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PMS-ONDANSETRON ODT is a brand name for Ondansetron, supplied as a tablet (orally disintegrating). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 02/2022 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 02/2022 7 WARNINGS AND PRECAUTIONS, Cardiovascular, Myocardial Ischemia and Coronary Artery Spasm 02/2022 7 WARNING AND PRECAUTIONS, Special Populations, 7.1.1 Pregnant Women 02/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the…
Verbatim from this product's HC label. Tap a section to expand.
1 Pregnant Women 02/2022 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 .............................................................................................. 4 4 DOSAGE AND ADMINISTRATION .............................................................................. 1 Dosing Considerations.................................................................................
2 Recommended Dose and Dosage Adjustment ........................................... 4 Administration............................................................................................. 8 5 OVERDOSAGE ..........................................................................................................
8
2 Clinical Trial Adverse Reactions Because 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 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.
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%). 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. g. blurred vision) have been reported during or shortly after intravenous administration of ondansetron, particularly at rates equal to or greater than 30 mg in 15 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. Local Reactions Pain, redness and burning at the site of injection have been reported.
1 Pregnant Women 02/2022 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 .............................................................................................. 4 4 DOSAGE AND ADMINISTRATION .............................................................................. 1 Dosing Considerations.................................................................................
2 Recommended Dose and Dosage Adjustment ........................................... 4 Administration............................................................................................. 8 5 OVERDOSAGE ..........................................................................................................
8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................... 8 7 WARNINGS AND PRECAUTIONS................................................................................ 1 Special Populations ...................................................................................
1 Pregnant Women ..................................................................................... 2 Breast-feeding .......................................................................................... 3 Pediatrics ..................................................................................................
Product Monograph pms-ONDANSETRON ODT (ondansetron) Page 5 of 40 pms-ONDANSETRON ODT (ondansetron) is contraindicated in patients with a history of hypersensitivity to the drug or any components of its formulations.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ondansetron in Canada.
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Product Monograph pms-ONDANSETRON ODT (ondansetron) Page 14 of 40 Metabolic There have been rare reports of hypokalaemia. 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-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.
, laryngeal oedema, stridor, laryngospasm and cardiopulmonary arrest) have also been reported. 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. Product Monograph pms-ONDANSETRON ODT (ondansetron) Page 15 of 40 Hepatic/ Biliary / Pancreatic Occasional asymptomatic increases in liver function tests have been reported.
1%) have been reported predominantly during or upon completion of IV infusion of ondansetron. ), movement disorders and dyskinesia have been reported without definitive evidence of persistent clinical sequelae. 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.
4 Geriatrics .................................................................................................. 12 8 ADVERSE REACTIONS ............................................................................................. 2 Clinical Trial Adverse Reactions ................................................................
5 Post-Market Adverse Reactions ................................................................ 14 Product Monograph pms-ONDANSETRON ODT (ondansetron) Page 3 of 40 9 DRUG INTERACTIONS .............................................................................................
1 Serious Drug Interactions .......................................................................... 2 Drug Interactions Overview ...................................................................... 4 Drug-Drug Interactions .............................................................................
5 Drug-Food Interactions ............................................................................. 6 Drug-Herb Interactions ............................................................................. 7 Drug-Laboratory Test Interactions ............................................................
18 10 CLINICAL PHARMACOLOGY .................................................................................... 1 Mechanism of Action ................................................................................ 2 Pharmacodynamics ...................................................................................
3 Pharmacokinetics ...................................................................................... 20 11 STORAGE, STABILITY AND DISPOSAL....................................................................... 23 PART II: SCIENTIFIC INFORMATION ..................................................................................
24 13 PHARMACEUTICAL INFORMATION ......................................................................... 24 14 CLINICAL TRIALS ..................................................................................................... 1 Trial Design and Study Demographics ......................................................
2 Study Results ............................................................................................. 3 Comparative Bioavailability Studies.......................................................... 26 16 NON-CLINICAL TOXICOLOGY ...................................................................................
27 17 SUPPORTING PRODUCT MONOGRAPHS ................................................................. 31 PATIENT MEDICATION INFORMATION ............................................................................. 1 Pediatrics (< 18 years of age) Post-Chemotherapy Induced Nausea and Vomiting Pediatrics (4 - 12 years of age): Ondansetron was effective and well tolerated when given to children 4-12 years of age.
Pediatrics (< 4 years of age): pms-ONDANSETRON ODT is not indicated for the treatment of children less than 4 years old. […]
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