artemether/lumefantrine (Rx)

Brand and Other Names:Coartem
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

artemether/lumefantrine

tablet

  • 20mg/120mg
more...

Malaria

35 kg or greater: Administer 24 tablets over 3 days; use a 3-day treatment schedule with total of 6 doses

Day 1: 4 tablets initially and 4 tablets again after 8 hours

Days 2 & 3: 4 tablets BID (morning & evening)

Administration

Take with food

If patient vomits out dose within 1-2 hours, give another dose

Dosage Forms & Strengths

artemether/lumefantrine

tablet

  • 20mg/120mg
more...

Malaria

5 to <15 kg: Administer 6 tablets over 3 days; 1 tablet initially and again after 8 hours on first day; follow by 1 tablet BID (morning & evening) for the next 2 days

15 to <25 kg: Administer 12 tablets over 3 days; 2 tablets initially and again after 8 hours on first day; follow by 2 tablets BID (morning & evening) for the next 2 days

25 to <35 kg: Administer 18 tablets over 3 days; 3 tablets initially and again after 8 hr on 1st day; follow by 3 tablets BID (morning & evening) for the next 2 days

35 kg or greater: As in adults; administer 24 tablets over 3 days; 4 tablets initially and again after 8 hr on 1st day; follow by 4 tablets BID (morning & evening) for the next 2 days

Administration

Take with food

May crush tablets & mix with small amount of water; follow dose with food or drink

If patient vomits out dose within 1-2 hours, give another dose

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Interactions

Interaction Checker

and artemether/lumefantrine

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    Contraindicated

      Serious - Use Alternative

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            Adverse Effects

            >10%

            Abdominal pain (17%)

            Anorexia (40%)

            Arthralgia (34%)

            Asthenia (38%)

            Chills (23%)

            Dizziness (39%)

            Fatigue (17%)

            Headache (56%)

            Myalgia (32%)

            Nausea (26%)

            Palpitations (18%)

            Pyrexia (25%)

            Sleep disorder (22%)

            Vomiting (17%)

            1-10%

            Anemia (4%)

            Cough (6%)

            Diarrhea (7%)

            Hepatomegaly (9%)

            Malaise (3%)

            Nasopharyngitis (3%)

            Pruritus (4%)

            Rash (3%)

            Splenomegaly (9%)

            Vertigo (3%)

            Postmarketing Reports

            Anaphylaxis

            Urticaria

            Angioedema

            Skin reactions (bullous eruption)

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            Warnings

            Contraindications

            Hypersensitivity

            Coadministration with strong CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin, St. John’s wort) can result in decreased artemether and/or lumefantrine serum concentrations and loss of antimalarial efficacy

            Cautions

            Not approved for severe/complicated P. falciparum infections

            Not approved for prevention

            Concurrent CYP3A4 or CYP2D6 inhibitors / inducers

            May render hormonal contraceptives ineffective

            If patient vomits out drug repeatedly, use alternative treatment

            Avoid with conditions that prolong QT

            • Long QT syndrome, history of symptomatic cardiac disease, clinically relevant bradycardia, or severe cardiac disease
            • Family history of congenital QT prolongation or sudden death
            • Electrolyte imbalance (eg, hypokalemia, hypomagnesemia)
            • Coadministration with other drugs that prolong QT interval (eg, class IA antiarrhythmics [quinidine, procainamide, disopyramide], or class III antiarrhythmics [amiodarone, sotalol] antiarrhythmic agents, antipsychotics [pimozide, ziprasidone], antidepressants; certain antibiotics [macrolide, fluoroquinolones], antiretrovirals [eg, ritonavir], cisapride
            • CYP3A4 and CYP2D6 inhibitors may increase serum levels by inhibiting metabolism, and therefore risk for QT prolongation
            • QT prolongation with other antimalarials; duplicate antimalarials should not be given concomitantly, unless there is no other treatment option, due to limited safety data
            • Not for concomitant administration with halofantrine within one month of each other due to potential additive effects on QT interval
            • Cautiously use quinine and quinidine for malaria following Coartem due to long half-life of Coartem and potential additive QT prolongation
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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: not known if either component enters breast milk, use caution

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Protein Bound: artemether: 95.4% & lumefantrine: 99.7%

            Peak Plasma Time: artemether 2 hr; lumefantrine 6-8 hr

            Half-Life, Elimination: artemether 2 hr; lumefantrine 3-6 d

            Metabolism: by CYP3A4

            Metabolites: artemether: dihydroartemisinin (DHA) (active); lumefantrine: desbutyl-lumefantrine

            Enzymes Inhibited: lumefantrine: CYP2D6

            Enzymes Induced: artemether: CYP3A4

            Excretion: urine (animal studies)

            Mechanism of Action

            Artemether and active metabolite (DHA): via endoperoxide

            Lumefantrine: unknown; possibly inhibits beta-hematin formation

            Both artemether and lumentantrine inhibit nucleic acid and protein synthesis

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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