Indications

FALCIDIN is indicated in treatment of almost all forms of malaria caused by Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, Plasmodium malariae, including those strains that are multi– drug resistant.
* Children from 6 months of age up to 3– year– old, pregnant women and nursing mothers: it should be used as directed by the physician.
– Administration:
+ The dosing of the first day should be given twice. Dosage on the second and third day is once a day.
+ The timing of the doses should be at 6, 24 and 48 hours after the first dose.

Present

Blister of 8 caplets. Box of 1 blister.

Composition

Dihydroartemisinin……………………………………………40mg
Piperaquine phosphate.4H2O equivalent to anhydrous piperaquine phosphate……………………..320mg
Excipients s.q. for…………………………………………..1 caplet

Pharmacology

– FALCIDINÒ is an antimalarial combination therapy that consists of dihydroartemisinin and piperaquine phosphate which are formulated together. It is rapid acting, highly effective, low in toxicity, safe and rapid clearance of the parasite. It is indicated in almost all forms of malaria including those caused by Plasmodium strains that are resistant to other antimalarials such as chloroquine, 4– aminoquinoline derivatives, proguanil, pyrimethamine and pyrimethamine – sulfonamide combinations.
– FALCIDINÒ is potent sporozoite inhibitor and sporozoiticide of Plasmodium species and therefore reduces malaria transmission.
* Dihydroartemisinin: it interferes principally with membrane of the trophozoite (asexual erythrocytic form of the plasmodium) such as digestive vacuole membrane swelling and spiral deformation, swelling of the parasite’s outer membrane, the mitochondrial membrane, the nuclear membrane, and detaching of ribosome from endoplasmic reticulum and finally the formation of autophagic vacuoles in cytoplasm and autophagy. Furthermore, it also decreases protein and nucleic acid synthesis of the parasite.
* Piperaquine phosphate: it interferes with the physiological function of the food vacuole of the trophozoitic form of the parasite and lead to its autophagy.

Pharmacokinetics

– Dihydroartemisinin: it is rapidly absorbed with peak plasma concentration reached within 1 hr, the elimination half– time about 4 hrs following an oral administration. It is widely distributed into liver, renal and bile. About 80% is excreted in the urine and in the feces within 24 hrs after oral dose. Dihydroartemisinin is metabolized into two inactive forms (deoxydihydroartemisinin and dihydroxydihydroartemisinin).
– Piperaquine phosphate: following oral administration, about 80 – 90% of piperaquine phosphate is absorbed within 24 hrs. Widely distributed in body, mainly in liver, kidney, lung and spleen. About 25% of oral dose is metabolized in the liver about 8 hrs. It is slowly eliminated, the elimination half– time about 9 days. It is excreted via bile by hepatoenteric pathway.

Contra-Indications

Hypersensitivity to one of the ingredients of the drug.

Side effect

– The most frequent side– effects are mild and transient: nausea, vomiting, diarrhea, loss of appetite, itching, erythema,…
– Inform your doctor about side– effects when using this medicine.

Precaution

– Do not exceed prescribed dosing.
– FALCIDIN are not approved for the prevention of malaria.
PREGNANCY AND LACTATION:
Do not give FALCIDIN during pregnancy (specially, in the first trimester of pregnancy) and lactation, unless clearly needed and have prescribed by the
physician.

Interaction

– Avoid concomitant administration with antioxidant agents such as vitamin E, vitamin C, glutathione, because of possible diminution of antimalarial action.
– Antacids may decrease absorption of the drug.
OVERDOSAGE:
– Data on FALCIDIN overdosage is not available.
– In case of suspected overdose, symptomatic and supportive therapy should be given as appropriate, including ECG monitoring because of the possibility of QTc interval prolongation.

Shelf life

– 36 months from the manufacturing date.
Never use after the expiry date clearly indicated on the outer packaging.

Storage

Store in a cool, dry place. Protect from light.