INDICATION: Management of nausea & vomiting in cytotoxic chemotherapy & for prevention & treatment of post-op nausea & vomiting

DOSAGE: Management of nausea & vomiting by cytotoxic chemotherapy & radiography in less emetogenic chemotherapy & radiotherapy Adult Slow IV/IM 8 mg immediately before treatment. To be followed by 8 mg orally after 12 hr. Prevention of delayed emesis Orally 8 mg bid up to 5 days. Highly emetogenic chemotherapy Slow IV/IM 8 mg immediately before chemotherapy, followed by 2 IV doses of 8 mg 2-4 hr apart, as needed by a constant infusion of 1 mg/hr for up to 24 hr. Alternatively, a single dose of 32 mg diluted in 50-100 mL of saline or other compatible infusion fluid infused over 15 min immediately before chemotherapy. Prevention of delayed emesis Continue orally 8 mg bid up to 5 days after a course of chemotherapy. Childn IV 5 mg/m2 for 15 min immediately before chemotherapy followed by 4 mg orally every 12 hr or bid continued for up to 5 days after a course of treatment. Prevention of post-op nausea & vomiting Adult 16 mg orally 1 hr prior to anaesth or 8 mg 1 hr prior to anesth followed by 2 further doses of 8 mg at 8-hr intervals. Alternatively, 4 mg single dose slow IV inj at induction of anaesth. Childn IV 0.1 mg/kg. Max: 4 mg. Treatment of post-op nausea & vomiting Adult Slow IV 4 mg as a single dose. Childn Slow IV 0.1 mg/kg as a single dose before, during or after anesth. Max: 4 mg. Hepatic impairment Max: 8 mg daily.

OVERDOSAGE: Management of nausea & vomiting by cytotoxic chemotherapy & radiography in less emetogenic chemotherapy & radiotherapy Adult Slow IV/IM 8 mg immediately before treatment. To be followed by 8 mg orally after 12 hr. Prevention of delayed emesis Orally 8 mg bid up to 5 days. Highly emetogenic chemotherapy Slow IV/IM 8 mg immediately before chemotherapy, followed by 2 IV doses of 8 mg 2-4 hr apart, as needed by a constant infusion of 1 mg/hr for up to 24 hr. Alternatively, a single dose of 32 mg diluted in 50-100 mL of saline or other compatible infusion fluid infused over 15 min immediately before chemotherapy. Prevention of delayed emesis Continue orally 8 mg bid up to 5 days after a course of chemotherapy. Childn IV 5 mg/m2 for 15 min immediately before chemotherapy followed by 4 mg orally every 12 hr or bid continued for up to 5 days after a course of treatment. Prevention of post-op nausea & vomiting Adult 16 mg orally 1 hr prior to anaesth or 8 mg 1 hr prior to anesth followed by 2 further doses of 8 mg at 8-hr intervals. Alternatively, 4 mg single dose slow IV inj at induction of anaesth. Childn IV 0.1 mg/kg. Max: 4 mg. Treatment of post-op nausea & vomiting Adult Slow IV 4 mg as a single dose. Childn Slow IV 0.1 mg/kg as a single dose before, during or after anesth. Max: 4 mg. Hepatic impairment Max: 8 mg daily.

CONTRAINDICATION:  Patients with a history of hypersensitivity to this drug.

SPECIAL PRECAUTION: selective 5-HT3 receptor antagonists.
As Ondansetron is known to increase large bowel transit time, patients with signs of sub-acute intestinal obstruction should be monitored following administration.
Patients with severe hepatic impairment.
In psychomotor testing, Ondansetron does not impair performance nor cause sedation.
Use in Children: The safety in children has not been established sufficiently. Experience of the use of ondansetron in children is limited.
Use in the Elderly: Dosage adjustment is not needed in patients over the age of 65. Prevention of nausea and vomiting in elderly patients was no different than in younger age-groups.
Use in pregnancy & lactation: There are no adequate and controlled studies to date using Ondansetron in pregnant women. Reproduction studies have been performed in pregnant rats and rabbits at I.V. doses up to 4 mg/kg per day and have revealed no evidence of impaired fertility or harm to the fetus due to Ondansetron. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Animal tests (with rats) have shown that Ondansetron is excreted in the breast milk. It is therefore recommended that mothers receiving this drug should not breast-feed their babies.

ADVERSE REACTION:  Hypersensitivity: Patients should be carefully observed as this drug may cause hypersensitivity such as occasional rash, pruritus, rarely anaphylaxis. If these are noted, the drug should be discontinued and appropriate measures taken.
Mental-Neurological System: Occasional headache, a feeling of head heaviness, drowsiness, a sensation of flushing or warmth in the head and epigastrium, and transient asymptomatic increase in aminotransferases. Uncommon: seizures and movement disorders have been observed.
Gastrointestinal System: Occasionally, diarrhea and constipation (result from increase of large bowel transit time) may occur.
Cardiovascular System: Occasionally, chest pain, arrhythmia, hypotension and bradycardia may occur.
Liver: Transient increases in AST, ALT, LDH, r-ALT and total bilirubin may occasionally occur.
Others: Visual disturbance and vertigo may occur by rapid injection. Occasionally heat sensation, face flush, febricity, malaise, hiccup and sweating may occur. Occasionally, hypersensitivity reactions (e.g. rash, urticaria, itching) around the injection site, sometimes along the administrated vein, may occur.

STORAGE: Store at temperatures not exceeding 30ºC. Protect from light.

PRESENTATION: Form
Emistop 2mg/4ml Ampule