J Gricin
J-GRICIN
Dihydroartemisinin and Piperaquine Phosphate Capsules
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Composition
Each soft gelatine capsule contains:
Dihydroartemisinin: 40 mg
Piperaquine Phosphate: 320 mg
Excipients: q.s.
Approved colour used in capsule shell.
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PHARMACOLOGY & PHARMACOKINETICS
- 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. In 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 faeces within 24 hrs after administration. It is metabolized to two inactive metabolites, deoxydihydroartemisinin and dihydroxydihydroartemisinin.
- Experimental results show that POP interferes with physiological function of the food vacuole membrane of the trophozoites leading to autophagocytosis of the parasites. Lt has no marked effect on the ring forms, immature or mature schizonts and the male or 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.
Mode of action of Dihydroartemisinin
Mode of action of Piperaquine Phosphate
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INDICATIONS
Treatment of all kinds of malarias, even malaria caused by multi-resistant Plasmodium Falciparum. -
CONTRAINDICATIONS
J-Gricin is not recommended for use in women during the first 3 months of pregnancy. -
ADMINISTRATION
J-Gricin should be administered orally over three consecutive days for a total of three doses taken at the same time each day. -
DOSAGE
As directed by the physician or as per the insert or chart given below. Age (Years) <6 Years old 6 -16 Years old > 16 Years old
Day 1 1 Capsule 2 Capsules 3 Capsules
Day 2 1 Capsule 2 Capsules 3 Capsules
Day 3 1 Capsule 2 Capsules 2 Capsules
Total 3 Capsules 6 Capsules 8 Capsules -
WARNINGS
If a patient vomits within 30 minutes of taking J-Gricin, the whole dose should be re-administered. If a patient vomits within 30-60 minutes, half the dose should be re-administered. Re-dosing with J-Gricin should not be attempted more than once. If the second dose is vomited alternative antimalarial therapy should be instituted.
If a dose is missed, it should be taken as soon as realised and then the recommended regimen continued until the full course of treatment has been completed. No more than two courses of J-Gricin may be given within a 12 month period. A second course of J-Gncin should not be given within 2 months after the first course due to the long elimination half-Iife of piperaquine.
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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 POP 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. -
STORAGE
Store below 25'C in a cool & dry place. Protect from light of moisture. Keep out of reach of children. -
PACKAGING
A composite blister strip of 3 x 3 capsules in a carton. -
NAFDAC Reg. No.
B4-5246