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can buy [35:<15 kg: One tablet at hour 0 and hour 8 on the first day, then 1 tablet twice daily on day 2 and day 3 (total of 6 tablets per treatment course) 15 to> <25 kg: Two tablets at hour 0 and hour 8 on the first day, then 2 tablets twice daily on day 2 and day 3 (total of 12 tablets per treatment course) 25 to> <35 kg: Three tablets at hour 0 and hour 8 on the first day, then 3 tablets twice daily on day 2 and day 3 (total of 18 tablets per treatment course) 35 kg: Four tablets at hour 0 and hour 8 on the first day, then 4 tablets twice daily on day 2 and day 3 (total of 24 tablets per treatment course) Adolescents> 16 years: Refer to adult dosing. Dosing: Renal Impairment Dosage adjustments are not recommended in mild or moderate impairment. Use caution in severe impairment (has not been studied). Dosing: Hepatic Impairment Dosage adjustments are not recommended in mild or moderate impairment. Use caution in severe impairment (has not been studied). Administration Administer with a full meal for best absorption. For patients unable to swallow tablets: Crush tablet and mix with 5-10 mL of water. Administer to patient. Rinse container with water and administer contents to the patient. The crushed mixture should be followed with food/drink if possible. Repeat dose if vomiting occurs within 2 hours of administration; for persistent vomiting, explore alternative therapy. Dietary Considerations Administer with a full meal for best absorption. Patients should be encouraged to take with a meal as soon as food can be tolerated. Patients who remain averse to food during treatment should be closely monitored as the risk of recrudescence may be great. Storage Store at 25 C (77 F); excursions permitted to 15 C to 30 C (59 F to 86 F). Drug Interactions Amifampridine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination Antimalarial Agents: Artemether may enhance the adverse/toxic effect of Antimalarial Agents. Management: Artemether/Lumefantrine (combination product) should not be used with other antimalarials unless there is no other treatment option. Avoid combination Antimalarial Agents: May enhance the adverse/toxic effect of Lumefantrine. Management: Artemether/Lumefantrine (combination product) should not be used with other antimalarials unless there is no other treatment option. Avoid combination Antipsychotic Agents (Phenothiazines): Antimalarial Agents may increase the serum concentration of Antipsychotic Agents (Phenothiazines). Monitor therapy Artemether: May enhance the adverse/toxic effect of Antimalarial Agents. Management: Artemether/Lumefantrine (combination product) should not be used with other antimalarials unless there is no other treatment option. Avoid combination Bilastine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Monitor therapy Bosentan: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy Buprenorphine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Monitor therapy CYP2D6 Substrates (High risk with Inhibitors): Lumefantrine may increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Monitor therapy CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy CYP3A4 Inducers (Strong): May decrease serum concentrations of the active metabolite(s) of Artemether. Specifically, dihydroartemisinin concentrations may be reduced. CYP3A4 Inducers (Strong) may decrease the serum concentration of Artemether. Avoid combination CYP3A4 Inducers (Strong): May decrease the serum concentration of Lumefantrine. Avoid combination CYP3A4 Inhibitors (Strong): May increase the serum concentration of Lumefantrine. Monitor therapy Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Consider therapy modification Dapsone (Systemic): Antimalarial Agents may enhance the adverse/toxic effect of Dapsone (Systemic). Specifically, concomitant use of antimalarial agents with dapsone may increase the risk of hemolytic reactions. Dapsone (Systemic) may enhance the adverse/toxic effect of Antimalarial Agents. Specifically, concomitant use of dapsone with antimalarial agents may increase the risk for hemolytic reactions. Management: Closely monitor patients for signs/symptoms of hemolytic reactions with concomitant use of dapsone and antimalarial agents, particularly in patients deficient in glucose-6-phosphate dehydrogenase (G6PD), methemoglobin reductase, or with hemoglobin M. Consider therapy modification Dapsone (Topical): Antimalarial Agents may enhance the adverse/toxic effect of Dapsone (Topical). Specifically, the risk of hemolytic reactions may be increased. Management: Closely monitor for signs/symptoms of hemolytic reactions with concomitant use of topical dapsone and antimalarial agents. Patients with glucose-6-phosphate dehydrogenase deficiency may be at particularly high risk for adverse hematologic effects. Consider therapy modification Deferasirox: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy Estrogen Derivatives (Contraceptive): Artemether may decrease the serum concentration of Estrogen Derivatives (Contraceptive). Management: Consider the use of an alternative (i.e., non-hormonal) means of contraception in all women of childbearing potential who are using artemether. Consider therapy modification Etravirine: May decrease serum concentrations of the active metabolite(s) of Artemether. Specifically, concentrations of dihydroartemisinin may be decreased. Artemether may increase the serum concentration of Etravirine. Etravirine may increase the serum concentration of Artemether. Monitor therapy Grapefruit Juice: May increase the serum concentration of Artemether. Monitor therapy Halofantrine: Lumefantrine may enhance the QTc-prolonging effect of Halofantrine. Management: Halofantrine and lumefantrine (as artemether-lumefantrine combination) should not be used within 1 month of each other. Avoid combination HYDROcodone: CYP3A4 Inducers (Weak) may decrease the serum concentration of HYDROcodone. Monitor therapy Hydroxychloroquine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination Indapamide: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Consider therapy modification Lumefantrine: Antimalarial Agents may enhance the adverse/toxic effect of Lumefantrine. Management: Artemether/Lumefantrine (combination product) should not be used with other antimalarials unless there is no other treatment option. Avoid combination MiFEPRIStone: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination Mizolastine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination Nevirapine: May decrease the serum concentration of Artemether. Nevirapine may also increase or decrease serum concentrations of lumefantrine. Monitor therapy NiMODipine: CYP3A4 Inducers (Weak) may decrease the serum concentration of NiMODipine. Monitor therapy Pitolisant: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Combined use of pitolisant with a CYP3A4 substrate that has a narrow therapeutic index should be avoided. Other CYP3A4 substrates should be monitored more closely when used with pitolisant. Consider therapy modification Probucol: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination Progestins (Contraceptive): Artemether may decrease the serum concentration of Progestins (Contraceptive). Management: Consider the use of an alternative (i.e., non-hormonal) means of contraception in all women of childbearing potential who are using artemether. Consider therapy modification Promazine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination QTc-Prolonging Agents (Highest Risk): May enhance the QTc-prolonging effect of other QTc-Prolonging Agents (Highest Risk). Avoid combination QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying): May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Management: Avoid such combinations when possible. Use should be accompanied by close monitoring for evidence of QT prolongation or other alterations of cardiac rhythm. Consider therapy modification QTc-Prolonging Agents (Moderate Risk): May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination Sarilumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy Siltuximab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy St John's Wort: May decrease serum concentrations of the active metabolite(s) of Artemether. Specifically, dihydroartemisinin concentrations may be reduced. St John's Wort may decrease the serum concentration of Artemether. Avoid combination St John's Wort: May decrease the serum concentration of Lumefantrine. Avoid combination Teneligliptin: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Monitor therapy Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy Vinflunine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination Xipamide: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Monitor therapy Adverse Reactions >10%: Cardiovascular: Palpitation (adults: 18%) Central nervous system: Headache (adults 56%; children 13%), dizziness (adults 39%; children 4%), fever (25% to 29%), chills (adults 23%; children 5%), sleep disorder (adults: 22%), fatigue (adults 17%; children 3%) Gastrointestinal: Anorexia (adults 40%; children 13%), nausea (adults 26%; children 5%), vomiting (17% to 18%), abdominal pain (8% to 17%) Infection: Plasmodium falciparum (exacerbation: children: 17%) Neuromuscular & skeletal: Weakness (adults 38%; children 5%), arthralgia (adults 34%; children 3%), myalgia (adults 32%; children 3%) Respiratory: Cough (adults 6%; children 23%) Miscellaneous: Fever (25% to 29%) 3% to 10%: Central nervous system: Insomnia (adults: 5%), malaise (adults: 3%), vertigo (adults: 3%) Dermatologic: Pruritus (adults: 4%), skin rash (3%) Gastrointestinal: Diarrhea (7% to 8%) Hematologic & oncologic: Anemia (4% to 9%) Hepatic: Hepatomegaly (6% to 9%), increased serum AST ( 4%) Infection: Malaria ( 3%) Respiratory: Rhinitis (4%), nasopharyngitis ( 3%) <3% (Limited to important or life-threatening): Abnormal gait, abnormal lymphocytes, abscess, agitation, asthma, ataxia, back pain, bullous dermatitis, conjunctivitis, decreased hematocirt, decreased platelet count, decreased white blood cell count, dysphagia, emotional lability, eosinophilia, fine motor control disorder, hematuria, hyper-reflexia, hypoesthesia, hypokalemia, impetigo, leukocytosis, nystagmus, oral herpes, otic infection, peptic ulcer, pneumonia, proteinuria, tinnitus, tremor, upper respiratory tract infection, urinary tract infection, urticaria Warnings/Precautions Concerns related to adverse effects: QT prolongation: Use associated with prolonging the QT interval; avoid use in patients at risk for QT prolongation, including patients with a history of long QT syndrome, family history of congenital QT prolongation or sudden death, symptomatic arrhythmias, clinically relevant bradycardia, severe heart disease, known hypokalemia, hypomagnesemia or concurrent administration of antiarrhythmics (eg, Class Ia or III), drugs metabolized by CYP2D6 known to have cardiac effects (eg, flecainide, tricyclic antidepressants), or other drugs known to prolong the QT interval (eg, antipsychotics, antidepressants, macrolides, fluoroquinolones, triazole antifungals, or cisapride). Disease-related concerns: Hepatic impairment: Use caution in patients with severe hepatic impairment; has not been adequately studied. Renal impairment: Use caution in patients with severe renal impairment; has not been adequately studied. Concurrent drug therapy issues: Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Drugs that prolong the QT interval: Avoid use in patients receiving other agents that prolong the QT interval; consider alternative therapy. ECG monitoring is advised if concomitant use of agents that prolong the QT interval is medically required. In addition, do not use halofantrine (not available in the U.S.) and artemether/lumefantrine within one month of one another due to the potential additive effects on the QT interval. After discontinuation of artemether/lumefantrine, drugs that prolong the QT interval, including quinidine and quinine, should be used with caution. Duplicate therapy: Antimalarials should not be given concomitantly unless there is no other treatment option. Other warnings/precautions: Appropriate use: Not indicated for the treatment of severe or complicated malaria or for the prevention of malaria. Recrudescence: In the event of disease reappearance after a quiescent period, patients should be treated with a different antimalarial drug. Monitoring Parameters Monitor patients for adequate food consumption (to ensure absorption and efficacy); ECG monitoring is advised if concomitant use of other agents that prolong the QT interval is medically required Pregnancy Risk Factor C Pregnancy Considerations Adverse events were observed in some animal reproduction studies. Safety data from an observational pregnancy study included 500 pregnant women exposed to artemether/lumefantrine and did not show an increased in adverse outcomes or teratogenic effects over background rate. Approximately one-third of these patients were in the third trimester. Efficacy has not been established in pregnant patients. Treatment failures with standard doses have been reported in pregnant women in areas where drug resistant parasites are prevalent. This may be attributed to lower serum concentration of both artemether and lumefantrine in this population (McGready 2008). Malaria infection in pregnant women may be more severe than in nonpregnant women. Because P. falciparum malaria can cause maternal death and fetal loss, pregnant women traveling to malaria-endemic areas must use personal protection against mosquito bites. Artemether and lumefantrine may be used as an alternative treatment of malaria in pregnant women but use in the first trimester is generally avoided; consult current CDC guidelines. Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience headache, chills, nausea, vomiting, cough, abdominal pain, lack of appetite, muscle pain, joint pain, diarrhea, or insomnia. Have patient report immediately to prescriber tachycardia, abnormal heartbeat, severe dizziness, passing out, severe loss of strength and energy, or difficulty swallowing (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients. Next Interactions Print this page Add to My Med List More about artemether/lumefantrine Side Effects During Pregnancy Dosage Information Drug Interactions Compare Alternatives Support Group En Español 4 Reviews Add your own review/rating Drug class: antimalarial combinations Consumer resources Artemether and lumefantrine Artemether and lumefantrine (Advanced Reading) Professional resources Artemether and Lumefantrine (AHFS Monograph) Other brands: Coartem Related treatment guides Malaria> ]} Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Artemether / lumefantrine Rating 4 User Reviews 9.0 /10 4 User Reviews 9.0 Rate it! 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...} } organization


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