Tranexamic Acid Injection (250 mg)
Healthy Inc is a specialized global supplier and exporter of targeted hemostatic and antifibrinolytic therapies. We provide high-purity Tranexamic Acid Injection (250 mg / 5 ml), manufactured in WHO–GMP certified sterile facilities. This specialized “Low-Dose / Pediatric” presentation is a mandatory export to pediatric surgery units, maxillofacial and dental clinics, and government health ministries in Africa, LATAM, and Southeast Asia, serving as a precise intervention for preventing localized bleeding and managing hemorrhage in lower-weight patients.
Product Overview
This formulation contains a specifically calibrated 250 mg dose of Tranexamic Acid (TXA), a synthetic lysine derivative and potent antifibrinolytic.
The “Precision Hemostasis” Specialist:
- Mechanism (Plasminogen Blockade): TXA competitively binds to the lysine receptor sites on plasminogen, preventing its conversion into active plasmin. This stops the premature dissolution of the fibrin matrix, stabilizing the clot at the site of vascular injury or surgical trauma.
- Pediatric Trauma & Surgery: In pediatric critical care, precise weight-based dosing (typically 15 mg/kg) is vital to prevent neurotoxicity (seizures) associated with TXA overdose. The 250 mg ampoule allows pediatric anesthesiologists to draw exact doses without massive drug wastage.
- Maxillofacial & Dental Utility: Highly utilized for local hemostasis. It is frequently administered systemically or applied locally (as a mouth rinse or soaked gauze) following dental extractions in patients with coagulopathies (e.g., hemophilia) or those on active anticoagulant therapy.
Product Composition & Strength
We supply this product as a Sterile, Clear, Colorless Aqueous Solution in glass ampoules.
| Active Ingredient | Concentration | Total Content & Format |
|---|---|---|
| Tranexamic Acid BP/USP | 50 mg / ml | 250 mg in 5 ml Glass Ampoule |
| Excipients | Water for Injection | Preservative-Free Formulation |
*Pack Sizes: Tray of 5 or 10 Ampoules.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.90.99 (Medicaments containing other active substances) |
| CAS Number | 1197-18-8 |
| Dosage Form | Injection (Liquid Solution) |
| Packaging | Type I Glass Ampoule. |
| Storage | Store below 30°C. 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.
- Micro-Dosing Precision: The 50 mg/ml (250 mg/5 ml) concentration requires highly precise compounding and volumetric filling to ensure absolute dose uniformity, which is critical when calculating exact mg/kg dosages for neonates and infants.
- Terminal Sterilization: The filled ampoules are terminally sterilized via autoclaving to guarantee a 100% pyrogen-free product, ensuring safety for direct intravenous injection or localized surgical field application.
Therapeutic Indications (Human Use)
Indicated for the prevention and treatment of hemorrhage, particularly in specialized scenarios:
- Pediatric Surgery & Trauma: Prevention of massive blood loss in pediatric orthopedic or cardiac surgeries.
- Dental Extractions: Prevention of bleeding in patients with hemophilia or those on anticoagulant therapy.
- Epistaxis & ENT Surgery: Management of severe nosebleeds and tonsillectomy bleeding.
- Ophthalmic Hemorrhage: Secondary bleeding following traumatic hyphema.
Dosage & Administration
Recommended Dosage (Strictly as per Physician):
- Route: Slow Intravenous (IV) Injection. (May also be used topically on surgical gauze per surgeon’s protocol).
- CRITICAL WARNING (Administration Rate): DO NOT INJECT RAPIDLY. Rapid IV injection can cause severe, sudden hypotension. The maximum injection rate is 1 ml/minute (50 mg/minute).
- Pediatric Dose: Typically 10 mg to 15 mg per kg body weight by slow IV injection, 2 to 3 times daily.
- Dental Extractions (Hemophiliacs): Often administered systemically immediately before surgery, combined with local application (mouthwash/gauze) utilizing the 5% (50 mg/ml) solution.
Safety Warnings (CRITICAL):
- Neurotoxicity / Seizures: High doses or accidental over-accumulation (especially in pediatric patients or those with renal failure) have been associated with severe post-operative seizures.
- Thrombotic Risk: Contraindicated in patients with active intravascular clotting conditions (like Deep Vein Thrombosis, Pulmonary Embolism) or a history of thromboembolic disease.
- Renal Impairment: Dosages must be drastically reduced in patients with renal failure to prevent toxic accumulation.
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 and Pediatric 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.