| DESCRIPTION |
Each 4 mg Cametron Orally Disintegrating Tablet contains 4 mg Ondansetron base.
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| MECHANISM OF ACTION |
Pharmacodynamics: Ondansetron is a selective 5-HT3 receptor antagonist. While its mechanism of action has not been fully characterized, Ondansetron is not a dopamine-receptor antagonist. Serotonin receptors of the 5-HT3 type are present both peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema.
Ondansetron’s antiemetic action is mediated centrally, peripherally, or in both sites. However, cytotoxic chemotherapy appears to be associated with release of serotonin from the enterochromaffin cells of the small intestine. In humans, urinary 5-HIAA (5-hydroxyindoleacetic acid) excretion increases after Cisplatin administration in parallel with the onset of emesis. The released serotonin may stimulate the vagal afferents through the 5-HT3 receptors and initiate the vomiting reflex.
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| INDICATIONS |
For the treatment of nausea and vomiting
· Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including Cisplatin.
· Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
· Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.
· Prevention of postoperative nausea and/or vomiting.
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| PREGNANCY AND LACTATION |
Pregnancy:
Teratogenic Effects: Pregnancy Category B.
There are, however, no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed.
Nursing Mothers:
Ondansetron is not known whether Ondansetron is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ondansetron is administered to a nursing woman.
Pediatric Use: Little information is available about dosage in pediatric patients 4 years of age or younger.
Geriatric Use: Dosage adjustment is not needed in patients over the age of 65.
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| CONTRAINDICATIONS |
· Contraindicated for patients known to have hypersensitivity to the drug.
· The concomitant use of apomorphine with Ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with Ondansetron.
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| WARNINGS |
Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists.
Avoid cametron in patients with congenital long QT syndrome. ECG monitoring is recommended in patients with electrolyte abnormalities
(e.g. hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias or patients taking other medicinal products that lead to QT prolongation.
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| PRECAUTIONS |
General: Ondansetron is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction.
Information for Patients: Phenylketonurics: Phenylketonuric patients should be informed that Cametron ODT Orally Disintegrating Tablets contain phenylalanine (a component of aspartame). Each 4mg and 8mg orally disintegrating tablet contains < 0.03 mg phenylalanine.
Patients should be instructed not to remove Cametron ODT Tablets from the blister until just prior to dosing. The tablet should not be pushed through the foil. With dry hands, the blister backing should be peeled completely off the blister. The tablet should be gently removed and immediately placed on the tongue to dissolve and be swallowed with the saliva.
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| DRUG INTERACTIONS |
Ondansetron does not itself appear to induce or inhibit the cytochrome
P-450 drug-metabolizing enzyme system of the liver.
Because Ondansetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes (CYP3A4, CYP2D6, CYP1A2), inducers or inhibitors of these enzymes may change the clearance and, hence, the half-life of Ondansetron. On the basis of available data, no dosage adjustment is recommended for patients on these drugs.
Apomorphine: Based on reports of profound hypotension and loss of consciousness when apomorphine was administered with Ondansetron, concomitant use of apomorphine with Ondansetron is contraindicated.
Phenytoin, Carbamazepine, and Rifampicin: In patients treated with potent inducers of CYP3A4, the clearance of Ondansetron was significantly increased and Ondansetron blood concentrations were decreased. Dosage adjustment for Ondansetron is recommended for patients on these drugs.
Tramadol: No pharmacokinetic drug interaction between Ondansetron and tramadol has been observed.
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| ADVERSE REACTIONS |
Headache, malaise/fatigue, constipation, diarrhea, dizziness.
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| DOSAGE & ADMINISTRATION |
Instructions for use/handling Cametron ODT Orally Disintegrating Tablets:
Do not attempt to push Cametron ODT tablets through the foil backing. With dry hands, peel back the foil backing of 1 blister and gently remove the tablet. Immediately place the Cametron ODT tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.
Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy: The recommended adult oral dosage of CAMETRON is 24 mg given as three 8mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy.
Pediatric Use: There is no experience with the use of a 24 mg dosage in pediatric patients.
Geriatric Use: The dosage recommendation is the same as for the general population.
Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy: The recommended adult oral dosage is one 8mg CAMETRON ODT Tablet
The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose.
One 8mg CAMETRON ODT Tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
Pediatric Use: For pediatric patients 12 years of age and older, the dosage is the same as for adults.
For pediatric patients 4 through 11 years of age, the dosage is one 4mg CAMETRON ODT Tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent 4 mg dose every 8 hours after the first dose. One 4mg CAMETRON ODT Tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.
Geriatric Use: The dosage is the same as for the general population.
Prevention of Nausea and Vomiting Associated With Radiotherapy:
The recommended oral dosage is one 8mg CAMETRON ODT Tablet given 3 times a day.
For total body irradiation, one 8mg CAMETRON ODT Tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
For single high-dose fraction radiotherapy to the abdomen, one 8-mg CAMETRON ODT Tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
For daily fractionated radiotherapy to the abdomen, 8-mg CAMETRON ODT Tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.
Pediatric Use: There is no experience with the use of CAMETRON ODT Tablets in the prevention of radiation-induced nausea and vomiting in pediatric patients.
Geriatric Use: The dosage recommendation is the same as for the general population.
Postoperative Nausea and Vomiting: The recommended dosage is 16 mg given as two 8mg CAMETRON ODT Tablets 1 hour before induction of anesthesia.
Pediatric Use: There is no experience with the use of CAMETRON Tablets, CAMETRON ODT Tablets, or CAMETRON Oral Solution in the prevention of postoperative nausea and vomiting in pediatric patients.
Geriatric Use: The dosage is the same as for the general population
Dosage Adjustment for Patients with Impaired Renal Function: The dosage recommendation is the same as for the general population.
Dosage Adjustment for Patients with Impaired Hepatic Function: In patients with severe hepatic impairment, clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.
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| OVERDOSAGE |
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There is no specific antidote for Ondansetron overdose. Patients should be managed with appropriate supportive therapy.
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| PACKAGE |
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Cametron 4 ODT :10 or 20 ODT Tablets packed in 1 or 2 PVC/Aluminum blister inside a carton box with a leaflet.
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| Storage |
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Store below 30⁰C, store blisters in carton to protect it from light, Keep away from children.
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