Description
Terlipressin for Injection
Healthy Inc is a specialized global supplier and exporter of advanced critical care and hepatology therapeutics. We provide high-purity Terlipressin for Injection (1 mg), manufactured in WHO–GMP certified sterile peptide lyophilization facilities. This “Vasopressin Analogue” is a mandatory export to intensive care units (ICU), gastroenterology departments, and government health ministries in Africa, LATAM, and Southeast Asia, serving as a life-saving, first-line pharmacological intervention for acute bleeding esophageal varices and Hepatorenal Syndrome (HRS).
Product Overview
This formulation contains Terlipressin (as Terlipressin Acetate), a synthetic polypeptide analogue of the natural posterior pituitary hormone, vasopressin.
The “Portal Decompressor” Specialist:
- Mechanism (The Prodrug Advantage): Terlipressin is a prodrug consisting of lysine vasopressin with three glycyl residues attached. Once injected, tissue peptidases slowly cleave the glycyl residues, releasing active lysine vasopressin in a sustained manner. This provides a significantly longer biological half-life (4 to 6 hours) compared to natural vasopressin, allowing for intermittent bolus dosing rather than a continuous, difficult-to-manage infusion.
- Splanchnic Vasoconstriction: The active moiety selectively binds to V1 receptors on the smooth muscle of the splanchnic (abdominal) vasculature. The resulting profound vasoconstriction drastically reduces blood flow into the portal vein, which directly lowers portal hypertension and physically stops the hemorrhaging of ruptured esophageal varices.
- Hepatorenal Syndrome (HRS) Reversal: In patients with severe liver cirrhosis, splanchnic vasodilation causes a massive pooling of blood, depriving the kidneys of perfusion. Terlipressin reverses this vasodilation, increasing effective arterial blood volume and restoring renal blood flow, thereby pulling patients out of acute kidney failure.
Product Composition & Strength
We supply this product as a Sterile Lyophilized Powder (White to Off-White Cake) in glass vials, requiring reconstitution with a provided sterile diluent.
| Active Ingredient | Strength | Reconstitution Requirement |
|---|---|---|
| Terlipressin (as Acetate) USP/BP | 1 mg | Requires 5 ml of 0.9% Sodium Chloride Diluent |
| Excipients | Mannitol / Glacial Acetic Acid | Bulking Agent / pH Adjustment |
*Pack Sizes: 1 Vial of Lyophilized Powder + 1 Ampoule of Diluent (5 ml) per box.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.39.00 (Medicaments containing hormones, but not containing antibiotics) |
| CAS Number | 14636-12-5 |
| Dosage Form | Lyophilized Powder for IV Injection |
| Packaging | Type I Glass Vial with Flip-off Seal. |
| Storage (Strict Cold Chain) | Store refrigerated at 2°C to 8°C. Protect from Light. Do Not Freeze. Reconstituted solution must be used immediately; discard any unused portion to prevent peptide degradation. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified biological units.
- Peptide Stability & Lyophilization: Terlipressin is a fragile peptide that degrades rapidly in aqueous solutions at room temperature. Our advanced lyophilization cycle ensures a moisture content of <2%, preserving the peptide bonds and ensuring instantaneous reconstitution when mixed with the saline diluent in emergency settings.
- Aseptic Processing: Manufactured under Grade A laminar airflow within Grade B cleanrooms to guarantee absolute sterility and pyrogen-free output, critical for patients with decompensated liver disease who are highly vulnerable to sepsis.
Therapeutic Indications (Human Use)
Indicated for emergency management in patients with portal hypertension and decompensated cirrhosis:
- Bleeding Esophageal Varices: Emergency treatment of acute variceal hemorrhage pending endoscopic intervention (banding/sclerotherapy).
- Hepatorenal Syndrome (Type 1): Management of rapidly progressive renal failure in patients with cirrhosis and ascites (often used in combination with human albumin).
Dosage & Administration
Recommended Dosage (Strictly as per Hepatologist/Intensivist):
- Route: Intravenous (IV) Bolus Injection ONLY.
- Acute Variceal Bleeding: Initial dose is 2 mg IV injected slowly over 1 minute. Followed by a maintenance dose of 1 mg to 2 mg every 4 to 6 hours for a maximum of 48 to 72 hours, or until bleeding has been controlled for 24 hours.
- Hepatorenal Syndrome (HRS-1): Typically 1 mg IV every 6 hours for at least 3 days. If serum creatinine does not decrease by at least 25% after 3 days, the dose may be escalated to 2 mg every 6 hours (often combined with Albumin infusion).
- Administration Warning: Monitor blood pressure and heart rate continuously; hypertension and bradycardia are common pharmacological responses.
Safety Warnings (CRITICAL):
- Ischemic Complications: Due to its profound vasoconstrictive effects, Terlipressin can cause severe ischemia. It is generally contraindicated (or used with extreme caution) in patients with a history of coronary artery disease, myocardial infarction, severe hypertension, or peripheral vascular disease (can cause necrosis of fingers/toes).
- Pregnancy (ABSOLUTE CONTRAINDICATION): FATAL RISK TO FETUS. Terlipressin causes intense uterine contractions and decreases uterine blood flow, leading to abortion or fetal death.
- Respiratory Failure: In HRS treatment, it can trigger fluid overload and severe pulmonary edema; strict monitoring of fluid balance is mandatory.
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 Critical Care Peptides, 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 secure cold-chain 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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