COMPOSITIONS :
Kliran® Film coated caplet 8 mg, each film coated caplet contains : Ondansetron HCl.2H2O equivalent to Ondansetron 8 mg.
DESCRIPTIONS :
Kliran® contains Ondansetron HCl.2H2O (equivalent to Ondansetron) are available in 4 mg and 8 mg film coated caplet.
INDICATIONS :
- Management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy.
- Prevention and treatment of post-operative nausea and vomiting.
Kliran® not to be used in emesis of other causes.
DOSAGE AND ADMINISTRATIONS :
Chemotherapy and radiotherapy-induced nausea and vomiting :
- Adults :
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 and selected as shown below.
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- Emetogenic chemotherapy and radiotherapy :
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For most patients receiving emetogenic chemotherapy or radiotherapy, Ondansetron 8 mg should be administered as a slow intravenous injection immediately before treatment, or orally 1 – 2 hours before treatment, followed by 8 mg orally twelve hourly.
To protect against delayed emesis after the first 24 hours, Ondansetron should be continued orally, 8 mg twice daily for up to 5 days after a course of treatment.
2. Highly emetogenic chemotherapy :
For patients receiving highly emetogenic chemotherapy e.g. high dose Cisplatin, 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 doses of 8 mg two to four hours a part, or by a constant infusion of 1 mg/hour for up to 24 hours.
A single dose of 32 mg administered in 50 – 100 ml of saline or other compatible infusion fluid and infused over not less than 15 minutes immediately before chemotherapy.
The selection of dose regimen should be determined by the severity of the emetogenic challenge.
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 emesis after the first 24 hours, Ondansetron should be continued orally, 8 mg twice daily for up to 5 days after a course of treatment.
- Children :
Ondansetron may be administered as a single intravenous dose of 5 mg/m2 immediately before chemotherapy, followed by 4 mg orally twelve hours later. 4 mg orally twice daily should be continued for up to 5 days after a course of treatment.
- Elderly :
Ondansetron is well tolerated by patient over 65 years and no alteration of dosage, dosing frequency or route of administration are required.
Post-operative nausea and vomiting :
- Adults :
For prevention of post-operative nausea and vomiting Ondansetron may be administered orally at a dose of 8 mg given one hour prior to anaesthesia followed by two further doses of 8 mg at eight hourly intervals. Alternatively, a single dose of 4 mg may be given by slow intravenous injection at induction of anaesthesia.
For treatment of established post-operative nausea and vomiting a single dose of 4 mg given by intramuscular or slow intravenous injection is recommended.
- Children :
There is no experience in the use of Ondansetron in the prevention and treatment of post-operative nausea and vomiting in the children.
Patients with renal/hepatic impairment :
- Patient with renal impairment :
No alteration of daily dosage or frequency of dosing, or route of administration are required.
- Patient 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.
OVERDOSAGE :
- Little is at present known about overdosage with Ondansetron. However two patients who received doses of 84 – 145 mg IV reported only mild side effects and required no active therapy.
- In cases of suspected overdose, symptomatic and supportive therapy should be given as appropriate.
CONTRAINDICATION :
Hypersensitivity to any component of the preparation.
WARNINGS AND PRECAUTIONS :
- Pregnancy : Ondansetron is not teratogenic in animals. There is no experience in humans. As with other medicines Ondansetron should not be used during pregnancy, especially during 1st trimester, unless the expected benefit to the patient is thought to outweigh any possible risk to the fetus.
- Lactation : Test have shown that Ondansetron is excreted in the breast milk of rats. It is therefore recommended that mothers receiving Ondansetron should not breast-feed their babies.
PRESENTATIONS :
Kliran® Film coated caplet 8 mg Box, 3 strips @ 10 film coated caplets
Reg. No. DKL9502321409A1
STORAGE :
STORE BELOW 30ºC, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
PT. BERNOFARM
Sidoarjo – Indonesia
