In the pharmaceutical industry, Amiodarone tablets (typically available in 100 mg and 200 mg) are classified as a Class III anti-arrhythmic agent. As a pharmacist, I consider Amiodarone a “broad-spectrum” anti-arrhythmic because, while it is primarily a potassium channel blocker, it also exhibits characteristics of all four Vaughan-Williams classes, making it exceptionally potent for complex cardiac rhythms.

Primary Clinical Uses

• Ventricular Arrhythmias: Indicated for the treatment of life-threatening recurrent ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT).

• Atrial Fibrillation (AFib): Widely used for rhythm control to convert AFib to a normal sinus rhythm and to maintain that rhythm over the long term.

• Supraventricular Tachycardias (SVT): Effective in managing various forms of SVT, particularly in patients with impaired left ventricular function where other agents might be contraindicated.

  Refractory Cases: Often utilized when other anti-arrhythmic medications have failed or are not tolerated by the patient.

  Mechanism of Action

Amiodarone’s primary action is the blockade of potassium channels, which prolongs the action potential duration and the refractory period in myocardial tissue (Class III effect). However, it also:

Inhibits inactivated sodium channels (Class I effect).

Exhibits non-competitive alpha- and beta-adrenergic inhibition (Class II effect).

Exhibits weak calcium channel blocking activity (Class IV effect).

This comprehensive blockade helps stabilize the cardiac membrane and slow the conduction of electrical impulses that cause irregular heartbeats.

The Manufacturer’s Perspective: Formulation & Export

From a manufacturing and global trade standpoint, Amiodarone 200 mg is a critical chronic care molecule requiring strict quality oversight:

• Lipid Solubility & Bioavailability: Amiodarone is highly lipophilic, which leads to a very long half-life (up to 60 days). As a WHO-GMP manufacturer, we ensure precise formulation to maintain consistent dissolution profiles, which is vital given the drug’s narrow therapeutic index.

• Photosensitivity & Packaging: The molecule is sensitive to light. We utilize amber-colored PVC or Alu-Alu blister packaging to protect the integrity of the tablets during transit and storage in various global climates.

• Global Export Niche: Amiodarone is a high-value export item for B2B partners supplying cardiology clinics and hospitals. Our Mumbai-based facility provides the necessary CTD/eCTD Dossiers to facilitate registration in highly regulated and semi-regulated markets.

• Technical Support: We provide comprehensive stability data for Zone IVb, ensuring that our international partners in Africa, SE Asia, and Latin America receive a product that maintains its potency in hot and humid conditions.