Ondavell

Ondavell

ondansetron

Manufacturer:

Novell Pharma
Concise Prescribing Info
Contents
Ondansetron
Indications/Uses
Management of nausea & vomiting induced by cytotoxic chemotherapy & RT. Prevention of post-op nausea & vomiting.
Dosage/Direction for Use
Adult Emetogenic chemotherapy & RT 8 mg twice daily 1-2 hr before treatment, followed by 8 mg orally 12 hr later. Highly emetogenic chemotherapy (eg, high dose cisplatin) 24 mg taken together w/ oral dexamethasone Na phosphate 12 mg, 1-2 hr before treatment. Protection against delayed or prolonged emesis after the 1st 24 hr: Treatment should be continued for up to 5 days after a course of treatment. Childn 5 mg/m2 as a single dose immediately before chemotherapy, followed by 4 mg orally 12 hr later. 4 mg orally twice daily should be continued for up to 5 days after a course of treatment. Adult doses must not be exceeded. Patient w/ hepatic impairment Max total daily dose: 8 mg. Post-op nausea & vomiting Adult Prevention: 8 mg given 1 hr prior to anaesth. Followed by further dosage of 8 mg at 8 hr intervals, alternatively 4 mg single dose may be given at induction on anaesth. Treatment: 4 mg single dose. Patient w/ hepatic impairment Max total daily dose: 8 mg.
Administration
May be taken with or without food: Place the oral dissolving film on top of the tongue, where it will disperse w/in sec, then swallow. Do not drink water.
Contraindications
Special Precautions
Patients w/ hypersensitivity to other selective 5-HT3 receptor antagonists. Prolonged transient ECG changes including QT interval prolongation. Monitor patients w/ signs of subacute intestinal obstruction following administration. Not recommended during pregnancy. Mothers should not breast-feed during treatment.
Adverse Reactions
Headache. Warmth or flushing sensation; constipation, local burning sensation following insertion of supp; local IV inj site reactions (in patients receiving chemotherapy w/ cisplatin).
Drug Interactions
Increased oral clearance & decreased blood conc w/ potent CYP3A4 inducers (eg, phenytoin, carbamazepine, rifampicin). 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
Ondavell oral dissolving film 8 mg
Packing/Price
10 × 1's (Rp240,000/boks)
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