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Emistat 4mg/5ml (Syrup)

Manufactured by: Healthcare Pharmaceuticals Ltd.

Ondansetron Similar medicine

Emistat is indicated for Post-op nausea and vomiting, Nausea and vomiting associated w/ cancer chemotherapy

Precautions and warnings

May cause QT prolongation; caution when used in cardiac diseases, patients who are on medications that can prolong QT or patients with electrolyte abnormalities. Severe hepatic impairment. May mask progressive ileus and/or gastric distension. Pregnancy, lactation.

Side-effects

Headache, malaise/fatigue, constipation; drowsiness, fever, dizziness, anxiety, cold sensation; pruritus, rash; diarrhoea; gynaecological disorder, urinary retention; elevated transaminase; local inj site reaction (pain, redness, burning); paresthesia; hypoxia. Rarely: Anaphylaxis, angina, bronchospasm, ECG changes, extrapyramidal symptoms, grand mal seizure, hypokalaemia, tachycardia, vascular occlusive events.

Drug Interactions

May reduce analgesic effect of tramadol. Rifampicin and other CYP3A4 inducers may reduce levels/effects of ondansetron. Concomitant use of QT-prolonging agents (e.g. antiarrhythmics) may cause additive prolongation of QT interval. May increase the risk of arrhythmias w/ cardiotoxic drugs (e.g. anthracyclines).
Potentially Fatal: May increase the hypotensive effect of apomorphine.

Contraindications

Use with apomorphine (profound hypotension).

Mode of actions

Ondansetron antagonises selective 5-HT3-receptor, blocking serotonin, both peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone. This action of ondansetron gives it its antiemetic property to prevent emesis due to acute chemotherapy mediated by serotonin.

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/oral film) administered 30 minutes before start of emetogenic chemotherapy

Moderate emetogenic cancer chemotherapy: 8 mg (one 8 mg tablet/oral film) 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/oral film 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/oral film 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/oral film 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/oral film 3 times a day.

For total body irradiation: One 8 mg tablet/oral film 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/oral film 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/oral film 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

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/oral film) 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.

4. 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.


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

Pregnancy & Lactation

Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.