Hormonal Contraceptives: CYP3A4 Inducers (Weak) may decrease serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration, and to continue back-up contraception for 28 days after discontinuing a weak CYP3A4 inducer to ensure contraceptive reliability. Risk D: Consider Therapy Modification
Levoketoconazole: QT-prolonging Agents (Indeterminate Risk - Avoid) may increase QTc-prolonging effects of Levoketoconazole. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor
Nevirapine: May decrease serum concentration of Artemether and Lumefantrine. Nevirapine may increase serum concentration of Artemether and Lumefantrine. Specifically, lumefantrine concentrations may increase. Nevirapine may decrease active metabolite exposure of Artemether and Lumefantrine. Specifically, concentrations of dihydroartemisinin (DHA), the active metabolite of artemether may be decreased. Risk C: Monitor
NiMODipine: CYP3A4 Inducers (Weak) may decrease serum concentration of NiMODipine. Risk C: Monitor
Protease Inhibitors: May increase serum concentration of Artemether and Lumefantrine. Specifically, the concentrations of lumefantrine may be increased. Protease Inhibitors may decrease serum concentration of Artemether and Lumefantrine. Specifically, concentrations of artemether and dihydroartemisinin (DHA), the active metabolite of artemether, may be decreased. Risk C: Monitor
QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Avoid) may increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor
Selpercatinib: CYP3A4 Inducers (Weak) may decrease serum concentration of Selpercatinib. Risk C: Monitor
Sirolimus (Conventional): CYP3A4 Inducers (Weak) may decrease serum concentration of Sirolimus (Conventional). Risk C: Monitor
Sirolimus (Protein Bound): CYP3A4 Inducers (Weak) may decrease serum concentration of Sirolimus (Protein Bound). Risk C: Monitor
St John's Wort: May decrease serum concentration of Artemether and Lumefantrine. St John's Wort may decrease active metabolite exposure of Artemether and Lumefantrine. Specifically, concentrations of dihydroartemisinin (DHA), the active metabolite of artemether may be decreased. Risk X: Avoid
Tacrolimus (Systemic): CYP3A4 Inducers (Weak) may decrease serum concentration of Tacrolimus (Systemic). Risk C: Monitor
Ubrogepant: CYP3A4 Inducers (Weak) may decrease serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 100 mg and second dose (if needed) of 100 mg when used with a weak CYP3A4 inducer. Risk D: Consider Therapy Modification
Absorption of artemether and lumefantrine is increased in the presence of food. The bioavailability of artemether increases two- to threefold and lumefantrine increases 16-fold (particularly a high-fat meal). Administration with grapefruit juice may result in increased concentrations of artemether and/or lumefantrine and potentiate QT prolongation. Management: Administer with a full meal for maximal absorption. Avoid grapefruit juice.
Artemether may reduce the effectiveness of hormonal contraceptives. An additional nonhormonal method of birth control should be used during therapy. Consult drug interactions database for more detailed information related to the use of artemether/lumefantrine and specific contraceptives
A meta-analysis of observational pregnancy studies, which included 500 pregnant patients exposed to artemether/lumefantrine in their first trimester, and data from observational and open-label studies of >1,200 pregnant patients exposed to artemether/lumefantrine in their second or third trimesters have not shown an increased risk of major birth defects, miscarriage, or adverse maternal/fetal outcomes.
Malaria infection during pregnancy may be more severe than in nonpregnant people and has a high risk of maternal and perinatal morbidity and mortality. Malaria infection during pregnancy can lead to miscarriage, premature delivery, low birth weight, congenital infection, and/or perinatal death. Therefore, pregnant patients are advised to avoid travel to malaria-risk areas. When travel is unavoidable, pregnant patients should take precautions to avoid mosquito bites and use effective prophylactic medications (CDC 2024a; CDC Yellow Book 2024).
Artemether/lumefantrine may be used to treat chloroquine-resistant uncomplicated malaria due to P. falciparum during any trimester of pregnancy. The use of artemether/lumefantrine for the treatment of severe malaria during pregnancy is the same as for nonpregnant patients (CDC 2024a). Consult current CDC malaria guidelines.
It is not known if artemether or lumefantrine are present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. The CDC does not recommend use of this combination when breastfeeding infants weighing <5 kg (CDC 2024a; CDC Yellow Book 2024).
Administer with a full meal for best absorption. Patients should be encouraged to take with a meal as soon as food can be tolerated. Patients who remain averse to food during treatment should be closely monitored as the risk of recrudescence may be great.
Monitor patients for adequate food consumption (to ensure absorption and efficacy); ECG monitoring is advised if concomitant use of other agents that prolong the QT interval is medically required
A coformulation of artemether and lumefantrine with activity against Plasmodium falciparum. Artemether and major metabolite dihydroartemisinin (DHA) are rapid schizontocides with activity attributed to the endoperoxide moiety common to each substance. Artemether inhibits an essential calcium adenosine triphosphatase. The exact mechanism of lumefantrine is unknown, but it may inhibit the formation of β-hematin by complexing with hemin. Both artemether and lumefantrine inhibit nucleic acid and protein synthesis. Artemether rapidly reduces parasite biomass and lumefantrine eliminates residual parasites.
Absorption: Artemether: Rapid; Lumefantrine: Initial absorption at 2 hours; enhanced with food
Protein binding: Artemether: 95%; Dihydroartemisinin (DHA): 47% to 76%; Lumefantrine: 99.7%
Metabolism:
Artemether is hepatically metabolized to an active metabolite, dihydroartemisinin (DHA), catalyzed predominately by CYP3A4/5 and to a lesser extent by CYP2B6, CYP2C9 and CYP2C19. The artemether/DHA AUC ratio is 1.2 after 1 dose and 0.3 after 6 doses which may indicate autoinduction.
Lumefantrine is hepatically metabolized to desbutyl-lumefantrine by CYP3A4.
Bioavailability: Absorption of artemether and lumefantrine is increased in the presence of food. The bioavailability of artemether increases two- to threefold and lumefantrine increases 16-fold (particularly a high-fat meal).
Half-life elimination: Artemether: 1-2 hours; DHA: 2 hours; Lumefantrine: 72-144 hours
Time to peak, plasma: Artemether: ~2 hours; Lumefantrine: ~6-8 hours
Molecular weight: artemether 298.4; lumefantrine 528.9.
