Brand Name
Coartem
Generic Name
Lumefantrine
View Brand Information FDA approval date: April 07, 2009
Classification: Antimalarial
Form: Tablet
What is Coartem (Lumefantrine)?
Coartem Tablets are indicated for treatment of acute, uncomplicated malaria infections due to Plasmodium 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 (1.
Approved To Treat
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Brand Information
COARTEM (artemether and lumefantrine)
1INDICATIONS AND USAGE
Coartem Tablets are indicated for treatment of acute, uncomplicated malaria infections due to
Limitations of Use:
- Coartem Tablets are not approved for patients with severe or complicated
- Coartem Tablets are not approved for the prevention of malaria.
2DOSAGE 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.
3CONTRAINDICATIONS
Hypersensitivity
Known hypersensitivity to artemether, lumefantrine, or to any of the excipients of Coartem Tablets
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
4ADVERSE REACTIONS
The following serious and otherwise important adverse reactions are discussed in greater detail in other sections of labeling:
- Hypersensitivity Reactions
- Prolongation of the QT Interval
- Use of QT Prolonging Drugs and Other Antimalarials
- Drug Interactions with CYP3A4
- Drug Interactions with CYP2D6
4.1Clinical 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.
Clinically significant adverse reactions reported in adults and/or children treated with the 6-dose regimen of Coartem Tablets, which occurred in clinical studies at less than 3% regardless of causality are listed below:
Blood and Lymphatic System Disorders: eosinophilia
Ear and Labyrinth Disorders: tinnitus
Eye Disorders: conjunctivitis
Gastrointestinal Disorders: constipation, dyspepsia, dysphagia, peptic ulcer
General Disorders: gait disturbance
Infections and Infestations: abscess, acrodermatitis, bronchitis, ear infection, gastroenteritis, helminthic infection, hook-worm infection, impetigo, influenza, lower respiratory tract infection, malaria, nasopharyngitis, oral herpes, pneumonia, respiratory tract infection, subcutaneous abscess, upper respiratory tract infection, urinary tract infection
Investigations: alanine aminotransferase increased, aspartate aminotransferase increased, hematocrit decreased, lymphocyte morphology abnormal, platelet count decreased, platelet count increased, white blood cell count decreased, white blood cell count increased
Metabolism and Nutrition Disorders: hypokalemia
Musculoskeletal and Connective Tissue Disorders: back pain
Nervous System Disorders: ataxia, clonus, fine motor delay, hyperreflexia, hypoesthesia, nystagmus, tremor
Psychiatric Disorders: agitation, mood swings
Renal and Urinary Disorders: hematuria, proteinuria
Respiratory, Thoracic and Mediastinal Disorders: asthma, pharyngo-laryngeal pain
Skin and Subcutaneous Tissue Disorders: urticaria
4.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of Coartem Tablets. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Hypersensitivity Reactions: anaphylaxis, urticaria, angioedema, and serious skin reactions (bullous eruption) have been reported.
- Blood and Lymphatic System Disorders: Cases of delayed hemolytic anemia have been reported following treatment with artemether-lumefantrine, mostly when used for treatment of severe malaria in patients initially treated with IV/parenteral artesunate. Coartem Tablets should not be used to treat severe malaria as it is not an approved indication.
5OVERDOSAGE
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.
6DESCRIPTION
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
The chemical name of lumefantrine is (1
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.
7HOW 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)
Dispense in tight container (USP).
8PATIENT 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
Hypersensitivity
Patients with known hypersensitivity to artemether, lumefantrine, or to any of the excipients should not receive Coartem Tablets
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
- 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)
- 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
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)
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
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
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
Prior Use of Mefloquine
Closely monitor food intake in patients who received mefloquine immediately prior to treatment with Coartem Tablets
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
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
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9PRINCIPAL DISPLAY PANEL
NDC 0078-0568-45 Rx only
Coartem
20 mg/120 mg per tablet
24 Tablets
NOVARTIS
