Emistop

Emistop

ondansetron

Manufacturer:

Baxter Pharma

Distributor:

Masu
Full Prescribing Info
Contents
Ondansetron hydrochloride dihydrate.
Description
Each ml contains Ondansetron Hydrochloride Dihydrate USP Equivalent to Ondansetron 2 mg, Water for Injections BP q.s.
Ondansetron is a potent, highly selective 5-HT3 receptor antagonist. Its precise mode of action in the control of nausea and vomiting is not known. Chemotherapeutic agents and radiotherapy may cause release of 5-HT in the small intestine initiating a vomiting reflex by activating vagal afferents via 5-HT3 receptors. Ondansetron blocks the initiation of this reflex. Activation of vagal afferents may also cause a release of 5-HT in the area postrema, located on the floor of the fourth ventricle, and this may also promote emesis through a central mechanism. Thus, the effect of ondansetron in the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy is probably due to antagonism 5-HT3 receptors on neurons located both in the peripheral and central nervous system. The mechanism of action in post-operative nausea and vomiting are not known but there may be common pathways with cytotoxic-induced nausea and vomiting.
Indications/Uses
EMISTOP is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, and for the prevention and treatment of post-operative nausea and vomiting (PONV).
Dosage/Direction for Use
See Table 1.

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In highly emetogenic chemotherapy, efficacy of ondansetron over the first 24 hours may be enhanced by the addition of a single I.V. dose of 20 mg. Dexamethasone sodium phosphate prior to chemotherapy. (See Table 2.)

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RECOMMENDED INFUSION SOLUTIONS: In keeping with good pharmaceutical practice, intravenous solutions should be prepared at the time of infusion with the following recommended infusion solutions: Sodium Chloride Intravenous Infusion BP (0.9% w/v), Glucose Intravenous Infusion BP (5% w/v), Mannitol Intravenous Infusion BP (10% w/v), Ringers intravenous infusion, Potassium Chloride 0.3% w/v and Glucose 5% w/v.
FOR POST-OPERATIVE NAUSEA AND VOMITING (PONV): See Table 3.

Click on icon to see table/diagram/image

Children: There is no experience in the use of ondansetron in the prevention and treatment of post-operative nausea and vomiting in children.
Elderly: There is limited experience in the use of ondansetron in the prevention and treatment of post-operative nausea and vomiting in elderly.
Overdosage
Little at present is known about overdosage with ondansetron. However, two patients who received doses of 84 mg and 145 mg intravenously reported only mild side effects and required no active therapy. In case of suspected overdosage, symptomatic and supportive therapy should be given as appropriate.
Contraindications
Hypersensitivity to any components of the preparation.
Special Precautions
Pharmaceutical precautions: Dilutions of EMISTOP injection in compatible intravenous infusion fluids are stable under normal room lighting conditions or daylight for at least 24 hours, thus no protection from light is necessary while infusion takes place. EMISTOP injection should not be administered in the same syringe or infusion as any other medication. EMISTOP injection ampoules should not be autoclaved.
Patients with renal impairment: No alteration of daily dosage, or frequency of dosing or route of administration are required.
Patients 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.
Use in Pregnancy: EMISTOP is not teratogenic in animals. There is no experience in humans. As with other medications, EMISTOP should not be used during pregnancy, especially during the first trimester, unless the expected benefit to the patient is thought to outweigh any possible risk to the foetus.
Use in Lactation: Tests have shown that ondansetron is excreted in the breast milk of rats. It is therefore recommended that mothers receiving EMISTOP should not breast-feed their babies.
Use in Children: Little information is available about dosage in children under 3 years of age.
Use In Pregnancy & Lactation
Pregnancy: EMISTOP is not teratogenic in animals. There is no experience in humans. As with other medications, EMISTOP should not be used during pregnancy, especially during the first trimester, unless the expected benefit to the patient is thought to outweigh any possible risk to the foetus.
Lactation: Tests have shown that ondansetron is excreted in the breast milk of rats. It is therefore recommended that mothers receiving EMISTOP should not breast-feed their babies.
Side Effects
Ondansetron is known to increase large bowel transit time and may cause constipation in some patients. The following side effects can occur, headache, a sensation of flushing or warmth in the head and epigastrium, occasional transient asymptomatic increases in the levels of aminotransferases and possible extra pyramidal reactions.
There have been rare reports of immediate hypersensitivity reactions including anaphylaxis. Rare cases of transient visual disturbances (e.g. blurred vision) have been reported during rapid intravenous administration of ondansetron.
Storage
Store below 30°C. Protect from light.
ATC Classification
A04AA01 - ondansetron ; Belongs to the class of serotonin (5HT3) antagonists. Used for the prevention of nausea and vomiting.
Presentation/Packing
Inj (amp) 8 mg/4 mL x 5's, 10's.
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