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Drug Details

Ondansetron 2 mg/ml Injection.

• Presentation
  Solution for injection. Clear solution.
• Description
  1 ml of solution contains 2 mg of ondansetron. 1 ampoule with 2 ml solution for injection contains 4 mg ondansetron. 1 ampoule with 4 ml solution for injection contains 8 mg ondansetron
• Indications
  Management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, and for the prevention and treatment of post-operative nausea and vomiting (PONV).
• Adult Dosage
  

  For intravenous injection or after dilution for intravenous infusion.

  Chemotherapy and radiotherapy induced nausea and vomiting

  Adults

  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 and selected as explained below.

  Emetogenic chemotherapy and radiotherapy

  For patients receiving emetogenic chemotherapy or radiotherapy ondansetron can be given either by oral or intravenous administration.

  For most patients receiving emetogenic chemotherapy or radiotherapy, 8 mg of ondansetron should be administered as a slow intravenous injection or as a short-time intravenous infusion over 15 minutes immediately before treatment, followed by 8 mg orally every twelve hours.

  For oral administration: 8 mg 1-2 hours before treatment, followed by 8 mg 12 hours later.

  To protect against delayed or prolonged emesis after the first 24 hours, oral or rectal treatment with ondansetron should be continued for up to 5 days after a course of treatment. The recommended dose of orally administered ondansetron is 8 mg twice daily. For oral treatment, other medicinal products on the market must be used.

  Highly emetogenic chemotherapy

  For patients receiving highly emetogenic chemotherapy, e.g. high-dose cisplatin, ondansetron can be given by intravenous administration. Ondansetron has been shown to be equally effective in the following dose schedules over the first 24 hours of chemotherapy:

  A single dose of 8 mg by slow intravenous injection immediately before chemotherapy.

  A dose of 8 mg by slow intravenous injection or as a short-time intravenous infusion over 15 minutes immediately before chemotherapy, followed by two further intravenous doses of 8 mg 2 - 4 hours apart, or by a constant infusion of 1 mg/hour for up to 24 hours.

  A single dose of 32 mg diluted in 50-100 ml of sodium chloride 9 mg/ml (0.9%) solution for injection or other compatible infusion fluid and infused over not less than 15 minutes immediately before chemotherapy.

  The selection of dose regimen should be determined by the severity of the emetogenic challenge.

  To protect against delayed or prolonged emesis after the first 24 hours, oral treatment with ondansetron should be continued for up to 5 days after a course of treatment. The recommended dose of orally administered ondansetron is 8 mg twice daily. For oral treatment, other medicinal products on the market must be used.

  Children (aged 2 years and above) and adolescents (< 18 years)

  Experience in paediatric patients is limited. In children older than two years ondansetron may be administered as a single intravenous dose of 5 mg/m2 over 15 min. immediately before chemotherapy, followed by 4 mg orally twelve hours later. Oral treatment with a dose according to the body area should be continued for up to 5 days after a course of treatment. Children with a total body area between 0.6 and 1.2 m2 should receive a dosage schedule of 4 mg 2 times a day, while children with a body area above 1.2 m2 should receive 8 mg 2 times a day.

  There is no experience in children younger than 2 years old.

  Elderly patients

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

  Please also refer to “Special populations”.

  Post-operative nausea and vomiting (PONV)

  Adults

  For the prevention of PONV ondansetron may be administered orally or by intravenous injection.

  Ondansetron may be administered as a single dose of 4 mg given by or slow intravenous injection at induction of anaesthesia.

  For the treatment of established PONV a single dose of 4 mg given by slow intravenous injection is recommended.

  Children (aged 2 years and above) and adolescents (< 18 years)

  For prevention of PONV in paediatric patients having surgery performed under general anaesthesia, ondansetron may be administered by slow intravenous injection at a dose of 0.1 mg/kg up to a maximum of 4 mg either prior to, at or after induction of anaesthesia.

  For treatment of established PONV in paediatric patients, ondansetron may be administered by slow intravenous injection at a dose of 0.1 mg/kg up to a maximum of 4 mg.

  There is limited data on the use of ondansetron in the prevention and treatment of PONV in children under 2 years of age.

  Elderly patients

  There is limited experience in the use of ondansetron in the prevention and treatment of PONV in the elderly.

  Please also refer to “Special populations”

  Special populations

  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.

  Patients with poor sparteine/debrisoquine metabolism

  The elimination half-life of ondansetron is not altered in subjects classified as poor metabolisers of sparteine and debrisoquine. Consequently in such patients repeat dosing will give medicinal product exposure levels no different from those of the general population. No alteration of daily dosage or frequency of dosing is required.

• Contra Indications
  

  Hypersensitivity to the active substance or to other selective 5-HT₃ receptor antagonists (e.g. granisetron, dolasetron) or to any of the excipients.

• Special Precautions
  

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

  As ondansetron is known to increase large bowel transit time, patients with signs of subacute intestinal obstruction should be monitored following administration.

  Since there is little experience to date of the use of ondansetron in cardiac patients, caution should be exercised if ondansetron is co-administered with anaesthetics to patients with arrhythmias or cardiac conduction disorders or to patients who are being treated with antiarrhythmic agents or beta-blockers.

  The medicinal product should not be used for children younger than two years, as for these patients the experience is limited.

  In patients with adenotonsillar surgery prevention of nausea and vomiting with ondansetron may mask occult bleeding. Therefore, such patients should be followed carefully after ondansetron.

  Ondansetron 2 mg/ml solution for injection contains sodium. The solutions for injection (ampoules with 2 ml and 4 ml ondansetron) contain less than 1 mmol sodium (23 mg) each, i.e. essentially ”sodium-free”.

• Interactions
  

  There is no evidence that ondansetron either induces or inhibits the metabolism of other medicinal products commonly co-administered with it. Specific studies have shown that ondansetron does not interact with alcohol, temazepan, furosemide, alfentanil, propofol and thiopental.

  Ondansetron is metabolised by multiple hepatic cytochrome P-450 enzymes: CYP3A4, CYP2D6 and CYP1A2. Due to the multiplicity of metabolic enzymes capable of metabolising ondansetron, enzyme inhibition or reduced activity of one enzyme (e.g. CYP2D6 genetic deficiency) is normally compensated by other enzymes and should result in little or no significant change in overall ondansetron clearance or dose requirement.

  Phenytoin, Carbamazepine and Rifampicin: In patients treated with potent inducers of CYP3A4 (i.e. phenytoin, carbamazepine, and rifampicin), the oral clearance of ondansetron was increased and ondansetron blood concentrations were decreased.

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

• Adverse Drug Reactions
  

  Immune system disorders

  Rare (> 1/10,000, < 1/1,000): immediate hypersensitivity reactions, sometimes severe, including anaphylaxis. Anaphylaxis may be fatal.

  Hypersensitivity reactions were also observed in patients, which were sensitive to other selective 5-HT₃ antagonists.

  Nervous system disorders

  Rare (> 1/10000, < 1/1000): there have been reports suggestive of involuntary movement disorders such as extrapyramidal reactions e.g. oculogyric crisis/dystonic reactions without definitive evidence of persistent clinical sequelae and seizures have been rarely observed although no known pharmacological mechanism can account for ondansetron causing these effects.

  Cardiac disorders

  Rare (> 1/10000, < 1/1000): chest pain, with or without ST segment depression, cardiac arrhythmias, hypotension and bradycardia.

  Gastrointestinal disorders

  Common (> 1/100, < 1/10): ondansetron is known to increase the large bowel transit time and may cause constipation in some patients.

  Hepato-biliary disorders

  Occasional asymptomatic increases in liver function tests were observed.

  Skin and subcutaneous tissue disorders

  Occasionally, hypersensitivity reactions around the injection site (e.g. rash, urticaria, itching) may occur, sometimes extending along the medicinal product administration vein.

  General disorders and administration site conditions

  Common (> 1/100, < 1/10): headache, sensation of flushing and warmth, hiccups.

  Rare (> 1/10000, < 1/1000): transient visual disturbances (e.g. blurred vision) and dizziness during rapid intravenous administration of ondansetron.