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Artemether 80mg + Lumefantrine 480mg is indicated for the treatment of uncomplicated cases of malaria due to Plasmodium falciparum in adults and children of 35 kg and above.
The most recent official guidelines on the appropriate use of antimalarial agents and local information on the prevalence of resistance to antimalarial drugs must be taken into consideration for deciding on the appropriateness of therapy with Artemether 80mg + Lumefantrine 480mg.
Oral use
Treatment should be administered at the time of initial diagnosis or at the onset of symptoms. It is preferable that the patient has a positive diagnostic test before administration.
One tablet should be taken twice a day for three days (total six doses).The first dose should be followed by a second dose after 8 hours. The following two days the doses of Artemether 80mg + Lumefantrine 480mg should be given twice daily, morning and evening (i.e. 12 hours apart).
To increase absorption, Artemether 80mg + Lumefantrine 480mg should be taken with food or a milky drink. If a patient is unable to tolerate food, Artemether 80mg + Lumefantrine 480mgshould still be administered, but the systemic exposure may be reduced.
Patients who vomit within 1 hour of taking the medication should repeat the dose.
If a dose is missed, it should be taken as soon as realized and then the recommended regimen continued until the full course of treatment has been completed.
Renal or hepatic impairment
No dose adjustments are necessary in patients with renal or hepatic impairment. However, caution is advised when administering Artemether 80mg + Lumefantrine 480mg to patients with severe renal or hepatic problems.
Paediatric patients weighing less than 35 kg:
Appropriate dose adjustments cannot be achieved with this product. Other formulations containing lower amounts of artemether/lumefantrine are available for these patients.
Elderly
No special precautions or dosage adjustments are necessary in such patients.
Headache, sleep disorder, insomnia, Dizziness, Palpations, Electrocardiogram QT prolonged, Vomiting, Nausea, abnormal pain, Diarrhoea, Rash, Asthenia, Fatigue, Myalgia, Asthenia.
Artemether 80mg + Lumefantrine 480mg is not recommended during the first trimester of pregnancy in situations where other suitable and effective antimalarials are available.
Artemether 80mg + Lumefantrine 480mg has not been evaluated for the treatment of severe malaria, including cases of cerebral malaria or other severe manifestations such as pulmonary oedema or renal failure. Due to limited data on safety and efficacy, Artemether 80mg + Lumefantrine 480mg should not be given concurrently with any other antimalarial agent unless there is no other treatment option.
The long elimination half-life of lumefantrine must be taken into account when administering quinine in patients previously treated with Artemether 80mg + Lumefantrine 480mg.
If quinine is given after Artemether 80mg + Lumefantrine 480mg, close monitoring of the ECG is advised. If Artemether 80mg + Lumefantrine 480mg is given after mefloquine, close monitoring of food intake is advised.
In patients previously treated with halofantrine, Artemether 80mg + Lumefantrine 480mg should not be administered earlier than one month after the last halofantrine dose.
Artemether 80mg + Lumefantrine 480mg should be used cautiously in patients on anti-retroviral drugs (ARTs) since decreased artemether, DHA, and/or lumefantrine concentrations may result in a decrease of antimalarial efficacy of Artemether 80mg + Lumefantrine 480mg.
Like other antimalarials (e.g. halofantrine, quinine and quinidine) Artemether 80mg + Lumefantrine 480mg has the potential to cause QT prolongation.
Drugs that have a mixed inhibitory/induction effect on CYP3A4, especially anti-retroviral drugs such as HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors should be used with caution in patients taking Artemether 80mg + Lumefantrine 480mg.
Caution is recommended when combining Artemether 80mg + Lumefantrine 480mg with hormonal contraceptives.
Renal and Hepatic impairment: No dose adjustment for the use of Artemether 80mg + Lumefantrine 480mg in patients with renal or hepatic impairment is recommended. Caution is advised when administering Artemether 80mg + Lumefantrine 480mg to patients with severe renal or hepatic impairment. In these patients, ECG and blood potassium monitoring is advised.
Store below 30°C. Protect from light.
Keep out of reach of children.
1 x 6 Alu/Alu blister pack
Artemether & Lumefantrine Tablets 80mg/480mg – Artefantrine-Forte is available in an Alu/Alu blister of 6 tablets. Such 01 blister in a unit carton with package insert.
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