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Zofran

Zofran

ondansetron

Manufacturer:

Sandoz Manufacturing

Distributor:

Sandoz
Concise Prescribing Info
Contents
Ondansetron HCl dihydrate
Indications/Uses
Management of nausea & vomiting induced by cytotoxic chemotherapy & RT in adults & ped. Prevention & treatment of post-op nausea & vomiting in adults & ped.
Dosage/Direction for Use
Chemotherapy & RT-induced nausea & vomiting Dose regimen should be determined by severity of emetogenic challenge. Adult 8 mg as slow IM or IV inj in not <30 sec immediately before treatment. In highly emetogenic chemotherapy, max initial dose of 16 mg IV over 15 min may be used, & efficacy may be enhanced by addition of single IV dose of dexamethasone Na phosphate 20 mg administered prior to chemotherapy. IV doses >8 mg & up to max of 16 mg must be diluted in 50-100 mL of 0.9% NaCl inj or 5% dextrose inj before administration & infused over not <15 min. Initial dose may be followed by 2 additional 8 mg IV or IM doses 2-4 hr apart, or by constant infusion of 1 mg/hr for up to 24 hr. Oral treatment is recommended to protect against delayed or prolonged emesis after the 1st 24 hr. Childn & adolescent 6 mth-17 yr Dose can be calculated based on BSA or wt & is given by IV infusion diluted in 25-50 mL of saline or other infusion fluid & infused over not <15 min. Administer immediately before chemotherapy. Max IV dose: 8 mg. BSA >1.2 m2 Day 1: 5 mg/m2 IV, or 8 mg IV + 8 mg oral after 12 hr. Days 2-6: 8 mg oral every 12 hr, ≥0.6 m2 to ≤1.2 m2 Day 1: 5 mg/m2 IV + 4 mg oral after 12 hr. Days 2-6: 4 mg oral every 12 hr, <0.6 m2 Day 1: 5 mg/m2 IV + 2 mg oral after 12 hr. Days 2-6: 2 mg oral every 12 hr. Body wt >10 kg Day 1: Up to 3 doses of 0.15 mg/kg IV every 4 hr. Days 2-6: 4 mg oral every 12 hr, ≤10 kg Day 1: Up to 3 doses of 0.15 mg/kg IV every 4 hr. Days 2-6: 2 mg oral every 12 hr. Elderly All IV doses should be diluted & infused over 15 min, & if repeated, given no <4 hr apart, ≥75 yr Initial IV dose should not exceed 8 mg over 15 min, & may be followed by 2 doses of 8 mg over 15 min & given no <4 hr apart, 65-74 yr Initially 8 mg or 16 mg IV over 15 min, may be followed by 2 doses of 8 mg over 15 min & given no <4 hr apart. Post-op nausea & vomiting (PONV) Adult Prevention: Single dose of 4 mg IM or slow IV inj administered at induction of anaesth. Treatment: Single dose of 4 mg IM or slow IV inj. Childn & adolescent ≥1 mth-17 yr Prevention & treatment: 0.1 mg/kg up to max of 4 mg by slow IV inj (not <30 sec) either prior to, at or after induction of anaesth, or after surgery. Patient w/ moderate or severe hepatic impairment Max: Not to exceed 8 mg IV daily.
Contraindications
Hypersensitivity. Concomitant use w/ apomorphine HCl.
Special Precautions
Hypersensitivity to other selective 5HT3-receptor antagonists. Avoid use in patients w/ congenital long QT syndrome. Caution in patients who have or may develop QTc prolongation, including those w/ electrolyte abnormalities, CHF, bradyarrhythmias or taking other medicinal products that lead to QT prolongation or electrolyte abnormalities. Reports of myocardial ischemia. Correct hypokalemia & hypomagnesemia prior to administration. Monitor patients w/ signs of subacute intestinal obstruction following administration. Concomitant use w/ other serotonergic drugs. Patients w/ moderate or severe hepatic impairment. Sexually active females of reproductive potential should use effective contraception during treatment & for 2 days after stopping treatment. Not recommended during pregnancy. Do not breast-feed during treatment. Limited experience in prevention & treatment of PONV in elderly >65 yr.
Adverse Reactions
Headache. Sensation of warmth or flushing; constipation; local IV inj site reactions.
Drug Interactions
Co-administration w/ drugs prolonging the QT interval &/or causing electrolyte abnormalities. Reports of profound hypotension & loss of consciousness w/ apomorphine HCl. Increased oral clearance & decreased blood conc w/ potent CYP3A4 inducers ie, phenytoin, carbamazepine, & rifampicin. Serotonin syndrome (including altered mental status, autonomic instability & neuromuscular abnormalities) w/ other serotonergic drugs including SSRIs & SNRIs. May reduce 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
Zofran soln for inj 2 mg/mL
Packing/Price
2 mL x 5 × 1's;4 mL x 5 × 1's
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