Ondansetron Fresenius

Ondansetron Fresenius

ondansetron

Manufacturer:

Fresenius Kabi

Distributor:

Zuellig
/
The Glory Medicina
Concise Prescribing Info
Contents
Ondansetron
Indications/Uses
Management of cytotoxic chemotherapy- & radiotherapy-induced nausea & vomiting in adults; chemotherapy-induced nausea & vomiting (CINV) in childn ≥6 mth. Prevention & treatment of post-op nausea & vomiting (PONV) in adults & childn ≥1 mth.
Dosage/Direction for Use
Chemotherapy- & radiotherapy-induced nausea & vomiting Adult 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 w/ oral or rectal treatment for up to 5 days to protect against delayed or prolonged emesis after the 1st 24 hr. Adult patient receiving highly emetogenic chemotherapy Single dose of 8 mg by slow IV inj (in not less than 30 sec) or IM inj immediately before chemotherapy; or a dose of 8 mg by slow IV inj (in not less than 30 sec) or IM doses of 8 mg 2-4 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 saline or other compatible infusion fluid & infused over not less than 15 min immediately before chemotherapy. The initial dose may be followed by 2 additional 8 mg IV doses (in not less than 30 sec) or IM doses 4 hr apart. Continue w/ oral or rectal treatment for up to 5 days to protect against delayed or prolonged emesis after the 1st 24 hr. Elderly ≥75 yr Initial IV dose should not exceed 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 adult dose schedule. All IV doses should be diluted in 50-100 mL saline or other compatible infusion fluid & infused over 15 min. Patient w/ renal impairment No alteration of daily dose, frequency of dosing, or route of administration is required. Patient w/ moderate or severe hepatic impairment Total daily dose should not exceed 8 mg. CINV Childn ≥6 mth & adolescent Dilute in dextrose 5% or NaCl 0.9% or other compatible infusion fluid & infuse over not less than 15 min. Single IV dose must not exceed 8 mg. Total dose over 24 hr (as divided doses) must not exceed adult dose of 32 mg. Dosing by BSA: 5 mg/m2 single IV dose, administered immediately before chemotherapy. Oral dosing can commence 12 hr later & may be continued for up to 5 days. Dosing by body wt: 0.15 mg/kg single IV dose, administered immediately before chemotherapy. 2 further IV doses may be given in 4-hrly intervals. Oral dosing can commence 12 hr later & may continued for up to 5 days. PONV Adult Prevention: 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 ≥1 mth & adolescent Prevention: Single dose of 0.1 mg/kg by slow IV inj (not less than 30 sec) either prior to, at or after induction of general anaesth. Max: 4 mg. Treatment: Single dose of 0.1 mg/kg by slow IV inj (not less than 30 sec). Max: 4 mg. Patient w/ moderate or severe hepatic impairment Total daily dose should not exceed 8 mg. Patient w/ renal impairment No alteration of daily dose, frequency of dosing, or route of administration is required.
Contraindications
Hypersensitivity. Concomitant use w/ apomorphine.
Special Precautions
Hypersensitivity reactions in patients who have exhibited hypersensitivity to other selective 5HT3 receptor antagonists. Resp events as precursors of hypersensitivity reactions. QT interval prolongation & Torsade de pointes. Avoid in patients w/ congenital long QT syndrome. Hypokalemia & hypomagnesemia should be corrected prior to administration. Increased large bowel transit time. May mask occult bleeding in patients w/ adenotonsillar surgery. Cases of serotonin syndrome following concomitant use w/ other serotonergic drugs [including SSRIs & serotonin noradrenaline reuptake inhibitors (SNRIs)]. Patients on a controlled Na diet. Women of childbearing potential should consider contraception use. Should not be used during the 1st trimester of pregnancy. Mothers receiving ondansetron should not breast-feed their babies. Closely monitor paed patients concomitantly receiving hepatotoxic chemotherapeutic agents for impaired hepatic function.
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)]. Serotonin syndrome w/ other serotonergic drugs (eg, SSRIs & SNRIs). Profound hypotension & loss of consciousness w/ apomorphine HCl. Increased oral clearance & decreased blood conc w/ potent CYP3A4 inducers (eg, 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 Fresenius soln for inj or infusion 4 mg/2 mL
Packing/Price
5 × 1's
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