Description
Ondansetron Injection
Healthy Inc is a specialized global supplier and exporter of highly targeted anti-emetic and supportive care therapies. We provide high-purity Ondansetron Injection (2 mg/ml), manufactured in WHO–GMP certified sterile facilities. This “5-HT3 Antagonist” is a mandatory export to oncology centers, post-operative recovery units, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the frontline defense against debilitating nausea and vomiting induced by chemotherapy, radiation, and surgery.
Product Overview
This formulation contains Ondansetron (as Hydrochloride Dihydrate), a highly specific and selective serotonin 5-HT3 receptor antagonist.
The “Serotonin Blocker” Specialist:
- Mechanism (Dual Blockade): Cytotoxic chemotherapy and radiotherapy damage the gastrointestinal mucosa, causing the release of massive amounts of serotonin (5-HT). This serotonin binds to 5-HT3 receptors, triggering the vomiting reflex. Ondansetron blocks these receptors both peripherally (on vagus nerve terminals in the gut) and centrally (in the Chemoreceptor Trigger Zone of the brainstem), effectively neutralizing the emetic signal.
- Chemotherapy Standard (CINV): It is the global standard of care for preventing acute nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy (e.g., Cisplatin protocols).
- Surgical Recovery (PONV): Highly effective in preventing post-operative nausea and vomiting without the severe extrapyramidal side effects (muscle spasms, restlessness) often associated with older dopamine antagonists like Metoclopramide or Haloperidol.
Product Composition & Strength
We supply this product as a Sterile, Clear, Aqueous Solution in glass ampoules or vials.
| Active Ingredient | Concentration | Total Content & Format |
|---|---|---|
| Ondansetron (as HCl Dihydrate) | 2 mg / ml | 4 mg in 2 ml Glass Ampoule |
| Ondansetron (as HCl Dihydrate) | 2 mg / ml | 8 mg in 4 ml Glass Ampoule |
| Excipients | Citric Acid / Sodium Citrate | pH Buffer System (pH 3.3 to 4.0) |
*Pack Sizes: Tray of 5/10 Ampoules or Box of 50 Ampoules.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.90.99 (Medicaments containing other active substances) |
| CAS Number | 103639-04-9 (Ondansetron Hydrochloride Dihydrate) |
| Dosage Form | Injection (Liquid Solution) |
| Packaging | Type I Glass Ampoule (Clear or Amber) with Color Break Ring. |
| Storage | Store below 30°C. Protect from Light. Do not freeze. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Precipitation Control: Ondansetron is known to precipitate under alkaline conditions. Our formulation utilizes a precise Citric Acid/Sodium Citrate buffer system to maintain an optimal acidic pH (3.3 – 4.0), ensuring 100% solubility and stability throughout its 36-month shelf life.
- Sterile Integrity: Manufactured using aseptic filling and terminal sterilization processes to guarantee absolute sterility, which is vital for immunocompromised oncology patients.
Therapeutic Indications (Human Use)
Indicated for the prevention and treatment of nausea and vomiting:
- Chemotherapy-Induced Nausea and Vomiting (CINV): Associated with initial and repeat courses of emetogenic cancer chemotherapy.
- Radiotherapy-Induced Nausea and Vomiting (RINV): Associated with total body irradiation or daily fractions to the abdomen.
- Post-Operative Nausea and Vomiting (PONV): Prevention and treatment in the recovery phase after surgery.
Dosage & Administration
Recommended Dosage (Strictly as per Physician/Oncologist):
- Route: Intravenous (IV) or Intramuscular (IM).
- CINV/RINV (Adults): 8 mg as a slow IV injection (over at least 30 seconds) or short IV infusion immediately before treatment, followed by oral maintenance.
- Highly Emetogenic Chemotherapy: A single 16 mg IV infusion (diluted in 50-100 ml saline/dextrose) over 15 minutes before chemotherapy. Do not exceed 16 mg per single IV dose due to QT prolongation risks.
- PONV (Adults): 4 mg as a single IV/IM injection at the induction of anesthesia or post-operatively if symptoms occur.
- Hepatic Impairment: Maximum total daily dose should not exceed 8 mg in patients with severe liver disease.
Safety Warnings (CRITICAL):
- QT Prolongation: Dose-dependent prolongation of the electrocardiographic QT interval can occur, leading to Torsades de Pointes (a fatal arrhythmia). Use with extreme caution in patients with electrolyte abnormalities (hypokalemia, hypomagnesemia) or those taking other QT-prolonging drugs.
- Serotonin Syndrome: Co-administration with other serotonergic drugs (SSRIs, SNRIs, MAOIs, Mirtazapine) can trigger potentially life-threatening serotonin syndrome (agitation, hallucinations, tachycardia, hyperthermia).
- Bowel Obstruction: Does not stimulate gastric motility. Use may mask progressive ileus or gastric distention in post-operative patients.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Anti-Emetic Injectables, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.
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