MINT-ONDANSETRON SOLUTION 4 MG / 5 ML — DIN 02524090

What is MINT-ONDANSETRON SOLUTION?

MINT-ONDANSETRON SOLUTION 4 MG / 5 ML contains ONDANSETRON (ONDANSETRON HYDROCHLORIDE) : 4 MG / 5 ML. It is listed in the Health Canada Drug Product Database under DIN 02524090, held by MINT PHARMACEUTICALS INC, supplied as SOLUTION for ORAL administration. Health Canada currently lists it as marketed, status dated 11-Sep-2024. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is MINT-ONDANSETRON SOLUTION used for?

MINT-ONDANSETRON SOLUTION (ondansetron hydrochloride dihydrate) is indicated for: • the prevention of nausea and vomiting associated with mildly and moderately emetogenic chemotherapy and radiotherapy. • the maintenance of anti-emesis following intravenous doses of ondansetron used for the prevention of nausea and vomiting associated with highly emetogenic chemotherapy, including cisplatin. • the prevention of post-operative nausea and vomiting. Pediatrics (4-12 years of age): Ondansetron hydrochloride dihydrate was effective and well tolerated when given to children 4-12 years of age. Geriatrics (>65 years of age): Efficacy and tolerance of ondansetron hydrochloride were similar to that observed in younger adults for the prevention of post-chemotherapy and radiotherapy induced nausea and vomiting.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

Dosing considerations that reduce cardiac risks: - Use the minimum effective dose. - Use oral formulations if possible (lower Cmax). Maintenance of Anti-Emesis Following Intravenous Doses of Ondansetron Used for the Prevention of Nausea and Vomiting Associated with Highly Emetogenic Chemotherapy: Adults: 8 mg orally every 8 hours, for up to 5 days; following the first 24 hours. Pediatrics (<18 years of age): MINT-ONDANSETRON SOLUTION is not indicated for this use in children under 18 years of age. Prevention of Less Emetogenic Chemotherapy Induced Nausea and Vomiting: 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 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 SOLUTION is only available as an oral solution. A product monograph for ondansetron hydrochloride injection should be consulted. Pediatrics (<4 years of age): MINT-ONDANSETRON SOLUTION is not indicated for this use in children under 4 years of age. Geriatrics (≥65 years of age): Efficacy and tolerance in patients aged over 65 years were similar to that seen in younger adults indicating no need to alter dosage schedules in this population. 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): MINT-ONDANSETRON SOLUTION is not indicated for this use in the pediatric population. Geriatrics (≥65 years of age): Efficacy and tolerance in patients aged over 65 years were similar to that seen in younger adults indicating no need to alter dosage schedules in this population. Prevention of Post-Operative Nausea and Vomiting: Adults: 16 mg orally, administered 1 hour prior to the induction of anaesthesia. Pediatrics (<18 years of age): MINT-ONDANSETRON SOLUTION is not indicated for this use in the pediatric population. Geriatrics (≥65 years of age): MINT-ONDANSETRON SOLUTION is not indicated for this use in the elderly.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

MINT-ONDANSETRON SOLUTION (ondansetron hydrochloride) is contraindicated in patients with a history of hypersensitivity to the drug or any components of its formulations. The concomitant use of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron.

Warnings and precautions

QTc Interval Prolongation: Ondansetron prolongs the QT interval. The magnitude of QTc prolongation will depend on the peak serum ondansetron concentration (Cmax), which is substantially determined by the route of administration, the dose and the infusion rate of intravenous ondansetron. Post-marketing cases of torsade de pointes have been reported. Torsade de pointes may be asymptomatic or experienced by the patient as dizziness, palpitations, syncope, or seizures. If sustained, torsade de pointes can progress to ventricular fibrillation and sudden cardiac death. Avoid ondansetron in patients with congenital long QT syndrome. Administer with caution to patients who have or may develop prolongation of QTc, including congestive heart failure, bradyarrhythmias or patients taking other medicinal products that lead to either QT prolongation or electrolyte abnormalities. Hypokalaemia, hypocalcaemia and hypomagnesemia should be corrected prior to ondansetron administration. Myocardial Ischemia and Coronary Artery Spasm: Ondansetron can cause coronary artery vasospasm and myocardial ischemia which may lead to myocardial infarction. Symptoms appeared immediately after IV infusion, or shortly after oral administration, including after low doses in patients without significant known pre-existing cardiovascular disease or other risk factors. Caution is advised during and after ondansetron administration, and close monitoring is recommended in patients with known or suspected ischemic or vasospastic coronary artery disease or other significant underlying cardiovascular disease. Serotonin syndrome/Neuroleptic Malignant Syndrome: Cases of life-threatening serotonin syndrome or neuroleptic malignant syndrome-like events have been reported with 5-HT3 receptor antagonist antiemetics, including ondansetron hydrochloride, when given in combination with other serotonergic and/or neuroleptic drugs. Symptoms may include mental status changes, autonomic instability, neuromuscular aberrations and/or gastrointestinal symptoms. Treatment should be discontinued if such events occur and supportive symptomatic treatment should be initiated. If concomitant treatment with MINT-ONDANSETRON SOLUTION with a drug affecting the serotonergic neurotransmitter system is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.