Description

Amiodarone Tablet

Amiodarone Hydrochloride Tablets BP / IP / USP

Healthy Life Pharma Private Limited, alongside our specialized global export division Healthy Inc, is a premier manufacturer, supplier, and exporter of advanced cardiology, resuscitation, and critical-care therapeutics. We manufacture ultra-high-purity, kinetically stable Amiodarone Hydrochloride Tablets in our WHO–GMP certified, high-precision solid dosage manufacturing facilities. This foundational “Class III Antiarrhythmic Agent” serves as a high-volume strategic export to cardiac centers, hospital intensive care networks, state procurement tenders, and international B2B wholesale marketplaces across Europe, the CIS region, Africa, LATAM, and SE Asia.

Product Overview

This formulation operates as a “Multichannel Cardiac Stabilizer.” It ensures patient safety by modifying the electrical conductive pathways of the heart, effectively preventing disorganized, life-threatening tachyarrhythmias.

• Mechanism 1 (Class III Potassium Channel Antagonism): Amiodarone physically blocks rectifying potassium channels responsible for repolarization. This chemically prolongs the cardiac action potential duration and the physical effective refractory period (ERP) in both atrial and ventricular muscle fibers.

• Mechanism 2 (Broad Ionic Channel Blockade): In addition to its primary Class III effect, it physically exhibits Class I (sodium channel blocking), Class II (non-competitive anti-adrenergic/beta-blocking), and Class IV (calcium channel blocking) properties. This “multi-channel” action makes it highly effective against multiple distinct arrhythmia pathways.

• Mechanism 3 (Myocardial Energy Optimization): It chemically induces a physical reduction in peripheral vascular resistance and decreases cardiac workload, physically lowering myocardial oxygen consumption to safeguard ischemic heart tissue.

Product Composition & Available Strengths

We manufacture Amiodarone in standard, internationally recognized strengths to allow for the intensive loading phase and lower maintenance doses required in cardiology.

Technical & Logistics Specifications

• HS Code: 3004.90.99 (Medicaments acting on the cardiovascular system / Others)

• CAS Number: 19774-82-4 (Amiodarone Hydrochloride)

• Dosage Form: Oral Solid Tablet (Scored for flexible division)

• Packaging: 10 Tablets per Blister in high-barrier Alu-Alu (Cold-Form Foil) or secure, light-shielded amber PVC/PVDC packs. Our premium packaging configurations physically prevent UV penetration, guaranteeing a 36-month shelf life in Zone IVb tropical environments.

Manufacturing Authority & Compliance

• Photo-Stability Engineering: Amiodarone is highly physically sensitive to light degradation. Our manufacturing process utilizes Opaque Film Coating Systems, and we pack the compressed matrices into deep-amber or high-opacity aluminum barriers, chemically preserving active molecular potency throughout global sea and air transit.

• Strict API Chemical Control: Amiodarone contains iodine in its structural core (approx. 37% by weight). We utilize High-Performance Liquid Chromatography (HPLC) to verify the purity of every raw material batch, physically ensuring zero free iodine contamination.

• Dose-Uniformity Validation: Because antiarrhythmic dosing demands precision to prevent proarrhythmic risks, we deploy Automated High-Speed Tableting Lines, physically guaranteeing that every tablet displays identical chemical disintegration and dissolution kinetics.

Primary Indications

• Cardiology: Suppression and prevention of recurrent, life-threatening Ventricular Fibrillation (VF) and hemodynamically unstable Ventricular Tachycardia (VT).

• Electrophysiology: Rhythm control in patients presenting with highly symptomatic Atrial Fibrillation (AF) or flutter, particularly when associated with structural heart disease or left ventricular dysfunction.

Usage Instructions

• Administration: Swallow the tablet physically whole with a glass of water. It should be taken consistently either with or without food to minimize absorption variance.

• The Loading Protocol: This medication has a uniquely long half-life (up to 60 days). It is physically critical to follow the physician’s multi-week high-dose oral loading phase before dropping down to the lower daily maintenance dose.

• Clinical Monitoring Requirements: Because Amiodarone concentrates heavily in peripheral tissues, regular Thyroid Function Tests (due to iodine content), Liver Function Tests ($ALT$/$AST$), Pulmonary Function Tests, and Ophthalmic Exams are physically mandatory during long-term therapy.

Safety Warning: POTENT ANTIARRHYTHMIC AGENT. For Cardiologist Supervision Only. Pulmonary Toxicity: May physically cause severe, progressive pulmonary fibrosis; monitor breathing patterns and chest X-rays chemically if changes occur. Hormonal Note: May chemically induce either hyperthyroidism or hypothyroidism due to high structural iodine content. Contraindication: Do not use in patients presenting with cardiogenic shock, severe sinoatrial node dysfunction causing marked sinus bradycardia, second or third-degree AV block (without a functioning pacemaker), or known hypersensitivity to iodine.

Global Export & Contract Manufacturing (CDMO Services)

Healthy Life Pharma Private Limited provides complete, internationally validated Third-Party Contract Manufacturing (CDMO) for generic Amiodarone Hydrochloride Tablets. Whether you are stocking a major hospital infrastructure in the CIS, fulfilling a National Cardiology Service Tender in Africa, or integrating inventory into an international B2B Pharmaceutical Marketplace in South-East Asia or LATAM, we prepare all required regulatory dossiers (WHO-GMP, COPP, COA, Stability Data) for rapid import clearance.

Commercial & Bulk Procurement Inquiries:

• Corporate Head Office: Mumbai, Maharashtra, India

• Primary Manufacturing Base: Boisar, Maharashtra, India

• WhatsApp / Direct Call: +91 7710003340

• Corporate Email: info@healthyinc.co.in