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Ondansetron

Structure

Ondansetron-4 Tablets
Each film-coated tablet contains Ondansetron hydrochloride dihydrate equivalent to Ondansetron 4.

Ondansetron-8 Tablets
Each film-coated tablet contains Ondansetron hydrochloride dihydrate equivalent to Ondansetron 8.

Ondansetron 2 ml Injection
Each 2 ml ampoule contains Ondansetron hydrochloride dihydrate equivalent to Ondansetron 4 and water for injection IP q.s.

Ondansetron 4 ml Injection
Each 4 ml ampoule contains Ondansetron hydrochloride dihydrate equivalent to Ondansetron 8 and water for injection IP q.s.

No Prescription

Ondansetron is prescribed for the treatment of:
Ondansetron is prescribed for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, and for the prevention and treatment of post-operative nausea and vomiting (PONV).

Dosage

Cancer chemotherapy and radiotherapy

Adults
Highly Emetogenic Chemotherapy

Day 1 Days 2 - 5
A single dose of 8 by slow intravenous injection immediately before chemotherapy 8 mg orally twice daily for up to 5 days

OR

A dose of 8 by slow intravenous injection immediately before chemotherapy followed by two further intravenous doses of 8 mg two to four hours apart, or by a constant infusion of 1 mg/hour for up to 24 hours 8 mg orally twice daily for up to 5 days

OR

A single dose of 32 diluted in 50-100 ml of saline or other compatible infusion fluid and infused over a period of not less than 15 minutes immediately before chemotherapy 8 mg orally twice daily for up to five days.

Emetogenic Chemotherapy/Radiotherapy

Day 1 Days 2 - 5
A single dose of 8 administered as a slow intravenous injection immediately before chemotherapy/radiotherapy 8 mg orally twice daily for up to 5 days

OR
8 orally, 1-2 hours before chemotherapy/radiotherapy followed by 8 mg orally 12 hourly 8 mg orally twice daily for up to 5 days.

Children
Emetogenic Chemotherapy/Radiotherapy

Day 1 Days 2 - 5
A single intravenous dose of 5/m2 immediately before chemotherapy followed by 4 mg orally 12 hours later 4 mg orally twice daily for up to 5 days.

In both, adults and children, in highly emetogenic chemotherapy, efficacy of ondansetron over the first 24 hours may be enhanced by the addition of a single intravenous dose of 20 dexamethasone sodium phosphate prior to chemotherapy.

Elderly and in impaired renal function
No alteration of dosage, dose frequency or route of administration is
required in patients over 65 years or with renal impairment.

In impaired hepatic function
In patients with moderate or severe hepatic impairment, a total daily dosage
of 8 should not be exceeded.

Post-operative Nausea and Vomiting (PONV)

INDICATIONS DOSAGE
For the prevention of post-operative nausea and vomiting 8 given orally one hour prior to anaesthesia followed by two further doses of 8 mg at eight-hourly intervals

OR

A single dose of undiluted 4 given by slow intravenous injection at induction of anaesthesia.
For the treatment of established post-operative nausea and vomiting A single dose of undiluted 4 given by slow intravenous injection

Paediatric use
There is no experience in the use of ondansetron in the prevention and treatment of post-operative nausea and vomiting in children.

In the elderly
There is limited experience in the use of ondansetron in the prevention and treatment of post-operative nausea and vomiting in the elderly.

In impaired renal function
No alteration of daily dosage or frequency of dosing, or route of administration are required.

In impaired hepatic function
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 should not be exceeded.

Compatibility with intravenous fluids
In keeping with good pharmaceutical practice, intravenous solutions should be prepared at the time of infusion with the following recommended infusion solutions:

Sodium chloride intravenous infusion IP 0.9% w/v
Dextrose intravenous infusion IP 5% w/v
Mannitol intravenous infusion IP 10% w/v
Ringers’ intravenous solution
Potassium chloride 0.3% w/v and glucose 5% w/v

Contraindications

Ondansetron is contraindicated if you have any of the following conditions:
- Hypersensitivity to any component of the preparation.

Package

- Strip of 10 tablets;
- Injections 2 ml and 4 ml in carton of 5 ampoules;
(c) 2017