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ONDANSETRON is a brand name for Ondansetron, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 11/2024 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 11/2024 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 11/2024 4 DOSAGE AND ADMINISTRATION, 4.5 Missed Dose 11/2024 7 WARNINGS AND PRECAUTIONS, Serotonin Toxicity/Neuroleptic Malignant Syndrome 11/2024 TABLE OF CONTENTS Sections or…
Verbatim from this product's HC label. Tap a section to expand.
5 Missed Dose 11/2024 7 WARNINGS AND PRECAUTIONS, Serotonin Toxicity/Neuroleptic Malignant Syndrome 11/2024 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 .................................................................................................................... 4 2 CONTRAINDICATIONS ..................................................................................................
5 4 DOSAGE AND ADMINISTRATION.................................................................................. 1 Dosing Considerations ............................................................................................... 2 Recommended Dose and Dosage Adjustment ..........................................................
4 Administration ........................................................................................................... 5 Missed Dose ...............................................................................................................
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 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 (Ondansetron Tablets) page 14 of 42 Protected B / Protégé B 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.
, Serotonin Toxicity/Neuroleptic Malignant Syndrome 11/2024 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 .................................................................................................................... 4 2 CONTRAINDICATIONS ..................................................................................................
5 4 DOSAGE AND ADMINISTRATION.................................................................................. 1 Dosing Considerations ............................................................................................... 2 Recommended Dose and Dosage Adjustment ..........................................................
4 Administration ........................................................................................................... 5 Missed Dose ...............................................................................................................
8 5 OVERDOSAGE.............................................................................................................. 9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................. 9 7 WARNINGS AND PRECAUTIONS .................................................................................
• ONDANSETRON 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).
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 hypokalaemia. 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- 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 oedema, stridor, laryngospasm and cardiopulmonary arrest) have also 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).
ONDANSETRON (Ondansetron Tablets) page 16 of 42 Protected B / Protégé B 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.
1 Special Populations .................................................................................................. 1 Pregnant Women .....................................................................................................
2 Breast-feeding .......................................................................................................... 3 Pediatrics..................................................................................................................
4 Geriatrics .................................................................................................................. 13 8 ADVERSE REACTIONS.................................................................................................
1 Adverse Reaction Overview ..................................................................................... 2 Clinical Trial Adverse Reactions ............................................................................... 5 Post-Market Adverse Reactions...............................................................................
14 9 DRUG INTERACTIONS ................................................................................................ 1 Serious Drug Interactions ........................................................................................
2 Drug Interactions Overview ..................................................................................... 3 Drug-Behavioural Interactions ................................................................................. 4 Drug-Drug Interactions ............................................................................................
5 Drug-Food Interactions ............................................................................................ 6 Drug-Herb Interactions ............................................................................................
7 Drug-Laboratory Test Interactions........................................................................... 19 10 CLINICAL PHARMACOLOGY ........................................................................................ 1 Mechanism of Action.................................................................................................
2 Pharmacodynamics .................................................................................................. 3 Pharmacokinetics .....................................................................................................
21 11 STORAGE, STABILITY AND DISPOSAL .......................................................................... 23 12 SPECIAL HANDLING INSTRUCTIONS............................................................................ 23 PART II: SCIENTIFIC INFORMATION .......................................................................................
24 13 PHARMACEUTICAL INFORMATION ............................................................................ 24 14 CLINICAL TRIALS ........................................................................................................
1 Clinical Trials by Indication ...................................................................................... 25 Prevention of Chemotherapy Induced Emesis .................................................................. 25 Prevention of Post-Operative Emesis ................................................................................
25 Prevention of Radiotherapy Induced Emesis..................................................................... 3 Comparative Bioavailability Studies ........................................................................ 27 15 MICROBIOLOGY ........................................................................................................
27 16 NON-CLINICAL TOXICOLOGY […]
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