Onsia

Ondansetron HCl dihydrate

Chemotherapy- & RT-induced nausea & vomiting. Prevention & treatment of post-op nausea & vomiting.

Tab Adult Chemotherapy- & RT-induced nausea & vomiting Highly emetogenic chemotherapy: 24 mg as single dose 1-2 hr before single-day chemotherapy &/or RT. Emetogenic chemotherapy &/or RT: 8 mg 1-2 hr before chemotherapy &/or RT followed by 8 mg 8-12 hr after 1st dose. Continue w/ 8 mg every 12 hr for up to 5 days therapy. Prevention of post-op nausea & vomiting 16 mg as single dose 1 hr before anesth. Childn 4-11 yr Chemotherapy- & RT-induced nausea & vomiting Emetogenic chemotherapy &/or RT: 4 mg 1-2 hr before chemotherapy &/or RT, followed by 4 mg administered 4 & 8 hr after 1st dose. Continue 4 mg every 8 hr for 1-2 days after chemotherapy &/or RT. Moderate or severe liver disease Max: 8 mg. Inj Chemotherapy- & RT-induced nausea & vomiting Highly emetogenic chemotherapy: Adult 8 mg as single slow IV or IM over 15 min, beginning 30 min before chemotherapy. Alternatively, 8 mg as single slow IV or IM immediately before chemotherapy, followed by 2 doses of 8 mg at 2-4 hr interval or by continuous 1 mg/hr infusion for up to 24 hr. May give IV dexamethasone 20 mg before chemotherapy. Administer 8 mg PO bid for up to 5 days after chemotherapy course. Childn 6 mth-17 yr 5 mg/m² as single IV immediately before chemotherapy &/or RT, followed by 4 mg PO 12 hr later, or 8 mg as single IV before chemotherapy followed by 8 mg PO 12 hr later. May continue ondansetron PO for up to 5 days after end of chemotherapy course, >6 mth 0.15 mg/kg as single IV before chemotherapy, followed by subsequent doses, 4 & 8 hr after 1st dose. Max: 8 mg. Prevention & treatment of post-op nausea & vomiting Adult 4 mg as single IV bolus or IM before induction of anesth. Childn 1 mth-17 yr weighing >40 kg 4 mg as single IV bolus, <40 kg 0.1 mg/kg as single IV bolus. Severe hepatic impairment Max daily dose: 8 mg infused over 15 min, 30 min before chemotherapy &/or RT.

May be taken with or without food.

Hypersensitivity to ondansetron or other selective 5-HT₃ antagonist.

Discontinue at 1st sign of rash or any other sign of hypersensitivity eg, urticaria, angioedema, hypotension, bronchospasm, labored respiration. Not to be used as substitute for nasogastric suction. May mask progressive ileus &/or gastric distension in patients undergoing abdominal surgery or w/ chemotherapy- &/or RT-induced nausea & vomiting. Patients w/ hypersensitivity to other selective 5-HT₃ receptor antagonists. Monitor hypersensitivity reactions including urticaria, angioedema, hypotension, bronchospasm & labored respiration. Moderate to severe hepatic impairment. Severe renal function impairment (CrCl <30 mL/min). Pregnancy & lactation. Childn <4 yr. Elderly. Inj: Transient ECG changes including QT interval prolongation w/ IV use. Not to be mixed w/ alkaline soln.

Headache, malaise/fatigue, drowsiness, fever, dizziness, anxiety, cold sensation, insomnia; constipation, diarrhea, dyspepsia, heartburn, thirst, flatulence, abdominal cramp, abnormal taste, anorexia, intestinal obstruction; pruritus, rash, inj site reaction (pain, erythema, swelling & burning), urticaria; gynecological disorder, urinary retention; paresthesia; hypoxia, hiccups; hypotension, HTN; increased ALT/AST, hepatosplenomegaly, jaundice, liver failure, increased bilirubin & γ-glutamyltransferase; transient blurred vision, blindness, oculogyric crisis; anaphylactoid reactions, anaphylaxis, angina, angioedema, arrhythmia, bradycardia, bronchospasm, cardiopulmonary arrest, ECG changes, electrocardiographic alterations (2nd degree heart block & ST-segment depression), extrapyramidal symptoms, flushing, laryngeal edema, laryngospasm, increased QT interval, shock, stridor, supraventricular tachycardia, syncope, tachycardia, vascular occlusive events, ventricular arrhythmia. FC tab: Dyspnea, dystonic reaction, grand mal seizure, hypokalemia, palpitation, premature ventricular contractions.

Increased clearance w/ carbamazepine & phenytoin. Decreased plasma conc w/ rifamycins. Decreased plasma conc of cisplatin & cyclophosphamide. Enhanced hypotensive effect of apomorphine.

Supportive Care Therapy / Antiemetics

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

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