Description

Amiodarone Tablets (100mg / 200mg)

Manufactured by Healthy Life Pharma Pvt. Ltd. | Exported by Healthy Inc

1. Product Introduction Healthy Life Pharma Pvt. Ltd. is a specialized manufacturer of Amiodarone Tablets in India. This Class III Antiarrhythmic agent is the most effective medication available for managing life-threatening irregular heartbeats, such as Ventricular Tachycardia and Atrial Fibrillation. We produce high-precision tablets that ensure stable plasma levels. Our facility adheres to strict WHO-GMP standards. Healthy Inc manages our global exports and cardiology tenders.

2. Product Specifications | Parameter | Specification | | :— | :— | | Product Name | Amiodarone Tablets | | Generic Name | Amiodarone Hydrochloride USP / BP / IP | | Strength | 100mg / 200mg | | Dosage Form | Uncoated Tablet (Scored) | | Standard | USP / BP / IP Compliant | | Therapeutic Class | Antiarrhythmic (Class III) | | Shelf Life | 36 Months | | Packaging | 10×10 Amber Blister / 1000s Bulk Jar |

3. Manufacturing Amiodarone Tablets We divide our operations to ensure specialized focus.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd. First, Healthy Life Pharma handles manufacturing. We operate a WHO-GMP certified plant in Mumbai. Amiodarone has a narrow therapeutic window. To ensure safety, we use High-Shear Granulation to achieve perfect homogeneity in the powder blend. We perform rigorous Content Uniformity Testing on every batch to guarantee that every single tablet contains the exact intended dose. We also package the tablets in Light-Resistant (Amber) Blisters to prevent photodegradation.

• The Exporter: Healthy Inc Second, Healthy Inc manages international trade. This division handles logistics for Amiodarone Tablets. We supply specialized heart hospitals and emergency care units globally. We provide scored tablets to allow physicians to fine-tune the maintenance dose for long-term therapy.

4. Quality Assurance We test every batch rigorously.

• Dissolution: We test how the tablet releases the drug. Amiodarone is lipophilic (fat-loving) and difficult to dissolve. We ensure our formulation matches the dissolution profile of the innovator to guarantee bioequivalence.

• Iodine Content: Amiodarone contains iodine. We ensure the chemical structure is intact and pure.

• Impurity Profiling: We strictly monitor for organic impurities to minimize the risk of toxicity.

5. Why Use Amiodarone Tablets? This drug stabilizes the heart’s electrical rhythm.

• Mechanism: It primarily blocks Potassium Channels, prolonging the repolarization phase of the heartbeat. It also blocks sodium and calcium channels and beta-receptors.

• Effect: It slows down nerve impulses in the heart and increases the refractory period, stopping chaotic rhythms like fibrillation.

Key Indications:

• Ventricular Arrhythmias: Recurrent Ventricular Fibrillation (VF) and unstable Ventricular Tachycardia (VT).

• Atrial Fibrillation (AFib): Rhythm control and maintenance of sinus rhythm.

• Heart Failure: Often the antiarrhythmic of choice in patients with heart failure.

6. Export and Regulatory Support We provide complete documentation for registration.

• Dossier: We offer CTD and ACTD formats.

• Certificates: We supply the Free Sale Certificate (FSC) and COPP.

• Logistics: We ship via FOB Mumbai or CIF.

7. Frequently Asked Questions

• Q: Who manufactures Amiodarone Tablets? A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Is the 200mg tablet scored? A: Yes, our 200mg tablets have a functional score line to allow splitting into 100mg doses for maintenance therapy.

• Q: Does this contain Iodine? A: Yes, the molecule contains iodine, which is why thyroid monitoring is required during treatment.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION (For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Loading Dose: High doses (e.g., 800-1600 mg/day) are used initially in the hospital to saturate the tissues.

• Maintenance Dose: Usually reduced to 200mg or 400mg daily.

• Administration: Take with food to improve absorption and reduce stomach upset. Consistency is key (always with food or always without).

9. Side Effects and Precautions

• Thyroid Toxicity: Can cause Hypothyroidism or Hyperthyroidism due to high iodine content. Regular TSH testing is mandatory.

• Pulmonary Toxicity: Risk of lung fibrosis (scarring). Report any new cough or shortness of breath immediately.

• Photosensitivity: Patients may develop a blue-grey skin discoloration if exposed to the sun. Use sunscreen.

• Corneal Microdeposits: Deposits in the eye are common but usually do not affect vision.

10. Storage Instructions

• Store below 25°C in a dry place.

• Critical: Protect from light. Keep in the carton until use.

• Keep out of reach of children.