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MINT-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: , Adults 06/2022 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 06/2022 7 WARNING AND PRECAUTIONS, Cardiovascular, Myocardial Ischemia and Coronary Artery Spasm 06/2022 7 WARNING AND PRECAUTIONS, Special Populations, 7.1.1 Pregnant Women 04/2021 TABLE OF CONTENTS Sections or subsections that…
Verbatim from this product's HC label. Tap a section to expand.
1 Pregnant Women 04/2021 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 ......................................................................................................... 7 5 OVERDOSAGE .................................................................................................................
7
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 hydrochloride 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:
Product Monograph MINT-ONDANSETRON (ondansetron hydrochloride dihydrate) Page 12 of 37 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.
, Hepatic. MINT-ONDANSETRON has important cardiac side-effects (dose-dependent QTc prolongation, coronary artery spasm, myocardial ischemia, and sequelae). These effects are reported more often with intravenous administration, and are expected to be greater with a faster rate of infusion.
2 Pharmacodynamics, Electrocardiography. Though ondansetron hydrochloride efficacy and tolerance were similar for elderly compared to younger adults in chemotherapy clinical trials, exposure-response modelling predicted a greater effect on QTcF in patients ≥75 years of age compared to young adults.
3 Pharmacokinetics, Geriatrics. Dosing considerations that reduce cardiac risks: - Use the minimum effective dose. - Use oral formulations if possible (lower Cmax). 2 Recommended Dose and Dosage Adjustment Prevention of Highly Emetogenic Chemotherapy Induced Nausea and Vomiting MINT-ONDANSETRON is not indicated for this use.
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: o 8 mg orally every 8 hours, for up to 5 days; following the first 24 hours Product Monograph MINT-ONDANSETRON (ondansetron hydrochloride dihydrate) Page 6 of 37 Pediatrics (<18 years of age): o MINT-ONDANSETRON ODT is not indicated for this use in children under 18 years of age.
1 Dosing Considerations. Adults: o 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): o Following chemotherapy: 4 mg orally, every 8 hours. For prevention of chemotherapy induced nausea and vomiting in children 4-18 years of age, intravenous ondansetron should be administered 30 minutes before chemotherapy.
Note:
MINT-ONDANSETRON (ondansetron hydrochloride) 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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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.
Metabolic:
There have been rare reports of hypokalaemia. 5 Post-Market Adverse Reactions Over 250 million patient treatment days of ondansetron hydrochloride have been supplied since the launch of the product worldwide. The following events have been spontaneously reported during post-approval use of ondansetron hydrochloride, 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 Product Monograph MINT-ONDANSETRON (ondansetron hydrochloride dihydrate) Page 13 of 37 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. 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 MINT-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.
MINT-ONDANSETRON is only available as oral tablets. A product monograph for ondansetron hydrochloride injection should be consulted. Pediatrics (<4 years of age): MINT-ONDANSETRON is not indicated for use in children under 4 years of age.
3 Pharmacokinetics, Geriatrics). 1 Dosing Considerations. 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): MINT-ONDANSETRON is not indicated for this use in this pediatric population.
3 Pharmacokinetics, Geriatrics). Product Monograph MINT-ONDANSETRON (ondansetron hydrochloride dihydrate) Page 7 of 37 Prevention of Post-Operative Nausea and Vomiting Adults: o 16 mg orally, administered 1 hour prior to induction of anaesthesia Pediatrics (<18 years of age): MINT-ONDANSETRON is not indicated for this use in this pediatric population.
Geriatrics (>65 years of age): MINT-ONDANSETRON is not indicated for this use in the elderly. 4 Administration Administration of Tablets MINT-ONDANSETRON tablets should be swallowed whole, with a liquid. 5 OVERDOSAGE At present there is little information concerning overdosage with ondansetron.
Individual doses of 84 mg and 145 mg and total daily doses as large as 252 mg have been administered with only mild side effects. There is no specific antidote for ondansetron, therefore, in cases of suspected overdosage, symptomatic and supportive therapy should be given as appropriate.
The use of Ipecac to treat overdosage with ondansetron is not recommended as patients are unlikely to respond due to the antiemetic action of ondansetron itself. “Sudden blindness” (amaurosis) of 2 to 3 minutes duration plus severe constipation occurred in one patient that was administered 72 mg of ondansetron intravenously as a single dose.
Hypotension (and faintness) occurred in another patient that took 48 mg of oral ondansetron. Following infusion of 32 mg over only a 4-minute period, a vasovagal episode with transient second-degree heart block was observed. 15 mg/kg dose for a paediatric patient).
In all instances, the events resolved completely. 2 Pharmacodynamics). ECG monitoring is recommended in cases of overdose. Cases consistent with serotonin syndrome have been reported in young children following oral overdose. For management of a suspected drug overdose, contact your regional poison control centre.
Product Monograph MINT-ONDANSETRON (ondansetron hydrochloride dihydrate) Page 8 of 37 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging MINT-ONDANSETRON Tablets 4 mg: Yellow colored, round shaped, biconvex film-coated tablets debossed with ‘I’ on one side and ‘55’ on other side.
Each tablet contains 4 mg ondansetron (as ondansetron hydrochloride dihydrate). Available […]
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