ONSIA (ONDANSETRON)

FORMULATION
Injection:
Each vial 2 ml contains Ondansetron (as hydrochloride dihydrate) 4 mg
Each vial 4 ml contains Ondansetron (as hydrochloride dihydrate) 8 mg

INDICATIONS
For the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy.
For the prevention and treatment of post -operative nausea and vomiting

DOSAGE AND ADMINISTRATION
Chemotherapy and radiotherapy induced nausea and vomiting:
Adult Injection: Administered 8 mg as a slow intravenous injection immediately before chemotherapy.
Oral: Administered 8 mg 1-2 hours before treatment, followed by 8 mg orally twelve hours later. To protect against delayed or prolonged emesis after the first 24 hours, Ondansetron should be continued orally, 8 mg twice daily for up to 5 days after a course of treatment

Highly emetogenic chemotherapy:
Initial treatment by intravenous administration is recommended. The selection of rout of administration should be determined by the severity of the emetogenic challenge. Administered as a single 8 mg by slow intravenous injection immediately before chemotherapy. Alternatively administered as a single 8 mg by slow intravenous injection immediately before chemotherapy, followed by two further intravenous doses of 8 mg two to four hours apart, or by a constant fusion of 1 mg/hour for up to 24 hours

Post-operative nausea and vomiting:
Adult Injection: The recommended dose is 4 mg by slow intravenous injection over 30 seconds, given immediately 1 hour before induction of anesthesia. Oral: The recommended dose is 16 mg as a single dose, given 1 hour before induction of anesthesia.

CONTRAINDICATIONS
Hypersensitivity to Ondansetron.

ADVERSE DRUG REACTIONS
Adverse reactions such as headache, a sensation of flushing or warmth, hiccup, constipation have been occurred. The transient elevations in aminotransferases occurred in some courses. There have been rare cases of immediate hypersensitivity reactions sometimes severe including anaphylaxis.

DRUG INTERACTIONS
Because Ondansetron is metabolized by hepatic cytochrome P-450 drug metabolizing enzymes, inducers or inhibitors of these enzymes may change the clearance and, hence, the half-life of Ondansetron. However, on the basis of available data, no dosage adjustment is recommended for patients on these drugs.

PRECAUTION
• Peristalsis: Ondansetron does not stimulate gastric or intestinal peristalsis. Do not use instead of nasogastric suction.
• Pregnancy: There are no adequate and well controlled studies in pregnant women. Use in pregnancy is not recommended
• Lactation: Ondansetron is excreted in breast milk of rats. Therefore, it is recommended that mothers receiving Ondansetron should not breast - feed their babies.
• Children: Little information is available about dosage in children  3 years of age.
• There have been reported of hypersensitivity in patients who are sensitive to other drugs such as Selective 5- HT3 receptor antagonist.

AVAILABILITY
USP Type 1 clear glass ampoule x 2 mL (4mg/2mL). Box of 5 ampoules
USP Type 1 clear glass ampoule x 4 mL (8mg/4mL). Box of 5 ampoules