Generic Name
OndansetronTherapeutic Class: Anti Emetic
Indications:
Ondansetron tablet: Each film coated tablet contains Ondansetron Hydrochloride Dihydrate BP 9.977 mg equivalent to Ondansetron 8 mg.
Ondansetron 4 ml IV injection: Each ml contains Ondansetron Hydrochloride Dihydrate BP 2.49 mg equivalent to Ondansetron 2 mg.
Ondansetron oral solution: Each 5 ml contains Ondansetron Hydrochloride Dihydrate BP equivalent to Ondansetron 4 mg.
Ondansetron ODT tablet: Each tablet contains Ondansetron USP 4 mg.
Description:
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. It is not certain whether Ondansetron's antiemetic action is mediated centrally, peripherally, or in both sites. However, cytotoxic chemotherapy appears to be associated with the release of serotonin from the enterochromaffin cells of the small intestine.
Dosage & Administration:
1. Prevention of nausea-vomiting associated with chemotherapy
Adult:
Parenteral: 32 mg single dose infused over 15 minutes by diluting with 50 ml saline (5% dextrose or 0.9% NaCl) 30 minutes before starting chemotherapy. Alternative therapy: Three doses of 0.15 mg/kg body weight. The first dose is infused over 15 minutes beginning 30 minutes before the starting chemotherapy. Subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of administration.
Oral:
- Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including Cisplatin >/= 50 mg/m2.
- 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.
- Nausea-vomiting associated with pregnancy
- Nausea-vomiting associated with gastroenteritis
Ondansetron tablet: Each film coated tablet contains Ondansetron Hydrochloride Dihydrate BP 9.977 mg equivalent to Ondansetron 8 mg.
Ondansetron 4 ml IV injection: Each ml contains Ondansetron Hydrochloride Dihydrate BP 2.49 mg equivalent to Ondansetron 2 mg.
Ondansetron oral solution: Each 5 ml contains Ondansetron Hydrochloride Dihydrate BP equivalent to Ondansetron 4 mg.
Ondansetron ODT tablet: Each tablet contains Ondansetron USP 4 mg.
Description:
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. It is not certain whether Ondansetron's antiemetic action is mediated centrally, peripherally, or in both sites. However, cytotoxic chemotherapy appears to be associated with the release of serotonin from the enterochromaffin cells of the small intestine.
Dosage & Administration:
1. Prevention of nausea-vomiting associated with chemotherapy
Adult:
Parenteral: 32 mg single dose infused over 15 minutes by diluting with 50 ml saline (5% dextrose or 0.9% NaCl) 30 minutes before starting chemotherapy. Alternative therapy: Three doses of 0.15 mg/kg body weight. The first dose is infused over 15 minutes beginning 30 minutes before the starting chemotherapy. Subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of administration.
Oral:
Highly emetogenic cancer chemotherapy: 24 mg (three 8 mg tablet) administered 30 minutes before the start of emetogenic chemotherapy
Moderate emetogenic cancer chemotherapy: 8 mg (one 8 mg tablet) administered 30 minutes before the start of emetogenic chemotherapy. A further 8 mg dose should be administered after 8 hours of the first dose. One 8 mg tablet should be administered twice a day (every 12 hours) for 1-2 days after completion of chemotherapy.
Pediatric:
5. Nausea vomiting in pregnancy 8 mg (1 tablet) 2-3 times daily
Ondansetron ODT administration procedure:
Ondansetron ODT should be removed from the blister gently. Then it should be immediately placed on top of the tongue where it will dissolve in seconds and swallowed with saliva. Administration with liquid is not necessary.
Side Effects:
Generally, Ondansetron is well tolerated. However few side effects including headache, diarrhea, fatigue, dizziness, and constipation may be seen after Ondansetron is administered.
Precautions:
Ondansetron is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction. The use of Ondansetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distension.
Use in Pregnancy & Lactation:
Pregnancy: Pregnancy category B.
Nursing mother: It 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.
Interaction:
The following drugs should be used with caution when concomitantly used with Ondansetron:
Phenytoin, Carbamazepine, Rifampicin & Tramadol.
Overdose:
There is no specific antidote for Ondansetron overdose. Hypotension (and faintness) occurred in a patient that took 48 mg of Ondansetron tablets.
Moderate emetogenic cancer chemotherapy: 8 mg (one 8 mg tablet) administered 30 minutes before the start of emetogenic chemotherapy. A further 8 mg dose should be administered after 8 hours of the first dose. One 8 mg tablet should be administered twice a day (every 12 hours) for 1-2 days after completion of chemotherapy.
Pediatric:
Parenteral (6 months onwards): Three doses of 0.15 mg/kg body weight. The first dose is infused over 15 minutes beginning 30 minutes before starting moderately to highly emetogenic chemotherapy. Subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of administration.
Oral (4-11 years): 4 mg tablet should be taken 30 minutes before the start of chemotherapy. The other 2 doses should be taken 4 and 8 hours after the first dose. Then 4 mg tablet should be administered 3 times a day (every 8 hours) for 1-2 days after completion of chemotherapy.
2. Prevention of nausea-vomiting associated with radiotherapy
Adults/ Geriatric/ Child of 12 years or over
The recommended dose is 8 mg tablet 3 times a day.
For total body irradiation: One 8 mg 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 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: One 8 mg tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day.
3. Prevention of post-operative nausea-vomiting
Adults/ Geriatric/ Child of 12 years or over
Parenteral: Undiluted 4 mg intravenously or intramuscularly immediately before induction of anesthesia. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes. Alternatively, the dose can be administered post-operatively if the patient experiences nausea and/or vomiting shortly after surgery
Oral (4-11 years): 4 mg tablet should be taken 30 minutes before the start of chemotherapy. The other 2 doses should be taken 4 and 8 hours after the first dose. Then 4 mg tablet should be administered 3 times a day (every 8 hours) for 1-2 days after completion of chemotherapy.
2. Prevention of nausea-vomiting associated with radiotherapy
Adults/ Geriatric/ Child of 12 years or over
The recommended dose is 8 mg tablet 3 times a day.
For total body irradiation: One 8 mg 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 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: One 8 mg tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day.
3. Prevention of post-operative nausea-vomiting
Adults/ Geriatric/ Child of 12 years or over
Parenteral: Undiluted 4 mg intravenously or intramuscularly immediately before induction of anesthesia. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes. Alternatively, the dose can be administered post-operatively if the patient experiences nausea and/or vomiting shortly after surgery
Oral: 16 mg (two 8 mg tablets) 1 hour before induction of anesthesia.
Pediatric (1-month to12 years)
Parenteral: Weighing less than 40 kg: 0.1-mg/kg body weight in a single dose. Weighing more than 40 kg: 4mg single dose The dose should be immediately before induction of anesthesia. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes.
Alternatively, the dose can be administered post-operatively if the patient experiences nausea and/or vomiting shortly after surgery.
4. Nausea-vomiting in gastroenteritis
Adult: 8 mg three times daily.
Pediatric (1 month or over): 0.15 mg/kg body weight three times daily.
Pediatric (1-month to12 years)
Parenteral: Weighing less than 40 kg: 0.1-mg/kg body weight in a single dose. Weighing more than 40 kg: 4mg single dose The dose should be immediately before induction of anesthesia. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes.
Alternatively, the dose can be administered post-operatively if the patient experiences nausea and/or vomiting shortly after surgery.
4. Nausea-vomiting in gastroenteritis
Adult: 8 mg three times daily.
Pediatric (1 month or over): 0.15 mg/kg body weight three times daily.
5. Nausea vomiting in pregnancy 8 mg (1 tablet) 2-3 times daily
Ondansetron ODT administration procedure:
Ondansetron ODT should be removed from the blister gently. Then it should be immediately placed on top of the tongue where it will dissolve in seconds and swallowed with saliva. Administration with liquid is not necessary.
Side Effects:
Generally, Ondansetron is well tolerated. However few side effects including headache, diarrhea, fatigue, dizziness, and constipation may be seen after Ondansetron is administered.
Precautions:
Ondansetron is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction. The use of Ondansetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distension.
Use in Pregnancy & Lactation:
Pregnancy: Pregnancy category B.
Nursing mother: It 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.
Interaction:
The following drugs should be used with caution when concomitantly used with Ondansetron:
Phenytoin, Carbamazepine, Rifampicin & Tramadol.
Overdose:
There is no specific antidote for Ondansetron overdose. Hypotension (and faintness) occurred in a patient that took 48 mg of Ondansetron tablets.
Geriatric Use: Dosage adjustment is not needed in patients over the age of 65.
Hepatic Impairment: A total daily dose of 8mg should not be exceeded (patients with severe hepatic impairment).
Renal Impairment: No dosage adjustment is recommended.
Storage:
Store at temperature not exceeding 30ºC in a dry place. Protect from light and moisture.
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