Ondansetron 8mg/5ml Oral Solution Abbreviated Prescribing Information

Abbreviated Prescribing Information: Ondansetron 8mg/5ml oral solution Consult Summary of Product Characteristics before prescribing. Presentation: Oral solution. Clear, colourless to light yellow liquid with characteristic strawberry odour containing 8 mg of ondansetron (as hydrochloride dihydrate) in every 5 ml of oral solution. Therapeutic Indications: Ondansetron oral solution is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy and for the prevention of post-operative nausea and vomiting (PONV). Posology and Method of Administration: Adults: The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. The selection of dose regimen should be determined by the severity of the emetogenic challenge. Emetogenic chemotherapy and radiotherapy: Ondansetron can be given either by rectal, oral (tablets or syrup), intravenous or intramuscular administration. For oral administration : 5 ml (8 mg) taken 1 to 2 hours before chemotherapy or radiation treatment, followed by 5 ml (8 mg) every 12 hours for a maximum of 5 days to protect against delayed or prolonged emesis. For highly emetogenic chemotherapy : a single dose of up to 15 ml (24 mg) Ondansetron taken with 12 mg oral dexamethasone sodium phosphate, 1 to 2 hours before chemotherapy, may be used. Furthermore, to protect against delayed or prolonged emesis after the first 24 hours, oral or rectal treatment with Ondansetron may be continued for up to 5 days after a course of treatment. The recommended dose for oral administration is 5 ml (8 mg) to be taken twice daily. Paediatric Population: CINV in children aged ≥ 6 months and adolescents: The dose for CINV can be calculated based on body surface area (BSA) or weight. Dosing by BSA: Ondansetron should be administered immediately before chemotherapy as a single intravenous dose of 5mg/m2. The single intravenous dose must not exceed 8 mg. Oral dosing can commence 12 hours later and may be continued for up to 5 days. The total dose over 24 hours (given as divided doses) must not exceed adult dose of 20ml (32 mg). Dosing by bodyweight: Ondansetron should be administered immediately before chemotherapy as a single intravenous dose of 0.15 mg/kg. The intravenous dose must not exceed 8 mg. Two (2) further intravenous doses may be given in 4-hourly intervals. Oral dosing can commence 12 hours later and may be continued for up to 5 days. The total dose over 24 hours (given as divided doses) must not exceed adult dose of 20 ml (32 mg). Elderly : No alteration of oral dose or frequency of administration is required. Post operative nausea and vomiting (PONV). Adults: Ondansetron can be administered orally or by intravenous or intramuscular injection. For oral administration: 10ml (16 mg) one (1) hour prior to anaesthesia. For the treatment of established PONV : Intravenous or intramuscular administration is recommended. Paediatric population: PONV in children aged ≥ 1 month and adolescents : Slow IV injection (not less than 30 seconds) is recommended for this purpose. Injection: For prevention of PONV in paediatric patients having surgery performed under general anaesthesia, a single dose of Ondansetron may be administered by slow intravenous injection (not less than 30 seconds) 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 the treatment of PONV after surgery in paediatric patients having surgery performed under general anaesthesia, a single dose of Ondansetron may be administered by slow intravenous injection (not less than 30 seconds) at a dose of 0.1 mg/kg up to a maximum of 4 mg. There are no data on the use of Ondansetron in the treatment of PONV in children below 2 years of age. Elderly: There is limited experience in the use of Ondansetron in the prevention and treatment of PONV in the elderly, however Ondansetron is well tolerated in patients over 65 years receiving chemotherapy. Patients with Renal impairment: No alteration of daily dosage or frequency of dosing, or route of administration are required. Patients with Hepatic impairment: A total daily dose of 5 ml (8 mg) should not be exceeded. Patients with poor Sparteine/Debrisoquine Metabolism: No alteration of daily dosage or frequency of dosing is required. Contra-indications: Concomitant use with apomorphine. Hypersensitivity to any component of the preparation. Special Warnings and Precautions for use: Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5HT receptor antagonists. Respiratory events should be treated symptomatically and clinicians should pay particular attention to them as precursors of hypersensitivity reactions. In addition, post-marketing cases of Torsade de Pointes have been reported in patients using Ondansetron. Avoid Ondansetron in patients with congenital long QT syndrome. Caution should be exercised in patients who have or may develop prolongation of QTc, including patients with electrolyte abnormalities, congestive heart failure, bradyarrhythmias or patients taking other medicinal products that lead to QT prolongation or electrolyte abnormalities. Hypokalaemia and hypomagnesaemia should be corrected prior to Ondansetron administration. Concomitant use of Ondansetron with other serotonergic drugs (including selective serotonin reuptake inhibitors (SSRIs), serotonin noradrenaline reuptake inhibitors (SNRIs) and opioid/opiate medicines (e.g. buprenorphine)) can develop potentially life-threatening serotonin syndrome, hence appropriate observation of the patient is advised. As Ondansetron is known to increase large bowel transit time, patients with signs of subacute intestinal obstruction should be monitored following administration. 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. Patients with hereditary fructose intolerance (HFI) should not take / be given this medicine as it contains sorbitol. Sorbitol may cause gastrointestinal discomfort and mild laxative effect. The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly. This product contains sodium benzoate. Increase in bilirubinaemia following its displacement from albumin may increase neonatal jaundice which may develop into kernicterus (non-conjugated bilirubin deposits in brain tissue). This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per 5ml. Cases of myocardial ischemia have been reported in patients treated with ondansetron. Paediatric patients receiving Ondansetron with hepatotoxic chemotherapeutic agents should be monitored closely for impaired hepatic function. Any warning from the MC, CHM CSM or MHRA: No. Black Triangle notice: N/A. Legal Category: POM. The reported adverse reactions are: Very common: Headache. Common: Sensation of warmth or flushing and Constipation. Uncommon: Seizures, movement disorders (including extrapyramidal reactions such as dystonic reactions, oculogyric crisis, and dyskinesia), Arrhythmias, chest pain with or without ST segment depression, bradycardia, Hiccups, and Asymptomatic increases in liver function tests. Rare: Immediate hypersensitivity reactions sometimes severe, including anaphylaxis, Dizziness predominantly during rapid IV administration, Transient visual disturbances (e.g. blurred vision) predominantly during IV administration, and QTc prolongation (including Torsade de Pointes). Very rare: Transient blindness predominantly during IV administration. Not known: myocardial ischemia. Pack Size and NHS Price: 100ml – £130.46. Marketing Authorisation Number: PL 00427/0271. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [January 2023].