Description

Amiodarone Hydrochloride Tablets (100 mg / 200 mg)

Healthy Inc is a premier global supplier of high-precision cardiovascular therapies. We provide premium Amiodarone Hydrochloride Tablets, manufactured in WHO–GMP certified specialized solid dosage units. As a potent broad-spectrum anti-arrhythmic agent, this product is a vital export for cardiology institutes, critical care units, and Ministry of Health (MOH) tenders in Southeast Asia, Africa, and the Middle East.

Product Overview

Amiodarone is a benzofuran derivative and a member of the Class III anti-arrhythmic family. It is specifically engineered to stabilize cardiac rhythm by prolonging the action potential duration and refractory period in both atrial and ventricular myocardial tissues.

The “Multi-Channel” Cardiac Specialist:

• Mechanism of Action: While classified as Class III (potassium channel blocker), Amiodarone possesses multi-channel blocking properties. It inhibits inactivated sodium channels (Class I effect), has non-competitive anti-adrenergic activity (Class II effect), and blocks calcium channels (Class IV effect). This comprehensive profile makes it effective where other agents fail.
• Superior Rhythm Control: It is the gold standard for the prevention of recurrent life-threatening ventricular fibrillation and hemodynamically unstable ventricular tachycardia. It is also widely used for the maintenance of sinus rhythm in patients with atrial fibrillation.
• High Lipophilicity: Amiodarone is highly lipid-soluble, leading to a large volume of distribution and a significantly long half-life, which ensures sustained protection against cardiac electrical instability.

Technical & Manufacturing Specifications

Formulated for absolute content uniformity and protection against photo-degradation.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from ISO 9001:2015 certified units.

• Photostability Protocols: Amiodarone is sensitive to light. Our manufacturing process uses light-resistant coating materials and specialized primary packaging (Amber PVC or Alu-Alu) to maintain chemical integrity for 36 months.
• Dissolution Precision: Due to its low aqueous solubility, we utilize micronized API and specific surfactants to ensure consistent dissolution and absorption, providing predictable plasma concentrations for patients.
• Rigorous Impurity Screening: We monitor for iodine-related impurities and benzofuran precursors, ensuring the highest purity profile to reduce the risk of long-term side effects.

Therapeutic Indications & Clinical Symptoms

• Ventricular Arrhythmias: Treatment of recurrent ventricular fibrillation and unstable ventricular tachycardia.
• Atrial Fibrillation/Flutter: Conversion and maintenance of sinus rhythm in supraventricular arrhythmias.
• Refractory Arrhythmias: Management of cardiac rhythm disorders that do not respond to other anti-arrhythmic agents.

Dosage & Administration

• Loading Phase: Typically 600 mg to 1000 mg daily for 1 to 3 weeks to achieve tissue saturation.
• Maintenance Phase: Reduced to 200 mg daily or the lowest effective dose.
• Safety Note: Patients require regular monitoring of thyroid function, liver enzymes, and pulmonary health due to the drug’s high iodine content and tissue accumulation. Avoid grapefruit juice as it increases plasma levels.

Global Export & Contract Manufacturing Services

Healthy Inc is a verified Pharmaceutical Exporter in Mumbai, catering to Cardiology Hospitals and Ministry of Health Tenders. We offer Third Party Manufacturing for Amiodarone with full CTD Dossier and COPP support. Our logistics network ensures secure transit to Vietnam, Nigeria, UAE, and Europe, providing WHO-GMP quality at competitive B2B prices.

Commercial Inquiries

WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in