- Approval Id
- d6013702f0931a04
- Drug Name
- Ondansetron Sandoz 8mg Tablets
- Product Name
- Ondansetron Sandoz 8mg Tablets
- Approval Number
- SIN13446P
- Approval Date
- 2008-04-16
- Registrant
- NOVARTIS (SINGAPORE) PTE LTD
- Licence Holder
- SANDOZ SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- **4.2 Posology and method of administration**
**CHEMOTHERAPY AND RADIOTHERAPY INDUCED NAUSEA AND VOMITING (CINV and RINV)**
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 oral dose is 8 mg taken 1 to 2 hours before chemotherapy or radiation treatment, followed by 8 mg orally every 12 hours later for a maximum of 5 days.
To protect against delayed or prolonged emesis after the first 24 hours, oral treatment with ondansetron should be continued for up to five 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**
Ondansetron can be given by oral, intravenous (IV), or intramuscular (IM) administration.
Ondansetron has been shown to be equally effective in the following dose schedules over the first 24 hours of chemotherapy:
- A single dose of 8 mg by slow intravenous injection immediately before chemotherapy.
- A dose of 8 mg by slow intravenous injection immediately before chemotherapy, followed by two further intravenous dose of 8 mg two to four hours apart, or by a constant infusion of 1 mg/hour for up to 24 hours. Doses of greater than 8 mg up to 16 mg of ondansetron may only be given by IV infusion diluted in 50–100 ml of saline or other compatible infusion fluid and infused over not less than 15 minutes immediately before chemotherapy. A single dose greater than 16 mg should not be given due to dose-dependent increase of QT-prolongation risk (see section 4.4, 4.8 and 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
The efficacy of ondansetron in highly emetogenic chemotherapy may be enhanced by the addition of a single intravenous dose of dexamethasone sodium phosphate 20 mg administered prior to chemotherapy.
To protect against delayed or prolonged emesis after the first 24 hours, oral treatment with ondansetron should be continued for up to five days after a course of treatment. The recommended oral dose is 8 mg to be taken twice daily.
**CINV in Children and Adolescents (aged 2 years and over)**
In children with a body surface area of 0.6 to 1.2 m2 ondansetron is administered as a single i.v. dose of 5 mg/m2 immediately before chemotherapy, followed by 4 mg orally 12 hours later. 4 mg orally twice daily can be continued for up to five days after a course of treatment.
**CINV and RINV in Elderly**
No alteration of oral dose or frequency of administration is required.
**POST-OPERATIVE NAUSEA AND VOMITING (PONV)**
**PONV in Adults**
For prevention of post-operative nausea and vomiting, the recommended oral dose is 16 mg given 1 hour prior to anaesthesia.
For treatment of established post-operative nausea and vomiting, ondansetron administration by injection is recommended.
**PONV in Children and Adolescents (aged 2 years and over)**
No studies have been conducted on the use of orally administered ondansetron in the prevention or treatment of post-operative nausea and vomiting; slow IV injection (not less than 30 seconds) is recommended for this purpose.
**PONV in 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.
**SPECIAL POPULATIONS**
**Renal Impairment**
No alteration of daily dosage or frequency of dosing, or route of administration are required.
**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 IV or oral 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.
- Route Of Administration
- ORAL
- Indication Info
- **4.1 Therapeutic indications**
**Adults**
Ondansetron oral formulations are indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy.
Ondansetron is also indicated for the prevention and treatment of post-operative nausea and vomiting.
**Paediatric population**
Ondansetron is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy.
No studies have been conducted on the use of orally administered ondansetron in the prevention or treatment of post-operative nausea and vomiting; IV injection is recommended for this purpose.
- Contraindications
- **4.3 Contraindications**
Based on reports of profound hypotension and loss of consciousness when ondansetron was administered with apomorphine hydrochloride, concomitant use with apomorphine is contraindicated (see section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
Hypersensitivity to any component of the preparation (see section 4.4 and 4.8 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
- Atc Code
- A04AA01
- Atc Item Name
- ondansetron
- Pharma Manufacturer Name
- SANDOZ SINGAPORE PTE. LTD.
- Company Detail Path
- /organization/sandoz-singapore-pte-ltd
