Description

Rabeprazole Sodium for Injection

Healthy Inc is a specialized global supplier and exporter of advanced gastrointestinal and critical care therapies. We provide high-purity Rabeprazole Injection (20 mg), manufactured in WHO–GMP certified sterile lyophilization facilities. Known as the “Fastest-Acting PPI,” this specialized intervention is a mandatory export to intensive care units (ICU), gastroenterology departments, and government health ministries in Africa, LATAM, and Southeast Asia, serving as a rapid-response agent for acute peptic ulcer bleeding and refractory acid hypersecretion.

Product Overview

This formulation contains Rabeprazole Sodium, a substituted benzimidazole proton pump inhibitor (PPI) with unique pharmacokinetic properties compared to older-generation PPIs.

The “Rapid-Onset” Specialist:

• Mechanism (The High pKa Advantage): Like all PPIs, Rabeprazole is a prodrug that activates in the acidic environment of the parietal cell to covalently bind the H+/K+ ATPase enzyme. However, Rabeprazole has a significantly higher pKa (~5.0) than Omeprazole or Pantoprazole. This means it activates much faster at a less acidic pH, resulting in a more rapid onset of acid suppression—a critical advantage in acute GI bleeding scenarios.
• Hemostatic Clot Protection: By rapidly driving the intragastric pH above 6.0, IV Rabeprazole immediately halts the proteolytic activity of pepsin, securing fragile blood clots over bleeding gastric or duodenal ulcers and drastically reducing the need for repeat endoscopic interventions.
• Non-Enzymatic Metabolism: Unlike Omeprazole, Rabeprazole is primarily metabolized via a non-enzymatic pathway (with only minor involvement of CYP2C19 and CYP3A4). This results in far fewer drug-drug interactions, making it exceptionally safe for polypharmacy ICU patients.

Product Composition & Strength

We supply this product as a Sterile Lyophilized Powder (White to Pale Yellow Cake) in clear glass vials.

*Pack Sizes: Single Vial or Tray of 10 Vials. (Often packed with a 5 ml diluent ampoule).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Distributors.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• Lyophilization Stability: Rabeprazole is highly susceptible to acid-catalyzed degradation. Our lyophilized formulation includes precise Sodium Hydroxide buffering to maintain a high alkaline pH upon reconstitution, ensuring the active pharmaceutical ingredient (API) remains 100% potent without precipitating prior to administration.
• Aseptic Processing: Manufactured utilizing advanced sterile filtration and filling under Grade A laminar airflow within Grade B cleanrooms, ensuring absolute sterility and a particulate-free profile for direct intravenous use.

Therapeutic Indications (Human Use)

Indicated for conditions requiring rapid and profound acid suppression where oral administration is not feasible:

• Acute Peptic Ulcer Bleeding: Hemostasis and prevention of re-bleeding in gastric and duodenal ulcers.
• Stress Ulcer Prophylaxis: In critically ill, mechanically ventilated, or severe trauma patients in the ICU.
• Severe Gastroesophageal Reflux Disease (GERD): Erosive or ulcerative esophagitis.
• Zollinger-Ellison Syndrome: Emergency management of pathological hypersecretory states.

Dosage & Administration

Recommended Dosage (Strictly as per Physician):

• Route: Intravenous (IV) Injection or Infusion ONLY. (Do not administer Intramuscularly/IM).
• Standard IV Bolus: 20 mg administered slowly over at least 5 to 15 minutes.
• Severe GI Bleed Protocol: Often managed with a higher initial loading dose followed by continuous infusion, as directed by the gastroenterologist.
• Reconstitution Warning: Must be reconstituted strictly with the provided solvent or 0.9% Normal Saline. Flush IV lines thoroughly before and after administration to prevent precipitation with other drugs.

Safety Warnings (CRITICAL):

• Bone Fractures & Hypomagnesemia: Prolonged high-dose PPI therapy may increase the risk of osteoporosis-related fractures and severe magnesium deficiency. Monitor electrolytes in long-term ICU patients.
• Clostridium difficile Associated Diarrhea (CDAD): Deep gastric acid suppression alters the gut microbiome, slightly elevating the risk of hospital-acquired enteric infections.
• Hepatic Impairment: While less metabolically dependent on the liver than other PPIs, use with caution 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.