Ondanil®

Adults:

Prevention of nausea and vomiting associated with chemotherapy:

• Ondansetron Injection should be diluted in 50 ml of 5% dextrose injection or 0.9% sodium chloride injection before administration.

  The recommended adult intravenous dosage of ondansetron is three 0.15-mg/kg doses up to a maximum of 16 mg per dose. The first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of ondansetron.

• Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy: 24 mg orally, given 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin greater than or equal to 50 mg/m2 or more.
• Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy:8 mg tablet or one 8mg Ondanil ODT tablet orally given 2 times 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;then give 8mg twice a day(every12hours)for 1 to 2 days after completion of chemotherapy.
• Prevention of nausea and vomiting associated with radiotherapy:
  • Usual dosage: 8 mg tablet or one 8-mg Ondanil ODT tablet orally 3 times a day
  • For total body irradiation: 8 mg tablet or one 8-mg Ondanil ODT tablet orally 1 to 2 hours before each fraction of radiotherapy administered each day.
  • For single high-dose fraction radiotherapy to the abdomen: 8 mg tablet or one 8-mg Ondanil ODT tablet orally given 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: 8 mg tablet or one 8-mg Ondanil ODT tablet orally given 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.
• Postoperative nausea and vomiting:
  • 16 mg given as two 8mg tablets or two 8-mg Ondanil ODT tablets orally administered 1 hour before induction of anesthesia.
  • 4 mg undiluted intravenously immediately before induction of anesthesia, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring within 2 hours after surgery.
  • Alternative dosage: 4 mg undiluted intramuscularly as a single injection.

Children:

• Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy:
  • 6 months to 18 years of age: the intravenous dosage of ondansetron is three 0.15-mg/kg doses up to a maximum of 16 mg per dose. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of ondansetron. The drug should be infused intravenously over 15 minutes
  • 12 years of age and older: the oral dosage is the same as for adults.
  • 4 to 11 years of age: 4 mg Ondanil tablet or one 4mg Ondanil ODT tablet orally 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. Then give 4 mg Ondanil tablet or one 4mg Ondanil ODT tablet orally 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.
• Postoperative nausea and vomiting: 1 month to 12 years of age: the intravenous dosage for patients:
  weighing 40 kg or less: 0.1-mg/kg IV as a single dose
  weighing more than 40 kg: 4-mg IV as a single dose. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring shortly after surgery.

Instructions for use Ondanil ODT (Orally Disintegrating Tablets):

Do not attempt to push Ondanil ODT Tablets through the foil backing.With dry hands, peel back the foil backing of 1 blister and gently remove the tablet. Immediately place the Ondanil ODT tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

Contraindications:

Ondansetron tablets are contraindicated for patients known to have hypersensitivity to the drug.

The concomitant use of apomorphine with Ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with Ondansetron.

Interactions:

Phenytoin, Carbamazepine and Rifampicin

Ondansetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes (CYP3A4, CYP2D6, CYP1A2), so inducers or inhibitors of these enzymes may change the clearance of ondansetron. In patients treated with potent inducers of CYP3A4 (i.e., phenytoin, carbamazepine and rifampicin), the clearance of Ondansetron was significantly increased and ondansetron blood concentrations were decreased.

Use of ondansetron with QT prolonging drugs may result in additional QT prolongation. Concomitant use of ondansetron with Cardiotoxic drugs (e.g. anthracyclines such as doxorubicin, daunorubicin or trastuzumab), Antibiotics (such as erythromycin), Antifungals (such as ketoconazole), Antiarrhythmics (such as amiodarone) and Beta blockers (such as atenolol or timolol) may increase the risk of arrhythmias.

Tramadol

Data from small studies indicate that ondansetron may reduce the analgesic effect of tramadol.

Pregnancy and Lactation:

Pregnancy: Category B
There are no adequate and well controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed.
Breast-feeding: It is not known whether Ondansetron is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ondansetron is administered to a nursing woman.

Warning and Precaution:

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

Phenylketonuric patients should be informed that Ondanil ODT (orally disintegrating tablets) contain phenylalanine (a component of aspartame). Each 4mg and 8mg orally disintegrating tablet contains < 0.03 mg phenylalanine.

Adverse Reactions:

Headache, Drowsiness/sedation, Hiccups, Injection site reaction, Fever, Flushing, Urticaria, Rare cases of hypersensitivity reactions sometimes severe (e.g., anaphylaxis/anaphylactoid reactions, angioedema, bronchospasm, shortness of breath, hypotension, laryngeal edema.) and Liver enzyme abnormalities.

Storage:

Store below 30 and protect from light and moisture.