Onaseron ODT Tablet 10pcs

Side Effects

Common side effects include headache, constipation, and diarrhea, usually mild to moderate. Rash, sensation of warmth, hiccups, and liver enzyme abnormalities have been reported. Rarely, anaphylaxis, bronchospasm, tachycardia, angina, hypokalemia, and shortness of breath may occur. Extrapyramidal reactions are very rare.

Pharmacology

Ondansetron is a potent and highly selective 5-HT3 receptor antagonist. Its precise mode of action in controlling nausea and vomiting is not fully known. Chemotherapeutic agents and radiotherapy can release 5-HT in the small intestine, initiating a vomiting reflex via 5-HT3 receptors on vagal afferents. Ondansetron blocks this reflex. The release of 5-HT in the area postrema (brainstem) may also contribute to emesis through a central mechanism. Thus, ondansetron likely manages nausea and vomiting by antagonizing 5-HT3 receptors in both the peripheral and central nervous systems. The mechanism for post-operative nausea and vomiting may involve similar pathways.

Radiotherapy-Induced Nausea and Vomiting:

• Adults:
  • Tablets/Oral Solution: 8 mg 1-2 hours before radiotherapy, then 8 mg every 8 hours for up to 5 days.

Postoperative Nausea and Vomiting:

• Adults:
  • Tablets: 16 mg given as two 8 mg tablets.
  • Injection: 4 mg.
• Pediatrics (>40 kg): Injection: 4 mg.
• Pediatrics (<40 kg): Injection: 0.1 mg/kg.

Chemotherapy-Induced Nausea and Vomiting:

• Adults and Pediatric (6 months to 18 years):
  • Tablets/Oral Solution: Three 0.15 mg/kg doses, up to 16 mg per dose.
  • Injection: Three 0.15 mg/kg doses, up to 16 mg per dose, infused intravenously over 15 minutes.

Directions for Use:

It can be taken with or without a meal as advised by the doctor. Swallow the tablet as a whole with a glass of water. Do not break, crush, or chew it. 

Before taking Onaseron ODT Tablet, inform your doctor, if you are taking any of the following medicine:

• Apomorphine (used to manage Parkinson’s disease)
• Medicines used to manage epilepsy (Ex. phenytoin, carbamazepine)
• Medicines used to manage lung infections like Tuberculosis (Ex. rifampicin)
• Tramadol, methadone (medicine used to provide relief from pain)
• Medicines used for psychotic disorders (Ex. haloperidol)
• Medicines used to manage heart problems such as abnormal heartbeats (Ex. amiodarone) and/or high blood pressure (Ex. atenolol, timolol)
• Cancer medicines (Ex. doxorubicin, daunorubicin, monoclonal, trastuzumab)
• Erythromycin, ketoconazole (used to manage infections)
• Medicines used to manage depression and anxiety (ex. fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, venlafaxine, duloxetine escitalopram)

Contraindications

Onaseron is contraindicated in patients with hypersensitivity to the drug or its components and in those taking apomorphine

Pregnancy & Lactation

Animal studies have not shown evidence of harm to the fetus, but there are no adequate studies in pregnant women. Ondansetron is excreted in rat milk, so caution is advised when administering it to breastfeeding women

Use in Special Populations

• Renal impairment: No dosage adjustment is necessary.
• Hepatic impairment: Maximum daily dose is 8 mg for severe impairment.
• Children (≤4 years): Limited data available.
• Elderly (>65 years): No dosage adjustment is needed.

Precautions & Warnings

Hypersensitivity reactions have been reported in patients sensitive to other 5-HT3 antagonists. Onaseron should not replace nasogastric suction in cases of gastric or intestinal peristalsis issues. It may mask progressive ileus or gastric distension post-abdominal surgery or chemotherapy-induced nausea and vomiting. 

Storage Conditions

Store below 30ºC in a dry place, protected from light and moisture.