Ondavell

Ondavell

ondansetron

Manufacturer:

Novell

Distributor:

Goldplus
Concise Prescribing Info
Contents
Ondansetron
Indications/Uses
Adult: Management of nausea & vomiting induced by cytotoxic chemotherapy & radiotherapy. Prevention & treatment of post-op nausea & vomiting. Paed: Management of nausea & vomiting induced by cytotoxic chemotherapy.
Dosage/Direction for Use
Tab Adult Prevention of post-op nausea & vomiting (PONV) 16 mg given 1 hr prior anaesth. Inj Adult Chemotherapy & radiotherapy induced nausea & vomiting (CINV & RINV) 8 mg IV or IM immediately before treatment. Doses of ≤8 mg do not need to be diluted & may be administered as slow IM or IV inj in not less than 30 sec. The initial dose may be followed by 2 additional IV or IM doses of 8 mg 2-4 hr apart or by constant infusion of 1 mg/hr for up to 24 hr. Highly emetogenic chemotherapy Max initial dose of 16 mg IV infused over 15 min. CINV Childn & adolescent (≥2 yr) of 0.6-1.2 m2 5 mg/m2 as single IV immediately before chemotherapy followed by 4 mg orally 12 hr later. Continue orally w/ 4 mg bd for up to 5 days after a course of treatment. CINV & RINV Elderly ≥75 yr Max: 8 mg infused over 15 min. Initially 8 mg followed by 2 doses of 8 mg infused over 15 min & given less than 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 less than 4 hr apart. Prevention of PONV Adult 4 mg as single dose by IM or slow IV inj administered at the induction of anaesth. Treatment of established PONV 4 mg as single dose by IM or slow IV inj. Prevention & treatment of PONV Childn & adolescent (≥2 yr) 0.1 mg/kg up to a max of 4 mg administered by slow IV inj (not less than 30 sec) prior to , at or after induction of anaesth or after surgery.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concomitant use w/ apomorphine.
Special Precautions
Hypersensitivity to other selective 5-HT3 receptor antagonists. Avoid in patients w/ congenital long QT syndrome. Patients w/ electrolyte abnormalities, CHF, bradyarrhythmias; cardiac rhythm or conduction disturbances, those treated w/ antiarrhythmics or β-adrenergic blocking agents. Hypokalaemia & hypomagnesaemia should be corrected prior to administration. Concomitant use w/ other serotonergic drugs. Monitor signs of subacute intestinal obstruction. Moderate or severe hepatic impairment. Do not use during pregnancy (especially during 1st trimester) & lactation. Childn <2 yr (in the prevention & treatment of PONV).
Adverse Reactions
Headache, sensation of warmth or flushing, constipation, local IV inj site reactions.
Drug Interactions
Caution w/ drugs that prolong QT interval &/or cause electrolyte abnormalities. May increase risk of arrhythmia 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). Profound hypotension & loss of consciousness w/ apomorphine HCl. Increased oral clearance & decreased blood conc w/ potent CYP3A4 inducers (eg, phenytoin, carbamazepine & rifampicin). Serotonin syndrome may occur in concomitant w/ other serotonergic drugs including (SSRIs & serotonin nonadrenaline reuptake inhibitors). Reduced analgesic effect of tramadol.
MIMS Class
ATC Classification
A04AA01 - ondansetron ; Belongs to the class of serotonin (5HT3) antagonists. Used for the prevention of nausea and vomiting.
Presentation/Packing
Form
Ondavell FC tab 8 mg
Packing/Price
12's
Form
Ondavell inj 2 mg/mL
Packing/Price
2 mL x 5 × 1's
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