and so on [3%:<35 kg body weight), is comparable to that of the recommended dosing regimen in adult patients. Table 4: Summary of Pharmacokinetic Parameters for Lumefantrine, Artemether and DHA in Pediatric and Adult Patients with Malaria Following Administration of a 6-dose Regimen of Coartem Tablets Adults 1 Pediatric patients (body weight, kg) 2 Drug 5 to> <15 15 to> <25 25 to> <35 Lumefantrine Mean C max , range (mcg/mL) 5.60 - 9.0 4.71 12.6 Not Available Mean AUC last , range (mcg h/mL) 410 - 561 372 699 Not Available Artemether Mean C max SD (ng/mL) 186 125 223 309 198 179 174 145 Dihydroartemisinin Mean C max SD (ng/mL) 101 58 54.7 58.9 79.8 80.5 65.3 23.6 1 There are a total of 181 adults for lumefantrine pharmacokinetic parameters and a total of 25 adults for artemether and dihydroartemisinin pharmacokinetic parameters. 2 There are 477 children for the lumefantrine pharmacokinetic parameters; for artemether and dihydroartemisinin pharmacokinetic parameters there are 55, 29, and 8 children for the 5 to> <15, 15 to> <25 and the 25 to> <35 kg groups, respectively. Geriatric Patients No specific pharmacokinetic studies have been performed in patients older than 65 years of age. Drug Interactions Rifampin (strong CYP3A4 inducer) Oral administration of rifampin (600 mg daily), a strong CYP3A4 inducer, with Coartem Tablets (6-dose regimen over 3 days) in 6 HIV-1 and tuberculosis co-infected adults without malaria resulted in significant decreases in exposure, in terms of AUC, to artemether, DHA 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)] . Ketoconazole (potent CYP3A4 inhibitor) Concurrent oral administration of ketoconazole (400 mg on day 1 followed by 200 mg on days 2, 3, 4 and 5) with Coartem Tablets (single dose of 4 tablets of 20 mg artemether/120 mg lumefantrine per tablet) with a meal led to an increase in exposure, in terms of area under the curve (AUC), of artemether (2.3-fold), DHA (1.5-fold), and lumefantrine (1.6-fold) in 13 healthy subjects. The pharmacokinetics of ketoconazole was not evaluated. Based on this study, dose adjustment of Coartem Tablets is considered unnecessary when administered with ketoconazole or other 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 other drugs that inhibit CYP3A4 (e.g., antiretroviral drugs, macrolide antibiotics, antidepressants, imidazole antifungal agents) [see Warnings and Precautions (5.1, 5.3)] . Antimalarials The oral administration of mefloquine in 14 healthy volunteers administered as 3 doses of 500 mg, 250 mg and 250 mg, followed 12 hours later by Coartem Tablets (6 doses of 4 tablets of 20 mg artemether/120 mg lumefantrine per tablet), had no effect on plasma concentrations of artemether or the artemether/DHA ratio. In the same study, there was a 30% reduction in C max and 40% reduction in AUC of lumefantrine, possibly due to lower absorption secondary to a mefloquine-induced decrease in bile production. Intravenous administration of a single dose of quinine (10 mg/kg bodyweight) concurrent with the last dose of a 6-dose regimen of Coartem Tablets had no effect on systemic exposure of DHA, lumefantrine or quinine in 14 healthy volunteers. Mean AUC of artemether were 46% lower when administered with quinine compared to Coartem Tablets alone. This decrease in artemether exposure is not thought to be clinically significant. However, quinine should be used cautiously in patients following treatment with 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 quinine is medically required [see Warnings and Precautions (5.2)] . Antiretroviral Drugs The oral administration of lopinavir/ritonavir (400 mg/100 mg twice daily for 26 days) in 10 healthy volunteers coadministered with Coartem Tablets (6-dose regimen over 3 days), resulted in a decrease in systemic exposures, in terms of AUC, to artemether and DHA by approximately 40%, but an increase in exposure to lumefantrine by approximately 2.3-fold. The oral administration of efavirenz (600 mg once daily for 26 days) in 12 healthy volunteers coadministered with Coartem Tablets (6-dose regimen over 3 days), resulted in a decrease in exposures to artemether, DHA, and lumefantrine by approximately 50%, 45%, and 20%, respectively. Exposures to lopinavir/ritonavir and efavirenz were not significantly affected by concomitant use of Coartem Tablets. Coartem Tablets should be used cautiously in patients on antiretroviral drugs such as HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors 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) and Drug Interactions (7.3)] . Hormonal Contraceptives No clinical drug-drug interaction studies between Coartem Tablets and hormonal contraceptives have been performed. In vitro studies revealed that 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 CYP3A. Therefore, coadministration of Coartem Tablets may potentially reduce the effectiveness of hormonal contraceptives [see Warnings and Precautions (5.3) and Drug Interactions (7.5)] . Microbiology Mechanism of Action Coartem Tablets, a fixed ratio of 1:6 parts of artemether and lumefantrine, respectively, is an antimalarial agent. Artemether is rapidly metabolized into an active metabolite dihydroartemisinin (DHA). The antimalarial activity of artemether and DHA has been attributed to endoperoxide moiety. The exact mechanism by which lumefantrine exerts its antimalarial effect is not well defined. Available data suggest lumefantrine inhibits the formation of β-hematin by forming a complex with hemin. Both artemether and lumefantrine were shown to inhibit nucleic acid and protein synthesis. Activity In Vitro and In Vivo Artemether and lumefantrine are active against the erythrocytic stages of Plasmodium falciparum . Drug Resistance Strains of P. falciparum with a moderate decrease in susceptibility to artemether or lumefantrine alone can be selected in vitro or in vivo, but not maintained in the case of artemether. The clinical relevance of such an effect is not known. Effects on the Electrocardiogram In a healthy adult volunteer parallel-group study including a placebo and moxifloxacin control-group (n=42 per group), the administration of the 6-dose regimen of Coartem Tablets was associated with prolongation of QTcF (Fridericia). Following administration of a 6-dose regimen of Coartem Tablets consisting of 4 tablets per dose (total of 4 tablets of 80 mg artemether/480 mg lumefantrine) taken with food, the maximum mean change from baseline and placebo adjusted QTcF was 7.5 msec (1-sided 95% Upper CI: 11 msec). There was a concentration-dependent increase in QTcF for lumefantrine. In clinical trials conducted in children, no patient had QTcF> 500 msec. Over 5% of patients had an increase in QTcF of over 60 msec. In clinical trials conducted in adults, QTcF prolongation of >500 msec was reported in 3 (0.3%) patients. Over 6% of adults had a QTcF increase of over 60 msec from baseline. NONCLINICAL TOXICOLOGY Carcinogenesis, 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 body surface area comparisons). Male rats dosed for 70 days showed increases in abnormal sperm (87% abnormal) and increased testes weights at 30 mg/kg doses (about one-third the clinical dose). Higher doses (about 9 times the clinical dose) resulted in decreased sperm motility and 100% abnormal sperm cells. Animal 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. CLINICAL STUDIES Treatment 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 ( 5kg 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 >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 parasite clearance time (PCT) and fever clearance time (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] 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 >37.5 C at baseline only 4 95% CI (Coartem Tablets artemether) on 28-day cure rate: 37.8%, 66.0% 5 P-value comparing Coartem Tablets to lumefantrine on parasite clearance time (PCT) and fever clearance time (FCT): <0.001 6 P-value comparing Coartem Tablets to lumefantrine on parasite clearance time (PCT):> <0.001 and on fever clearance time (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-center study conducted in Thailand in adults and children (aged 2 years), which compared the 4-dose regimen (administered over 48 hours) of Coartem Tablets to a 6-dose regimen (administered over 60 hours). Twenty-eight day cure rate in mITT subjects was 81% (96/118) for the Coartem Tablets 6-dose arm as compared to 71% (85/120) in the 4-dose arm. Studies 4, 5, 6, 7, and 8: In these studies, Coartem Tablets were administered as the 6-dose regimen. In study 4, a total of 150 adults and children aged 2 years received Coartem Tablets. In study 5, a total 164 adults and children 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 falciparum 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 37.5ºC. Study 8 was conducted in Africa in 452 infants and children, aged 3 months to 12 years, weighing 5 kg to> <35 kg, with fever ( 37.5 C axillary or 38 C rectally) or history of fever in the preceding 24 hours. Results of 28-day cure rate, median parasite clearance time (PCT), and fever clearance time (FCT) for Studies 3 to 8 are reported in Table 6. Table 6: Clinical Efficacy of 6-dose Regimen of Coartem Tablets Study No. Region/ages 28-day cure rate 1 n/N (%) patients Median FCT 2 [25 th , 75 th percentile] Median PCT [25 th , 75 th percentile] mITT 3 Evaluable Study 3 Thailand, ages 3 62 years 96/118 (81.4) 93/96 (96.9) 35 hours [20, 46] 44 hours [22, 47] Early failure 4 0 0 Late failure 5 4 (3.4) 3 (3.1) Lost to follow-up 18 (15.3) Other 6 0 Study 4 Thailand, ages 2 63 years 130/149 (87.2) 130/134 (97.0) 22 hours [19, 44] NA Early failure 4 0 0 Late failure 5 4 (2.7) 4 (3.0) Lost to follow-up 13 (8.7) Other 6 2 (1.3) Study 5 Thailand, ages 12 71 years 148/164 (90.2) 148/155 (95.5) 29 hours [8, 51] 29 hours [18, 40] Early failure 4 0 0 Late failure 5 7 (4.3) 7 (4.5) Lost to follow-up 9 (5.5) Other 6 0 Study 6 Europe/Columbia, ages 16 66 years 120/162 (74.1) 119/124 (96.0) 37 hours [18, 44] 42 hours [34, 63] Early failure 4 6 (3.7) 1 (0.8) Late failure 5 3 (1.9) 3 (2.4) Lost to follow-up 17 (10.5) Other 6 16 (9.9) 1 (0.8) Study 7 Africa, ages 2 months 9 years 268/310 (86.5) 267/300 (89.0) 8 hours [8, 24] 24 hours [24, 36] Early failure 4 2 (0.6) 0 Late failure 5 34 (11.0) 33 (11.0) Lost to follow-up 2 (0.6) Other 6 4 (1.3) Study 8 Africa, ages 3 months 12 years 374/452 (82.7) 370/419 (88.3) 8 hours [8, 23] 35 hours [24, 36] Early failure 4 13 (2.9) 0 Late failure 5 49 (10.8) 49 (11.7) Lost to follow-up 6 (1.3) Other 6 10 (2.2) 1 Efficacy cure rate based on blood smear microscopy 2 For patients who had a body temperature> 37.5 C at baseline only 3 In mITT analysis, patients whose status was uncertain were classified as treatment failures. 4 Early failures were usually defined as patients withdrawn for unsatisfactory therapeutic effect within the first 7 days or because they received another antimalarial medication within the first 7 days 5 Late failures were defined as patients achieving parasite clearance within 7 days but having parasite reappearance including recrudescence or new infection during the 28-day follow-up period 6 Other includes withdrawn due to protocol violation or non-compliance, received additional medication after day 7, withdrew consent, missing day 7 or 28 assessment In all studies, patients signs and symptoms of malaria resolved when parasites were cleared. In studies conducted in areas with high transmission rates, such as Africa, reappearance of P. falciparum 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. Table 7: Clinical Efficacy by Weight for Pediatric Studies Study No. Age category Coartem Tablets 6-dose Regimen mITT population 1 Evaluable population Median PCT [25 th ,75 th percentile] 28-day cure rate 2 n/N (%) patients 28-day cure rate 2 n/N (%) patients Study 7 5 to <10 kg 24 [24, 36] 133/154 (86.4) 133/149 (89.3) 10 to> <15 kg 35 [24, 36] 94/110 (85.5) 94/107 (87.9) 15 to 25 kg 24 [24, 36] 41/46 (89.1) 40/44 (90.9) Study 8 3 5 to> <10 kg 36 [24, 36] 61/83 (73.5) 61/69 (88.4) 10 to> <15 kg 35 [24, 36] 160/190 (84.2) 157/179 (87.7) 15 to> <25 kg 35 [24, 36] 123/145 (84.8) 123/140 (87.9) 25 to> <35 kg 26 [24, 36] 30/34 (88.2) 29/31 (93.5) 1 In mITT analysis, patients whose status was uncertain were classified as treatment failures. 2 Efficacy cure rate based on blood smear microscopy 3 Coartem Tablets administered as crushed tablets The efficacy of Coartem Tablets for the treatment P. falciparum infections mixed with P. vivax was assessed in a small number of patients. Coartem Tablets are only active against the erythrocytic phase of P. vivax 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 P. vivax requires additional treatment with other antimalarial agents to achieve radical cure i.e., eradicate any hypnozoite forms that may remain dormant in the liver. 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 25ºC (77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [ see USP Controlled Room Temperature ]. Dispense in tight container (USP). PATIENT COUNSELING INFORMATION Advise patients to read the FDA-Approved Patient Labeling. Information for Safe Use 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. Patients with known hypersensitivity to artemether, lumefantrine, or to any of the excipients should not receive Coartem Tablets. 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. 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). Inform patients that based on animal data, Coartem Tablets administered during pregnancy may result in fetal loss. Fetal defects have been reported when artemisinins are administered to animals. 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. 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. Closely monitor food intake in patients who received mefloquine immediately prior to treatment with Coartem Tablets. 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. Coartem Tablets may reduce the effectiveness of hormonal contraceptives. Therefore, patients using oral, transdermal patch, or other systemic hormonal contraceptives should be advised to use an additional non-hormonal method of birth control. 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. T2015-44 March 2015 FDA-Approved Patient Labeling Patient Information Coartem (co-AR-tem) (artemether and lumefantrine) Tablets Read this patient information 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 in adults and children who weigh at least 11 pounds (5 kg). Who should not take Coartem? Do not take Coartem if you are allergic to any of the ingredients. See the end of this leaflet for a complete list of ingredients in Coartem. Do not take Coartem if you are taking rifampin (medicine to treat leprosy or tuberculosis), certain medicines used to treat epilepsy (such as carbamazepine, phenytoin), 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 you take Coartem, tell your healthcare provider about all 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 are planning to become pregnant. Coartem may increase your risk for loss of pregnancy. Fetal defects have been reported when artemisinins are administered to animals. Talk to your healthcare provider before taking Coartem. are breastfeeding. It is not known if Coartem passes into your breast milk. You and your doctor will decide the best way to feed your baby if you take Coartem. Tell your doctor about all the medicines you take, including prescription and non-prescription 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 doctor 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) medicines to treat HIV-infection hormonal methods of birth control (for example, birth control pills or patch). If you are taking a hormonal birth control medicine, you should also use an additional method of birth control. Ask your healthcare provider if you are not sure if your medicine is 1 that is listed above. Know the medicines you take. Keep a list of your medicines with you to show your healthcare providers when you get a new medicine. How should I take Coartem? Take Coartem exactly as prescribed. If you weigh 77 pounds (35 kg) or more, 1 dose of Coartem is 4 tablets. If you weigh less than 77 pounds (35 kg), your healthcare provider will tell you how many tablets to take for each dose. A full course of treatment is 6 doses of Coartem taken over 3 days: Day 1 : take 1 dose; 8 hours later take 1 dose Day 2: take 1 dose in the morning, 1 dose in the evening Day 3: take 1 dose in the morning, 1 dose in the evening Take Coartem for 3 days even if you are feeling better. Every dose of Coartem should be taken with food, such as milk, infant formula, pudding, porridge, or broth. It is important for you to eat as soon as you can so that your malaria will go away and not get worse. Do not drink grapefruit juice while you take Coartem. Drinking grapefruit juice during treatment with Coartem can cause you to have too much medicine in your blood. Coartem may be crushed and mixed with 1 to 2 teaspoons of water in a clean container. If you vomit within 1 hour of taking Coartem you should take another dose of Coartem. If you vomit the second dose, tell your healthcare provider. A different medicine may need to be prescribed for you. Tell your healthcare provider right away if: your malaria does not get better you vomited any of your doses of Coartem you are not able to eat you get flu-like symptoms (chills, fever, muscle pains, or headaches) again after you have finished your treatment with Coartem. you have any change in the way your heart beats or a loss of consciousness (fainting). What are the possible side effects of Coartem? Coartem can cause serious side effects including: A heart problem called QT prolongation that can cause an abnormal heartbeat can happen in people who take Coartem. The chance of this happening is higher in people with a family history of prolonged QT interval, low potassium (hypokalemia), and in people who take medicines to control heartbeats. Allergic reactions . Symptoms of an allergic reaction include: rash, hives, fast heartbeat, trouble swallowing or breathing, swelling of lips, tongue, face, tightness of the throat, or trouble speaking. If you have a serious allergic reaction, stop taking Coartem and get emergency medical help right away. The most common side effects in adults are: headache feeling dizzy feeling weak loss of appetite muscle and joint pain or stiffness feeling tired chills fever The most common side effects in children are: fever cough vomiting headache loss of appetite These are not all the possible side effects of Coartem. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store Coartem? Store Coartem between 59ºF to 86ºF (15ºC to 30ºC). Keep Coartem and all medicines out of the reach of children. General information about the safe and effective use of Coartem. Medicines are sometimes prescribed for purposes other than those listed in patient information leaflets. Do not use Coartem for a condition for which it was not prescribed. Do not give Coartem to other people, even if they have the same symptoms that you have. It may harm them. This patient information leaflet summarizes the most important information about Coartem. If you would like more information about Coartem talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Coartem that is written for health professionals. For more information call 1-855-262-7836. What are the ingredients in Coartem? Active ingredients include: artemether, lumefantrine Inactive ingredients include: colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polysorbate 80 Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 Novartis T2015-45 March 2015 PRINCIPAL DISPLAY PANEL Package Label 20 mg/120 mg per tablet Rx Only NDC 0078-0568-45 Coartem (artemether/lumefantrine) Tablets 24 Tablets 20 mg/120 mg per tablet Coartem artemether and lumefantrine tablet Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0078-0568 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARTEMETHER (ARTEMETHER) ARTEMETHER 20 mg LUMEFANTRINE (LUMEFANTRINE) LUMEFANTRINE 120 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYSORBATE 80 WATER Product Characteristics Color YELLOW Score 2 pieces Shape ROUND (round and flat tablet with bevelled edges) Size 9mm Flavor Imprint Code N;C;CG Contains Packaging # Item Code Package Description 1 NDC:0078-0568-45 24 TABLET in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022268 04/07/2009 Labeler - Novartis Pharmaceuticals Corporation (002147023) Revised: 09/2017 Novartis Pharmaceuticals Corporation Next Interactions Print this page Add to My Med List More about Coartem (artemether / lumefantrine) Side Effects During Pregnancy Dosage Information Drug Images Drug Interactions Compare Alternatives Support Group Pricing & Coupons En Español 4 Reviews Add your own review/rating Drug class: antimalarial combinations Consumer resources Coartem Coartem (Advanced Reading) Professional resources Coartem (AHFS Monograph) Related treatment guides Malaria> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug 8 years Approval History FDA approved 2009 Manufacturer Novartis Pharmaceuticals Corporation Drug Class Antimalarial combinations Related Drugs antimalarial combinations Malarone , atovaquone / proguanil , pyrimethamine / sulfadoxine , artemether / lumefantrine , Fansidar , Malarone Pediatric Malaria doxycycline , hydroxychloroquine , clindamycin , Plaquenil , Cleocin , Vibramycin , quinine , Malarone , atovaquone , Monodox , quinidine , mefloquine , Qualaquin , Mepron , atovaquone / proguanil , Doryx , Lariam , Vibra-Tabs , primaquine , Doryx MPC , artemether / lumefantrine , pyrimethamine / sulfadoxine , More... Coartem Rating 4 User Reviews 9.8 /10 4 User Reviews 9.8 Rate it! Coartem Images Coartem artemether 20mg / lumefantrine 120mg (N C CG) View larger images} } ignored
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