PRODUCT DETAILS

Ondansetron is a selective 5-hydroxytryptamine-3 (5-HT3) receptor antagonist with anti-emetic activity. The effect of Ondansetron in the management of the nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy is probably due to antagonism of 5-HT3 receptors on neurons located both in the peripheral and central nervous system. The mechanisms of action in postoperative nausea and vomiting are not known but there may be common pathways with cytotoxic induced nausea and vomiting.

Presentation:

Novatron™ 8 mg Tablet: Each film-coated tablet contains Ondansetron Hydrochloride USP equivalent to 8 mg Ondansetron.

Novatron™ 8 mg/4 ml i.m./i.v. Injection: Each 4 ml ampoule contains Ondansetron Hydrochloride USP equivalent to 8 mg Ondansetron.

  Dosage and Administration

Novatron™ 8 mg Tablet: Postoperative Nausea and Vomiting: The recommended dose is 16 mg (two 8 mg Tablets) 1 hour before induction of anesthesia. Chemotherapy-induced Nausea and Vomiting: a. For highly emetogenic cancer chemotherapy, the recommended adult oral dose is three 8 mg Ondansetron tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin≥50 mg/m. Geriatric use is same as the general population. b. For moderately emetogenic cancer chemotherapy, the recommended adult oral dose is one 8 mg Ondansetron tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. Ondansetron tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy. Pediatric use for patients 4 to 11 years of age, the dosage is 4 mg Ondansetron given three times a day (every 8 hours). Radiotherapy-induced Nausea and Vomiting: The recommended oral dose is one 8 mg Ondansetron tablet given three times a day. For total body irradiation, one 8 mg Ondansetron tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day. For single high-dose fraction radiotherapy to the abdomen, one 8 mg Ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy. For daily fractionated radiotherapy to the abdomen, one 8 mg Ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose, for each day radiotherapy is given. Dosage Adjustment for Patients with Impaired Renal Function: The dosage recommendation is the same as for the general population. Dosage Adjustment for Patients with Impaired Hepatic Function: In patients with severe hepatic impairment, a total daily dose of 8 mg should not be exceeded. Novatron™ 8 mg/4 ml i.m./i.v. Injection: Postoperative Nausea and Vomiting: The recommended IM/IV dosage of Ondansetron for adults is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient experiences nausea and/or vomiting occurring shortly after surgery. Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, pre-induction IM/IV dose of Ondansetron 4 mg, administration of a second IM/IV dose of 4 mg Ondansetron postoperatively does not provide additional control of nausea and vomiting. Pediatric Use: The recommended IM/IV dosage of Ondansetron for pediatric patients (1 month to 12 years of age) is single 0.1 mg/kg dose for pediatric patients weighing 40 kg or less, or a single 4 mg dose for pediatric patients weighing more than 40 kg. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes. Geriatric Use: The dosage recommendation is the same as for the general population. Chemotherapy-induced Nausea and Vomiting: The recommended IM/IV dosage of Ondansetron 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 emetogenic chemotherapy. Subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of Ondansetron. Pediatric Use: The dosage in pediatric patients (1 month to 12 years of age) should be three 0.15 mg/kg doses. Dosage Adjustment for Patients with Impaired Renal Function: The dosage recommendation is the same as for the general population. Dosage Adjustment for Patients with Impaired Hepatic Function: In patients with severe hepatic impairment, a single maximal daily dose of 8 mg to be infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended.

  Side Effects

Frequently reported adverse events were headache, constipation and diarrhea, but the majority has been mild or moderate in nature. In chemotherapy-induced nausea and vomiting, rash has occurred in approximately 1% of patients receiving Ondansetron. There also have been reports of a sensation of flushing and warmth, hiccups and liver enzyme abnormalities. Rare cases of anaphylaxis, bronchospasm, tachycardia, angina (chest pain), hypokalemia, shortness of breath have also been reported, except for bronchospasm and anaphylaxis, the relationship to Ondansetron is unclear. There has been no evidence to extrapyramidal reactions, in rare case oculogyric crisis appearing alone, as well as with other dystonic reactions without definite clinical evidence. In case of PONV, with the exception of headache, rates of these events were not significantly different in the Ondansetron and placebo groups.

  Contraindications

Ondansetron is contraindicated for patients known to have hypersensitivity to the drug.

  Use in Pregnancy and Lactation

Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15 and 30 mg/kg per day, respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to Ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Ondansetron is excreted in the breast milk of rats. So caution should be exercised when Ondansetron is administered to a nursing woman.

  Drug Interaction

Drug Interaction Ondansetron does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver. Ondansetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes, so inducers or inhibitors of these enzymes may change the clearance and hence, the half-life of Ondansetron. On the basis of available data, no dosage adjustment of Ondansetron is recommended for patients on these drugs.

Carcinogenesis, Mutagenesis, Impairment of Fertility:
Carcinogenic effects were not seen in 2-years studies in rats and mice with oral Ondansetron doses up to 10 and 30 mg/kg per day, respectively. Ondansetron was not mutagenic in standard tests for mutagenicity. Oral administration of Ondansetron up to 15 mg/kg per day did not affect fertility or general reproduction performance of male and female rats.

  Over Dosage

There is no specific antidote for Ondansetron overdose. In addition to the adverse effects, hypotension (and faintness) occurred in a patient who administered 48 mg of Ondansetron Hydrochloride tablets. In all instances, the events resolved completely.

  Storage

Store in cool and dry place below 30o C, protect from light. Keep out of reach of children.

  Commercial Pack

Novatron™ 8 mg Tablet: Each box contains 30 tablets (3 x 10\'s) in Alu-PVC blister pack.

Novatron™ 8 mg/4 ml i.m./i.v. Injection: Each box contains 5 ampoules (1 x 5\'s) in Alu-PVC blister pack.

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