Amiodarone Tablets 100mg

Amiodarone Tablets 100mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Amiodarone Tablets USP 100mg
B) Amiodarone Tablets USP 200mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Amiodarone Tablets USP 100mg
Each film-coated tablet contains:
Amiodarone Hydrochloride USP…………………100mg
Excipients…………………………………………………q.s

B) Amiodarone Tablets USP 200mg
Each film-coated tablet contains:
Amiodarone Hydrochloride USP…………………200mg
Excipients…………………………………………………q.s.

THERAPEUTIC INDICATIONS:

Amiodarone is an antiarrhythmic medication used to treat and prevent a number of types of cardiac dysrhythmias. This includes ventricular tachycardia, ventricular fibrillation, and wide complex tachycardia, as well as atrial fibrillation and paroxysmal supraventricular tachycardia.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.

WARNING:TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store below 30°C.
Protect from Light and moisture.
Dosage: As directed by the Physician

Introduction to Amiodarone Tablets 100mg

Amiodarone Tablets 100mg is a prescription-only anti-arrhythmic medication used for treating life-threatening irregular heartbeats, such as ventricular fibrillation and ventricular tachycardia. It is prescribed when other treatments have proven ineffective and works by stabilizing the electrical activity of the heart to maintain a steady rhythm.

Globally, the demand for Amiodarone Tablets 100mg is increasing due to rising cardiovascular disorders, the prevalence of arrhythmias, and the need for effective, reliable anti-arrhythmic treatment. Hospitals, clinics, and pharmacies across Europe, the Middle East, Africa, and Asia rely on trusted manufacturers like Taj Pharma to ensure uninterrupted supply of this vital medication.

Taj Pharma, a leading Amiodarone Tablets 100mg Manufacturer in India, provides assurance of high-quality production, international certifications, and adherence to stringent pharmaceutical standards.

Therapeutic Uses and Benefits

Amiodarone Tablets 100mg is widely used for:

• Life-threatening ventricular arrhythmias

• Atrial fibrillation

• Ventricular tachycardia

• Prevention of sudden cardiac arrest in high-risk patients

Benefits:

• Rapidly restores heart rhythm to normal

• Helps prevent recurrence of irregular heartbeat

• Reduces risk of complications such as stroke or cardiac arrest

• Can be taken orally, providing long-term management for chronic arrhythmias

By regulating the heart’s electrical activity, Amiodarone ensures that patients with severe arrhythmias can maintain safer cardiac function and improved quality of life.

Safety Profile and Side Effects

While effective, Amiodarone Tablets 100mg requires careful monitoring due to potential side effects.

Common Side Effects:

• Lung damage (pulmonary toxicity)

• Tachycardia or bradycardia

• Congestive heart failure

• Elevation of liver enzymes

• Thyroid dysfunction

• Neuropathy

Precautions:

• Take with or without food at the same time daily

• Continuous monitoring of blood pressure, heart rate, liver, and thyroid function

• Inform your doctor of all existing conditions, including liver, heart, thyroid problems, or alcohol use

• Avoid interactions with antibiotics, antidepressants, or other medications affecting heart rhythm

Taj Pharma emphasizes rigorous quality control to minimize risks while delivering safe and reliable Amiodarone Tablets 100mg to global buyers.

In-Depth Details for Importers and Exporters

Regulatory Documentation Provided

Taj Pharma provides complete documentation for hassle-free international trade:

• WHO-GMP Certification

• EU-GMP Certificate

• Certificate of Pharmaceutical Product (COPP)

• CTD/eCTD Dossier for registration

• Batch-wise Certificate of Analysis (COA)

Custom Packaging & Labeling

• Blister packs, bottles, or bulk packaging

• Multi-language labeling for international markets

• Private labeling for distributors and PCD Pharma franchisees

Shelf-Life, Storage & Dosage Form

• Dosage Form: Tablet

• Strength: 100mg

• Shelf-Life: 36 months

• Storage: Store below 25°C, away from moisture and direct sunlight

Export Certifications

• WHO-GMP

• ISO 9001:2015

• COPP

• CTD Dossier for regulatory compliance in target countries

Target Countries & Export Markets

Taj Pharma exports Amiodarone Tablets 100mg to over 20 countries including:

• USA

• UK

• Germany

• France

• Italy

• Spain

• UAE

• Saudi Arabia

• Qatar

• Kuwait

• Nigeria

• Kenya

• South Africa

• Malaysia

• Philippines

• Vietnam

• Bangladesh

• Sri Lanka

• Indonesia

• Brazil

Why Taj Pharma is the Most Trusted Manufacturer & Supplier

State-of-the-Art Manufacturing

Taj Pharma’s Vapi, Gujarat facility features:

• Advanced tablet compression and coating machinery

• State-of-the-art quality control laboratories

• Fully GMP-compliant production lines

• Continuous quality assurance protocols

Affordable Pricing & Quality Assurance

• Competitive pricing for bulk orders

• Stringent quality checks at every production stage

• Compliance with global regulatory standards

Global Presence & Supply Chain Support

• Timely international shipping

• Regulatory and registration assistance

• Reliable supply chain for distributors, hospitals, and PCD franchisees

Top 20 Exporting Countries

India , Bangladesh, Nepal, Sri Lanka, Vietnam, Philippines, Cambodia, Nigeria, Kenya, Ghana, Egypt, Ethiopia, Morocco, Peru, Colombia, Ecuador, Bolivia , Ukraine, Uzbekistan, Kazakhstan

Technical Product Specification Table

Call to Action

Looking for a trusted Amiodarone Tablets 100mg Manufacturer Supplier in India?

Taj Pharma offers WHO-GMP certified, export-ready tablets for distributors, PCD Pharma franchisees, and global healthcare providers.

📩 Contact Taj Pharma today for bulk orders, export inquiries, and tailored pharmaceutical solutions.

Top 20 FAQs

1. What is Amiodarone Tablets 100mg used for?
To treat life-threatening arrhythmias such as ventricular fibrillation and tachycardia.

2. How should it be taken?
Orally, at the same time daily, with or without food.

3. Can it cause liver issues?
Yes, monitor liver function regularly.

4. Are there heart-related side effects?
Tachycardia, bradycardia, and congestive heart failure may occur.

5. Can it be used long-term?
Yes, under strict medical supervision.

6. Can it affect the thyroid?
Yes, may cause hypo- or hyperthyroidism.

7. Who should avoid this medicine?
Patients with low blood pressure, liver disease, or thyroid issues without doctor consultation.

8. Is monitoring required?
Yes, regular heart rate, blood pressure, and blood tests are needed.

9. Can it interact with other medications?
Yes, avoid certain antibiotics, antidepressants, and other antiarrhythmics.

10. Is it safe during pregnancy?
Only under medical supervision.

11. What is the shelf life?
36 months from manufacturing.

12. Are export documents provided?
Yes, WHO-GMP, COPP, and CTD dossiers are available.

13. Can it be used for atrial fibrillation?
Yes, it is effective for several types of arrhythmias.

14. How is it packaged?
Blister packs, bottles, or bulk packaging.

15. Can it be stopped abruptly?
No, stopping abruptly may cause dangerous arrhythmias.

16. Is Taj Pharma WHO-GMP certified?
Yes, ensuring global compliance.

17. How is it shipped internationally?
Through reliable logistic partners with temperature-controlled options.

18. Can it be used with alcohol?
Avoid alcohol to reduce liver toxicity risk.

19. How long does it stay in the body?
It has a long half-life; side effects may persist after discontinuation.

20. What makes Taj Pharma the best supplier?
WHO-GMP certification, advanced manufacturing, competitive pricing, and global distribution support.