Powder for Oral Suspension
Artmether and Lumefantrine for Oral Suspension
Each 60 ml Suspension after reconstitution contains:
Artemether 180 mg.
Lumefantrine 1080 mg.
Artemether is the most active derivative of the Artemisinines, a new class of antimalarial drugs derived from Artemisinin. The latter compound is extracted from the plant Artemisia Annua and Artemether is prepared semi -synthetically. Lumefantrine is a synthetic aryl amino alcohol similar to mefloquine and halo-fantrine.
WINART 180/1080 SUSPENSION is indicated for the treatment of malaria in children, caused by Plasmodium including malaria caused by multiple drug resistant strains of P. Falciparum.
PHARMACEUTICAL PRECAUTIONS AND CONTRAINDICATIONS
WINART 180/1080 SUSPENSION is contraindicated in individuals hypersensitive to Artemether and Lumefantrine. Therefore, there are no strict contra-indications for the use of Artemether in children. Nevertheless, no correlation has been found between QTC interval prolongation and plasma concentrations of lumefantrine caution is advised to patients who are taking drugs that are known to prolong the QT interval, such as certain antibiotics (macrolides, fluoroquinolones, imidazole) or who are predisposed to cardiac arrhythmias. It is advisable not to use drugs during pregnancy but in view of the risk of malaria during pregnancy for mother and foetus, the responsible physician may consider it essential, as in the case of cerebral acting schizontocides and rapid clearance of parasites is essential. Since WINART 180/1080 SUSPENSION has been designed for its use in children it is unlikely that this problem arises. WINART 180/1080 SUSPENSION should not be taken during breast-feeding. Due to the long elimination half-life of lumefantrine, it is recommended that breast-feeding should not start until at least one week after stopping an Artemether/Lumefantrine combination treatment.
Specific negative drug interactions were not seen. Artemether potentialises the antimalarial activity of other antimalarials. As grapefruit juice retards the metabolism of some antimalarials, it would be better not to drink grapefruit juice while taking WINART 180/1080 SUSPENSION.
With Artemether virtually no side effects have been seen. Laboratory abnormalities such as slight rise in transaminases and a decrease in reticulocyte count are rare and transient abdominal pain, tinnitus and diarrhea have been described but a casual relationship is unclear. Some anti-malarials as halofantrine and quinine can influence the ECG pattern. Attention should be made to patients previously treated with those antimalarials. A reasonable period should be taken in account before to start a treatment with lumefantrine combinations. For those patients physicians will be prescribed Artemisinin derivatives in mono therapy in cause of severe paludism. Sometimes it could be possible that the following common side effect occur; rash, check this with your doctor. Other common side effects may occur as trouble of sleeping, nausea, vomiting, diarrhea, coughing. They need medical attention when persisting.
RESISTANCE AND RECRUDESCENCE
Resistance of Plasmodia to artemther has not been observed. It is also unlikely to occur in view of the specific mechanism of action which is very cytotoxic for Plasmodia (opening of a peroxide bridge). An apparent resistance is sometimes seen but is mainly due to multiple broods of plasmodia developing at different times in the same patient. In controlled studies recrudescence does not exceed 10%. In case of recrudescence (renal or apparent) a new complete treatment for three days is advisable.
DOSAGE AND ADMINISTRATION
WINART 180/1 080 SUSPENSION
|Body Weight||Number of Milliliters|
|1st Day||2nd Day||3rd Day|
SYMPTOMS AND TREATMENT OF OVER DOSAGE
There is no information on overdoses of WINART 180/1080 SUSPENSION higher than the doses recommended for treatment. In case of suspected overdosage, symptomatic and supportive therapy, which would include ECG and blood electrolyte monitoring, should be given as appropriate.
WINART 180/1080 SUSPENSION bottles should be stored below 25°C. In a closed bottle WINART 180/1080 SUSPENSION powders are stable. Once the Suspension has been made up, it is stable for a minimum of 14 days. Longer conservation is not recommended.
DIRECTION FOR CONSTITUTION
Shake the bottle well to loosen the powder. Add boiled and cooled water to constitute the powder up to the mark shown on the bottle, shake the bottle well to mix the medicine properly. Constituted suspension should be stored in a cool and dry place.
LIST OF EXCIPIENTS
Known to be safety concern for some patients:
Sweetner agent: Pharma grade Sugar BP
Each show box contains 1 bottle.
NAFDAC Reg. No.: B4-1285
SWISS PHARMA PVT. LTD.
3709, G.I.D.C., Phase IV, Vatva,
Ahmedabad – 382445, India.
Transglobe Pharmaceuticals Co. Ltd.,
No. 6A Okoh Street, Off Port Harcourt Road,