1, African Church close, off Coker Road, Ilupeju, Lagos, Nigeria
Tel: 01-773-1473, 01-8179648, 08033160649
MEDIWIN PHARMACEUTICALS 128/A, Phase I & ll, G.I.D.C., Naroda, Ahmedabad - 382330, India.
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Tablet (NRN: 04-9650): Each Tablet contains: Dilydroartemisinin 40 mg, Piperaquine Phosphate 320 mg, Excipients q.s.
Pack Size: 8 Tablets per blister pack
Mode of action of Dilydroartemisinin:
Dilydroartemisinin mainly interferes with the membrane structures of trophozoites (erythrocytic asexual forms). i.e. whorled food vacuole membrane, distended mitochondria, swollen nuclear membranes, dissociation of ribosomes from endoplasmic reticulum leading to cytoplasma vacuolization and autophagocytosis. In addition, biochemical depression of protein synthesis and nucleic acid synthesis are exhibited.
Upon oral administration Dihydroartemisinin is rapidly absorbed and maximum blood concentration attained 1 hour afterwards, with a half-life of about 4 hours. It is widely distributed in the liver, kidneys and bile. Approximately 80% is excreted through the urine and feces within 24 hrs after administration. It is metabolized to two inactive metabolites, dexydilhydroartemisinin and dilydroxdilhydroartemisinin.
Mode of action of Piperaquine Phosphate:
Experimental results show that PQP interferes with physiological function of the food vacuole membrane of the trophozoites leading to autophagocytosis of the parasites. It has no marked effect on the ring forms, immature or mature schizonts and the male of female gametocytes.
Upon oral administration about 80-90 % is absorbed within 24 hrs. It is widely distributed in the body mainly in the liver, kidneys, lungs and spleen. About 25% of the total dose is partitioned in the liver within 8 hrs of intake. Elimination is very slow with the half-life of about 9.4 days. It is excreted through bile by hepatoenteral circulation.
Treatment of clinical attacks of Malaria caused by P. falciparum, P. Vivax and P.malariae
The product is not recommended for use in women during the just 3 months of pregnancy
1. Do not exceed the stated dosage.
2. Lactation: excretion of Ibasunate Tablets through breast milk has not been established.
1. Nausea or vomiting may occur occasionally with incidence of less than 6%.
2. No noticeable side effect of Dilydroartemisinin is reported. The Dilydroartemisinin world, for certain individuals, bring effects of greater or lesser severity: For example, a reversible reduction in reticulocyte counts.
3. Possible side - effect or PQP include mild dizziness, vertigo, headache, nausea, vomiting and abdominal discomfort. Reversible leucopenia was infrequently reported; dyspnea and palpitations were also reported but no further specified
Dosage & Administration
Patient should follow doctor’s instruction. There commended dosages are in the following table.
|Day 1||1 Tablet||1½ Tablet||2 Tablet||3 Tablet|
|Day 2||1 Tablet||1½ Tablet||2 Tablet||3 Tablet|
|Day 3||1 Tablet||1 Tablet||2 Tablet||2 Tablet|
|Total||3 Tablet||4 Tablet||6 Tablet||8 Tablet|
Preserve in light-resistant containers. Store below 30°C