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Welcome to the Session of
PERISET
(Ondansetron Hydrochloride USP)
Presented by
Mohammed Moshiur Rahaman
Product Executive
Product Management Department
The ACME Laboratories Ltd.
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 :
 Pack Size : 3 X 10’ 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)
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 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
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
Indication Dosage
1) PONV 16 mg or two tablets 1 hour before anesthesia
2)Chemotherapy induce
nausea & vomiting
●Highly chemotherapy 24 mg or three tablets 30 minutes before the
start of single day chemotherapy
● Moderately
chemotherapy
Recommended dose one 8 mg tablet twice a
day During chemotherapy:
The first dose should be administrated 30
minutes before chemotherapy and second dose
8 hours after the first dose
After cmpletation of chemotherapy
8 mg tablet administrated twice a day (every
12 hours) for 1-2 days
Oral tablet
Indication Dosage
● Paediatric use
(4-11 yrs)
Half of 8 mg tablet three times a day (every 8
hours).
• The first dose should be administrated 30
minutes before chemotherapy
• Second dose 8 hours after the first dose
• Third dose 16 hours after the first dose
● Radiotherapy induced
nausea & vomiting
One 8 mg tablet thrice a day (The first dose
should be administrated 30 minutes before
chemotherapy and second dose 8 hours after the
first dose and Third dose 16 hours after the first
dose )
For total body irradiation: one tablet 1 to 2 hours
before each fraction of radiotherapy adm. each day
For single high dose radiotherapy to the
abdomen: one tablet 1 to 2 hours before
radiotherapy with subsequent dose every 8 hours
after the first dose for 1 to 2 days after completion
of radiotherapy
Geriatric Use The same as for the general
Population (Chemotherapy induced nausea
and Vomiting)
Patients with impaired
renal function
The same as for the general
population(Chemotherapy induced nausea
and Vomiting)
Patients with impaired
hepatic function
Total daily dose of 8
mg should not be exceeded
For Injection (IM/IV)
Indication Dosage
Prevention of chemotherapy
induced nausea & vomiting
Adults & Geriatric
Recommended dose is a single 32 mg dose or
three 0.15 mg/kg doses.
A single 32 mg dose is infused over 15 minutes,
beginning 30 minutes before the start of
chemotherapy.
OR
 0.15 mg/kg over 15 minutes, beginning 30
minutes before the start of chemotherapy
 Second dose 4 hours after the first dose
 Third dose 8 hours after the first dose
Peadiatric use (1 month to 18
years)
Three 0.15 mg/kg doses
OR
 0.15 mg/kg over 15 minutes, beginning 30
minutes before the start of chemotherapy
 Second dose 4 hours after the first dose
 Third dose 8 hours after the first dose
Prevention of POVN ►intravenously
4 mg undiluted intravenously in not less than
30 seconds over 2 to 5 minutes, immediately
before anesthesia, or
postoperatively if the patient experience nausea
and/or vomiting occurring shortly after surgery.
►intramuscularly
Alternatively, 4 mg undiluted may be
administered intramuscularly as a single
injection for adults.
Pediatric use (1 month to 12
years)
Single 0.1 mg/kg dose for weighing 40 kg or
less Or,
single 4 mg dose for weighing more than 40 kg.
Administration should not be Not less than 30
seconds, preferably over 2 to 5 minutes.
Geriatric use The same as for the general population.
(Single 32 mg Or Three 0.15mg/Kg)
Patients with impaired renal
function
The same as for the general population.
(Single 32 mg Or Three 0.15mg/Kg)
Patients with impaired
hepatic function
Single maximal daily dose of 8 mg to be infused
over 15 minutes beginning 30 minutes before the
chemotherapy.
Side effects
Most people have no problems when taking Ondansetron. Patients
may rarely experience blurring vision and very rarely suffer from
temporary blindness, which usually resolves within 20 minutes.
Frequently reported side effects were headache, constipation and
diarrhoea, but the majority have been mild or moderate in nature.
USE IN PREGNANCY &
LACTATION
Pregnancy category B.
there are no adequate and well controlled studies in
pregnant women. So, this drug should be used during
pregnancy only if clearly needed. It is not known
whether Ondansetron is excreted in human milk. So,
caution should be exercised when Ondansetron is
administered to nursing women.
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:
The market size of Ondansetron is 16.82 crore (app.) with Growth 78.28%.
Ref: 2nd
Q, 2011
Brand Company Sales value(crore)
yearly
Emistat Healthcare 7.55
Anset Opsonin 2.59
Onaseron Incepta 2.23
Zofra SK+F 2.45
Highlighting Points
PERISET…
◙ Control nausea & vomiting in various condition
◙ Effective & safe for controlling PONV after cardiac
surgery
◙ Ensures effective control of vomiting in acute
gastroenterititis
◙ Prophylactic control of PONV after cardiac surgery
◙ Safe for child (1 month-18 years)
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 from 4 years)
Thank you all

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Periset.ppt

  • 1. Welcome to the Session of PERISET (Ondansetron Hydrochloride USP) Presented by Mohammed Moshiur Rahaman Product Executive Product Management Department The ACME Laboratories Ltd.
  • 2. 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 :  Pack Size : 3 X 10’ 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)
  • 3. 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.
  • 4. 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
  • 5. 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. Indication Dosage 1) PONV 16 mg or two tablets 1 hour before anesthesia 2)Chemotherapy induce nausea & vomiting ●Highly chemotherapy 24 mg or three tablets 30 minutes before the start of single day chemotherapy ● Moderately chemotherapy Recommended dose one 8 mg tablet twice a day During chemotherapy: The first dose should be administrated 30 minutes before chemotherapy and second dose 8 hours after the first dose After cmpletation of chemotherapy 8 mg tablet administrated twice a day (every 12 hours) for 1-2 days Oral tablet
  • 8. Indication Dosage ● Paediatric use (4-11 yrs) Half of 8 mg tablet three times a day (every 8 hours). • The first dose should be administrated 30 minutes before chemotherapy • Second dose 8 hours after the first dose • Third dose 16 hours after the first dose ● Radiotherapy induced nausea & vomiting One 8 mg tablet thrice a day (The first dose should be administrated 30 minutes before chemotherapy and second dose 8 hours after the first dose and Third dose 16 hours after the first dose ) For total body irradiation: one tablet 1 to 2 hours before each fraction of radiotherapy adm. each day For single high dose radiotherapy to the abdomen: one tablet 1 to 2 hours before radiotherapy with subsequent dose every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy
  • 9. Geriatric Use The same as for the general Population (Chemotherapy induced nausea and Vomiting) Patients with impaired renal function The same as for the general population(Chemotherapy induced nausea and Vomiting) Patients with impaired hepatic function Total daily dose of 8 mg should not be exceeded
  • 11. Indication Dosage Prevention of chemotherapy induced nausea & vomiting Adults & Geriatric Recommended dose is a single 32 mg dose or three 0.15 mg/kg doses. A single 32 mg dose is infused over 15 minutes, beginning 30 minutes before the start of chemotherapy. OR  0.15 mg/kg over 15 minutes, beginning 30 minutes before the start of chemotherapy  Second dose 4 hours after the first dose  Third dose 8 hours after the first dose Peadiatric use (1 month to 18 years) Three 0.15 mg/kg doses OR  0.15 mg/kg over 15 minutes, beginning 30 minutes before the start of chemotherapy  Second dose 4 hours after the first dose  Third dose 8 hours after the first dose
  • 12. Prevention of POVN ►intravenously 4 mg undiluted intravenously in not less than 30 seconds over 2 to 5 minutes, immediately before anesthesia, or postoperatively if the patient experience nausea and/or vomiting occurring shortly after surgery. ►intramuscularly Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults. Pediatric use (1 month to 12 years) Single 0.1 mg/kg dose for weighing 40 kg or less Or, single 4 mg dose for weighing more than 40 kg. Administration should not be Not less than 30 seconds, preferably over 2 to 5 minutes.
  • 13. Geriatric use The same as for the general population. (Single 32 mg Or Three 0.15mg/Kg) Patients with impaired renal function The same as for the general population. (Single 32 mg Or Three 0.15mg/Kg) Patients with impaired hepatic function Single maximal daily dose of 8 mg to be infused over 15 minutes beginning 30 minutes before the chemotherapy.
  • 14. Side effects Most people have no problems when taking Ondansetron. Patients may rarely experience blurring vision and very rarely suffer from temporary blindness, which usually resolves within 20 minutes. Frequently reported side effects were headache, constipation and diarrhoea, but the majority have been mild or moderate in nature.
  • 15. USE IN PREGNANCY & LACTATION Pregnancy category B. there are no adequate and well controlled studies in pregnant women. So, this drug should be used during pregnancy only if clearly needed. It is not known whether Ondansetron is excreted in human milk. So, caution should be exercised when Ondansetron is administered to nursing women.
  • 16. Use In Children This drug Ondansetron IM/IV injection is recommended for child (from 1 month).
  • 17. Target Doctors  Oncology  Surgery practitioners  Hospital practitioners  General practitioners  Gyane practitioners  PC doctors  Child specialist
  • 18. Market Information: The market size of Ondansetron is 16.82 crore (app.) with Growth 78.28%. Ref: 2nd Q, 2011 Brand Company Sales value(crore) yearly Emistat Healthcare 7.55 Anset Opsonin 2.59 Onaseron Incepta 2.23 Zofra SK+F 2.45
  • 19. Highlighting Points PERISET… ◙ Control nausea & vomiting in various condition ◙ Effective & safe for controlling PONV after cardiac surgery ◙ Ensures effective control of vomiting in acute gastroenterititis ◙ Prophylactic control of PONV after cardiac surgery ◙ Safe for child (1 month-18 years)
  • 20.
  • 21.
  • 22.
  • 23.
  • 24. 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 from 4 years)