Cause of Nausea & Vomiting

Radiotherapy & ChemotherapyDuring Pregnancy (Hyperemesis Gravidarum)SurgeryDuring Journey Severe Diarrhea (Acute Gastroenteritis)After Accident

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 10’s tablets (8 mg tablet)

1 X 5’s ampoules (4 ml injection)

Unit Price (proposed) : 10.00 tk (8 mg tablet) 30.00 tk (4 ml injection)

NEW Product Information

Brand Name : PERISET Composition : Ondansetron Hydrochloride USP

Therapeutic group : Anti-emetic Product group : B & G Pack Size : 1 X 1’s Phial 50 ml Oral Solution (4 mg/ 5 ml) in PET

bottle Unit Price (proposed) : 40.00 tk (50 ml Oral Solution

)

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.

Serotonin release from Small intestine

Vomiting center(medulla)

Serotonin binds with central 5-HT3 receptor inChemoreceptor Trigger zone

Radio & Chemotherapy

Serotonin binds with Serotonin binds with peripheral 5-HT3 receptorperipheral 5-HT3 receptor in GI Tract in GI Tract

VOM reflex

VOM reflex

P

E

R

I

S

E

T

X

X

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.

Dosage And Administration

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

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 is given.

Radiotherapy induced nausea and Vomiting

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

Pregnancy category B.

Use In Children

This drug Ondansetron IM/IV injection is recommended for child (from 1 month).

Target Doctors

Oncology Surgery practitioners Hospital practitioners General practitioners Gyane practitioners PC doctors Child specialist

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

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

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

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)

PERISET(Ondansetron Hydrochloride USP)

Presented by

Mohammed Moshiur Rahaman

Brand Executive

Brand Management Department

The ACME Laboratories Ltd.