Oral Solution Ondansetron 4mg/5ml ( 60 ml )
|Generic Name of Product||Brand Name||Dosage Form||Strength||Pharmacologic Group||Therapeutic Group||Unit Per Pack|
|Ondansetrone||-||Ampoule /tablet / syrup||2mg/ml (4ml) – 4mg – 4mg/5ml (60ml)||Serotonin 5-HT3 receptor antagonist, Antiemetic||Gastrointestinal agents||10 /30 /1|
Indications And Usage
In the adult patient population: orally administered ondansetron tablets are indicated for: - the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, including high dose (ie. greater than or equal to 50 mg/m2) cisplatin therapy, and radiotherapy, and - the prevention and treatment of postoperative nausea and vomiting
intravenously administered ondansetron injection formulations are indicated for: - the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, including high dose (ie. greater than or equal to 50 mg/m2) cisplatin therapy, and - the prevention and treatment of postoperative nausea and vomiting
In the pediatric (4-18 years of age) patient population: ondansetron was effective and well tolerated when given to children 4-12 years of age for the treatment of post-chemotherapy induced nausea and vomiting, ii) ondansetron tablets, ondansetron injection are not indicated for the treatment of children 3 years of age or younger) ondansetron tablets, ondansetron injection are not indicated for use in any age group of the pediatric population for the treatment of post-radiotherapy induced nausea and vomiting) ondansetron tablets, ondansetron injection are not indicated for use in any age group of the pediatric population for the treatment of postoperative nausea and vomiting
In the geriatric (>65 years of age) patient population: efficacy and tolerance of ondansetron were similar to that observed in younger adults for the treatment of post-chemotherapy and radiotherapy-induced nausea and vomiting,
clinical experience in the use of ondansetron in the prevention and treatment of postoperative nausea and vomiting is limited and is not indicated for use in the geriatric patient population
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 route of administration and dose of ondansetron should be flexible in the range of 8-32 mg a day.
Emetogenic chemotherapy and radiotherapy:
Ondansetron can be given either by rectal, oral (tablets or syrup), intravenous or intramuscular administration.
For most patients receiving emetogenic chemotherapy or radiotherapy, ondansetron 8 mg should be administered as a slow intravenous or intramuscular injection immediately before treatment, followed by 8 mg orally twelve hourly.
For oral administration:
8 mg 1-2 hours before treatment, followed by 8 mg 12 hours later.
Hypersensitivity to the ondansetron or to any of the excipients.
Hypersensitivity to other selective 5-HT3 receptor antagonists (e.g. granisetron, dolasetron).
Concomitant use with apomorphine (see Interactions with other medicinial products).
Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists.
Pediatric patients receiving ondansetron with hepatotoxic chemotherapeutic agents should be monitored closely for impaired hepatic function.
Immune system disorders:
Rare: Immediate hypersensitivity reactions sometimes severe, including anaphylaxis.
Nervous system disorders
Very common: Headache.
Rare: Transient visual disturbances
Common: Sensation of warmth or flushing.
Common: Ondansetron is known to increase the large bowel transit time and may cause constipation in some patients
Pregnancy and lactation
Ondansetron should not be used during the first trimester of pregnancy.
recommended that mothers receiving ondansetron should not breast-feed their babies.
Renal and liver Impairment
Patients with renal impairment
No alteration of daily dosage or frequency of dosing, or route of administration is 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.