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ONDISSOLVE ODF is a brand name for Ondansetron, supplied as a film, soluble. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: , Adults (18-64 years of age) 08/2024 1 INDICATIONS, 1.1 Pediatrics (<18 years of age) 08/2024 1 INDICATIONS, 1.2 Geriatrics (≥65 years of age) 08/2024
Verbatim from this product's HC label. Tap a section to expand.
3 Pediatrics 08/ 2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS................................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS ................................................................................................................ 1 Pediatrics (<18 years of age) ...................................................................................
2 Geriatrics (≥65 years of age) .................................................................................... 4 2 CONTRAINDICATIONS ...................................................................................................
5 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations ............................................................................................. 2 Recommended Dose and Dosage Adjustment .........................................................
4 Administration ......................................................................................................... 8 5 OVERDOSAGE ...............................................................................................................
9
1 Adverse Reaction Overview The most frequent adverse events reported in controlled clinical trials were headache (11%) and constipation (4%). Other adverse events include sensations of flushing or warmth (< 1%). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared Product Monograph ONDISSOLVE® ODF (ondansetron) Page 14 of 42 to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Ondansetron has been administered to over 2500 patients worldwide in controlled clinical trials and has been well tolerated.
Cardiovascular There have been rare reports of tachycardia, angina (chest pain), bradycardia, hypotension, syncope and electrocardiographic alterations. Central Nervous System There have been rare reports of seizures. 3%. Dermatological Rash has occurred in approximately 1% of patients receiving ondansetron.
Eye Disorder There have been reports of transient visual disturbances, including blurred vision, and, in very rare cases, transient blindness, during or shortly after ondansetron treatment. These were observed generally within the recommended dosing range and predominantly during intravenous administration.
The majority of blindness cases resolved within 20 minutes. Hepatic/Biliary/Pancreatic There were transient increases of SGOT and SGPT of over twice the upper limit of normal in approximately 5% of patients. These increases did not appear to be related to dose or duration of therapy.
There have been reports of liver failure and death in patients with cancer receiving concurrent medications including potentially hepatotoxic cytotoxic chemotherapy and antibiotics. The etiology of the liver failure is unclear. Hypersensitivity Rare cases of immediate hypersensitivity reactions, sometimes severe, including anaphylaxis, bronchospasm, urticaria and angioedema have been reported.
3 Pharmacokinetics, Geriatrics. Prevention of Post-Operative Nausea and Vomiting Clinical experience in the use of ondansetron in the prevention and treatment of post-operative nausea and vomiting in elderly patients is limited. Therefore, Health Canada has not authorized an indication for this use in the geriatric population.
Product Monograph ONDISSOLVE® ODF (ondansetron) Page 5 of 42 2 CONTRAINDICATIONS • ONDISSOLVE ODF is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 4 Drug-Drug Interactions). 1 Dosing Considerations ONDISSOLVE ODF (ondansetron)is an orally disintegrating film. When injectable ondansetron is used, the product monograph for ondansetron hydrochloride dihydrate injection should be consulted.
• In patients with moderate or severe hepatic impairment, the total daily dose should not exceed 8 mg (See 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic). 3 Pharmacokinetics, Geriatrics). Dosing considerations that reduce cardiac risks: ▪ Carefully follow the dosing guidelines ▪ Use the minimum effective dose.
2 Recommended Dose and Dosage Adjustment Prevention of Highly Emetogenic Chemotherapy Induced Nausea and Vomiting • Adults ONDISSOLVE ODF is not indicated for this use. Oral formulations of ondansetron, such as ONDISSOLVE ODF, are not intended for the prevention of nausea and vomiting associated with highly emetogenic chemotherapy, such as cisplatin.
An intravenous formulation should be given as an initial dose prior to chemotherapy and within the first 24 hours.
Note:
ONDISSOLVE ODF is only available as an orally disintegrating film. A product monograph for ondansetron hydrochloride injection should be consulted. Product Monograph ONDISSOLVE® ODF (ondansetron) Page 6 of 42 • Pediatrics (<18 years) Ondansetron is not indicated for this use in children.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Metabolic There have been rare reports of hypokalemia. Other There have been reports of abdominal pain, weakness and xerostomia. 5 Post-Market Adverse Reactions Over 250 million patient treatment days of ondansetron have been supplied since the launch of the product worldwide.
The following events have been spontaneously reported during post- Product Monograph ONDISSOLVE® ODF (ondansetron) Page 15 of 42 approval use of ondansetron, although the link to ondansetron cannot always be clearly established. The adverse event profiles in children and adolescents were comparable to that seen in adults.
01%) of myocardial infarction, myocardial ischemia, angina, chest pain with or without ST segment depression, arrhythmias (including ventricular or supraventricular tachycardia, premature ventricular contractions, and atrial fibrillation), electrocardiographic alterations (including second degree heart block), palpitations and syncope.
Rarely and predominantly with intravenous ondansetron, transient ECG changes including QTc interval prolongation, Torsade de Pointes, ventricular fibrillation, coronary artery spasm, myocardial ischemia, cardiac arrest, and sudden death have been reported (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
Eye Disorder There have been very rare cases of transient blindness following ondansetron treatment, generally within the recommended dosing range and predominantly during intravenous administration. The majority of blindness cases reported resolved within 20 minutes.
Although most patients had received chemotherapeutic agents, including cisplatin, a few cases of transient blindness occurred following ondansetron administration for the treatment of post-operative nausea or vomiting and in the absence of cisplatin treatment.
Some cases of transient blindness were reported as cortical in origin. Hepatic/Biliary/Pancreatic Occasional asymptomatic increases in liver function tests have been reported. , laryngeal edema, stridor, laryngospasm and cardiopulmonary arrest) have also been reported.
1%) have been reported predominantly during or upon completion of intravenous infusion of ondansetron. ), movement disorders and dyskinesia have been reported without definitive evidence of persistent clinical sequelae. Product Monograph ONDISSOLVE® ODF (ondansetron) Page 16 of 42 Serotonin syndrome and neuroleptic malignant syndrome-like events have been reported with 5-HT3 receptor antagonist antiemetics, including ondansetron, when given in combination with other serotonergic and/or neuroleptic drugs (see 7 WARNINGS AND PRECAUTIONS, Neurologic).
Respiratory, Thoracic and Mediastinal Disorders There have also been rare reports of hiccups. Skin and Subcutaneous Tissue Disorders Very rare reports have been received for bullous skin and mucosal reactions, including fatal cases.
These reports include toxic skin eruptions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, and have occurred in patients taking other medications that can be associated with bullous skin and mucosal reactions.
Maintenance of Anti-Emesis Following Intravenous Doses of Ondansetron used for the Prevention of Nausea and Vomiting Associated with Highly Emetogenic Chemotherapy • Adults: For the maintenance of anti-emesis established by intravenous ondansetron: - 8 mg orally, every 8 hours, for up to 5 days; following the first 24 hours • Pediatrics (<18 years of age): ONDISSOLVE ODF is not indicated for this use in children under 18 years of age.
• Geriatrics Efficacy and tolerance in patients 65 years of age and older were similar to that seen in younger adults. 3 Pharmacokinetics, Geriatrics). • Hepatic Insufficiency No dosage adjustment is needed in patients with mild hepatic impairment.
3 Pharmacokinetics). This may be given as a single oral dose. 3 Pharmacokinetics, Renal Insufficiency). • Prevention of Nausea and Vomiting Associated With Mildly And Moderately Emetogenic Chemotherapy Adults 8 mg orally, 1-2 hours prior to chemotherapy followed by 8 mg orally, twice daily, for up to 5 days.
• Pediatrics (4-<18 years of age): Following chemotherapy*: 4 mg orally, every 8 hours, for up to 5 days *For prevention of chemotherapy induced nausea and vomiting in children 4-17 years of age, intravenous ondansetron should be administered 30 minutes before chemotherapy.
Note:
ONDISSOLVE ODF is only available as an orally disintegrating film. A product monograph for ondansetron hydrochloride injection should be consulted. • Pediatrics (<4 years of age): ONDISSOLVE ODF is not indicated for this use in children under 4 years of age.
3 Pharmacokinetics, Geriatrics). • Hepatic Insufficiency No dosage adjustment is needed in patients with mild hepatic impairment. 3 Pharmacokinetics). This may be given as a single oral dose. 3 Pharmacokinetics, Renal Insufficiency). Prevention of Radiotherapy Induced Nausea and Vomiting • Adults: 8 mg orally, given 1 to 2 hours before radiotherapy followed by 8 mg orally, given every 8 hours, for up to 5 days after a course of treatment.
• Pediatrics (<18 years of age): ONDISSOLVE ODF is not indicated for this use in the pediatric population. 3 Pharmacokinetics, Geriatrics). • Hepatic Insufficiency No dosage adjustment is […]
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