| |
| Lonart Suppository / Lonart Forte Suppository |
| Composition |
| LONART® SUPPOSITORIES |
Each suppository Contains : Artemether 20 mg + Lumefantrine 120 mg., Excipients q.s. |
| LONART FORTE® SUPPOSITORIES |
Each suppository Contains : Artemether 40 mg + Lumefantrine 240 mg., Excipients q.s. |
|
| Properties |
Artemether is the most active derivate 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. |
| Pharmacological Properties |
Pharmacodynamics:
Both components of LONART/LONART FORTE® have their own action site in the malarial parasite. The presence of the endoperioxide bridge in Artemether (generating singlet oxygen and free
radicals : those are very cytotoxic to the plasmodia) appears to be essential for antimalarial activity. Morphological changes of the parasitic membranes induced by Artemether have been
described, being the result of free-radical action.
Lumefantrine interferes more in the polymerization processes.
Other in vitro test suggest that both cause a marked diminution of nucleic acid synthesis. Inhibition of protein synthesis as the basic mechanism of action is suggested in studies which showed
morphological changes in ribosomes as well as in the endoplasmic reticulum.
Although Artemether acts essentially as a blood schizonticide, LONART /LONART FORTE® did clear gametocytes in comparative clinical trials. |
| Indications |
LONART/LONART FORTE® Suppositories is indicated for the treatment of malaria, caused by all forms of Plasmodium including severe malaria caused by multiple drug resistant
strains of P. Falciparum. |
| Pharmaceutical
Precautions and Contra-Indications |
LONART / LONART FORTE® 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 know to
prolong the QTc 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 high risk of malaria during pregnancy for mother and foetus, the responsible physician may consider it essential, as in the case of
cerebral malaria, to treat a pregnant woman. Artemisinin derivatives like Artemether are the fastest acting schizontocides and rapid clearance of parasites is essential. Since LONART/ LONART
FORTE® has been designed for its use in children it is unlikely that this problem arises.
LONART / LONART FORTE® 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. |
| Drug Interactions |
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 LONART / LONART FORTE®. |
| Side Effects |
With Artemether virtually no side effect have been seen. Laboratory abnormalities such as slight rise in transaminases and a decrease in reticulocyte count are rare and
transient. A lowering of sinus frequency without causing ECG changes has been noticed. At high doses transient abdominal pain, tinnitus and diarrhea have been described but a causal
relationship is unclear.
Some antimalarials 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,
diarrhoea, coughing. They need medical attention when persisting. |
| Resistance and Recurdescence |
| Resistance of Plasmodia to artemether 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 |
| LONART® SUPPOSITORIES (For Paediatric use): |
| Weight in Kg |
Total Supp. |
Dosage Regimen |
|
|
Day- 1 |
Day - 2 |
Day 3 |
|
|
0 Hour |
8 Hours |
24 hours |
36 hours |
48 hours |
60 hours |
| Less than 10 |
|
Not recommended |
| 10-14 |
6 |
1 |
1 |
1 |
1 |
1 |
1 |
| 15-24 |
12 |
2 |
2 |
2 |
2 |
2 |
2 |
| 25-34 |
18 |
3 |
3 |
3 |
3 |
3 |
3 |
|
| |
| LONART® FORTE SUPPOSITORIES (For Adult use): |
| Weight In Kg |
Total Supp. |
Dosage Regimen |
|
|
Day-1 |
Day - 2 |
Day - 3 |
|
|
0 Hour |
8 Hours |
24 hours |
36 hours |
48 hours |
60 hours |
| 35 and more (Adults) |
12 |
2 |
2 |
2 |
2 |
2 |
2 |
|
| Breastfeeding |
| Data on excretion in breast milk are not available for humans. |
| Storage Condition |
| Store below 25° C. |
| Dispensing Category |
| Prescription only Medicine. |
| Presentation |
LONART® SUPPOSITORIES : Each carton contains strip of 1 x 6 Supp.
LONART® FORTE SUPPOSITORIES : Each carton contains strips of 2 x 6 Supp. |
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