Ondansetron-Teva

Ondansetron (as HCl dihydrate)

Management of nausea & vomiting induced by cytotoxic chemotherapy & RT (CINV & RINV) in adults. Prevention of post-op nausea & vomiting (PONV) in adults.

CINV & RINV Adult Recommended dose: 8 mg taken 1-2 hr before chemotherapy or RT, followed by 8 mg every 12 hr for a max of 5 days to protect against delayed or prolonged emesis. For highly emetogenic chemotherapy: Single dose of up to 24 mg ondansetron taken 1-2 hr before chemotherapy w/ 12 mg oral dexamethasone Na phosphate. May be continued for up to 5 days after a course of treatment to protect against delayed or prolonged emesis after the 1st 24 hr. Patient w/ moderate or severe hepatic impairment Max daily dose: 8 mg. PONV Adult Recommended dose: 16 mg taken 1 hr prior to anaesth. Patient w/ moderate or severe hepatic impairment Max daily dose: 8 mg.

May be taken with or without food.

Hypersensitivity. Concomitant use w/ apomorphine.

Reports of hypersensitivity reactions in patients w/ hypersensitivity to other selective 5-HT₃ receptor antagonists. Prolongs QT interval in a dose-dependent manner. Post-marketing reports of torsade de pointes. Avoid use in patients w/ congenital long QT syndrome. Caution in patients who have or may develop QTc prolongation, including those w/ electrolyte abnormalities, CHF, bradyarrhythmias. Hypokalaemia & hypomagnesaemia should be corrected prior to treatment administration. Discontinue treatment if serotonin syndrome occurs. Known to increase large bowel transit time; monitor patients w/ signs of subacute intestinal obstruction following administration. May mask occult bleeding in patients w/ adenotonsillar surgery. Patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Women of childbearing potential should consider contraception use. Do not use during the 1st trimester of pregnancy. Not recommended to breast-feed during treatment. Limited experience in prevention & treatment of PONV in the elderly.

Headache. Sensation of warmth or flushing; constipation.

Caution when co-administered w/ drugs that prolong the QT interval &/or cause electrolyte abnormalities. Additional QT prolongation w/ QT-prolonging drugs. Increased risk of arrhythmias w/ cardiotoxic drugs (eg, anthracyclines [eg, doxorubicin, daunorubicin] or trastuzumab), antibiotics (eg, erythromycin), antifungals (eg, ketoconazole), antiarrhythmics (eg, amiodarone), & β-blockers (eg, atenolol, timolol). Risk of serotonin syndrome w/ other serotonergic drugs, including SSRIs & SNRIs. Profound hypotension & loss of consciousness w/ apomorphine HCl. Decreased blood conc w/ potent CYP3A4 inducers (ie, phenytoin, carbamazepine, rifampicin). Reduced analgesic effect of tramadol.

Antiemetics / Supportive Care Therapy

A04AA01 - ondansetron ; Belongs to the class of serotonin (5HT3) antagonists. Used for the prevention of nausea and vomiting.

P₁S₁S₃