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August, 2010
25th Annual Report 2009-10 |
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May 31, 2010
Audited Financial Result For March 2010 Qtr |
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January 27, 2010
Unaudited Financial Result For December 2009 Qtr |
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| Click here to know more about your health and health care info... |
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| P-Alaxin Oral Suspension |
| Composition |
| Each 80 ml suspension after reconstitution contains |
| Dihydroartemisinin |
80 mg |
| Piperaquine Phosphate |
640 mg |
| Excipients : |
q.s. |
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| Pharmacology
& Pharmacokinetics |
Mode of action of Dihydroartemisinin :
Dihydroartemisinin 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 cytoplasmic vacuolization and autophagocytosis. ln addition, biochemical depression of protein synthesis and nucleic acid synthesis are exhibited. Upon oral administration Dihydroartemisin 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, deoxydihydroartemisinin and dihydroxydihydroartemisinin.
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| 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. |
| Indications |
Treatment of clinical attacks of Malaria caused by P. falciparum, P. Vivax
and P. malariae |
| Contraindications |
| The product is not recommended for use in women during the first 3
months of pregnancy. |
| Storage |
| Preserve in well closed, light resistant containers below 30° C |
| Packaging |
| 80 ml bottle. |
| Administration
and Dosage |
| Age (Years) |
Adolescent between 7 to 10 years |
Children between 1 to 7 years |
Children less than 1 year |
| Initial |
40 ml. |
20 ml. |
10 ml. |
| 6th Hr. |
40 ml. |
20 ml. |
10 ml. |
| 24th Hr. |
40 ml. |
20 ml. |
10 ml. |
| 32nd Hr. |
40 ml. |
20 ml. |
10 ml. |
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| Adverse Reactions |
- Nausea or vomiting may occur occasionally with incidence of less
than 6%
- No noticeable side effect of Dihydroartemisinin is reported. The
Dihydroartemisinin would, for certain individuals, bring effects of
greater or lesser severity : for example, a reversible reduction in
reticulocyte counts.
- Possible side-effect of PQP include mild dizziness, vertigo,
headache, nausea, vomiting and abdominal discomfort. Reversible
leucopenia was infrequently reported; dyspnea and palpitations were
also reported but not further specified.
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| Precautions |
- Do not exceed the stated dosage.
- Lactation : excretion of P-ALAXIN ORAL SUSPENSION through
breast milk has not been established.
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| Shelf Life |
| 2 Years |
| Dispensing Category |
| Prescription only Medicine. |
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