Ondansetron-Teva

Ondansetron-Teva Dosage/Direction for Use

ondansetron

Manufacturer:

Teva

Distributor:

KLN Pharma
Full Prescribing Info
Dosage/Direction for Use
Chemotherapy- and radiotherapy-induced nausea and vomiting (CINV and RINV): Adults: 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.
Emetogenic Chemotherapy and Radiotherapy: Ondansetron can be given by oral administration.
The recommended oral dose is 8 mg taken 1 to 2 hours before chemotherapy or radiation treatment, followed by 8 mg every 12 hours for a maximum of 5 days to protect against delayed or prolonged emesis.
For highly emetogenic chemotherapy, a single dose of up to 24 mg ondansetron taken with 12 mg oral dexamethasone sodium phosphate, 1 to 2 hours before chemotherapy, may be used.
To protect against delayed or prolonged emesis after the first 24 hours, oral treatment with ondansetron may be continued for up to 5 days after a course of treatment.
The recommended dose for oral administration is 8 mg to be taken twice daily.
Elderly: No alteration of oral dose or frequency of administration is 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 should not be exceeded.
Patients with Poor Sparteine/Debrisoquine Metabolism: The elimination half-life of ondansetron is not altered in subjects classified as poor metabolisers of sparteine and debrisoquine. Consequently in such patients, repeat dosing will give drug exposure levels no different from those of the general population. No alteration of daily dosage or frequency of dosing is required.
Post-operative nausea and vomiting (PONV): Adults: For the prevention of PONV, ondansetron can be administered orally. The recommended oral dose is 16 mg taken one hour prior to anaesthesia.
Elderly: There is limited experience in the use of ondansetron in the prevention and treatment of post-operative nausea and vomiting in the elderly, however, ondansetron is well tolerated in patients over 65 years receiving chemotherapy.
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 should not be exceeded.
Patients with Poor Sparteine/Debrisoquine Metabolism: The elimination half-life of ondansetron is not altered in subjects classified as poor metabolisers of sparteine and debrisoquine. Consequently in such patients, repeat dosing will give drug exposure levels no different from those of the general population. No alteration of daily dosage or frequency of dosing is required.
Method of Administration: The tablets should be swallowed whole with liquid.
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