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Coartem artemether and lumefantrine 20 mg; 120 mg Tablet, 24-count — NDC 00078-0568-45 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Coartem artemether and lumefantrine 20 mg; 120 mg Tablet, 24-count — NDC 0078-0568-45 (Billing 00078-0568-45)

by Novartis Pharmaceuticals Corporation · 24 TABLET in 1 BOTTLE

This is a package of 24 tablets of Coartem artemether and lumefantrine 20 mg; 120 mg Tablet from Novartis Pharmaceuticals Corporation, marketed since Apr 2009 and currently FDA-listed; retail pharmacies pay about $5.36 per tablet (NADAC). It is this product's only package size.

NDC 00078-0568-45
🏷️ FDA NDC (as labeled) 0078-0568-45 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0078-0568-45 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0078 labeler · 0568 product · 45 package
Package marketed since
Apr 7, 2009
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
24 EA per package
Barcode (UPC-A, from the NDC)
3 0078056845 6
Medicaid fills, this package
14 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0078-0568-45
Product NDC 0078-0568
11-digit billing NDC 00078056845
NCPDP billing unit EA — each (per item)
RxCUI 847731, 847734
UNII C7D6T3H22J, F38R0JR742
Application # NDA022268
SPL Set ID 7866ec19-dfac-47d4-a53f-511a12643cbf
Established class (EPC) Antimalarial
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2009-04-07
Route ORAL
Dosage form TABLET
Substance ARTEMETHER; LUMEFANTRINE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 13990002030320
GPI class Coartem
GCN Seq No 050710
GCN 17848
HICL code 024021
Ingredient (HICL) Artemether/Lumefantrine
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W4
Therapeutic class — intermediate (HIC2) Antiparasitics
HIC3 code W4A
Therapeutic class — specific (HIC3) Antimalarial Drugs
AHFS code 08:30.08.00
AHFS class Antimalarials
FDB label name COARTEM TABLETS
FDB brand name Coartem
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 050710
  • GCN: 17848
  • GPI-14 (Medi-Span): 13990002030320
  • HICL (First Databank): 024021
  • AHFS class code: 08:30.08.00
  • RxCUI (RxNorm): 847731
Why two NDCs? The FDA registers this code as 0078-0568-45 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00078-0568-45. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Antimalarial class.

Pharmacologic class Antimalarial
Drug family (ATC) Artemisinin and derivatives, plain
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name COARTEM TABLETS Ingredient Artemether/Lumefantrine
📖 What it is MedlinePlus · NLM

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.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats acute, uncomplicated malaria caused by Plasmodium falciparum. It is not for severe malaria and won't prevent malaria. Coartem tablets are approved for patients 2 months a...
  • Take it by mouth with food, for 6 doses over 3 days. The first two doses are 8 hours apart, then you take one in the morning and one in the evening for 2 days. Follow the tablet co...
  • Try to eat as soon as you can tolerate food, since food helps your body absorb the medicine. If you vomit within 1 to 2 hours of a dose, take a repeat dose. If you vomit that one t...
  • Headache, dizziness, loss of appetite, weakness, and joint or muscle aches are common. Children often have fever, cough or vomiting. Call right away if you notice allergic reaction...
📖 Read our full Artemether and Lumefantrine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $5.363 $128.71 / 24 tablets
Medicaid paysCMS SDUD · 12 mo $5.92 $141.99 / 24 tablets
Medicare drug plans payPart D · Q2 2026 $5.62 $134.85 / 24 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Jan 2026 Feb 2026 $5.363 $5.352
Flat over the last 3 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00078-0568-45 You're viewing this Main listing 24 TABLET in 1 BOTTLE 2009-04-07 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Coartem 20 mg/1; 120 mgthis 00078-0568-45 Novartis 24 tablets $5.363 — Availability likely —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2009
On the market since
Apr 2009
📍
2026
Currently FDA-listed
17 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color Yellow
ShapeRound
ImprintN;C;CG
Size9 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Artemether and Lumefantrine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

7 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerNovartis Pharmaceuticals Corporation
Application holderNOVARTIS PHARMACEUTICALS CORP
FDA applicationNDA022268 (NDA)
Labeler code00078
First marketedApr 2009
Product typeHuman Prescription Drug
Portfolio209 products on file

More NDCs from Novartis Pharmaceuticals Corporation labeler code 00078

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 184 words ▾

1 INDICATIONS AND USAGE Coartem Tablets are indicated for treatment of acute, uncomplicated malaria infections due to Plasmodium falciparum (P. falciparum) in patients 2 months of age and older with a bodyweight of 5 kg and above. Coartem Tablets have been shown to be effective in geographical regions where resistance to chloroquine has been reported [see Clinical Studies (14.1)] . Limitations of Use : Coartem Tablets are not approved for patients with severe or complicated P. falciparum malaria.

Coartem Tablets are not approved for the prevention of malaria. Coartem Tablets are a combination of artemether and lumefantrine, both antimalarials, indicated for treatment of acute, uncomplicated malaria infections due to Plasmodium falciparum (P. falciparum) in patients 2 months of age and older with a bodyweight of 5 kg and above. ( 1 ) Coartem Tablets have been shown to be effective in geographical regions where resistance to chloroquine has been reported.

( 1 ) Limitations of Use: ( 1 ) Coartem Tablets are not approved for patients with severe or complicated P. falciparum malaria . Coartem Tablets are not approved for the prevention of malaria.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Coartem Tablets should be taken with food. ( 2.1 , 5.2 ) Tablets may be crushed and mixed with 1 to 2 teaspoons of water immediately prior to administration to patients, including children. ( 2.1 ) Coartem Tablets should be administered over 3 days for a total of 6 doses: an initial dose, second dose after 8 hours, and then twice-daily (morning and evening) for the following 2 days.

( 2.2 , 2.3 ) The adult dosage for patients with bodyweight of 35 kg and above is 4 tablets per dose for a total of 6 doses. ( 2.2 ) The number of tablets per dose for children is determined by bodyweight, as shown in the chart below. ( 2.3 ) Tablets per dose by bodyweight; total of 6 doses over 3 days 5 to < 15 kg 1 tablet 15 to < 25 kg 2 tablets 25 to < 35 kg 3 tablets 35 kg and over 4 tablets

2.1Administration Instructions Coartem Tablets should be taken with food. Patients with acute malaria are frequently averse to food. Patients should be encouraged to resume normal eating as soon as food can be tolerated since this improves absorption of artemether and lumefantrine.

For patients who are unable to swallow the tablets such as infants and children, Coartem Tablets may be crushed and mixed with a small amount of water (1 to 2 teaspoons) in a clean container for administration immediately prior to use. The container can be rinsed with more water and the contents swallowed by the patient. The crushed tablet preparation should be followed whenever possible by food/drink (e.g., milk, formula, pudding, broth, and porridge).

In the event of vomiting within 1 to 2 hours after administration, a repeat dose should be taken. If the repeat dose is vomited, the patient should be given an alternative antimalarial for treatment.

2.2Dosage in Adult Patients (greater than 16 years of age) A 3-day treatment schedule with a total of 6 doses is recommended for adult patients with a bodyweight of 35 kg and above: Four tablets as a single initial dose, 4 tablets again after 8 hours, and then 4 tablets twice-daily (morning and evening) for the following 2 days (total course of 24 tablets). For patients weighing less than 35 kg, [see Dosage and Administration (2.3)] .

2.3Dosage in Pediatric Patients A 3-day treatment schedule with a total of 6 doses is recommended as below: 5 kg to less than 15 kg bodyweight : One tablet as an initial dose, 1 tablet again after 8 hours, and then 1 tablet twice daily (morning and evening) for the following 2 days (total course of 6 tablets). 15 kg to less than 25 kg bodyweight : Two tablets as an initial dose, 2 tablets again after 8 hours, and then 2 tablets twice daily (morning and evening) for the following 2 days (total course of 12 tablets).

25 kg to less than 35 kg bodyweight : Three tablets as an initial dose, 3 tablets again after 8 hours, and then 3 tablets twice daily (morning and evening) for the following 2 days (total course of 18 tablets). 35 kg bodyweight and above : Four tablets as a single initial dose, 4 tablets again after 8 hours, and then 4 tablets twice daily (morning and evening) for the following 2 days (total course of 24 tablets).

2.4Dosage in Patients With Hepatic or Renal Impairment No specific pharmacokinetic studies have been carried out in patients with hepatic or renal impairment. Most patients with acute malaria present with some degree of related hepatic and/or renal impairment. In clinical studies, the adverse event profile did not differ in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function.

No specific dose adjustments are needed for patients with mild or moderate hepatic impairment. In clinical studies, the adverse event profile did not differ in patients with mild or moderate renal impairment compared to patients with normal renal function. There were few patients with severe renal impairment in clinical studies.

There is no significant renal excretion of lumefantrine, artemether, and dihydroartemisinin (DHA) in healt… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 63 words ▾

3 DOSAGE FORMS AND STRENGTHS Coartem Tablets contain 20 mg of artemether and 120 mg of lumefantrine. Coartem Tablets are supplied as yellow, round, flat tablets with beveled edges and scored on one side. Tablets are imprinted with “N/C” on one side and “CG” on the other side. Tablets are scored and contain 20 mg artemether and 120 mg lumefantrine. ( 3 )

⛔ Contraindications 109 words ▾

4 CONTRAINDICATIONS Hypersensitivity Known hypersensitivity to artemether, lumefantrine, or to any of the excipients of Coartem Tablets [see Adverse Reactions (6.2)] . Strong CYP3A4 Inducers Coadministration of strong inducers of CYP3A4 such as rifampin, carbamazepine, phenytoin, and St. John’s wort with Coartem Tablets can result in decreased concentrations of artemether and/or lumefantrine and loss of antimalarial efficacy [see Warnings and Precautions (5.3), Drug Interactions (7.1), and Clinical Pharmacology (12.3)] .

Known hypersensitivity to artemether, lumefantrine, or to any of the excipients. ( 4 ) Coadministration of strong inducers of CYP3A4 such as rifampin, carbamazepine, phenytoin, and St. John’s wort with Coartem Tablets.

( 4 , 7.1 , 12.3 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Avoid use in patients with known QT prolongation, those with hypokalemia or hypomagnesemia, and those taking other drugs that prolong the QT interval. ( 5.1 , 12.6 ) Halofantrine and Coartem Tablets should not be administered within one month of each other due to potential additive effects on the QT interval. ( 5.1 , 5.2 , 12.3 ) Antimalarials should not be given concomitantly, unless there is no other treatment option, due to limited safety data.

( 5.2 ) QT prolonging drugs, including quinine and quinidine, should be used cautiously following Coartem Tablets. ( 5.1 , 5.2 , 7.7 , 12.3 ) Substrates, inhibitors, or inducers of CYP3A4, including antiretroviral medications, should be used cautiously with Coartem Tablets, due to a potential loss of efficacy of the concomitant drug or additive QT prolongation. ( 5.3 , 7.2 , 7.3 )

5.1Prolongation of the QT Interval Some antimalarials (e.g., halofantrine, quinine, quinidine) including Coartem Tablets have been associated with prolongation of the QT interval on the electrocardiogram (ECG). Coartem Tablets should be avoided in patients: With congenital prolongation of the QT interval (e.g., long QT syndrome) or any other clinical condition known to prolong the QTc interval such as patients with a history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease.

With a family history of congenital prolongation of the QT interval or sudden death. With known disturbances of electrolyte balance, e.g., hypokalemia or hypomagnesemia. Receiving other medications that prolong the QT interval, such as Class IA (quinidine, procainamide, disopyramide), or Class III (amiodarone, sotalol) antiarrhythmic agents; antipsychotics (pimozide, ziprasidone); antidepressants; certain antibiotics (macrolide antibiotics, fluoroquinolone antibiotics, imidazole, and triazole antifungal agents) [see Clinical Pharmacology (12.6)] .

Receiving medications that are metabolized by the cytochrome enzyme CYP2D6, which also have cardiac effects (e.g., flecainide, imipramine, amitriptyline, clomipramine) [see Warnings and Precautions (5.4), Drug Interactions (7.6), and Clinical Pharmacology (12.3)] .

5.2Use of QT Prolonging Drugs and Other Antimalarials Halofantrine and Coartem Tablets should not be administered within 1 month of each other due to the long elimination half-life of lumefantrine (3 to 6 days) and potential additive effects on the QT interval [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)] . Antimalarials should not be given concomitantly with Coartem Tablets, unless there is no other treatment option, due to limited safety data. Drugs that prolong the QT interval, including antimalarials such as quinine and quinidine, should be used cautiously following Coartem Tablets, due to the long elimination half-life of lumefantrine (3 to 6 days) and the potential for additive effects on the QT interval; ECG monitoring is advised if use of drugs that prolong the QT interval is medically required [see Warnings and Precautions (5.1), Drug Interactions (7.7), and Clinical Pharmacology (12.3)] .

If mefloquine is administered immediately prior to Coartem Tablets, there may be a decreased exposure to lumefantrine, possibly due to a mefloquine-induced decrease in bile production. Therefore, patients should be monitored for decreased efficacy and food consumption should be encouraged while taking Coartem Tablets [see Dosage and Administration (2.1), Drug Interactions (7.4), and Clinical Pharmacology (12.3)] .

5.3Drug Interactions With CYP3A4 When Coartem Tablets are coadministered with substrates of CYP3A4, it may result in decreased concentrations of the substrate and potential loss of substrate efficacy. When Coartem Tablets are coadministered with an inhibitor of CYP3A4, including grapefruit juice, it may result in increased concentrations of artemether and/or lumefantrine and potentiate QT prolongation. When Coartem Tablets… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious and otherwise important adverse reactions are discussed in greater detail in other sections of labeling: Hypersensitivity Reactions [see Contraindications (4)] Prolongation of the QT Interval [see Warnings and Precautions (5.1)] Use of QT Prolonging Drugs and Other Antimalarials [see Warnings and Precautions (5.2)] Drug Interactions with CYP3A4 [see Warnings and Precautions (5.3)] Drug Interactions with CYP2D6 [see Warnings and Precautions (5.4)] The most common adverse reactions in adults (greater than 30%) are headache, anorexia, dizziness, asthenia, arthralgia, and myalgia.

The most common adverse reactions in children (greater than 12%) are pyrexia, cough, vomiting, anorexia, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rate observed in practice. The data described below reflect exposure to a 6-dose regimen of Coartem Tablets in 1979 patients including 647 adults (older than 16 years) and 1332 children (16 years and younger). For the 6-dose regimen, Coartem Tablets was studied in active-controlled (366 patients) and noncontrolled, open-label trials (1613 patients).

The 6-dose Coartem Tablets population was patients with malaria between ages 2 months and 71 years: 67% (1332) were 16 years and younger and 33% (647) were older than 16 years. Males represented 73% and 53% of the adult and pediatric populations, respectively. The majority of adult patients were enrolled in studies in Thailand, while the majority of pediatric patients were enrolled in Africa.

Tables 1 and 2 show the most frequently reported adverse reactions (greater than or equal to 3%) in adults and children respectively who received the 6-dose regimen of Coartem Tablets. Adverse reactions collected in clinical trials included signs and symptoms at baseline, but only treatment emergent adverse events, defined as events that appeared or worsened after the start of treatment, are presented below. In adults, the most frequently reported adverse reactions were headache, anorexia, dizziness, and asthenia.

In children, the adverse reactions were pyrexia, cough, vomiting, anorexia, and headache. Most adverse reactions were mild, did not lead to discontinuation of study medication, and resolved. In limited comparative studies, the adverse reaction profile of Coartem Tablets appeared similar to that of another antimalarial regimen.

Discontinuation of Coartem Tablets due to adverse drug reactions occurred in 1.1% of patients treated with the 6-dose regimen overall: 0.2% (1/647) in adults and 1.6% (21/1332) in children. Table 1: Adverse Reactions Occurring in 3% or More of Adult Patients Treated in Clinical Trials With the 6-dose Regimen of Coartem Tablets *Adult patients defined as greater than 16 years of age. System Organ Class Preferred Term Adults* N = 647 (%) Nervous system disorders Headache 360 (56) Dizziness 253 (39) Metabolism and nutrition disorders Anorexia 260 (40) General disorders and administration site conditions Asthenia 243 (38) Pyrexia 159 (25) Chills 147 (23) Fatigue 111 (17) Malaise 20 (3) Musculoskeletal and connective tissue disorders Arthralgia 219 (34) Myalgia 206 (32) Gastrointestinal disorders Nausea 169 (26) Vomiting 113 (17) Abdominal pain 112 (17) Diarrhea 46 (7) Psychiatric disorders Sleep disorder 144 (22) Insomnia 32 (5) Cardiac disorders Palpitations 115 (18) Hepatobiliary disorders Hepatomegaly 59 (9) Blood and lymphatic system disorders Splenomegaly 57 (9) Anemia 23 (4) Respiratory, thoracic and mediastinal disorders Cough 37 (6) Skin and subcutaneous tissue disorders Pruritus 24 (4) Rash 21 (3) Ear and… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS CYP3A4 Inducers: Potential for loss of antimalarial efficacy. ( 4 , 5.3 , 7.1 , 12.3 ) CYP3A4 Inhibitors: Use cautiously due to potential for QT prolongation. ( 5.3 , 7.2 , 12.3 ) Antiretrovirals: Use cautiously due to potential for QT prolongation, loss of antiviral efficacy, or loss of antimalarial efficacy of Coartem Tablets.

( 5.3 , 7.3 , 12.3 ) Mefloquine: If used immediately before treatment, monitor for decreased efficacy of Coartem Tablets and encourage food consumption. ( 2.1 , 7.4 , 12.3 ) Hormonal Contraceptives: Effectiveness may be reduced; use an additional method of birth control. ( 5.3 , 7.5 , 12.3 ) CYP2D6 Substrates: Monitor for adverse reactions and potential QT prolongation.

( 5.1 , 5.4 , 7.6 )

7.1Rifampin Oral administration of rifampin, a strong CYP3A4 inducer, with Coartem Tablets resulted in significant decreases in exposure to artemether, DHA (metabolite of artemether), and lumefantrine by 89%, 85%, and 68%, respectively, when compared to exposure values after Coartem Tablets alone. Concomitant use of strong inducers of CYP3A4 such as rifampin, carbamazepine, phenytoin, and St. John’s wort is contraindicated with Coartem Tablets [see Contraindications (4) and Clinical Pharmacology (12.3)] .

7.2Ketoconazole Concurrent oral administration of ketoconazole, a potent CYP3A4 inhibitor, with a single dose of Coartem Tablets resulted in a moderate increase in exposure to artemether, DHA, and lumefantrine in a study of 15 healthy subjects. No dose adjustment of Coartem Tablets is necessary when administered with ketoconazole or other potent CYP3A4 inhibitors. However, due to the potential for increased concentrations of lumefantrine which could lead to QT prolongation, Coartem Tablets should be used cautiously with drugs that inhibit CYP3A4 [see Warnings and Precautions (5.1, 5.3) and Clinical Pharmacology (12.3)] .

7.3Antiretroviral Drugs Both artemether and lumefantrine are metabolized by CYP3A4. Antiretroviral drugs, such as protease inhibitors and non-nucleoside reverse transcriptase inhibitors, are known to have variable patterns of inhibition, induction or competition for CYP3A4. Therefore, the effects of antiretroviral drugs on the exposure to artemether, DHA, and lumefantrine are also variable [see Clinical Pharmacology (12.3)] .

Coartem Tablets should be used cautiously in patients on antiretroviral drugs because decreased artemether, DHA, and/or lumefantrine concentrations may result in a decrease of antimalarial efficacy of Coartem Tablets, and increased lumefantrine concentrations may cause QT prolongation [see Warnings and Precautions (5.3)] .

7.4Prior Use of Mefloquine Administration of 3 doses of mefloquine followed 12 hours later by a 6-dose regimen of Coartem Tablets in 14 healthy volunteers demonstrated no effect of mefloquine on plasma concentrations of artemether or the artemether/DHA ratio. However, exposure to lumefantrine was reduced, possibly due to lower absorption secondary to a mefloquine-induced decrease in bile production. Patients should be monitored for decreased efficacy and food consumption should be encouraged with administration of Coartem Tablets [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)] .

7.5Hormonal Contraceptives In vitro , the metabolism of ethinyl estradiol and levonorgestrel was not induced by artemether, DHA, or lumefantrine. However, artemether has been reported to weakly induce, in humans, the activity of CYP2C19, CYP2B6, and CYP3A4. Therefore, Coartem Tablets may potentially reduce the effectiveness of hormonal contraceptives.

Patients using hormonal contraception should be advised to use an alternative non-hormonal contraceptive method or add a barrier method of contraception during treatment with Coartem [see Warnings and Precautions (5.3), Use in Specific Populations (8.3) and Clinical Pharmacology (12.3)] .

7.6CYP2D6 Substrates Lumefantrine inhibits CYP2D6 in vitro . Administration of Coartem Tablets with dru… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Published data from clinical studies and pharmacovigilance data have not established an association with artemether/lumefantrine use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Malaria during and after pregnancy increases the 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.

Data Human Data While available studies cannot definitively establish the absence of risk, a meta-analysis of observational studies including over 500 artemether-lumefantrine exposed women in their first trimester of pregnancy, data from observational, and open label studies including more than 1200 pregnant women in their second- or third trimester exposed to artemether-lumefantrine compared to other antimalarials, and pharmacovigilance data have not demonstrated an increase in major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Published epidemiologic studies have important methodological limitations which hinder interpretation of data, including inability to control for confounders, such as underlying maternal disease, and maternal use of concomitant medications and missing information on the dose and duration of use. Animal Data Pregnant rats dosed orally during the period of organogenesis [gestational days (GD) 7 through 17] at 50 mg/kg/day artemether-lumefantrine combination (corresponding to 7 mg/kg/day artemether or higher, a dose of less than half the maximum recommended human dose (MRHD) of 1120 mg artemether-lumefantrine per day (based on body surface area (BSA) comparisons), showed increases in fetal loss, early resorptions, and postimplantation loss.

No adverse effects were observed in animals dosed at 25 mg/kg/day artemether-lumefantrine (corresponding to 3.6 mg/kg/day of artemether), about one-third the MRHD (based on BSA comparison). Similarly, oral dosing in pregnant rabbits during organogenesis (GD 7 through GD 19) at 175 mg/kg/day, (corresponding to 25 mg/kg/day artemether) about 3 times the MRHD (based on BSA comparisons) resulted in abortions, preimplantation loss, post implantation loss and decreases in the number of live fetuses. No adverse reproductive effects were detected in rabbits at 105 mg/kg/day artemether-lumefantrine (corresponding to 15 mg/kg/day artemether), about 2 times the MRHD.

Artemether and other artemisinins are associated with maternal toxicity and embryotoxicity and malformations in animals at clinically relevant exposures; however, lumefantrine doses as high as 1000 mg/kg/day, showed no evidence to suggest maternal, embryo- or fetotoxicity or teratogenicity in rats and rabbits. The relevance of the findings from the animal reproductive studies to human risk is unclear.

8.2Lactation Risk Summary There are no data on the presence of artemether or lumefantrine in human milk, the effects on the breastfed infant or the effects on milk production. Artemether and lumefantrine 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 Coartem and any potential adverse effects on the breastfed infant from Coartem or from the underlying… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Published data from clinical studies and pharmacovigilance data have not established an association with artemether/lumefantrine use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Malaria during and after pregnancy increases the 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.

Data Human Data While available studies cannot definitively establish the absence of risk, a meta-analysis of observational studies including over 500 artemether-lumefantrine exposed women in their first trimester of pregnancy, data from observational, and open label studies including more than 1200 pregnant women in their second- or third trimester exposed to artemether-lumefantrine compared to other antimalarials, and pharmacovigilance data have not demonstrated an increase in major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Published epidemiologic studies have important methodological limitations which hinder interpretation of data, including inability to control for confounders, such as underlying maternal disease, and maternal use of concomitant medications and missing information on the dose and duration of use. Animal Data Pregnant rats dosed orally during the period of organogenesis [gestational days (GD) 7 through 17] at 50 mg/kg/day artemether-lumefantrine combination (corresponding to 7 mg/kg/day artemether or higher, a dose of less than half the maximum recommended human dose (MRHD) of 1120 mg artemether-lumefantrine per day (based on body surface area (BSA) comparisons), showed increases in fetal loss, early resorptions, and postimplantation loss.

No adverse effects were observed in animals dosed at 25 mg/kg/day artemether-lumefantrine (corresponding to 3.6 mg/kg/day of artemether), about one-third the MRHD (based on BSA comparison). Similarly, oral dosing in pregnant rabbits during organogenesis (GD 7 through GD 19) at 175 mg/kg/day, (corresponding to 25 mg/kg/day artemether) about 3 times the MRHD (based on BSA comparisons) resulted in abortions, preimplantation loss, post implantation loss and decreases in the number of live fetuses. No adverse reproductive effects were detected in rabbits at 105 mg/kg/day artemether-lumefantrine (corresponding to 15 mg/kg/day artemether), about 2 times the MRHD.

Artemether and other artemisinins are associated with maternal toxicity and embryotoxicity and malformations in animals at clinically relevant exposures; however, lumefantrine doses as high as 1000 mg/kg/day, showed no evidence to suggest maternal, embryo- or fetotoxicity or teratogenicity in rats and rabbits. The relevance of the findings from the animal reproductive studies to human risk is unclear.

🧒 Pediatric Use 78 words ▾

8.4Pediatric Use The safety and effectiveness of Coartem Tablets have been established in pediatric patients aged 2 months and older with a bodyweight of 5 kg and above for the treatment of acute, uncomplicated malaria [see Clinical Studies (14.1)] . The safety and effectiveness of Coartem Tablets have not been established in pediatric patients younger than 2 months old or who weigh less than 5 kg. Pediatric patients from non-endemic countries were not included in clinical trials.

🧓 Geriatric Use 59 words ▾

8.5Geriatric Use Clinical studies of Coartem Tablets did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. In general, the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients should be considered when prescribing Coartem Tablets.

🆘 Overdosage 40 words ▾

10 OVERDOSAGE There is no information on overdoses of Coartem Tablets higher than the doses recommended for treatment. In cases of suspected overdosage, symptomatic and supportive therapy, which would include ECG and blood electrolyte monitoring, should be given as appropriate.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Coartem Tablets, a fixed dose combination of artemether and lumefantrine in the ratio of 1:6, is an antimalarial agent [see Microbiology (12.4)] .

12.3Pharmacokinetics Absorption Following administration of Coartem Tablets to healthy volunteers and patients with malaria, artemether is absorbed with peak plasma concentrations reached about 2 hours after dosing. Absorption of lumefantrine, a highly lipophilic compound, starts after a lag-time of up to 2 hours, with peak plasma concentrations about 6 to 8 hours after administration. The single dose (4 tablets) pharmacokinetic parameters for artemether, DHA, an active antimalarial metabolite of artemether, and lumefantrine in adult Caucasian healthy volunteers are given in Table 3.

Multiple dose data after the 6-dose regimen of Coartem Tablets in adult malaria patients are given in Table 4. Table 3: Single Dose Pharmacokinetic Parametersa for Artemether, Dihydroartemisinin, and Lumefantrine Under-Fed Conditions Abbreviations: DHA, dihydroartemisinin; SD, standard deviation; AUC, area under the curve. a Mean ± SD C max , AUC last , t ½ and Median T max . Study 2102 (n = 50) Study 2104 (n = 48) Artemether C max (ng/mL) 60.0 ± 32.5 83.8 ±

59.7T max (h) 1.50

2.00AUC last (ng·h/mL) 146 ± 72.2 259 ± 150 t ½ (h) 1.6 ± 0.7 2.2 ±

1.9DHA C max (ng/mL) 104 ± 35.3 90.4 ±

48.9T max (h) 1.76

2.00AUC last (ng·h/mL) 284 ± 83.8 285 ± 98.0 t ½ (h) 1.6 ± 0.6 2.2 ±

1.5Lumefantrine C max (µg/mL) 7.38 ± 3.19 9.80 ±

4.20T max (h) 6.01

8.00AUC last (µg·h/mL) 158 ± 70.1 243 ± 117 t ½ (h) 101 ± 35.6 119 ±

51.0Food enhances the absorption of both artemether and lumefantrine. In healthy volunteers, the relative bioavailability of artemether was increased between 2- to 3-fold, and that of lumefantrine 16-fold when Coartem Tablets were taken after a high-fat meal compared under fasted conditions. Patients should be encouraged to take Coartem Tablets with a meal as soon as food can be tolerated [see Dosage and Administration (2.1)] .

Distribution Artemether and lumefantrine are both highly bound to human serum proteins in vitro (95.4% and 99.7%, respectively). Dihydroartemisinin (DHA) is also bound to human serum proteins (47% to 76%). Protein binding to human plasma proteins is linear.

Biotransformation In human liver microsomes and recombinant CYP450 enzymes, the metabolism of artemether was catalyzed predominantly by CYP3A4/5. Dihydroartemisinin (DHA) is an active metabolite of artemether. The metabolism of artemether was also catalyzed to a lesser extent by CYP2B6, CYP2C9 and CYP2C19.

In vitro studies with artemether at therapeutic concentrations revealed no significant inhibition of the metabolic activities of CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/5, and CYP4A9/11. In vitro studies with artemether, DHA, and lumefantrine at therapeutic concentrations revealed no significant induction of the metabolic activities of CYP1A1, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, or CYP3A5. During repeated administration of Coartem Tablets, systemic exposure of artemether decreased significantly, while concentrations of DHA increased, although not to a statistically significant degree.

The artemether/DHA area under the curve (AUC) ratio is 1.2 after a single dose and 0.3 after 6 doses given over 3 days. This suggests that there was induction of enzymes responsible for the metabolism of artemether. In human liver microsomes and in recombinant CYP450 enzymes, lumefantrine was metabolized mainly by CYP3A4 to desbutyl-lumefantrine.

The systemic exposure to the metabolite desbutyl-lumefantrine was less than 1% of the exposure to the parent compound. In vitro , lumefantrine significantly inhibits the activity of CYP2D6 at therapeutic plasma concentrations. Caution is recommended when combining Coartem Tablets with substrates, inhibitors, or inducers of CYP3A4, especially antiretroviral drugs and those that prolong the QT interval (e.g., macrolide… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 27 words ▾

12.1Mechanism of Action Coartem Tablets, a fixed dose combination of artemether and lumefantrine in the ratio of 1:6, is an antimalarial agent [see Microbiology (12.4)] .

📦 How Supplied / Storage and Handling 71 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Coartem (artemether/lumefantrine) Tablets 20 mg/120 mg Tablets - yellow, round flat tablets with beveled edges and scored on one side. Tablets are imprinted with “N/C” on one side and “CG” on the other. Bottle of 24 NDC 0078-0568-45 Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature] . Dispense in tight container (USP).

📋 Description 199 words ▾

11 DESCRIPTION Coartem Tablets contain a fixed combination of 2 antimalarial active ingredients, artemether, an artemisinin derivative, and lumefantrine. Both components are blood schizontocides. The chemical name of artemether is (3 R ,5a S ,6 R ,8a S ,9 R ,10 S ,12 R ,12a R )-10-methoxy-3,6,9-trimethyldecahydro-3,12-epoxypyrano[4,3- j ]-1,2-benzodioxepine.

Artemether is a white, crystalline powder that is freely soluble in acetone, soluble in methanol and ethanol, and practically insoluble in water. It has the empirical formula C 16 H 26 O 5 with a molecular weight of 298.4 g/mol, and the following structural formula: The chemical name of lumefantrine is (1 RS )-2-(dibutylamino)-1-{(9Z)-2,7-dichloro-9-[(4-chlorophenyl)methylene]-9 H -fluorene-4-yl}ethanol. Lumefantrine is a yellow, crystalline powder that is freely soluble in N,N-dimethylformamide, chloroform, and ethyl acetate; soluble in dichloromethane; slightly soluble in ethanol and methanol; and insoluble in water.

It has the empirical formula C 30 H 32 Cl 3 NO with a molecular weight of 528.9 g/mol, and the following structural formula: Coartem Tablets are for oral administration. Each Coartem Tablet contains 20 mg of artemether and 120 mg lumefantrine. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, and polysorbate 80.

Artemether structural formula Lumefantrine structural formula

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise patients to read the FDA-Approved Patient Labeling (Patient Information). Administration Instructions Instruct patients to take Coartem Tablets with food. Patients who do not have an adequate intake of food are at risk for recrudescence of malaria [see Dosage and Administration (2.1)] .

Hypersensitivity Patients with known hypersensitivity to artemether, lumefantrine, or to any of the excipients should not receive Coartem Tablets [see Contraindications (4)] . Prolongation of the QT Interval Instruct patients to inform their physician of any personal or family history of QT prolongation or proarrhythmic conditions such as hypokalemia, bradycardia, or recent myocardial ischemia [see Warnings and Precautions (5.1)] . Instruct patients to inform their physician if they are taking any other medications that prolong the QT interval, such as Class IA (quinidine, procainamide, disopyramide), or Class III (amiodarone, sotalol) antiarrhythmic agents; antipsychotics (pimozide, ziprasidone); antidepressants; certain antibiotics (macrolide antibiotics, fluoroquinolone antibiotics, imidazole, and triazole antifungal agents) [see Warnings and Precautions (5.1)] .

Instruct patients to notify their physicians if they have any symptoms of prolongation of the QT interval, including prolonged heart palpitations or a loss of consciousness [see Warnings and Precautions (5.1)] . Drug Interactions With CYP2D6 Instruct patients to avoid medications that are metabolized by the cytochrome enzyme CYP2D6 while receiving Coartem Tablets since these drugs also have cardiac effects (e.g., flecainide, imipramine, amitriptyline, clomipramine) [see Warnings and Precautions (5.4)] . Contraception Advise patients that use of Coartem may reduce the efficacy of hormonal contraceptives.

Advise patients using hormonal contraceptive to use an alternative non-hormonal contraceptive method or add a barrier method of contraception during treatment with Coartem [see Drug Interactions (7.5) and Use in Specific Populations (8.3)] . Use of QT Prolonging Drugs and Other Antimalarials Halofantrine and Coartem Tablets should not be administered within 1 month of each other due to potential additive effects on the QT interval. Antimalarials should not be given concomitantly with Coartem Tablets, unless there is no other treatment option, due to limited safety data [see Warnings and Precautions (5.2)] .

Sequential Use of Quinine QT prolonging drugs, including quinine and quinidine, should be used cautiously following Coartem Tablets due to the long elimination half-life of lumefantrine and the potential for additive effects on the QT interval. ECG monitoring is advised if use of drugs that prolong the QT interval is medically required [see Drug Interactions (7.7)] . Prior Use of Mefloquine Closely monitor food intake in patients who received mefloquine immediately prior to treatment with Coartem Tablets [see Drug Interactions (7.4)] .

Drug Interactions With CYP3A4 Use Coartem Tablets cautiously in patients receiving other drugs that are substrates, inhibitors or inducers of CYP3A4, including grapefruit juice, especially those that prolong the QT interval or are antiretroviral drugs. Coadministration of strong inducers of CYP3A4 such as rifampin, carbamazepine, phenytoin, and St. John’s wort is contraindicated with Coartem Tablets [see Warnings and Precautions (5.3)] .

Hypersensitivity Reactions Inform patients that Coartem Tablets can cause hypersensitivity reactions. Instruct patients to discontinue the drug at the first sign of a skin rash, hives or other skin reactions, a rapid heartbeat, difficulty in swallowing or breathing, any swelling suggesting angioedema (e.g., swelling of the lips, tongue, face, tightness of the throat, hoarseness), or other symptoms of an allergic reaction [see Contraindications (4)] . T2019-88

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption Following administration of Coartem Tablets to healthy volunteers and patients with malaria, artemether is absorbed with peak plasma concentrations reached about 2 hours after dosing. Absorption of lumefantrine, a highly lipophilic compound, starts after a lag-time of up to 2 hours, with peak plasma concentrations about 6 to 8 hours after administration. The single dose (4 tablets) pharmacokinetic parameters for artemether, DHA, an active antimalarial metabolite of artemether, and lumefantrine in adult Caucasian healthy volunteers are given in Table 3.

Multiple dose data after the 6-dose regimen of Coartem Tablets in adult malaria patients are given in Table 4. Table 3: Single Dose Pharmacokinetic Parametersa for Artemether, Dihydroartemisinin, and Lumefantrine Under-Fed Conditions Abbreviations: DHA, dihydroartemisinin; SD, standard deviation; AUC, area under the curve. a Mean ± SD C max , AUC last , t ½ and Median T max . Study 2102 (n = 50) Study 2104 (n = 48) Artemether C max (ng/mL) 60.0 ± 32.5 83.8 ±

59.7T max (h) 1.50

2.00AUC last (ng·h/mL) 146 ± 72.2 259 ± 150 t ½ (h) 1.6 ± 0.7 2.2 ±

1.9DHA C max (ng/mL) 104 ± 35.3 90.4 ±

48.9T max (h) 1.76

2.00AUC last (ng·h/mL) 284 ± 83.8 285 ± 98.0 t ½ (h) 1.6 ± 0.6 2.2 ±

1.5Lumefantrine C max (µg/mL) 7.38 ± 3.19 9.80 ±

4.20T max (h) 6.01

8.00AUC last (µg·h/mL) 158 ± 70.1 243 ± 117 t ½ (h) 101 ± 35.6 119 ±

51.0Food enhances the absorption of both artemether and lumefantrine. In healthy volunteers, the relative bioavailability of artemether was increased between 2- to 3-fold, and that of lumefantrine 16-fold when Coartem Tablets were taken after a high-fat meal compared under fasted conditions. Patients should be encouraged to take Coartem Tablets with a meal as soon as food can be tolerated [see Dosage and Administration (2.1)] .

Distribution Artemether and lumefantrine are both highly bound to human serum proteins in vitro (95.4% and 99.7%, respectively). Dihydroartemisinin (DHA) is also bound to human serum proteins (47% to 76%). Protein binding to human plasma proteins is linear.

Biotransformation In human liver microsomes and recombinant CYP450 enzymes, the metabolism of artemether was catalyzed predominantly by CYP3A4/5. Dihydroartemisinin (DHA) is an active metabolite of artemether. The metabolism of artemether was also catalyzed to a lesser extent by CYP2B6, CYP2C9 and CYP2C19.

In vitro studies with artemether at therapeutic concentrations revealed no significant inhibition of the metabolic activities of CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/5, and CYP4A9/11. In vitro studies with artemether, DHA, and lumefantrine at therapeutic concentrations revealed no significant induction of the metabolic activities of CYP1A1, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, or CYP3A5. During repeated administration of Coartem Tablets, systemic exposure of artemether decreased significantly, while concentrations of DHA increased, although not to a statistically significant degree.

The artemether/DHA area under the curve (AUC) ratio is 1.2 after a single dose and 0.3 after 6 doses given over 3 days. This suggests that there was induction of enzymes responsible for the metabolism of artemether. In human liver microsomes and in recombinant CYP450 enzymes, lumefantrine was metabolized mainly by CYP3A4 to desbutyl-lumefantrine.

The systemic exposure to the metabolite desbutyl-lumefantrine was less than 1% of the exposure to the parent compound. In vitro , lumefantrine significantly inhibits the activity of CYP2D6 at therapeutic plasma concentrations. Caution is recommended when combining Coartem Tablets with substrates, inhibitors, or inducers of CYP3A4, especially antiretroviral drugs and those that prolong the QT interval (e.g., macrolide antibiotics, pimozide) [see Contraindications (4), Warnings and Precautions (5.1, 5.2, 5.3), and Drug Interactions (7)] .

Coadministration of Coartem Tablets with CYP2D6 substrates may result in i… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Treatment of Acute, Uncomplicated P. falciparum Malaria The efficacy of Coartem Tablets was evaluated for the treatment of acute, uncomplicated malaria caused by P. falciparum in HIV negative patients in 8 clinical studies. Uncomplicated malaria was defined as symptomatic P. falciparum malaria without signs and symptoms of severe malaria or evidence of vital organ dysfunction. Baseline parasite density ranged from 500/mcL to 200,000/mcL (0.01% to 4% parasitemia) in the majority of patients.

Studies were conducted in partially immune and non-immune adults and children (greater than or equal to 5 kg body weight) with uncomplicated malaria in China, Thailand, sub-Saharan Africa, Europe, and South America. Patients who had clinical features of severe malaria, severe cardiac, renal, or hepatic impairment were excluded. The studies include two 4-dose studies assessing the efficacy of the components of the regimen, a study comparing a 4-dose versus a 6-dose regimen, and 5 additional 6-dose regimen studies.

Coartem Tablets were administered at 0, 8, 24, and 48 hours in the 4-dose regimen, and at 0, 8, 24, 36, 48, and 60 hours in the 6-dose regimen. Efficacy endpoints consisted of: 28-day cure rate, defined as clearance of asexual parasites (the erythrocytic stage) within 7 days without recrudescence by Day 28 parasite clearance time (PCT), defined as time from first dose until first total and continued disappearance of asexual parasite which continues for a further 48 hours fever clearance time (FCT), defined as time from first dose until the first time body temperature fell below 37.5°C and remained below 37.5°C for at least a further 48 hours (only for patients with temperature greater than 37.5°C at baseline) The modified intent-to-treat (mITT) population includes all patients with malaria diagnosis confirmation who received at least 1 dose of study drug.

Evaluable patients generally are all patients who had a Day 7 and a Day 28 parasitological assessment or experienced treatment failure by Day 28. Studies 1 and 2: The 2 studies, which assessed the efficacy of Coartem Tablets (4 doses of 4 tablets of 20 mg artemether/120 mg lumefantrine) compared to each component alone, were randomized, double-blind, comparative, single center, conducted in China. The efficacy results (Table 5) support that the combination of artemether and lumefantrine in Coartem Tablets had a significantly higher 28-day cure rate compared to artemether and had a significantly faster PCT and FCT compared to lumefantrine.

Table 5: Clinical Efficacy of Coartem Tablets Versus Components (mITT Population) 1 Study No. Region/patient ages 28-day cure rate 2 n/N (%) patients Median FCT 3 [25 th , 75 th percentile] Median PCT [25 th , 75 th percentile] Study 1 China, ages 13 to 57 years Coartem Tablets 50/51 (98.0) 24 hours [9, 48] 30 hours [24, 36] Artemether 4 24/52 (46.2) 21 hours [12, 30] 30 hours [24, 33] Lumefantrine 5 47/52 (90.4) 60 hours [36, 78] 54 hours [45, 66] Study 2 China, ages 12 to 65 years Coartem Tablets 50/52 (96.2) 21 hours [6, 33] 30 hours [24, 36] Lumefantrine 6 45/51 (88.2) 36 hours [12, 60] 48 hours [42, 60] Abbreviations: FCT, fever clearance time; mITT, modified intent-to-treat; PCT, parasite clearance time.

1 In mITT analysis, patients whose status was uncertain were classified as treatment failures. 2 Efficacy cure rate based on blood smear microscopy. 3 For patients who had a body temperature greater than 37.5°C at baseline only.

4 95% Confidence Interval (Coartem Tablets–artemether) on 28-day cure rate: 37.8%, 66.0%. 5 P-value comparing Coartem Tablets to lumefantrine on PCT and FCT: < 0.001. 6 P-value comparing Coartem Tablets to lumefantrine on PCT: < 0.001 and on FCT: < 0.05.

Results of 4-dose studies conducted in areas with high resistance such as Thailand during 1995-96 showed lower efficacy results than the above studies. Therefore, Study 3 was conducted. Study 3: Study 3 was a randomized, double-blind, 2-cent… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 196 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity studies were not conducted. Mutagenesis No evidence of mutagenicity was detected. The artemether-lumefantrine combination was evaluated using the Salmonella and Escherichia /mammalian-microsome mutagenicity test, the gene mutation test with Chinese hamster cells V79, the cytogenetic test on Chinese hamster cells in vitro , and the rat micronucleus test, in vivo .

Impairment of Fertility Pregnancy rates were reduced by about one-half in female rats dosed for 2 to 4 weeks with the artemether-lumefantrine combination at 1000 mg/kg (about 9 times the clinical dose based on BSA comparisons). Male rats dosed for 89 to 93 days showed increases in abnormal sperm (87% abnormal) at 30 mg/kg doses (about one-third the clinical dose). Higher doses (about 9 times the MRHD) resulted in increased testes weights, decreased sperm motility, and 100% abnormal sperm cells.

13.2Animal Toxicology and/or Pharmacology Neonatal rats (7 to 21 days old) were more sensitive to the toxic effects of artemether (a component of Coartem Tablets) than older juvenile rats or adults. Mortality and severe clinical signs were observed in neonatal rats at doses which were well tolerated in pups above 22 days old.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 139 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity studies were not conducted. Mutagenesis No evidence of mutagenicity was detected. The artemether-lumefantrine combination was evaluated using the Salmonella and Escherichia /mammalian-microsome mutagenicity test, the gene mutation test with Chinese hamster cells V79, the cytogenetic test on Chinese hamster cells in vitro , and the rat micronucleus test, in vivo .

Impairment of Fertility Pregnancy rates were reduced by about one-half in female rats dosed for 2 to 4 weeks with the artemether-lumefantrine combination at 1000 mg/kg (about 9 times the clinical dose based on BSA comparisons). Male rats dosed for 89 to 93 days showed increases in abnormal sperm (87% abnormal) at 30 mg/kg doses (about one-third the clinical dose). Higher doses (about 9 times the MRHD) resulted in increased testes weights, decreased sperm motility, and 100% abnormal sperm cells.

📄 Patient Package Insert ~3 min read ▾

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: November 2024 Patient Information Coartem ® (co-AR-tem) (artemether and lumefantrine) tablets, for oral use Read this Patient Information leaflet before you start taking Coartem.

There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. What is Coartem?

Coartem is a prescription medicine used to treat uncomplicated malaria caused by the parasite Plasmodium falciparum (P. falciparum) in people 2 months of age and older who weigh at least 11 pounds (5 kg). Coartem is not approved to: Treat severe or complicated P. falciparum malaria Prevent malaria It is not known if Coartem is safe and effective in children who weigh less than 11 pounds (5 kg). Who should not take Coartem?

Do not take Coartem if you: are allergic to artemether, lumefantrine, or any of the ingredients in Coartem. See the end of this Patient Information leaflet for a complete list of ingredients in Coartem. Symptoms of a serious allergic reaction with Coartem can include: rash, hives, fast heartbeat, trouble swallowing or breathing, swelling of lips, tongue, face, tightness of the throat, or trouble speaking.

If you have any of these symptoms of a serious allergic reaction while taking Coartem, stop taking Coartem and get emergency medical help right away. are taking rifampin (medicine used to treat leprosy or tuberculosis), carbamazepine or phenytoin (medicines used to treat epilepsy), or St. John’s wort ( Hypericum perforatum , a medicinal plant or extract of this medicinal plant). What should I tell my healthcare provider before taking Coartem?

Before taking Coartem, tell your healthcare provider about all of your medical conditions, including if you: have heart disease or a family history of heart problems or heart disease. have liver or kidney problems. have recently taken other medicines used to treat malaria. are pregnant or plan to become pregnant. Treatment of malaria is important because it can be a serious disease for a pregnant woman and her unborn baby. are taking hormonal contraceptives (such as birth control pills). Coartem may affect how well hormonal contraceptives work and may cause them to not work as well.

Females who are able to become pregnant should use another effective non-hormonal form of birth control or an additional barrier method of birth control (such as male condoms) during treatment with Coartem. Talk with your healthcare provider if you have questions about birth control methods that may be right for you during this time. are breastfeeding or plan to breastfeed. It is not known if Coartem passes into your breast milk.

Talk to your healthcare provider about the best way to feed your baby while taking Coartem. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Coartem and other medicines may affect each other causing side effects.

Coartem may affect the way other medicines work and other medicines may affect how Coartem works. Especially tell your healthcare provider if you take: any other medicines to treat or prevent malaria medicines for your heart antipsychotic medicines antidepressants medicines for seizures or trigeminal neuralgia (facial nerve pain) antibiotics (including medicines to treat tuberculosis) antifungal medicines (such as itraconazole, ketoconazole, and fluconazole) medicines to treat HIV-infection hormonal methods of birth control.

See “ What should I tell my healthcare provider before taking Coartem? ” Ask your healthcare provider if you are not sure if your medicine is listed above. Know the medicines you take. Keep a list of your medicines with you and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take Coartem? Take Coartem exactly as prescribed. If you weigh 77 pounds (35… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 22 words ▾

PRINCIPAL DISPLAY PANEL NDC 0078-0568-45 Rx only Coartem ® (artemether/lumefantrine) Tablets 20 mg/120 mg per tablet 24 Tablets NOVARTIS Coartem Tablets label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
14
Units reimbursed last 4 qtrs
306
Gross reimbursed last 4 qtrs
$1.8K
Avg / prescription
$129.31
Avg / unit
$5.9161
Latest quarter Q1 2026
14Rx
Medicaid pays / ea
$5.9161
gross reimbursed
vs
NADAC / ea
$5.3628
acquisition cost
=
Spread
+$0.5533
+10% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
100% FFS
Fee-for-service · 14 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 306 units · 4.9 per 100k residents MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
4.94.9
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Missouri 4.9 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Coartem — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Coartem. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$10.7K
Claims incl. refills
44
Beneficiaries
32
Spend / beneficiary
$334.79
Spend / claim
$243.49
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for COARTEM (this brand).

Top reported reactions

Pyrexia22
Vomiting18
Dyspnoea17
Asthenia16
Malaise13
Malaria13
Headache10

Age at onset

Child1
Adult2
Elderly1

Reporter sex

196 reports
Male · 41%
Female · 58%
Unknown · 1%

Serious outcomes

Hospitalization61
Life-threatening23
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 10 3
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
← 00078-0567-51 · Novartis 00078-0592-51 · Novartis →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.