Artemether And Lumefantrine (Coartem)

Trade Name

COARTEM

Active Ingredient

Power

20; 120 mg/1; mg/1

Type / form

Tablets

Status

Manufacturer

Novartis Pharmaceuticals Corporation

Storage and handling for COARTEM

ARTEMETHER; LUMEFANTRINE Antimalarial [EPC],Antimalarial [EPC]

Disclaimer

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Artemether And Lumefantrine (Coartem) which is also known as COARTEM and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 20; 120 mg/1; mg/1 per ml. Read more

Artemether And Lumefantrine (Coartem) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

About GNH

GNH India a Global Orphan Drug specialist renowned for its adherence to stringent quality standards. GNH India holds ISO 9001:2015 certification and WHO Good Storage and Distribution Practices (GSDP) compliance, ensuring the highest levels of safety and reliability in our operations.

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  • No data
  • Coartem Tablets are indicated for treatment of acute, uncomplicated malaria infections due to 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:
  • Limitations of Use:
  • 1
  • No data
  • Coartem Tablets should be taken with food. (, )n
  • Tablets may be crushed and mixed with 1 to 2 teaspoons of water immediately prior to administration to patients, including children. ()n
  • 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. (, )n
  • The adult dosage for patients with bodyweight of 35 kg and above is 4 tablets per dose for a total of 6 doses. ()n
  • The number of tablets per dose for children is determined by bodyweight, as shown in the chart below. ()
  • Coartem Tablets contain 20u00a0mg of artemether and 120u00a0mg of lumefantrine. Coartem Tablets are supplied as yellow, round, flat tablets with beveled edges and scored on one side. Tablets are imprinted with u201cN/Cu201d on one side and u201cCGu201d on the other side.
  • Tablets are scored and contain 20u00a0mg artemether and 120u00a0mg lumefantrine. ()
  • 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. Johnu2019s wort with Coartem Tablets can result in decreased concentrations of artemether and/or lumefantrine and loss of antimalarial efficacy .
  • Known hypersensitivity to artemether, lumefantrine, or to any of the excipients. ()
  • Coadministration of strong inducers of CYP3A4 such as rifampin, carbamazepine, phenytoin, and St. Johnu2019s wort with Coartem Tablets. (, , )
  • No data
  • Avoid use in patients with known QT prolongation, those with hypokalemia or hypomagnesemia, and those taking other drugs that prolong the QT interval. (, )n
  • Halofantrine and Coartem Tablets should not be administered within one month of each other due to potential additive effects on the QT interval. (, , )n
  • Antimalarials should not be given concomitantly, unless there is no other treatment option, due to limited safety data. ()n
  • QT prolonging drugs, including quinine and quinidine, should be used cautiously following Coartem Tablets. (, , , ) n
  • 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. (, , )
  • The following serious and otherwise important adverse reactions are discussed in greater detail in other sections of labeling:
  • 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. ()
  • No data
  • CYP3A4 Inducers: Potential for loss of antimalarial efficacy. (, , , )
  • CYP3A4 Inhibitors: Use cautiously due to potential for QT prolongation. (, , )
  • Antiretrovirals: Use cautiously due to potential for QT prolongation, loss of antiviral efficacy, or loss of antimalarial efficacy of Coartem Tablets. (, , )
  • Mefloquine: If used immediately before treatment, monitor for decreased efficacy of Coartem Tablets and encourage food consumption. (, , )
  • Hormonal Contraceptives: Effectiveness may be reduced; use an additional method of birth control. (, , )
  • CYP2D6 Substrates: Monitor for adverse reactions and potential QT prolongation. (, , )
  • No data
  • 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.
  • 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 (3,5a,6,8a,9,10,12,12a)-10-methoxy-3,6,9-trimethyldecahydro-3,12-epoxypyrano[4,3-]-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 CHO with a molecular weight of 298.4 g/mol, and the following structural formula:
  • The chemical name of lumefantrine is (1)-2-(dibutylamino)-1-{(9Z)-2,7-dichloro-9-[(4-chlorophenyl)methylene]-9-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 CHClNO with a molecular weight of 528.9 g/mol, and the following structural formula:
  • Coartem Tablets are for oral administration. Each Coartem Tablet contains 20u00a0mg of artemether and 120u00a0mg lumefantrine. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, and polysorbate 80.
  • No data
  • No data
  • The efficacy of Coartem Tablets was evaluated for the treatment of acute, uncomplicated malaria caused by u00a0in HIV negative patients in 8 clinical studies. Uncomplicated malaria was defined as symptomatic 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:
  • 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:
  • 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:
  • Studies 4, 5, 6, 7, and 8:
  • In study 4, a total of 150 adults and children aged greater than or equal to 2 years received Coartem Tablets. In study 5, a total 164 adults and children greater than or equal to 12 years received Coartem Tablets. Both studies were conducted in Thailand.
  • Study 6 was a study of 165 non-immune adults residing in regions non-endemic for malaria (Europe and Colombia) who contracted acute uncomplicated malaria when traveling in endemic regions.
  • Study 7 was conducted in Africa in 310 infants and children aged 2 months to 9 years, weighing 5 kg to 25 kg, with an axillary temperature greater than or equal to 37.5u00baC.
  • Study 8 was conducted in Africa in 452 infants and children, aged 3 months to 12 years, weighing 5 kg to less than 35 kg, with fever (greater than or equal to 37.5u00b0C axillary or greater than or equal to 38u00b0C rectally) or history of fever in the preceding 24 hours.
  • Results of 28-day cure rate, median PCT, and FCT for Studies 3 to 8 are reported in Table 6.
  • In all studies, patientsu2019 signs and symptoms of malaria resolved when parasites were cleared.
  • In studies conducted in areas with high transmission rates, such as Africa, reappearance of parasites may be due to recrudescence or a new infection.
  • The efficacy by body weight category for studies 7 and 8 is summarized in Table 7.
  • The efficacy of Coartem Tablets for the treatment infections mixed with was assessed in a small number of patients. Coartem Tablets are only active against the erythrocytic phase of malaria. Of the 43 patients with mixed infections at baseline, all cleared their parasitemia within 48 hours. However, parasite relapse occurred commonly (14/43; 33%). Relapsing malaria caused by requires additional treatment with other antimalarial agents to achieve radical cure i.e., eradicate any hypnozoite forms that may remain dormant in the liver.
  • Coartem (artemether/lumefantrine) Tablets
  • 20 mg/120 mg Tablets -
  • Bottle of 24u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 0078-0568-45
  • Store at 20u00baC to 25u00baC (68u00baF to 77u00baF); excursions permitted to 15u00baC to 30u00baC (59u00baF to 86u00baF) [].
  • Dispense in tight container (USP).
  • 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 .ntttttt
  • Hypersensitivity
  • Patients with known hypersensitivity to artemether, lumefantrine, or to any of the excipients should not receive Coartem Tablets .ntttttt
  • Prolongation of the QT Interval
  • 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. Johnu2019s 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 .
  • T2019-88
  • No data
  • PRINCIPAL DISPLAY PANEL
  • NDC 0078-0568-45ntttttttu00a0u00a0u00a0u00a0u00a0ntttttttRx only
  • Coartemn (artemether/lumefantrine)Tablets
  • 20 mg/120 mg per tablet
  • 24 Tablets
  • NOVARTIS

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