SM Pharmaceuticals


SM Pharmaceuticals
Concise Prescribing Info
Ondansetron HCl dihydrate
Management of cytotoxic chemo- & radiotherapy-induced nausea & vomiting (CINV & RINV). Prevention & treatment of post-op nausea & vomiting (PONV).
Dosage/Direction for Use
CINV & RINV Adult 8 mg IV or IM prior to treatment, may be followed by 2 additional 8 mg IV or IM doses 2-4 hr apart or by constant 1 mg/hr infusion for up to 24 hr. Highly emetogenic chemotherapy Max initial dose: 16 mg IV infused over 15 min, may be enhanced w/ single IV dose of dexamethasone Na phosphate 20 mg prior to chemotherapy. Elderly ≥75 yr Initially not >8 mg infused over 15 min, may be followed by 2 doses of 8 mg infused over 15 min & given no <4 hr apart; 65-74 yr Initially 8 or 16 mg infused over 15 min, may be followed by 2 doses of 8 mg infused over 15 min & given no <4 hr apart. CINV Childn & adolescent 3-17 yr, >1.2 m2 5 mg/m2 or 8 mg IV + 8 mg tab after 12 hr on day 1, then 8 mg tab every 12 hr on days 2-6; ≥0.6 m2 to ≤1.2 m2 5 mg/m2 IV + 4 mg tab after 12 hr on day 1, then 4 mg tab every 12 hr on days 2-6; >10 kg Up to 3 doses of 0.15 mg/kg IV every 4 hr on day 1, then 4 mg tab every 12 hr on days 2-6. Prevention & treatment of established PONV Adult 4 mg single IM dose or slow IV inj at anesth induction. Childn & adolescent 3-17 yr 0.1 mg/kg by slow IV inj not <30 sec up to max: 4 mg prior to or after anesth induction, or after surgery. Moderate or severe hepatic impairment Not to exceed 8 mg total daily dose.
Hypersensitivity to ondansetron or other selective 5-HT3 receptor antagonists eg, granisetron, dolasetron. Concomitant use w/ apomorphine.
Special Precautions
Hypersensitivity to other selective 5-HT3 receptor antagonists. Avoid use in patients w/ congenital long QT syndrome. Patients w/ QTc prolongation, electrolyte abnormalities, CHF, bradyarrhythmias; serotonin syndrome eg, altered mental status, autonomic instability, neuromuscular abnormalities; signs of subacute intestinal obstruction; adenotonsillar surgery. Patients on controlled Na diet. Correct hypokalemia & hypomagnesaemia prior to treatment. Concomitant use w/ medicinal products leading to QT prolongation or electrolyte abnormalities; serotonergic drugs eg, SSRIs & SNRIs. Moderate to severe hepatic impairment. Not recommended during pregnancy & lactation. Monitor hepatic impairment in paed patients receiving concomitant hepatotoxic chemotherapeutic agents.
Adverse Reactions
Headache. Sensation of warmth or flushing; constipation; local IV inj site reactions.
Drug Interactions
Additional QT prolongation w/ QT prolonging drugs. Increased risk of arrhythmias w/ cardiotoxic drugs eg, anthracyclines (doxorubicin, daunorubicin, trastuzimab), antibiotics (erythromycin, ketoconazole), antiarrhythmics (amiodarone), β-blockers (atenolol or timolol). Serotonin syndrome w/ other serotonergic drugs eg, 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. Drugs causing electrolyte abnormalities.
MIMS Class
ATC Classification
A04AA01 - ondansetron ; Belongs to the class of serotonin (5HT3) antagonists. Used for the prevention of nausea and vomiting.
Ondrin soln for inj 4 mg/2 mL
5 × 1's
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