Tirofiban Hydrochloride I.V. Injection 5mg/100ml (Aggrixtaj)

Tirofiban Hydrochloride I.V. Injection (5mg/100ml) Technical Specification:

Product Name:	Tirofiban Hydrochloride I.V. Injection
Brand Name:	Aggrixtaj
Strength:	(5mg/100ml or 50mcg/ml), (12.5mg/250ml or 50mcg/ml)
Dosage Form:	I.V. Infusion Bottle (LVP)
Packing:	100mL, 250mL IV Bottle
Route of Administration:	For I.V. use only
Pack Insert/Leaflet:	PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:	COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:	Antiplatelet Agents – Cardiovascular (Glycoprotein IIb/IIIa Inhibitors).
Indication:	Tirofiban is indicated for the prevention of early myocardial infarction in adult patients presenting with acute coronary syndromes without ST elevation (NSTE-ACS) with the last episode of chest pain occurring within 12 hours and with ECG changes and/or elevated cardiac enzymes.
Storage:	Store at 25°C with excursions permitted between 15°C -20°C. Do not freeze. Protect from light during storage.

GENERIC NAME OF THE MEDICINAL PRODUCT:

Tirofiban Hydrochloride I.V. Injection (5mg/100ml or 50mcg/ml) (Aggrixtaj)
Tirofiban Hydrochloride I.V. Injection (12.5mg/250ml or 50mcg/ml) (Aggrixtaj)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Tirofiban Hydrochloride I.V. Injection (5mg/100ml or 50mcg/ml)
Composition:
Each 100 ml contains:
Tirofiban Hydrochloride
Eq. to Tirofiban……………………………5mg
Sodium Chloride BP……………………0.9%w/v
Water for Injection USP…………………q.s.
Tirofiban Hydrochloride I.V. Injection (12.5mg/250ml or 50mcg/ml)
Composition:
Each 250 ml contains:
Tirofiban Hydrochloride
Eq. to Tirofiban……………………………12.5mg
Sodium Chloride BP……………………2.25%w/v
Water for Injection USP…………………q.s.

THERAPEUTIC INDICATIONS:

Tirofiban is indicated for the prevention of early myocardial infarction in adult patients presenting with acute coronary syndromes without ST elevation (NSTE-ACS) with the last episode of chest pain occurring within 12 hours and with ECG changes and/or elevated cardiac enzymes.

Also prevent blood clots which can cause heart attacks or other health problems associated with excessive clotting.

PACKING:

Strength	Pack Size
5mg	100ml
12.5mg	250ml

DIRECTION OF USE:

To be used with Non-pyrogenic I.V. administration set with aseptic technique.
For I.V. use only.

Single Bolus + Short Infusion
Last up to 18hours

CAUTION & WARNING:

CAUTION: It is dangerous to take this preparation except in accordance with the medical advice.
Not to be sold by retail without the prescription of a Registered Medical Practitioner.
WARNING: Do not use the bottle if plastic bag is missing or tampered.

STORAGE & DOSAGE:

Storage: Store at 25°C with excursions permitted between 15°C -20°C. Do not freeze. Protect from light during storage.
STERILE, NON-PYROGENIC, SINGLE DOSE CONTAINER.
Keep medicine out of reach of children.
FOR HUMAN USE ONLY
Read enclosed leaflet before use.
Dosage: As directed by the Physician.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals is a trusted choice for Tirofiban Hydrochloride I.V. Injection due to several compelling reasons:

Pharmaceutical Expertise: Taj Pharmaceuticals boasts decades of experience in the pharmaceutical industry. This expertise translates into a deep understanding of cardiovascular medications and their critical role in healthcare.
Commitment to Quality: Taj Pharmaceuticals is renowned for its unwavering commitment to quality and safety in pharmaceutical products. Tirofiban Hydrochloride I.V. Injection is manufactured to the highest standards, ensuring its effectiveness and reliability.
Global Reach: Taj Pharmaceuticals is not only a respected manufacturer in India but also an exporter from India. This global presence means that their high-quality cardiovascular medications are accessible to a worldwide audience, contributing to global healthcare.
Advanced Manufacturing Facilities: Taj Pharmaceuticals operates state-of-the-art pharmaceutical manufacturing facilities, including the Taj Pharma plant in Vapi, Gujarat. These facilities adhere to stringent quality control measures, ensuring precise and consistent production.
Proven Track Record: Taj Pharmaceuticals has earned trust and reliability among healthcare providers, institutions, and patients. Their reputation as a dependable supplier of essential pharmaceuticals, including Tirofiban Hydrochloride I.V. Injection, underscores their commitment to quality and safety.
Patient-Centric Approach: Taj Pharmaceuticals places the well-being of patients at the forefront. Their dedication to providing reliable cardiovascular medications is a testament to their commitment to improving the lives of individuals who depend on these medications.

What is Tirofiban Hydrochloride I.V. Injection and its uses:

Tirofiban Hydrochloride I.V. Injection is a medication used in the management of cardiovascular conditions, particularly those related to blood clotting and platelet aggregation. Here’s an overview of Tirofiban Hydrochloride and its primary uses:

Mechanism of Action:

Tirofiban works by inhibiting the aggregation of platelets, which are blood cells involved in clot formation. It specifically targets the glycoprotein IIb/IIIa receptor on the surface of platelets, preventing them from binding together and forming clots.

Uses:

Acute Coronary Syndrome (ACS): Tirofiban Hydrochloride I.V. Injection is commonly used in individuals with acute coronary syndrome, which includes conditions like unstable angina and non-ST segment elevation myocardial infarction (NSTEMI). It helps prevent the formation of blood clots in the coronary arteries, reducing the risk of heart attack or worsening of the condition.
Percutaneous Coronary Intervention (PCI): Tirofiban is often administered during and after percutaneous coronary intervention, such as angioplasty and stent placement. This helps maintain blood flow through the treated coronary arteries and reduces the risk of stent thrombosis (clot formation).
Administration: Tirofiban Hydrochloride I.V. Injection is typically administered as an intravenous (IV) infusion in a healthcare setting, often during hospitalization. This allows for precise control of the medication’s effects and ensures its rapid onset of action.
Prevention of Thrombotic Complications: By inhibiting platelet aggregation and preventing clot formation, Tirofiban helps reduce the risk of thrombotic complications in individuals with ACS or those undergoing PCI. Thrombotic complications can lead to severe consequences, including heart attack or stroke.
Adjunctive Therapy: Tirofiban is often used in conjunction with other medications, such as aspirin and anticoagulants, as part of a comprehensive treatment strategy for cardiovascular conditions.

It’s important to note that Tirofiban Hydrochloride I.V. Injection should only be administered under the supervision of healthcare professionals who can monitor its effects and adjust the dosage as needed. The use of this medication is guided by a patient’s specific medical condition and the clinical judgment of the healthcare team.

How does Tirofiban Hydrochloride I.V. Injection Work?

Tirofiban Hydrochloride I.V. Injection works by inhibiting platelet aggregation, which is a crucial step in the formation of blood clots. Its mechanism of action is as follows:

Platelet Activation: When there is injury or damage to blood vessel walls, platelets are activated and become sticky. This activation is a normal part of the body’s response to injury and helps form clots to prevent excessive bleeding.
Role of Glycoprotein IIb/IIIa: One of the key components in platelet activation is the glycoprotein IIb/IIIa receptor, located on the surface of platelets. This receptor plays a vital role in platelet aggregation, as it allows platelets to bind together and form clots.
Tirofiban Binding: Tirofiban Hydrochloride is a glycoprotein IIb/IIIa inhibitor. It is designed to specifically and competitively bind to the glycoprotein IIb/IIIa receptor on the platelets.
Inhibition of Platelet Aggregation: By binding to these receptors, Tirofiban prevents platelets from binding together. This inhibits platelet aggregation, making it difficult for them to form clots.
Maintenance of Blood Flow: In conditions like acute coronary syndrome (ACS) or during percutaneous coronary intervention (PCI), where there is a risk of blood clot formation within coronary arteries, Tirofiban helps maintain blood flow by preventing clot formation. This is crucial to prevent further cardiac complications.

Benefits of Tirofiban Hydrochloride I.V. Injection:

Prevention of Clot Formation: The primary benefit of Tirofiban Hydrochloride I.V. Injection is its ability to prevent blood clot formation by inhibiting platelet aggregation. This is particularly important in conditions where clot formation can lead to serious consequences, such as acute coronary syndrome (ACS) and during percutaneous coronary intervention (PCI).
Reduced Risk of Cardiac Complications: Tirofiban helps maintain blood flow in coronary arteries, reducing the risk of cardiac complications like myocardial infarction (heart attack) and ischemic events.
Enhanced Outcomes in ACS: For individuals with ACS, Tirofiban is often used in conjunction with other medications and interventions to stabilize the condition and improve outcomes.
Effective Adjunctive Therapy: Tirofiban is an effective adjunctive therapy during PCI procedures (angioplasty and stent placement) to prevent stent thrombosis and ensure successful revascularization.
Rapid Onset of Action: When administered intravenously, Tirofiban has a rapid onset of action, providing prompt antiplatelet effects.

Side Effects of Tirofiban Hydrochloride I.V. Injection:

Bleeding: The most common side effect of Tirofiban is bleeding, which can range from mild to severe. This may include bleeding at the injection site, nosebleeds, gastrointestinal bleeding, or, in rare cases, intracranial bleeding.
Thrombocytopenia: Some individuals may experience a drop in platelet count (thrombocytopenia) as a side effect of Tirofiban. This condition requires monitoring and may necessitate discontinuation of the medication.
Hypersensitivity Reactions: Allergic reactions, including rash, itching, and swelling, may occur in response to Tirofiban. Severe allergic reactions are rare but require immediate medical attention.
Headache and Dizziness: Some patients may experience mild to moderate headache or dizziness as a side effect of Tirofiban.
Back Pain and Chest Pain: Back pain and chest pain are less common side effects but have been reported in some individuals.
Hypotension: Tirofiban may cause low blood pressure (hypotension) in some patients.
Fever and Chills: Mild flu-like symptoms, including fever and chills, may occur after administration.
Nausea and Vomiting: Nausea and vomiting are infrequent side effects but can happen in some cases.

Frequently Asked Questions About Tirofiban Hydrochloride I.V. Injection:

Certainly, here are some frequently asked questions (FAQs) about Tirofiban Hydrochloride I.V. Injection:

What is Tirofiban Hydrochloride I.V. Injection used for?

Tirofiban Hydrochloride I.V. Injection is used to prevent blood clot formation, especially in conditions like acute coronary syndrome (ACS) and during percutaneous coronary intervention (PCI) procedures.

How is Tirofiban Hydrochloride I.V. Injection administered?

It is administered as an intravenous (IV) infusion in a healthcare setting, typically during hospitalization. The dosage and duration of treatment are determined by the healthcare provider based on the patient’s condition.

How does Tirofiban work to prevent clot formation?

Tirofiban inhibits platelet aggregation by specifically blocking the glycoprotein IIb/IIIa receptor on the surface of platelets. This action prevents platelets from binding together and forming clots.

Are there any special precautions or considerations before receiving Tirofiban?

Patients should inform their healthcare providers about any bleeding disorders, recent surgeries, or other medical conditions. They should also disclose all medications and supplements they are taking, as some may interact with Tirofiban.

What are the potential side effects of Tirofiban Hydrochloride I.V. Injection?

Common side effects include bleeding, thrombocytopenia (low platelet count), hypersensitivity reactions, headache, and dizziness. Less common side effects may include chest pain, back pain, hypotension, and nausea.

How long does the antiplatelet effect of Tirofiban last?

The antiplatelet effect of Tirofiban is relatively shortlived, and platelet function typically returns to normal within hours after discontinuation. This property allows for rapid reversibility of its effects, which can be advantageous in emergency situations.

Can Tirofiban be used during pregnancy or breastfeeding?

The use of Tirofiban during pregnancy or breastfeeding should be carefully considered by healthcare providers, weighing the potential benefits against the risks. It is generally reserved for situations where the benefits clearly outweigh the potential risks.

Can Tirofiban be administered at home, or is it only given in a healthcare setting?

Tirofiban is typically administered in a controlled healthcare setting, allowing for close monitoring of the patient’s condition and rapid intervention in case of side effects or complications.

Is Tirofiban safe for individuals with a history of bleeding disorders?

Individuals with a history of bleeding disorders should discuss their medical history with their healthcare provider before receiving Tirofiban. The medication’s antiplatelet effects can increase the risk of bleeding.

How quickly does Tirofiban work to prevent clot formation during PCI?

Tirofiban has a rapid onset of action, and its antiplatelet effects are usually evident within minutes of administration. This is important during PCI procedures to prevent clot formation in coronary arteries.

As Tirofiban Hydrochloride I.V. Injection 5mg/100ml Exporters; We can cater to export business queries from the following geographies. We are exporting our Tirofiban Hydrochloride I.V. Injection 5mg/100ml product in the Following Countries:

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan, and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Tirofiban Hydrochloride I.V. Injection 5mg/100ml Regulatory Documents:

Certificate of Analysis (COA)
Method of Analysis (MOA)
Stability Data (Accelerated stability / Long term stability / Zone 4b)
CTD Dossier / ACTD Dossiers / eCTD Dossiers
Certificate of Pharmaceuticals Product (COPP)
Free Sale Certificate (FSC)

Note: FFS (Form Fill Seal) technology is an automated computer-operated technology, to prepare sterile products. Mostly it is applicable to I.V. infusion bottles.

Contact the most reliable manufacturer of Tirofiban Hydrochloride I.V. Injection 5mg/100ml, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274