Ondavell

Ondavell Dosage/Direction for Use

ondansetron

Manufacturer:

Novell Pharma
Full Prescribing Info
Dosage/Direction for Use
ONDAVELL is available for oral use to allow the route of administration and dosing to be flexible.
Place the ODF on top of the tongue, where it will disperse within seconds, then swallow.
Chemotherapy and radiotherapy induced nausea and vomiting: The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. The selection of dose regimen should be determined by the severity of the emetogenic challenge.
Adults: Emetogenic chemotherapy and radiotherapy: The recommended dose for oral administration is 8 mg 1-2 hours before treatment, followed by 8 mg orally 12 hours later. To protect against delayed or prolonged emesis after the first 24 hours, oral treatment with ONDAVELL should be continued for up to 5 days after a course of treatment. The recommended oral dose is 8 mg to be taken twice daily.
Highly emetogenic chemotherapy (e.g. high dose cisplatin): ONDAVELL can be given by oral.
The recommended oral dose is 24 mg taken together with oral dexamethasone sodium phosphate 12 mg, 1-2 hours before treatment.
To protect against delayed or prolonged emesis after the first 24 hours, oral treatment with ONDAVELL should be continued for up to 5 days after a course of treatment. The recommended dose for oral administration is 8 mg twice daily.
Children: In children ONDAVELL is administered as a single dose of 5 mg/m2 immediately before chemotherapy, followed by 4 mg orally 12 hours 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.
Elderly: ONDAVELL is well tolerated by patients over 65 years and no alteration of dosage, dosing frequency or route of administration are required.
Patients with renal impairment: No alteration of daily dosage or frequency of dosing, or route of administration are required.
Patients with hepatic impairment: Clearance of ondansetron is significantly reduced and serum half-life significantly prolonged in subjects with moderate or severe impairment of hepatic function. In such patients a total daily dose of 8 mg oral should not be exceeded.
Post operative nausea and vomiting: Adults: For prevention of post-operative nausea and vomiting, ONDAVELL may be administered orally at a dose of 8 mg given 1 hour prior to anaesthesia. Followed by further dosage of 8 mg at 8 hours intervals, alternatively single dose of 4 mg may be given at induction on anaesthesia. For treatment of established post-operative nausea and vomiting a single dose for 4 mg ONDAVELL recommended.
Children: No studies have been conducted on the use of ondansetron in the prevention of treatment of post- operative nausea and vomiting.
Patients with renal impairment: No alteration of daily dosage or frequency of dosing, or route of administration are required.
Patients with hepatic impairment: Clearance of ondansetron is significantly reduced and serum half-life significantly prolonged in subjects with moderate or severe impairment of hepatic function. In such patients a total daily dose of 8 mg oral should not be exceeded.
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