1. Cause of Nausea & Vomiting Radiotherapy & Chemotherapy During Pregnancy (Hyperemesis Gravidarum) Surgery During Journey Severe Diarrhea (Acute Gastroenteritis) After Accident
2. Existing Product Information Brand Name : PERISET Composition : Ondansetron Hydrochloride USP 8 mg tablet and 4 ml injection (2 mg/ml) Therapeutic group : Anti-emetic Product group : B & G Pack Size : 3 X 10s tablets (8 mg tablet) 1 X 5s ampoules (4 ml injection) Unit Price (proposed) : 10.00 tk (8 mg tablet) 30.00 tk (4 ml injection) 3. NEW Product Information Brand Name : PERISET Composition : Ondansetron Hydrochloride USP Therapeutic group : Anti-emetic Product group : B & G Pack Size : 1 X 1s Phial 50 ml Oral Solution (4 mg/ 5 ml) in PET bottle Unit Price (proposed) : 40.00 tk (50 ml Oral Solution ) 4. Indications The management of nausea and vomiting induced by cytotoxic chemotherapy, for the prevention and treatment of post-operative nausea and vomiting (PONV) for the prevention of nausea and vomiting associated with radiotherapy, either total body irradiation or single high dose fraction to the abdomen. 5. Serotonin release from Small intestine Vomiting center(medulla) Serotonin binds with central 5-HT3 receptor in Chemoreceptor Trigger zone Radio & Chemotherapy Serotonin binds withSerotonin binds with peripheral 5-HT3 receptorperipheral 5-HT3 receptor in GI Tractin GI Tract VOM reflex VOM reflex P E R I S E T X X 6. Mechanism of Action Ondansetron is a selective Serotonin 5-HT3 receptor antagonist. Its effects are thought to be on both peripherial and central Vagus nerves. Peripherharal reduce the activity of the peripheral vagus nerve, which activates the vomiting center in the medulla oblongata. Central The other is a blockage of serotonin receptors in the chemoreceptor tigger zone. 7. Dosage And Administration 8. Age Category Oral Solution Adults/ Geriatric / Child of 12 years or over Highly emetogenic cancer chemotherapy: 30 ml (24 mg) Periset Oral Solution administered 30 minutes before start of emetogenic chemotherapy. Moderate emetogenic cancer chemotherapy: 10 ml (8 mg) Periset Oral Solution administered 30 minutes before start of emetogenic chemotherapy. A further 10 ml (8 mg) dose should be administered after 8 hours of the first dose. One 10 ml (8 mg) dose should be administered twice a day (every 12 hours) for 1-2 days after completion of chemotherapy. Pediatric (4-11 years) 5 ml (4 mg) Periset Oral Solution should be taken 30 minutes before the start of chemotherapy. The other 2 doses should be taken 4 and 8 hours after the first dose. Then 5 ml (4 mg) oral solution should be administered 3 times a day (every 8 hours) for 1-2 days after completion of chemotherapy. Chemotherapy Induced Nausea and Vomiting 9. Age Category Oral Solution Adults/ Geriatric / Child of 12 years or over The recommended oral dosage is 10 ml (8 mg) Periset Oral Solution 3 times daily. For total body irradiation, 10 ml (8 mg) Periset Oral Solution should be administered 1-2 hours before each fraction of radiotherapy administered each day. For single high-dose fraction radiotherapy to the abdomen, one 10 ml (8 mg) Periset Oral Solution should be administered 1-2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1-2 days after completion of radiotherapy. For daily fractionated radiotherapy to the abdomen, 10 ml (8 mg) Periset Oral Solution should be administered 1-2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy Radiotherapy induced nausea and Vomiting 10. Age Category Oral Solution Adults/ Geriatric / Child of 12 years or over 20 ml (16 mg) Periset Oral Solution 1 hour before induction of anesthesia. Postoperative Nausea and Vomiting 11. Pregnancy category B. 12. Use In Children This drug Ondansetron IM/IV injection is recommended for child (from 1 month). 13. Target Doctors Oncology Surgery practitioners Hospital practitioners General practitioners Gyane practitioners PC doctors Child specialist 14. Market Information (Generic) The market size of Ondansetron is 22.38 crore (app.) with Growth 33.08%. Ref: 2nd Q, 2012 Brand Company Sales value(crore) yearly Emistat Healthcare 9.90 Zofra SK+F 3.31 Anset Opsonin 3.24 Onaseron Incepta 2.29 15. Market Information (Oral Solution) The market size of Ondansetron is 4.34 crore (app.). Ref: 2nd Q, 2012 Brand Company Sales value(crore) yearly Zofra SK+F 1.70 Anset Opsonin 1.08 Onaseron Incepta 0.52 16. Highlighting Points PERISET Relives nausea and vomiting effectively & safely in adults and children Ensures effective control of vomiting in acute gastroenteritis Is an effective first-line antiemetic for patients undergoing chemotherapy, radiotherapy and surgery Safe & effective in hyperemesis gravidarum 17. NVP Don-A Periset Nausea and vomiting during pregnancy Prevention and relief of acute nausea & vomiting, nausea associated with migraine Control nausea & vomiting in various condition (Radiotherapy, Chemotherapy, PONV, Acute gateroenterititis, Hyperemesis gravidarum) Stomach mortility Safe for child (IM/IV from 1 month and Tablet, Oral solution from 4 years) 18. PERISET (Ondansetron Hydrochloride USP) Presented by Mohammed Moshiur Rahaman Brand Executive Brand Management Department The ACME Laboratories Ltd.