Indications And Usage

In the adult patient population: orally administered ondansetron tablets are indicated for: - the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, including high dose (ie. greater than or equal to 50 mg/m2) cisplatin therapy, and radiotherapy, and - the prevention and treatment of postoperative nausea and vomiting

intravenously administered ondansetron injection formulations are indicated for: - the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, including high dose (ie. greater than or equal to 50 mg/m2) cisplatin therapy, and - the prevention and treatment of postoperative nausea and vomiting

In the pediatric (4-18 years of age) patient population: ondansetron was effective and well tolerated when given to children 4-12 years of age for the treatment of post-chemotherapy induced nausea and vomiting, ii) ondansetron tablets, ondansetron injection are not indicated for the treatment of children 3 years of age or younger) ondansetron tablets, ondansetron injection are not indicated for use in any age group of the pediatric population for the treatment of post-radiotherapy induced nausea and vomiting) ondansetron tablets, ondansetron injection are not indicated for use in any age group of the pediatric population for the treatment of postoperative nausea and vomiting

In the geriatric (>65 years of age) patient population: efficacy and tolerance of ondansetron were similar to that observed in younger adults for the treatment of post-chemotherapy and radiotherapy-induced nausea and vomiting,

clinical experience in the use of ondansetron in the prevention and treatment of postoperative nausea and vomiting is limited and is not indicated for use in the geriatric patient population

Administration

Chemotherapy and Radiotherapy induced nausea and vomiting:

The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. The route of administration and dose of ondansetron should be flexible in the range of 8-32 mg a day.

Emetogenic chemotherapy and radiotherapy:

Ondansetron can be given either by rectal, oral (tablets or syrup), intravenous or intramuscular administration.

For most patients receiving emetogenic chemotherapy or radiotherapy, ondansetron 8 mg should be administered as a slow intravenous or intramuscular injection immediately before treatment, followed by 8 mg orally twelve hourly.

For oral administration:

 8 mg 1-2 hours before treatment, followed by 8 mg 12 hours later.

Contraindications

Hypersensitivity to the ondansetron or to any of the excipients.

Hypersensitivity to other selective 5-HT3 receptor antagonists (e.g. granisetron, dolasetron).

 Concomitant use with apomorphine (see Interactions with other medicinial products).

Precautions

Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists.

Pediatric patients receiving ondansetron with hepatotoxic chemotherapeutic agents should be monitored closely for impaired hepatic function.

Adverse Reactions

Immune system disorders:

 Rare: Immediate hypersensitivity reactions sometimes severe, including anaphylaxis.

Nervous system disorders

Very common: Headache.

Eye disorders

Rare: Transient visual disturbances

Vascular disorders

Common: Sensation of warmth or flushing.

Gastrointestinal disorders

Common: Ondansetron is known to increase the large bowel transit time and may cause constipation in some patients

Pregnancy and lactation

pregnancy

Ondansetron should not be used during the first trimester of pregnancy.

Lactation

recommended that mothers receiving ondansetron should not breast-feed their babies.

Renal and liver Impairment

Patients with renal impairment

No alteration of daily dosage or frequency of dosing, or route of administration is required.

 Patients with hepatic impairment

Clearance of ondansetron is significantly reduced and serum half-life significantly prolonged in subjects with moderate or severe impairment of hepatic function. In such patients a total daily dose of 8 mg should not be exceeded.

Laboratory Tests