Arteméter y lumefantrina (artemether and lumefantrine)

Para qué se usa Arteméter y lumefantrina

Cita de la sección «Indications and Usage» (indicaciones y uso) de la etiqueta aprobada por la FDA. Se muestra en inglés, tal como la publica la FDA.

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 […]. Limitations of Use …

— Etiqueta de la FDA: Coartem, Novartis Pharmaceuticals Corporation, vigente desde el 26 de marzo de 2026. Leer la etiqueta completa en DailyMed →

Etiqueta citada: la de la presentación más común (tablet, oral), Coartem, Novartis Pharmaceuticals Corporation; abarca 1 producto del directorio NDC de la FDA. Las citas sobre efectos secundarios, interacciones, dosis y embarazo de abajo vienen de esta misma etiqueta.

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Efectos secundarios de Arteméter y lumefantrina

Cita de la sección «Adverse Reactions» (reacciones adversas) de la etiqueta aprobada por la FDA. Se muestra en inglés. Avise a su médico de cualquier efecto secundario que le preocupe.

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.

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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. 6.1 Clinical 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.

— Etiqueta de la FDA: Coartem, Novartis Pharmaceuticals Corporation, vigente desde el 26 de marzo de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Interacciones de Arteméter y lumefantrina

Cita de la sección «Drug Interactions» (interacciones) de la etiqueta aprobada por la FDA. Se muestra en inglés. Dígale a su farmacéutico todos los medicamentos, vitaminas y productos herbales que toma.

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.

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(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) 7.1 Rifampin 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)]. 7.2 Ketoconazole 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)]. 7.3 Antiretroviral 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)]. 7.4 Prior 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.

— Etiqueta de la FDA: Coartem, Novartis Pharmaceuticals Corporation, vigente desde el 26 de marzo de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Dosis de Arteméter y lumefantrina

Cita de la sección «Dosage and Administration» (dosis y administración) de la etiqueta aprobada por la FDA. Se muestra en inglés. Su dosis es la que le receta su médico: no la cambie por su cuenta.

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.

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(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 2.1 Administration 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. 2.2 Dosage 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).

— Etiqueta de la FDA: Coartem, Novartis Pharmaceuticals Corporation, vigente desde el 26 de marzo de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Arteméter y lumefantrina en el embarazo

Cita de la parte sobre embarazo (Pregnancy) de la etiqueta aprobada por la FDA. Se muestra en inglés. Pregunte a su médico antes de tomar cualquier medicamento si está embarazada o planea estarlo.

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.

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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.

— Etiqueta de la FDA: Coartem, Novartis Pharmaceuticals Corporation, vigente desde el 26 de marzo de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Cuándo no se debe usar Arteméter y lumefantrina

Cita de la sección «Contraindications» (contraindicaciones) de la etiqueta aprobada por la FDA. Se muestra en inglés.

Hypersensitivity Known hypersensitivity to artemether, lumefantrine, or to any of the excipients of Coartem Tablets [see Adverse Reactions (6.2)].

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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)

— Etiqueta de la FDA: Coartem, Novartis Pharmaceuticals Corporation, vigente desde el 26 de marzo de 2026. Leer la etiqueta completa en DailyMed →

Sobredosis de Arteméter y lumefantrina

Cita de la sección «Overdosage» (sobredosis) de la etiqueta aprobada por la FDA. Se muestra en inglés. Si alguien pudo haber tomado demasiado, llame a Poison Help al 1-800-222-1222 (o al 911 en una emergencia).

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.

— Etiqueta de la FDA: Coartem, Novartis Pharmaceuticals Corporation, vigente desde el 26 de marzo de 2026. Leer la etiqueta completa en DailyMed →

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• Novartis Pharmaceuticals Corporation1 producto

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Fuentes

1. Etiqueta aprobada por la FDA en DailyMed (Biblioteca Nacional de Medicina) — Coartem, Novartis Pharmaceuticals Corporation, vigente desde el 26 de marzo de 2026; vía openFDA, datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
2. NDC Directory (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
3. Drugs@FDA (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
4. Drug recall enforcement reports (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 27 de octubre de 2026, consultados el 31 de octubre de 2026
5. Drug shortages (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
6. Nombre en español: RxNorm (Biblioteca Nacional de Medicina de EE. UU.) y Wikidata, vinculados por el identificador RxNorm (RxCUI) del principio activo, sin coincidencias aproximadas.

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