Onseron 25ml Syrup 4mg/5ml

Yes

Ondansetron

Nausea & Vomiting

Ondansetron is a selective antagonist of the serotonin receptor subtype, 5-HT3. Its precise mode of action in the control of chemotherapy induced nausea and vomiting is not known. Cytotoxic chemotherapy and radiotherapy are associated with the release of serotonin (5-HT) from enterochromaffin cells of the small intestine, presumably initiating a vomiting reflex through stimulation of 5-HT3 receptors located on vagal afferents. Ondansetron may block the initiation of this reflex. Activation of vagal afferents may also cause a central release of serotonin from the chemoreceptor trigger zone of the area postrema, located on the floor of the fourth ventricle. Thus, the antiemetic effect of ondansetron is probably due to the selective antagonism of 5-HT3 receptors on neurons located in either the peripheral or central nervous systems, or both. The mechanisms of ondansetron’s antiemetic action in post-operative nausea and vomiting are not known.

Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Chemotherapy: Ondansetron Injection should be diluted in 50 ml of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration. Adults: The recommended adult intravenous dosage of Ondansetron is three 0.15-mg/kg doses up to a maximum of 16 mg per dose. The first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of Ondansetron. Pediatrics: For pediatric patients aged 6 months through 18 years, the intravenous dosage of Ondansetron is three 0.15-mg/kg doses up to a maximum of 16 mg per dose. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy. Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of Ondansetron. The drug should be infused intravenously over 15 minutes. Prevention of Postoperative Nausea and Vomiting: Ondansetron Injection should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form. Adults: The recommended adult intravenous dosage of Ondansetron is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring within 2 hours after surgery. Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, intravenous dose of ondansetron 4 mg, administration of a second intravenous dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting. Pediatrics: For pediatric patients aged 1 month through 12 years, the dosage is a single 0.1-mg/kg dose for patients weighing 40 kg or less, or a single 4-mg dose for patients weighing more than 40 kg. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring shortly after surgery. Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic Ondansetron.

Adverse reactions observed when ondansetron is used for Chemotherapy induced Nausea and Vomiting Diarrhea, Headache, Fever, Constipation, Rash. Cardiovascular: Rare cases of angina (chest pain), electrocardiographic alterations, hypotension, and tachycardia, QT prolongation, ST segment depression, bradycardia. Hepatic: In comparative trials in cisplatin chemotherapy patients with normal baseline values of aspartate transaminase (AST) and alanine transaminase (ALT), these enzymes have been reported to exceed twice the upper limit of normal in approximately 5% of patients. The increases were transient and did not appear to be related to dose or duration of therapy. On repeat exposure, similar transient elevations in transaminase values occurred in some courses, but symptomatic hepatic disease did not occur. Neurological: There have been rare reports consistent with, but not diagnostic of, extrapyramidal reactions in patients receiving ondansetron Injection and rare cases of grand mal seizure. Other: Rare cases of hypokalemia. Adverse reactions observed when ondansetron is used for Postoperative Nausea and Vomiting Headache, Drowsiness/sedation, Injection site reaction, Fever, Cold sensation, Pruritus and Paresthesia. OTHER ADVERSE REACTIONS: Local reactions: Pain, redness, burning at site of injection Lower respiratory: Hiccups Skin: Urticaria, Stenvens-Johnson syndrome, toxic epidermal necrolysis. Eye disorders: Transient blindness Neurological: Oculogyric crisis, appearing alone, as well as with other dystonic reactions. Transient dizziness during or shortly after intervenous administration.

Drugs Affecting Cytochrome P-450 Enzymes, Apomorphine, Phenytoin, Carbamazepine, and Rifampin, Tramadol, Serotonergic Drugs, carmustine, etoposide, and cisplatin, Temazepam, Alfentanil and Atracurium.

Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Cancer Chemotherapy.

Ondansetron is contraindicated for patients known to have hypersensitivity (e.g. anaphylaxis) to this product or any of its components. Anaphylactic reactions may be observed in patients taking ondansetron. 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.

Hypersensitivity reactions, including anaphylaxis and bronchospasm, have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists.

Ondansetron prolongs the QT interval in a dose-dependent manner. Avoid this medicine 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.

The use of ondansetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and gastric distention.

It is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction.

Always consult your physician before using any medicine.

Store this medicine at room temperature, away from direct light and heat.