INTRODUCTION

SETRONEM 2MG contains Ondansetron which belongs to a group of medicines called anti-emetics, which help to stop feeling or being sick. It is indicated to prevent and treat nausea and vomiting induced by cytotoxic therapy and radiotherapy and post-operative nausea and vomiting. This medicine works by blocking the action of serotonin levels in the brain which causes nausea and vomiting during chemotherapy or any other surgery.

Cytotoxic chemotherapy triggers the release of serotonin from the enterochromaffin cells of the small intestine. The released serotonins stimulate the vagal afferents through the 5-HT3 receptors and initiate the vomiting reflex. Ondansetron is a selective 5-HT3 receptor antagonist which blocks serotonin, both peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone. It works by blocking serotonin in the brain which causes nausea and vomiting during anti-cancer treatment (chemotherapy) or after surgery.

Before receiving SETRONEM 2MG, tell your doctor if you have liver, kidney or heart problems, pregnant women and breastfeeding mothers. Your doctor will administer the right dose depends on your child’s age and body weight. The common side effects are headache, constipation and dizziness.

USES OF SETRONEM 2MG

• Cancer chemotherapy-induced nausea and vomiting
• Postoperative nausea and/or vomiting

HOW SETRONEM 2MG WORKS

SETRONEM 2MG is a selective 5-HT3-receptor antagonist which blocks serotonin, both peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone. It works by blocking serotonin in the brain which causes nausea and vomiting during anti-cancer treatment (chemotherapy) or after surgery.

DIRECTIONS FOR USE

SETRONEM 2MG should be only given by a doctor or nurse. Your healthcare provider will administer as intravenous injection (into a vein) or, after dilution, as intravenous infusion.

SIDE EFFECTS OF SETRONEM 2MG

HOW TO MANAGE SIDE EFFECTS

Headache:

Rest and drink plenty of fluids.

Constipation:

Add fruits, vegetables whole grains and other high-fiber foods to your normal diet.

Dizziness:

Get up and move around to feel awake, take small naps to edge off the sleepiness. Give your eyes a break to avoid fatigue and eat a healthy food to boost energy.

WARNING & PRECAUTIONS

INTERACTIONS

Inform your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or the following,

• apomorphine (used to treat Parkinson’s Disease)
• phenytoin, carbamazepine (used to treat epilepsy)
• rifampicin, erythromycin (an antibiotic)
• tramadol (used to treat pain)
• haloperidol, methadone
• medicines used to treat heart problems such as abnormal heart beats (anti-arrhythmics)
• fluoxetine, paroxetine, sertraline (used to treat depression)
• anthracyclines
• ketoconazole (used to treat fungal infection)

SYNOPSIS

MORE INFORMATION

Store below 20-25°C and keep out of reach of children.

FAQs ABOUT SETRONEM 2MG

Can SETRONEM 2MG be given in children?

Your doctor will administer the right dose depends on your child’s age and body weight.

Can use SETRONEM 2MG during pregnancy?

It is not recommended in the first trimester of pregnancy unless necessary. Consult your doctor for advice.

REFERENCES

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3. Katzung BG. Histamine, Serotonin, & the Ergot Alkaloids. In: Katzung BG, Masters SB, Trevor AJ, editors. Basic and Clinical Pharmacology. 11th ed. New Delhi, India: Tata McGraw Hill Education Private Limited; 2009. Page – 285.

4. Parker, Samantha E. Van Bennekom, Carla, Anderka, Marlene, Mitchell, Allen A. Ondansetron for Treatment of Nausea and Vomiting of Pregnancy and the Risk of Specific Birth Defects. Aug 2018, vol-132; [Accessed Jan 5, 2021] https://journals.lww.com/greenjournal/Fulltext/2018/08000/Ondansetron_for_Treatment_of_Nausea_and_Vomiting.16.aspx

6. Siegfried Hameln GmbH (Germany); [Revised Sep, 2019] [Accessed Jan 6, 2021] https://mri.cts-mrp.eu/human/downloads/DE_H_0806_001_FinalPI_2of2.pdf

7. Mylan Pharmaceuticals ULC; [Revised March 19, 2015] [Accessed Jan 6, 2021] https://pdf.hres.ca/dpd_pm/00029957.PDF

8. GlaxoSmithKline. May, 2010. U.S. Food & Drug Administration [Accessed Jan 6, 2021] https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020007s040,020403s018lbl.pdf

9. Fresenius Kabi Australia Pty Limited. Nov 28, 2012; [Revised May 28, 2010] [Accessed Jan 6, 2021] https://www.fresenius-kabi.com/au/documents/Ondansetron__PI.pdf