4. Cause of Nausea & Vomiting
Radiotherapy & Chemotherapy
During Pregnancy (Hyperemesis Gravidarum)
Surgery
During Journey
Severe Diarrhea (Acute Gastroenteritis)
After Accident

5. 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)

6. 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 )

7. 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.

8. 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

9. 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.

10. Dosage And Administration

11. 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

12. 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

13. 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

14. Pregnancy category B.

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

16. Target Doctors
 Oncology
 Surgery practitioners
 Hospital practitioners
 General practitioners
 Gyane practitioners
 PC doctors
 Child specialist

17. 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

18. 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

19. 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

27. 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)

28. PERISET
(Ondansetron Hydrochloride USP)
Presented by
Mohammed Moshiur Rahaman
Brand Executive
Brand Management Department
The ACME Laboratories Ltd.