APO-ONDANSETRON 8 MG — DIN 02288192

What is APO-ONDANSETRON?

APO-ONDANSETRON 8 MG contains ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) : 8 MG. It is listed in the Health Canada Drug Product Database under DIN 02288192, held by APOTEX INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 16-Nov-2006. 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 APO-ONDANSETRON used for?

APO-ONDANSETRON (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 to 12 years of age): Ondansetron hydrochloride dihydrate was effective and well tolerated when given to children 4 to 12 years of age. Geriatrics (≥ 65 years of age): Efficacy and tolerance of ondansetron hydrochloride dihydrate were similar to that observed in younger adults for 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?

APO-ONDANSETRON is only marketed as an oral use formulation. Dosing considerations to reduce cardiac risks: Use the minimum effective dose and 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): Not indicated for this use. 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. Pediatrics (<4 years of age): Not indicated for this use. Geriatrics (≥65 years of age): No need to alter dosage schedules. 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): Not indicated for this use. Geriatrics (≥65 years of age): No need to alter dosage schedules. Post-Operative Nausea and Vomiting: Adults: 16 mg orally, administered 1 hour prior to the induction of anaesthesia. Pediatrics (<18 years of age): Not indicated for this use. Geriatrics (≥65 years of age): Not indicated for this use. Administration of Tablets: APO-ONDANSETRON tablets should be swallowed whole, with a liquid.

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

Contraindications

APO-ONDANSETRON 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 depends on peak serum ondansetron concentration, route of administration, dose, and infusion rate. Post-marketing cases of torsade de pointes have been reported. 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. Caution and close monitoring are advised 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, when given in combination with other serotonergic and/or neuroleptic drugs. Treatment should be discontinued if such events occur and supportive symptomatic treatment should be initiated. Careful observation is advised if concomitant treatment with a drug affecting the serotonergic neurotransmitter system is clinically warranted. Reproductive Health: Pregnancy status should be verified for females of reproductive potential. Females should be advised that APO-ONDANSETRON can cause harm to the developing foetus and should use effective contraception during treatment and for two days after stopping treatment.