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Europe — EMA

Ondansetron Kabi (Ondansetron Hydrochloride Dihydrate)

Ondansetron Hydrochloride Dihydrate, the active ingredient in Ondansetron Kabi, is a 5-HT3 receptor antagonist presented as a sterile injectable solution for intravenous use.

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What is Ondansetron Hydrochloride Dihydrate?

Ondansetron Hydrochloride Dihydrate, the active ingredient in Ondansetron Kabi, is a 5-HT3 receptor antagonist presented as a sterile injectable solution for intravenous use. It helps prevent nausea and vomiting caused by chemotherapy, radiotherapy, and surgery in adult and pediatric patients. GNH USA supplies Ondansetron Kabi as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.

GNH USA supplies Ondansetron Kabi as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.

What is Ondansetron Hydrochloride Dihydrate used for?

Ondansetron Kabi is a selective 5‑HT3 receptor antagonist used in the management of nausea and vomiting pathways associated with several clinical settings.

- Chemotherapy‑induced nausea and vomiting: Reduces the frequency and severity of acute and delayed episodes. - Radiotherapy‑induced nausea and vomiting: Helps control nausea during and after radiation treatment. - Post‑operative nausea and vomiting: Decreases incidence of nausea and vomiting after surgical procedures. - Pregnancy‑related hyperemesis gravidarum: Provides symptomatic relief when other measures are insufficient. - Anticipatory nausea: Lessens nausea that occurs before chemotherapy in patients with prior experience.

What are the side effects of Ondansetron Hydrochloride Dihydrate?

Side effects reported with ondansetron are generally mild to moderate and vary with the route of administration and patient population.

Common Side Effects: - Headache: mild to moderate intensity. - Constipation: occasional bowel habit changes. - Diarrhoea: transient loose stools. - Fatigue: feeling of tiredness or reduced energy. - Dizziness: light‑headed sensation. - Injection site reactions: erythema or mild pain at the IV site.

Serious or Rare Side Effects: - Cardiac arrhythmia: QT‑interval prolongation, especially with rapid IV administration. - Severe allergic reaction: anaphylaxis, urticaria, or angio‑edema. - Serotonin syndrome: rare when combined with other serotonergic agents. - Hepatic enzyme elevation: abnormal liver function tests. - Severe hypotension: abrupt drop in blood pressure following rapid infusion.

What precautions apply to Ondansetron Hydrochloride Dihydrate?

When using Ondansetron Kabi, clinicians should consider several safety aspects to optimise patient outcomes.

- Cardiac monitoring: assess baseline ECG in patients with known cardiac disease or electrolyte disturbances. - Electrolyte balance: correct hypokalaemia, hypomagnesemia, or hypocalcaemia before administration. - Concomitant serotonergic drugs: evaluate risk of serotonin syndrome. - Pregnancy and lactation: weigh benefits against potential risks; use only if clearly needed. - Pediatric dosing: ensure weight‑based calculations are performed by the prescriber. - Store at below 25°C: keep in the original packaging, protect from light and moisture.

What does Ondansetron Hydrochloride Dihydrate interact with?

Ondansetron may interact with several medicines that influence cardiac conduction or serotonergic pathways.

Major Interactions (Avoid): - Amiodarone: may increase risk of QT prolongation. - Certain anti‑malarial    ---

Moderate  ---

Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Ondansetron Hydrochloride Dihydrate
Route
Intravenous Use
Manufacturer
Fresenius Kabi France S.A.S.
Origin
EU

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