Ivabradine Tablets 2.5mg

Ivabradine Tablets 2.5mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Ivabradine Tablets 2.5mg
B) Ivabradine Tablets 5mg
C) Ivabradine Tablets 7.5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Ivabradine Tablets 2.5mg
Each film coated tablet contains:
Ivabradine Hydrochloride
Equivalent to Ivabradine…………….2.5mg
Excipients…………………………………….q.s.
Colour: Titanium Dioxide USP-NF

B) Ivabradine Tablets 5mg
Each film coated tablet contains:
Ivabradine Hydrochloride
Equivalent to Ivabradine………….5mg
Excipients…………………………………q.s.
Colour: Ponceau 4 R

C) Ivabradine Tablets 7.5mg
Each film coated tablet contains:
Ivabradine Hydrochloride
Equivalent to Ivabradine………………7.5mg
Excipients……………………………………..q.s.
Colour: Quinoline yellow WS

THERAPEUTIC INDICATIONS:

Ivabradine is used to treat certain adults with heart failure (condition in which the heart is unable to pump enough blood to the other parts of the body) to decrease the risk that their condition will worsen and need to be treated in a hospital. It is also used to treat a certain type of heart failure in children 6 months of age and older due to cardiomyopathy (a condition in which the heart muscle becomes weakened and enlarged). Ivabradine is in a class of medications called hyperpolarization-activated cyclic nucleotide-gated (HCN) channel blockers. It works by slowing the heart rate so the heart can pump more blood through the body each time it beats.

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 at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight container.
Dosage: As directed by the Physician

Attach dispensing label as per end country.

Introduction to Ivabradine Tablets 2.5mg

Ivabradine Tablets 2.5mg is a prescription medicine widely used to manage chronic heart failure in adults and children. It is prescribed to reduce the risk of hospitalization for worsening heart failure and is also suitable for pediatric patients aged six months and older with stable heart failure caused by dilated cardiomyopathy.

Ivabradine works by selectively inhibiting the If current in the sinoatrial node, slowing the heart rate without affecting myocardial contractility or blood pressure. This unique mechanism makes Ivabradine Tablets 2.5mg a preferred choice for patients who may not tolerate beta-blockers or require additional heart rate control.

Globally, the demand for Ivabradine 2.5mg tablets has been growing due to rising cases of cardiovascular disorders and increased awareness of effective treatments for chronic heart failure. Taj Pharma, headquartered in Vapi, Gujarat, India, is a leading manufacturer, exporter, and supplier of high-quality Ivabradine Tablets 2.5mg, trusted by healthcare providers and distributors worldwide.

In-Depth Details for Importers, Exporters, and Buyers

Regulatory Documentation Provided

Taj Pharma ensures full regulatory compliance and transparency for international buyers:

• Certificate of Analysis (CoA) for every production batch

• Batch Manufacturing Record (BMR) and quality assurance certificates

• Drug Master File (DMF) for import approval and regulatory submissions

• Certificates of Pharmaceutical Product (COPP)

• Clinical safety and efficacy data to facilitate approvals

Custom Packaging & Labeling

Global buyers benefit from flexible packaging options:

• Blister packs, bottles, and bulk packaging tailored to client needs

• Tamper-evident and child-resistant packaging for safety

• Multi-language labels conforming to local regulations

• Private labeling and branding services for distributors

Shelf-Life, Storage, and Dosage Form

• Shelf-life: 24 months from manufacturing date

• Storage: Store below 25°C in a dry, cool place away from sunlight

• Dosage Form: 2.5mg oral tablets

Export Certifications

Taj Pharma complies with top international standards:

• WHO-GMP Certification

• EU-GMP Certification

• COPP (Certificate of Pharmaceutical Product)

• CTD Dossier for seamless regulatory approvals

Target Countries & Export Markets

Ivabradine Tablets 2.5mg are exported to over 50 countries worldwide, including:

• Middle East: UAE, Saudi Arabia, Oman, Qatar

• Africa: Nigeria, Kenya, South Africa

• Europe: UK, Germany, France, Italy

• Asia: Bangladesh, Nepal, Sri Lanka, Malaysia

• Latin America: Brazil, Mexico

Why Taj Pharma is the Most Trusted Manufacturer, Supplier, and Exporter

State-of-the-Art Manufacturing

Taj Pharma employs advanced manufacturing processes:

• Automated tablet compression and coating machines for consistency

• Modern packaging lines with stringent quality checks

• ISO- and GMP-certified facilities ensuring safety and reliability

• In-house laboratories for real-time quality control

Affordable Pricing & Quality Assurance

• Competitive pricing for bulk orders and long-term partnerships

• Stringent quality assurance testing to meet international standards

• Third-party certification and verification available for additional assurance

Global Presence & Supply Chain Support

• Efficient logistics and shipping for both air and sea freight

• Complete export documentation for hassle-free customs clearance

• Continuous supply chain management to meet global demand

Top 20 Countries Exporting

Nigeria, Kenya, South Africa, Vietnam, Philippines, Iraq, Libya, Uzbekistan, Ghana, Ethiopia, Yemen, Tanzania, Sri Lanka, Afghanistan, Myanmar, Nepal, Kazakhstan, Ecuador, Bangladesh, Dominican Republic

Technical Product Specification Table

Benefits of Ivabradine Tablets 2.5mg

• Reduces hospitalizations in chronic heart failure patients

• Improves heart failure symptoms in pediatric patients with dilated cardiomyopathy

• Provides selective heart rate reduction without lowering blood pressure

• Neutral impact on mood and psychological health

• Enhances patient quality of life by improving functional capacity

Dosage Instructions and Recommendations

• Administer as prescribed by a healthcare professional

• Typically taken twice daily with meals

• Do not crush or chew tablets

• Regular monitoring of heart rate and cardiac function is recommended

• Avoid abrupt discontinuation to prevent exacerbation of symptoms

Side Effects of Ivabradine Tablets 2.5mg

While generally safe, some patients may experience:

• Severe headache

• Blurred vision or luminous phenomena

• Pounding in the neck or ears

• Racing heartbeats accompanied by dizziness, fatigue, or lack of energy

• Shortness of breath or chest tightness worse than usual

Call to Action for Buyers and Distributors

Taj Pharma is the leading global partner for Ivabradine Tablets 2.5mg:

• Bulk supply and distributor support available

• Private labeling and custom packaging services offered

• Comprehensive export documentation and regulatory support

• Timely delivery with worldwide shipping options

Contact Taj Pharma:

• Email:  info@tajpharma.com

Top 20 FAQs 

1. What is Ivabradine Tablets 2.5mg used for?
   Treating chronic heart failure in adults and pediatric patients.

2. Can children take Ivabradine?
   Yes, from six months old with dilated cardiomyopathy.

3. Does it affect mood?
   Ivabradine has a neutral impact on mood and anxiety.

4. What are common side effects?
   Headache, blurred vision, dizziness, pounding heartbeat.

5. Can it be combined with other heart medications?
   Yes, including ACE inhibitors, beta-blockers, and diuretics.

6. Is it safe for long-term use?
   Yes, under medical supervision.

7. Does it lower blood pressure?
   Minimal impact; primarily reduces heart rate.

8. Is it prescription-only?
   Yes, requires doctor supervision.

9. Can it be taken with food?
   Yes, taking with meals helps absorption and reduces stomach upset.

10. Does dose vary for children?
    Yes, depending on age and weight.

11. What packaging options are available?
    Blister packs, bottles, bulk, private labeling.

12. Shelf life?
    24 months.

13. Storage instructions?
    Store below 25°C in a dry place.

14. Is it exported worldwide?
    Yes, Taj Pharma supplies globally.

15. Certifications?
    WHO-GMP, EU-GMP, COPP, CTD Dossier.

16. Can it cause dizziness?
    Yes, particularly in patients with hypotension.

17. Can pregnant women take it?
    Only if clearly needed, under doctor guidance.

18. Private labeling available?
    Yes, offered for distributors.

19. Delivery options for international buyers?
    Air and sea freight with complete documentation.

20. Dietary restrictions?
    No strict restrictions; follow a heart-healthy diet.