Description
Pantoprazole Sodium for Injection
Healthy Inc is a specialized global supplier and exporter of advanced gastrointestinal and critical care therapies. We provide high-purity Pantoprazole Injection (40 mg), manufactured in WHO–GMP certified sterile lyophilization facilities. This “Proton Pump Inhibitor (PPI)” is a mandatory export to intensive care units (ICU), gastroenterology departments, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the gold standard for stress ulcer prophylaxis and the emergency management of upper gastrointestinal bleeding.
Product Overview
This formulation contains Pantoprazole Sodium, a substituted benzimidazole that suppresses the final step in gastric acid production.
The “Parietal Cell” Specialist:
- Mechanism (Proton Pump Blockade): Pantoprazole is a prodrug that accumulates in the acidic space of the gastric parietal cell. It converts into its active sulfenamide form and binds covalently to the H+/K+ ATPase enzyme system (the “proton pump”). This permanently shuts down acid secretion until new enzymes are synthesized.
- Clot Stability in GI Bleeding: In cases of bleeding peptic ulcers, maintaining a high intragastric pH (> 6.0) is crucial because blood clots dissolve in highly acidic environments. IV Pantoprazole rapidly raises the pH, stabilizing the clot and preventing re-bleeding.
- ICU Stress Ulcers: Critically ill patients on mechanical ventilation are at high risk for stress-induced mucosal damage. IV Pantoprazole is the first-line defense to prevent life-threatening stress ulcer bleeding.
Product Composition & Strength
We supply this product as a Sterile Lyophilized Powder (White to Off-White Cake) in clear glass vials.
| Active Ingredient | Strength | Reconstitution Requirement |
|---|---|---|
| Pantoprazole Sodium USP/BP | 40 mg | Requires 10 ml of 0.9% Sodium Chloride |
| Excipients | Sodium Hydroxide / Edetate Disodium | Alkalizing Agent / Stabilizer |
*Pack Sizes: Single Vial or Tray of 10 Vials. (Often packed with a 10 ml ampoule of 0.9% NaCl diluent).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.90.99 (Medicaments containing other active substances) |
| CAS Number | 138786-67-1 |
| Dosage Form | Lyophilized Powder for Injection |
| Packaging | Type I Glass Vial with Flip-off Seal. |
| Storage | Store below 25°C. Protect from Light. Use reconstituted solution within 12 hours. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- pH Stability & Buffering: Pantoprazole is highly unstable and rapidly degrades in acidic environments. Our lyophilized formulation includes precise alkaline buffers (Sodium Hydroxide) to ensure the reconstituted solution maintains a high pH (9.0 to 10.5), preventing precipitation and active pharmaceutical ingredient (API) degradation before injection.
- Lyophilization Integrity: Advanced freeze-drying cycles guarantee a moisture content of < 2%, preventing hydrolysis and ensuring a rapid reconstitution time of under 2 minutes.
Therapeutic Indications (Human Use)
Indicated for conditions where oral administration is inappropriate or impossible:
- Upper GI Bleeding: Adjunctive therapy to endoscopic treatment for bleeding peptic ulcers.
- Stress Ulcer Prophylaxis: In critically ill ICU patients.
- Severe GERD: Gastroesophageal Reflux Disease with erosive esophagitis.
- Zollinger-Ellison Syndrome: Pathological hypersecretory conditions.
Dosage & Administration
Recommended Dosage (Strictly as per Physician):
- Route: Intravenous (IV) Injection or Infusion ONLY. (Do not administer Intramuscularly/IM).
- Standard IV Bolus: 40 mg administered slowly over at least 2 minutes.
- IV Infusion (GI Bleeding): Initial 80 mg bolus, followed by a continuous infusion of 8 mg/hour for 72 hours.
- Reconstitution Warning: Must be reconstituted with 0.9% Normal Saline. Do not use Dextrose (5% Dextrose) for the initial reconstitution, as the lower pH may cause the drug to precipitate.
Safety Warnings (CRITICAL):
- In-Line Filters: If administering as a continuous infusion, the use of an in-line filter (1.2 micron) is highly recommended to trap any unseen precipitates.
- Clostridium difficile Infection: Rapidly reducing gastric acid can alter gut flora, slightly increasing the risk of C. difficile associated diarrhea (CDAD) in hospitalized patients.
- Hypomagnesemia: Prolonged PPI use can cause severe drops in magnesium levels, leading to arrhythmias. (More relevant to oral maintenance therapy, but must be monitored in long-term ICU stays).
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 Gastrointestinal 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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