Description
Amiodarone Hydrochloride Injection (Sterile Concentrate)
Healthy Inc is a specialized global supplier and exporter of critical care cardiac injectables. We provide high-purity Amiodarone Hydrochloride Injection (Sterile Concentrate), manufactured in our WHO–GMP certified facilities. This Class III Antiarrhythmic agent is a life-saving drug exported to hospitals and cardiac centers in Africa, LATAM, CIS, and Southeast Asia for the emergency management of life-threatening arrhythmias.
Product Overview
Amiodarone is a potent Class III Antiarrhythmic Drug that works by prolonging the action potential duration and refractory period in cardiac tissues. It also possesses alpha- and beta-adrenergic blocking properties.
It is the “First-Line injectable” for:
- Ventricular Arrhythmias: Hemodynamically unstable Ventricular Tachycardia (VT) and Ventricular Fibrillation (VF).
- Atrial Fibrillation: Rate control and conversion in patients with heart failure.
- Cardiac Arrest: Used in ACLS (Advanced Cardiac Life Support) protocols for shock-refractory VF/pulseless VT.
Product Composition & Strength
We supply this product as a Sterile Concentrate which must be diluted before administration.
| Active Ingredient | Strength | Presentation |
|---|---|---|
| Amiodarone Hydrochloride | 50 mg / ml | 3 ml Ampoule (150 mg total) |
*Excipients: Contains Polysorbate 80 and Benzyl Alcohol.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Hospital Tenders.
| HS Code | 3004.90.99 (Medicaments for therapeutic uses) |
| Dosage Form | Sterile Concentrate for Injection (Liquid) |
| Route of Administration | Intravenous (IV) Infusion only |
| Packaging | 3ml Amber Glass Ampoules (Tray/Blister Pack) |
| Storage | Store below 25°C. Protect from light. |
| Certificates | WHO-GMP, COPP, FSC, CTD Dossier |
Manufacturing Authority
Manufactured at our WHO-GMP & ISO 9001:2015 certified unit.
- Quality: Strict controls on Polysorbate quality to minimize risk of hypotension.
- Stability: Formulation stabilized to prevent precipitation during storage.
- Capacity: Dedicated sterile injectable lines for high-volume export.
Therapeutic Indications
Indicated for the treatment of patients with:
- Recurrent Ventricular Fibrillation (VF).
- Recurrent hemodynamically unstable Ventricular Tachycardia (VT).
- Patients intolerant to oral amiodarone therapy.
Dosage & Administration
Strict Medical Supervision Required (Hospital Use Only):
- Dilution: Must be diluted in 5% Dextrose (D5W). Do not use Saline (NS) as it may cause precipitation.
- Administration: Administer via a Central Venous Catheter whenever possible to prevent phlebitis.
- Loading Dose: Typically 150 mg over first 10 minutes, followed by 360 mg over next 6 hours (Slow Infusion).
- Maintenance: 540 mg over remaining 18 hours.
Warnings:
- Hypotension: Rapid injection may cause severe drop in blood pressure.
- Light Sensitive: Protect diluted solution from direct sunlight.
Commercial Inquiries
For hospital tenders, bulk export, or distributor pricing, please contact our export team.
WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in
