Ondansetron Kabi

Ondansetron Kabi

ondansetron

Manufacturer:

Fresenius Kabi

Distributor:

Zuellig
/
The Glory Medicina
Concise Prescribing Info
Contents
Ondansetron
Indications/Uses
Management of cytotoxic chemotherapy- & RT-induced nausea & vomiting (CINV & RINV) in adults; CINV in childn ≥6 mth. Prevention & treatment of post-op nausea & vomiting (PONV) in adults & childn ≥1 mth.
Dosage/Direction for Use
Adult CINV & RINV Receiving emetogenic chemotherapy & RT 8 mg by slow IV inj (in not less than 30 sec) or IM inj immediately before treatment, followed by 8 mg orally 12 hrly. Continue oral treatment for up to 5 days after a course of treatment to protect against delayed or prolonged emesis after the 1st 24 hr. Receiving highly emetogenic chemotherapy Efficacy of ondansetron may be enhanced by the administration of a single IV dose of 20 mg dexamethasone Na phosphate prior to chemotherapy. Dose schedules over the 1st 24 hr of chemotherapy: Single dose of 8 mg by slow IV inj (in not less than 30 sec) or IM inj immediately before chemotherapy; or 8 mg by slow IV inj (in not less than 30 sec) or IM inj immediately before chemotherapy, followed by 2 further IV inj (in not less than 30 sec) or IM doses of 8 mg 4 hr apart, or by a constant infusion of 1 mg/hr for up to 24 hr; or max initial IV dose of 16 mg diluted in 50-100 mL of saline or other compatible infusion fluid & infused over not less than 15 min immediately before chemotherapy. Max single dose: 16 mg. Continue oral treatment for up to 5 days after a course of treatment to protect against delayed or prolonged emesis after the 1st 24 hr. Prevention of PONV Single dose of 4 mg by IM or slow IV inj at induction of anaesth. Treatment of established PONV Single dose of 4 mg by IM or slow IV inj. Childn & adolescent 6 mth to 17 yr CINV Dilute in 5% dextrose or 0.9% NaCl or other compatible infusion fluid & infuse intravenously over not less than 15 min. Wt-based dosing results in higher total daily doses compared to BSA-based dosing. BSA-based dosing: Administer immediately before chemotherapy as a single IV dose of 5 mg/m2, must not exceed 8 mg. Oral dosing can commence 12 hr later & may be continued for up to 5 days. Total dose over 24 hr (given as divided doses) must not exceed adult dose of 32 mg. BSA >1.2 m2 5 mg/m2 or 8 mg IV + 8 mg syr or tab after 12 hr on day 1, followed by 8 mg syr or tab every 12 hr on days 2-6, 0.6-1.2 m2 5 mg/m2 IV + 4 mg syr or tab after 12 hr on day 1, followed by 4 mg syr or tab every 12 hr on days 2-6, <0.6 m2 5 mg/m2 IV + 2 mg syr after 12 hr on day 1, followed by 2 mg syr every 12 hr on days 2-6. Wt-based dosing: Administer immediately before chemotherapy as a single IV dose of 0.15 mg/kg, must not exceed 8 mg. 2 further IV doses may be given in 4 hrly intervals. Oral dosing can commence 12 hr later & may be continued for up to 5 days. Total dose over 24 hr (given as divided doses) must not exceed adult dose of 32 mg. Weighing >10 kg Up to 3 doses of 0.15 mg/kg IV every 4 hr on day 1, followed by 4 mg syr or 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, followed by 2 mg syr every 12 hr on days 2-6. Childn & adolescent 1 mth to 17 yr Prevention of PONV Single dose of 0.1 mg/kg by slow IV inj (not less than 30 sec) up to a max of 4 mg either prior to, at or after induction of anaesth. Treatment of PONV Single dose of 0.1 mg/kg by slow IV inj (not less than 30 sec) up to a max of 4 mg. Elderly CINV & RINV Dilute in 50-100 mL of saline or other compatible infusion fluid & infuse intravenously over 15 min. ≥75 yr Max initial IV dose: 8 mg, may be followed by 2 further IV doses of 8 mg, infused over 15 min & given no less than 4 hr apart, 65-74 yr Follow dose schedule for adults. Patient w/ moderate or severe hepatic impairment Max total daily dose: 8 mg.
Contraindications
Hypersensitivity. Concomitant use w/ apomorphine.
Special Precautions
Patients w/ hypersensitivity to other selective 5-HT3 receptor antagonists. Resp events as precursors of hypersensitivity reactions. Prolongs QT interval in a dose-dependent manner. Post-marketing reports of torsade de pointes. Avoid use in patients w/ congenital long QT syndrome. Administer w/ caution to patients who have or may develop QTc prolongation, including patients w/ electrolyte abnormalities, CHF, bradyarrhythmias or patients taking other medicinal products that lead to QT prolongation or electrolyte abnormalities. Correct hypokalaemia & hypomagnesaemia prior to administration. Monitor patients w/ signs of sub-acute intestinal obstruction following administration. Prevention of nausea & vomiting may mask occult bleeding in patients undergoing adenotonsillar surgery. Concomitant use w/ other serotonergic drugs (including SSRIs & SNRIs) &/or neuroleptic drugs. Patients w/ moderate or severe hepatic impairment. Women of childbearing potential should consider contraception use. Do not use during the 1st trimester of pregnancy. Do not breast-feed while on treatment. Limited experience in the prevention & treatment of PONV in the elderly. No data in the prevention of delayed or prolonged CINV in paed patients; treatment of PONV in childn <2 yr. Paed patients receiving ondansetron w/ hepatotoxic chemotherapeutic agents should be monitored closely for hepatic impairment.
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 [eg, doxorubicin, daunorubicin] or trastuzumab), antibiotics (eg, erythromycin), antifungals (eg, ketoconazole), antiarrhythmics (eg, amiodarone) & β-blockers (eg, atenolol or timolol). Post-marketing reports of serotonin syndrome w/ other serotonergic drugs (including SSRIs & SNRIs). Reports of profound hypotension & loss of consciousness w/ apomorphine HCl. Increased oral clearance & decreased blood conc w/ potent CYP3A4 inducers (ie, phenytoin, carbamazepine, rifampicin). Reduced analgesic effect of tramadol.
MIMS Class
Antiemetics / Supportive Care Therapy
ATC Classification
A04AA01 - ondansetron ; Belongs to the class of serotonin (5HT3) antagonists. Used for the prevention of nausea and vomiting.
Presentation/Packing
Form
Ondansetron Kabi soln for inj 4 mg/2 mL
Packing/Price
5 × 1's
Form
Ondansetron Kabi soln for inj 8 mg/4 mL
Packing/Price
5 × 1's
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