Product Specifications
| Specification | Details |
| Manufacturer / Brand | Hikma Pharmaceuticals USA Inc. |
| Manufacturer # / SKU | 00641607825 |
| NDC Number | 00641-6078-25 |
| Concentration / Strength | 2 mg / mL (4 mg per 2 mL) |
| Total Content per Vial | 4 mg of Ondansetron (as hydrochloride dihydrate) |
| Volume per Unit | 2 mL |
| Container Type | Glass Single-Dose Vial (SDV) |
| Administration Route | Intravenous (IV) or Intramuscular (IM) Injection |
| Formulation | Preservative-Free / Sterile / pH 3.3 to 4.0 |
| Storage Temperature | 20°C to 25°C (68°F to 77°F) (Protect from light; retain in carton) |
| Packaging Configuration | 25 Vials per Package / Box |
| Latex Content | Container closure is not made with natural rubber latex |
Key Features & Clinical Applications
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Selective 5-HT3 Receptor Antagonism: Rapidly inhibits serotonin signals both peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone (CTZ), blocking the emetic reflex arc.
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Chemotherapy-Induced Nausea & Vomiting (CINV): Serves as a first-line agent for preventing initial and recurrent emesis associated with moderately and highly emetogenic antineoplastic therapies.
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Post-Operative Nausea & Vomiting (PONV): Highly effective when administered routinely during induction or post-anaesthesia care unit (PACU) recovery to manage surgical nausea.
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Preservative-Free Single-Dose Design: Formulated without antimicrobial preservatives, minimizing chemical interactions and reducing cross-contamination risks across fast-paced clinical environments.
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Dual IV/IM Flexibility: Fully cleared for direct, undiluted slow intravenous push over 2 to 5 minutes or deep intramuscular injection when IV access is unestablished.
⚠️ Usage Note: Single-dose vial. Discard any unused portion remaining in the vial immediately after opening, as the preservative-free formulation does not prevent bacterial growth after initial puncture.
⚠️ Cardiac Precaution (QT Prolongation): Ondansetron produces dose-dependent prolongation of the Electrocardiogram (ECG) QT interval. Avoid rapid IV push boluses and exercise heightened monitoring in patients with congenital long QT syndrome, electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), or those taking concurrent QTc-prolonging medications.
⚠️ Light Sensitivity: Store vials inside their protective outer paper box until ready for immediate clinical use. Exposure to direct light degrades the active pharmaceutical ingredient over time.
