ARTEMETHER+LUMEFANTRINE TABLETS 80MG+480MG COMPOSITION: Each uncoated tablet contains: Artemether 80mg Lumefantrine 480mg Excipient q.s. INDICATIONS: Artemether and Lumefantrine tablet is a fixed dose combination of artemether and lumefantrine, which acts as a blood schizonticide. It is indicated for: Treatment, including stand-by emergency treatment of adults and children with acute, uncomplicated infections due to plasmodium falciparum or mixed infection including P. falciparum. Because Artemether and Lumefantrine tablet is effective against both drug-sensitive and drug-resistant P. falciparum, it is also recommended for malaria infections acquitted in areas where the parasites may be resistant to other antimalarials. Stand-by emergency treatment. Most tourists and business travelers, considered to be non-immune, will be able to obtain prompt medical attention if malaria is suspected. However, a minority at risk of infection may be unable to obtain such care within 24 hours of the onset of symptoms, particularly if they are in an isolated location far from medical services. In such case, physicians are advised to prescribe artemether and lumefantrine tablet to be carried by the traveler for self-administration ("stand-by emergency treatment"). Consideration should be given to official guidance regarding the appropriate use of antimalarial agents. DOSAGE & ADMINISTRATION: Tablets for oral administration. Patient with acute malaria is frequently averse to food. The dose may be taken with fluids. Patients should be encouraged to resume normal eating as soon as food can be tolerated since this improves absorption of artemether and lumefantrine. In the event of vomiting within 1 hour of administration a repeat dose should be taken. DOSAGE IN ELDERLY PATIENTS: Although no studies have been carried out in the elderly, no special precautions or dosage adjustments are considered necessary in such patients. DOSAGE IN PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT: Although no specific studies have been carried out, no special precautions or dosage adjustments are considered necessary for these conditions. ADVERSE EFFECTS, PRECAUTIONS: - May cause: headache, dizziness and gastrointestinal disturbances. - Administer with caution to patients taking drugs that prolong the QT interval: amiodarone, other antimalarials, antipsychotics, fluconazole, fluoroquinolones, hydroxyzine, macrolides, ondansetron, etc. - If the patient vomits within 30 minutes after administration: re-administer the full dose. If the patient vomits between 30 minutes and 1 hour after administration, re-administer half of the dose. CONTRAINDICATIONS: Known hypersensitivity to artemether, lumefantrine, or to any of the excipients of Coartem Tablets. STORAGE AND CONSERVATION: Store in a dry place at a temperature below 25 ºC. PRESENTATION: 1x6tabs per box. SHELF LIFE: 3 Years. KEEP OUT OF THE REACH OF CHILDREN.
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