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SETOFILM is a brand name for Ondansetron. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Adults: • Prophylaxis of acute nausea and vomiting induced by moderately emetogenic chemotherapy. • Prophylaxis and treatment of delayed nausea and vomiting induced by moderately to highly emetogenic chemotherapy. • Prophylaxis and treatment of acute and delayed nausea and vomiting induced by highly emetogenic…
Verbatim from this product's MHRA label. Tap a section to expand.
SETOFILM is only indicated for oral use. Please refer to the relevant SmPC for other dosage forms of ondansetron. SETOFILM may be recommended in patients with an enhanced risk of aspiration. , children or the elderly. Method of administration: • SETOFILM orodispersible film should be removed from each individual sachet taking care not to damage the film.
• Open the sachet only at the tear tag and tear this off slowly. Do not cut the sachet. • Before use check the film for damage. Only undamaged films should be used. • The patients’ mouth should be empty and their fingers dry before placing SETOFILM orodispersible film on to the tongue.
• The film should disintegrate on the tongue without water in a few seconds (in saliva which should be subsequently swallowed). 1 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 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, intravenous or intramuscular administration. SETOFILM is an oral formulation.
The recommended oral dose is 8mg 1 to 2 hours before treatment, followed by 8mg orally 12 hours later. To protect against delayed or prolonged emesis after the first 24 hours, oral treatment with SETOFILM should be continued for up to 5 days after a course of treatment.
The recommended oral dosage is 8mg to be taken twice daily. g. high dose cisplatin) Ondansetron can be given either by oral, rectal, intravenous or intramuscular administration. SETOFILM is an oral formulation. The recommended oral dose is 24 mg taken together with oral dexamethasone sodium phosphate 12mg, 1 to 2 hours before treatment.
To protect against delayed or prolonged emesis after the first 24 hours, oral treatment with SETOFILM should be continued for up to 5 days after a course of treatment. The recommended oral dosage is 8mg to be taken twice daily. Paediatric Population Chemotherapy induced nausea and vomiting (CINV) The dose for CINV can be calculated based on body surface area (BSA) or weight – see table 1 below.
Weight – based dosing results in higher total daily doses compared to BSA based dosing. 1) There are no data from controlled clinical trials on the use of ondansetron in the prevention of delayed or prolonged CINV or on the use of ondansetron for radiotherapy-induced nausea and vomiting (RINV) in children.
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 and <1/10), uncommon (≥ 1/1000 and <1/100), rare (≥ 1/10,000 and <1/1000) and very rare (<1/10,000).
Very common, common and uncommon events were generally determined from clinical trial data. The incidence in placebo was taken into account. Rare and very rare events were generally determined from post marketing spontaneous data. The following frequencies are estimated at the standard recommended doses of ondansetron according to indication and formulation.
Immune system disorders Rare:
Immediate hypersensitivity reactions sometimes severe, including anaphylaxis.
Nervous system disorders Very common:
Headache. Uncommon: seizures, movement disorders including extrapyramidal reactions (such as dystonic reactions, oculogyric crisis and dyskinesia have been observed without definitive evidence of persistent clinical sequelae).
Rare:
Dizziness during rapid intravenous administration. g. blurred vision) predominantly during intravenous administration. Very rare: transient blindness predominantly during intravenous administration. The majority of the blindness cases reported resolved within 20 minutes.
Most patients had received chemotherapeutic agents, which included cisplatin. Some cases of transient blindness were reported as cortical in origin.
Cardiac disorders Uncommon:
Arrhythmias, chest pain with or without ST segment depression, bradycardia.
Rare:
Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5HT3 receptor antagonists. Respiratory events should be treated symptomatically and clinicians should pay particular attention to them as precursors of hypersensitivity reactions.
Ondansetron prolongs the QT interval in a dose-dependent manner (see Clinical Pharmacology). 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.
Ondansetron should be administered with caution to 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.
Hypokalemia and hypomagnesemia should be corrected prior to ondansetron administration. There have been post-marketing reports describing patients with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the concomitant use of ondansetron and other serotonergic drugs (including selective serotonin reuptake inhibitors (SSRI) and serotonin noradrenaline reuptake inhibitors (SNRIs)).
If concomitant treatment with ondansetron and other serotonergic drugs is clinically warranted, appropriate observation of the patient is advised. As ondansetron is known to increase large bowel transit time, patients with signs of sub-acute intestinal obstruction should therefore be monitored following administration.
In patients with adeno-tonsillar surgery prevention of nausea and vomiting with ondansetron may mask occult bleeding. Therefore, such patients should be followed carefully after ondansetron administration.
Paediatric Population:
g. 1. Based on reports of profound hypotension and loss of consciousness when ondansetron was administered with apomorphine hydrochloride, concomitant use with apomorphine is contraindicated
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Ondansetron should be administered immediately before chemotherapy as a single intravenous dose. The intravenous dose must not exceed 8 mg. Oral dosing can commence twelve hours later and may be continued for up to 5 days. See Table 1 below.
The total daily dose must not exceed adult dose of 32 mg. 15mg/kg every 4 hrs 4 mg orally every 12 hrs a The intravenous dose must not exceed 8 mg. b The total daily dose must not exceed adult dose of 32 mg *SETOFILM is an oral preparation only, and is not available in an intravenous formulation **SETOFILM is only available in films of 4mg and 8mg.
It is not possible to divide the film to obtain a 2mg dosage. Elderly Ondansetron is well tolerated by patients over 65 years and no alteration of dosage, dosing frequency or route of administration is required. Prescribers intending to use ondansetron in the prevention of delayed nausea and vomiting associated with chemotherapy or radiotherapy in adults, adolescents or children should take into consideration current practice and appropriate guidelines.
2 Post-operative nausea and vomiting (PONV) Adults Prevention of Post-operative nausea and vomiting (PONV) For the prevention of post-operative nausea and vomiting, the recommended oral dose is 16mg given 1 hour prior to anaesthesia.
Alternatively, use 8 mg one hour prior to anaesthesia followed by two further doses of 8 mg at eight hourly intervals. Treatment of established Post-operative nausea and vomiting (PONV) For the treatment of established PONV, intravenous or intramuscular administration by injection is recommended.
Paediatric population:
Post-operative nausea and vomiting For the prevention and treatment of PONV, slow intravenous injection is recommended. Alternatively, for administration in children weighing ≥ 40kg SETOFILM can be administered orally as a 4 mg dose, one hour prior to anaesthesia, followed by one further dose of 4 mg after 12 hours.
There are no data on the use of ondansetron for the treatment of PONV in children under 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.
Special populations – both indications:
Patients with renal impairment: No alteration of daily dosage or frequency of dosing, or route of administration are 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 8mg 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 drug exposure levels […]
QTc prolongation (including Torsade de Pointes) Vascular disorders Common: Sensation of warmth or flushing.
Uncommon:
Hypotension.
Respiratory, thoracic and mediastinal disorders Uncommon:
Hiccups.
Gastrointestinal disorders Common:
Constipation Hepatobiliary disorders Uncommon: Asymptomatic increases in liver function tests. These events were observed commonly in patients receiving chemotherapy with cisplatin.
Skin and subcutaneous tissue disorders Very rare:
Toxic skin eruption, including toxic epidermal necrolysis Paediatric Population The adverse event profile in children and adolescents was comparable to that seen in adults. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.
Paediatric patients receiving ondansetron with hepatotoxic chemo-therapeutic agents should be monitored closely for impaired hepatic function.
Chemotherapy-induced nausea and vomiting:
When calculating the dose on a mg/kg basis and administering three doses at 4 hourly intervals, the total daily dose will be higher than if one single dose of 5mg/m2 followed by an oral dose is given. The comparative efficacy of these two different dosing regimens has not been investigated in clinical trials.
1.