Lumertam20 mg+120 mg

Lumertam is a fixed-dose antimalarial combination indicated for the treatment ofacute, uncomplicated malaria caused by Plasmodium falciparum, including in geographicregions where chloroquine resistance has been reported. It is an FDA-approved and WHO-recommendedfirst-line artemisinin-based combination therapy (ACT).

• Established/approved use: treatment of acute, uncomplicated P. falciparum malariain adults, infants, and children weighing 5 kg or more.
• Guideline-supported use: also used for uncomplicated mixed-species malaria infectionsthat include P. falciparum, per WHO treatment guidelines.
• Not indicated for: severe or complicated malaria (which requires injectable therapy),and not indicated for malaria chemoprophylaxis (prevention).

Each film-coated tablet of Artemether + Lumefantrine contains a fixed-dose combination of Artemether 20 mgand Lumefantrine 120 mg (a 1:6 ratio). Artemether + Lumefantrine is also available in Bangladesh as an oralsuspension for pediatric use in the same fixed ratio.

Lumertam is a fixed-dose combination antimalarial medicine consisting of artemether, afast-acting artemisinin derivative, and lumefantrine, a longer-acting partner compound. It is used as anartemisinin-based combination therapy (ACT) for treating acute, uncomplicated malaria caused byPlasmodium falciparum. The combination is designed so artemether rapidly reduces the initialparasite burden while lumefantrine, with its longer half-life, clears residual parasites and helpsprevent recrudescence and the development of resistance.

Antimalarial agent - Artemisinin-based Combination Therapy (ACT). Lumertam combines anartemisinin derivative (artemether) with a synthetic aryl-aminoalcohol partner drug (lumefantrine).

Artemether + Lumefantrine acts against the blood (erythrocytic) stage of Plasmodium falciparum.

• Artemether is rapidly converted to its active metabolite, dihydroartemisinin (DHA).The endoperoxide bridge reacts with intraparasitic heme iron released during hemoglobin digestion,generating reactive free radicals that alkylate parasite proteins and damage parasite membranes, producingrapid parasite killing.
• Lumefantrine has a longer elimination half-life and is thought to inhibit formation ofbeta-hematin (a heme detoxification product), causing toxic heme to accumulate within the parasite, andalso inhibits parasite nucleic acid and protein synthesis.

Together, the two components of Artemether + Lumefantrine act synergistically: artemether provides fastinitial parasite clearance while lumefantrine's longer half-life eliminates residual parasites, reducingthe risk of recrudescence.

Lumertam should always be taken with fatty food or whole milk to ensure adequate absorption;efficacy is significantly reduced if taken on an empty stomach. Tablets may be crushed and mixed with asmall amount of water for children unable to swallow them whole. If vomiting occurs within 1 hour of adose, repeat the full dose. Complete the entire 3-day course of Lumertam exactly as prescribed,even if symptoms resolve early.

The following interactions with Lumertam are clinically significant:

• QT-prolonging drugs (e.g., certain antiarrhythmics, antipsychotics, macrolide andfluoroquinolone antibiotics, and halofantrine): concurrent use with Lumertam increases therisk of serious ventricular arrhythmia and should be avoided; halofantrine should not be given within onemonth of Lumertam.
• Strong CYP3A4 inducers (rifampicin, carbamazepine, phenytoin, St. John's Wort):substantially reduce blood levels of both components of Lumertam, risking treatment failure;concurrent use is contraindicated.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): increase lumefantrineexposure and QT-prolongation risk when combined with Lumertam; use only with caution andmonitoring.
• CYP2D6 substrates (e.g., flecainide, tricyclic antidepressants): lumefantrine inhibitsCYP2D6 and may raise levels of these drugs when co-administered with Lumertam.
• Mefloquine: may reduce lumefantrine absorption when given close to Lumertam.
• Hormonal contraceptives: efficacy may be reduced; additional contraceptive precautionsare advised during and after treatment with Lumertam.
• Grapefruit juice: may increase lumefantrine levels; avoid during treatment withLumertam.

Side effects of Lumertam are usually mild to moderate and self-limiting.

Common

• Headache, dizziness, sleep disturbances
• Loss of appetite, nausea, vomiting, abdominal pain, diarrhea
• Joint pain (arthralgia), muscle pain (myalgia), weakness (asthenia)
• Palpitations
• In children: fever, cough

Less common / serious

• QT interval prolongation and, rarely, serious cardiac arrhythmia
• Enlarged liver or spleen
• Allergic reactions including rash, angioedema, and rarely anaphylaxis
• Delayed hemolytic anemia, reported particularly when used after injectable artesunate for severemalaria

Seek prompt medical attention for signs of an allergic reaction, irregular heartbeat, fainting, orunusual bleeding or pallor while taking Lumertam.

Pregnancy: Lumertam should be used in pregnancy only if clearly needed andif the potential benefit justifies the potential risk to the fetus, particularly during the firsttrimester, when alternative treatments should be considered first if available. Untreated malaria inpregnancy carries serious risks to both mother and fetus, so a physician must weigh these risksindividually. Available human data have not established a clear association between Lumertamand major birth defects or miscarriage, but animal studies have shown embryo-fetal toxicity at higherdoses. Always consult a physician before use in pregnancy.

Lactation: It is not established with certainty whether artemether or lumefantrine passinto human breast milk, although this is likely based on animal data. Breastfeeding mothers should useLumertam only under medical supervision, weighing the benefits of breastfeeding and treatingthe mother's malaria against any potential risk to the infant.

Lumertam should be used with caution in the following situations:

• Cardiac conduction abnormalities: Lumertam can prolong the QT interval;use with caution in patients with structural heart disease, uncontrolled arrhythmias, bradycardia, orelectrolyte disturbances (hypokalemia, hypomagnesemia). Correct electrolyte abnormalities before startingtreatment.
• Must be taken with fatty food or milk: absorption of lumefantrine is markedly reducedwithout dietary fat; see Administration.
• Severe hepatic impairment: use with caution, as metabolism of both components may beaffected.
• First trimester of pregnancy: see Pregnancy and Lactation.
• Complete the full course: take exactly as prescribed by your physician; do not stop,extend, skip doses, or share this medicine with others without medical advice, as incomplete treatmentincreases the risk of recrudescence and antimalarial drug resistance.
• Lumertam is not indicated for severe or complicated malaria, or for malariaprophylaxis.
• May cause dizziness or fatigue; use caution when driving or operating machinery.

There is limited information on overdose with Lumertam. An overdose may increase the riskof QT prolongation, cardiac arrhythmia, and gastrointestinal or neurological symptoms. If an overdose ofLumertam is suspected, seek immediate medical attention or contact a poison control center oremergency services. Treatment is supportive, with monitoring of cardiac rhythm (ECG) and electrolytes in amedical facility; there is no specific antidote.

Store Lumertam at room temperature (below 30°C), away from light and moisture. Keep out ofreach of children.

Children: Lumertam is approved for use in infants and children from 2months of age and weighing at least 5 kg, dosed according to body weight (see Dosage). Safety and efficacyin infants under 2 months of age or weighing less than 5 kg have not been established.

Elderly: Limited specific data are available; use with the same weight-based dosing andmonitor for cardiac and hepatic issues that are more common in older adults.

Hepatic impairment: Use with caution in severe hepatic impairment; monitor clinically.

Renal impairment: No dose adjustment is generally required in mild-to-moderate renalimpairment; limited data exist in severe renal impairment, so Lumertam should be used withcaution and clinical monitoring in these patients.

The standard course of Lumertam is 3 days, comprising 6 doses given at 0, 8, 24, 36, 48, and60 hours. The full course must be completed even if symptoms improve after the first few doses.

Antimalarial; Artemisinin-based Combination Therapy (ACT); artemisinin derivative (artemether) combined with an aryl-aminoalcohol partner drug (lumefantrine) - together forming Artemether + Lumefantrine.

Artemether + Lumefantrine combines two antimalarials with complementary mechanisms. Artemether is convertedto dihydroartemisinin, which generates free radicals via cleavage of its endoperoxide bridge on contactwith intraparasitic heme, damaging parasite proteins and membranes and producing rapid, broad-stageparasite killing. Lumefantrine, with a longer half-life, appears to inhibit formation of beta-hematin fromheme, causing toxic heme to accumulate within the parasite, clearing residual parasitemia after theartemether component has acted and reducing the chance of recrudescence.

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Lumertam is approved for use in infants and children from 2 months of age and weighing 5 kgor more, using weight-based dosing (see Dosage). Safety and efficacy have not been established in infantsyounger than 2 months or weighing less than 5 kg. Tablets may be crushed and mixed with water for childrenwho cannot swallow them whole, and the medicine should be given with food or milk to ensure adequateabsorption.