Onaseron 50ml

Indications

1. Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including Cisplatin >/= 50 mg/m2.
2. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
3. 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.
4. Prevention of postoperative nausea and/or vomiting.
5. Nausea-vomiting associated with pregnancy
6. Nausea-vomiting associated with gastroenteritis

Dosage & Administration

1. Prevention of nausea-vomiting associated with chemotherapy

1 a. 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 dose 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 start of emetogenic chemotherapy

Moderate emetogenic cancer chemotherapy: 8 mg (one 8 mg tablet) administered 30 minutes before 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.

1 b. Pediatric

Parenteral (6 months onwards): Three dose 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.

1. 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.

1. Prevention of post-operative nausea-vomiting

3 a. 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.

3 b. Pediatric (1 months 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.

1. Nausea-vomiting in gastroenteritis

4 a. Adult: 8 mg three times daily.

4 b. Pediatric (1 month or over): 0.15 mg/kg body weight three times daily.

1. Nausea vomiting in pregnancy
   8 mg (1 tablet) 2-3 times daily

Onaseron ODT administration procedure:
Onaseron 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, diarrhoea, 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.

Contraindications

Ondansetron is contraindicated for patients known to have hypersensitivity to the drug.

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.