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 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

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