Omeprazole Sodium for Injection
Healthy Inc is a specialized global supplier and exporter of essential gastrointestinal and critical care therapies. We provide high-purity Omeprazole Injection (40 mg), manufactured in WHO–GMP certified sterile lyophilization facilities. This “First-in-Class 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 frontline intervention for acute peptic ulcer bleeding, severe acid reflux, and critical stress ulcer prophylaxis.
Product Overview
This formulation contains Omeprazole Sodium, a substituted benzimidazole that profoundly and irreversibly suppresses gastric acid secretion.
The “Parietal Cell” Specialist:
- Mechanism (Proton Pump Blockade): Omeprazole is a weak base that concentrates in the highly acidic secretory canaliculi of the gastric parietal cell. Here, it is converted into its active sulfenamide form, which covalently binds to the H+/K+ ATPase enzyme system (the “proton pump”). This blocks the final step of acid production, effectively reducing both basal and stimulated acid secretion.
- Hemostasis in GI Bleeding: Pepsinogen is activated to pepsin in highly acidic environments, which dissolves blood clots. By rapidly increasing the intragastric pH above 6.0, IV Omeprazole halts pepsin activity, stabilizing the clot over a bleeding ulcer and significantly reducing the rate of re-bleeding.
- Critical Care Utility: Essential for protecting the gastric mucosa in mechanically ventilated or severely burned patients who are at immense risk for stress-induced mucosal disease (stress ulcers).
Product Composition & Strength
We supply this product as a Sterile Lyophilized Powder (White to Off-White Cake) in clear glass vials, typically accompanied by a specialized sterile solvent.
| Active Ingredient | Strength | Reconstitution Requirement |
|---|---|---|
| Omeprazole Sodium USP/BP | 40 mg | Requires provided 10 ml solvent or specific diluent |
| Excipients | Sodium Hydroxide / Disodium Edetate | Alkalizing Agent / Stabilizer |
*Pack Sizes: Single Vial + 10 ml Solvent Ampoule, or Tray of 10 Vials.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.90.99 (Medicaments containing other active substances) |
| CAS Number | 73590-58-6 (Omeprazole) |
| Dosage Form | Lyophilized Powder for Injection |
| Packaging | Type I Glass Vial with Flip-off Seal + Glass Ampoule (Solvent). |
| Storage | Store below 25°C. Protect from Light. Reconstituted solution must be used immediately or within specific timeframes based on the diluent. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Strict pH Control: Omeprazole rapidly degrades in aqueous solutions at neutral or acidic pH. Our lyophilization formulation uses precise alkaline buffering (pH > 9.0 upon reconstitution) to ensure the API remains completely stable and soluble without precipitation prior to injection.
- Moisture Containment: The freeze-drying cycle is optimized to achieve an ultra-low moisture content (< 1.5%), ensuring a robust 24-month shelf life without degradation or discoloration of the lyophilized cake.
Therapeutic Indications (Human Use)
Indicated for conditions where rapid acid suppression is required and oral administration is not feasible:
- Bleeding Peptic Ulcers: Adjunctive management following endoscopic treatment for severe upper GI bleeds.
- Stress Ulcer Prophylaxis: In critically ill ICU trauma and burn patients.
- Severe Reflux Esophagitis: Short-term treatment of severe GERD.
- Zollinger-Ellison Syndrome: Pathological hypersecretory conditions requiring massive acid suppression.
- Aspiration Prophylaxis: Prevention of acid aspiration (Mendelson’s syndrome) prior to general anesthesia.
Dosage & Administration
Recommended Dosage (Strictly as per Physician):
- Route: Intravenous (IV) Injection or Infusion ONLY. (Never administer Intramuscularly).
- Standard Dose: 40 mg once daily.
- Severe GI Bleed Protocol: An initial bolus of 80 mg IV, followed by a continuous infusion of 8 mg/hour for 72 hours.
- Administration (Injection): Reconstitute with the provided solvent. Inject slowly over at least 2.5 to 5 minutes at a maximum rate of 4 ml/min.
- Administration (Infusion): Dissolve the 40 mg vial in 100 ml of 0.9% Sodium Chloride or 5% Dextrose. Infuse over 20 to 30 minutes.
Safety Warnings (CRITICAL):
- Reconstitution Error: Omeprazole for IV Injection is physically incompatible with many other IV drugs due to its high pH. Flush IV lines thoroughly before and after administration. Do not mix with other medications.
- Gastrointestinal Infections: Deep acid suppression slightly increases the risk of hospital-acquired infections, such as Salmonella, Campylobacter, and Clostridium difficile-associated diarrhea (CDAD).
- Hepatic Impairment: Omeprazole is extensively metabolized by the liver (CYP2C19). Dose adjustments may be required in patients with severe hepatic disease.
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.