GENERIC NAME OF THE MEDICINAL PRODUCT:

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

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. 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.

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

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.

Tirofiban Hydrochloride I.V. Injection (5mg/100ml) Manufacturers and Suppliers in India:

Taj Pharmaceuticals is one of the prominent Tirofiban Hydrochloride I.V. Injection (5mg/100ml) Manufacturers in India that brings the best quality products. Our company Taj Pharma carries rich experience in the niche manufacturing of Tirofiban Hydrochloride I.V. Injection (5mg/100ml)

Taj Pharmaceuticals is a reputed manufacturer and Tirofiban Hydrochloride I.V. Injection (5mg/100ml) Suppliers in India prefer Taj Pharma is best known for the topmost standards and consistent quality of its products.

Taj Pharma is a well-known Tirofiban Hydrochloride I.V. Injection (5mg/100ml)  Manufacturer in India that gives the assurance of high- quality and high standards. Strict quality control ensures that every batch of medicine brings a harmonious standard.

Tirofiban Hydrochloride I.V. Injection (5mg/100ml)  manufactured at Taj Pharma follows USP (United States Pharmacopeia); i.e. the product is manufactured to comply with USP quality standards which are considered the Best in the world. Further, Taj Pharma uses Tirofiban Hydrochloride I.V. Injection (5mg/100ml)  grade best active ingredient to manufacture its Injections to comply with international standards of European products.

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

Product Name:Tirofiban Hydrochloride I.V. Injection
Brand Name:Aggrix – H
Strength:5mg/100ml
Dosage Form:I.V. Infusion Glass Bottle (LVP)
Packing:100mL, 250mL IV Glass 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:

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Tirofiban Hydrochloride I.V. Injection 5mg/100ml 
    Composition:
    Each 100 ml contains:
    Tirofiban Hydrochloride
    Eq. to Tirofiban……………………………5mg
    Sodium Chloride BP……………………0.9%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.

CAUTION & WARNING:

CAUTION: It is dangerous to take this preparation except in accordance with medical advice.

Not to be sold by retail without the prescription of a Registered Medical Practitioner.

WARNING: Do not use the bottle if a plastic bag is missing or tampered with.

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 the medicine out of reach of children.
FOR HUMAN USE ONLY
Read the enclosed leaflet before use.
Dosage: As directed by the Physician.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals is your go-to source for Tirofiban Hydrochloride I.V. Injection, offering a wealth of reasons to trust in our products:

  • Pharmaceutical Expertise: With a rich history in the industry, Taj Pharmaceuticals boasts extensive experience and knowledge in pharmaceuticals, ensuring top-notch quality.
  • Stringent Quality Control: We adhere to the highest standards of quality control, subjecting every batch of Tirofiban Hydrochloride I.V. Injection to rigorous testing for safety and effectiveness.
  • Patient-Centric Approach: Patient safety is our utmost priority, reflected in our meticulous manufacturing processes and commitment to meeting safety standards.
    Reliable Delivery: Count on Taj Pharmaceuticals to consistently provide on-time delivery of pharmaceutical products, ensuring your healthcare needs are met.
  • Global Accessibility: Our vast distribution network ensures worldwide accessibility to Tirofiban Hydrochloride I.V. Injection, reaching healthcare providers and patients across the globe.
  • Innovation: We’re dedicated to continuous improvement and innovation, striving to enhance the efficacy and safety of our products.
  • Comprehensive Support: Taj Pharmaceuticals offers comprehensive support, including resources and expertise, to healthcare professionals and patients for the best possible outcomes.

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

Tirofiban Hydrochloride I.V. Injection is a pharmaceutical product that contains the active ingredient tirofiban hydrochloride. It is typically administered intravenously (through a vein) and is used for specific medical purposes. Here’s an overview of its uses:

  • Antiplatelet Medication: Tirofiban is classified as an antiplatelet drug. It works by inhibiting the aggregation or clumping together of platelets in the blood. Platelets are small cell fragments in the blood that play a crucial role in blood clot formation. Tirofiban helps prevent excessive platelet aggregation, reducing the risk of unwanted blood clots.
  • Acute Coronary Syndrome (ACS): One of the primary uses of Tirofiban Hydrochloride I.V. Injection is in the management of Acute Coronary Syndrome. ACS includes conditions like unstable angina and myocardial infarction (heart attack). Tirofiban is often given to patients with ACS to help prevent the formation of blood clots in the coronary arteries, which can lead to heart tissue damage.
  • Percutaneous Coronary Intervention (PCI): Tirofiban is also used during procedures such as angioplasty and stent placement, collectively known as percutaneous coronary intervention (PCI). These procedures involve the insertion of a catheter to open narrowed or blocked coronary arteries. Tirofiban is administered to reduce the risk of blood clot formation during and after the procedure, enhancing the success and safety of PCI.
  • Reduction of Ischemic Events: Tirofiban Hydrochloride I.V. Injection can be employed to reduce the risk of ischemic events, which occur when blood flow to an organ or tissue is restricted due to clot formation. This is particularly important in the context of cardiovascular events where maintaining blood flow to the heart muscle is critical.

How does Tirofiban Hydrochloride I.V. Injection work?

Tirofiban Hydrochloride I.V. Injection is an antiplatelet medication that works by interfering with the aggregation or clumping together of platelets in the blood. Here’s how it works:

  • Inhibition of Platelet Aggregation: Platelets are small cell fragments in the blood that play a crucial role in blood clot formation. When blood vessels are injured, platelets rush to the site of injury and adhere to the damaged area, forming a plug to stop bleeding. However, excessive platelet aggregation can lead to unwanted blood clots in blood vessels, especially in arteries, which can have serious consequences such as heart attacks or strokes.
  • Blocking Platelet Receptors: Tirofiban specifically targets and blocks certain receptors on the surface of platelets called glycoprotein IIb/IIIa receptors. These receptors are involved in the final step of platelet aggregation, where platelets stick together to form a clot.
  • Preventing Clot Formation: By inhibiting the glycoprotein IIb/IIIa receptors, Tirofiban prevents platelets from binding to each other and forming large clots. This action reduces the risk of excessive blood clotting in blood vessels, particularly in coronary arteries (the arteries that supply the heart) and during procedures like angioplasty or stent placement.
  • Maintaining Blood Flow: By reducing platelet aggregation, Tirofiban helps maintain adequate blood flow through the arteries, which is vital for supplying oxygen and nutrients to various organs and tissues. In conditions like acute coronary syndrome (ACS) or during percutaneous coronary interventions (PCI), maintaining blood flow to the heart muscle is crucial to prevent heart tissue damage.

Tirofiban is administered intravenously to ensure rapid and effective action. It is typically used in situations where there is a heightened risk of blood clot formation, such as during and after certain medical procedures or in patients with acute coronary syndromes. The medication’s antiplatelet properties help reduce the risk of potentially life-threatening thrombotic events by preventing the excessive aggregation of platelets in the bloodstream.

Benefits of Tirofiban Hydrochloride I.V. Injection:

  • Prevention of Blood Clots: Tirofiban is effective at preventing the formation of blood clots in blood vessels. This is particularly important in situations where the risk of clot formation is high, such as in ACS or during PCI procedures. Preventing clots can reduce the risk of heart attacks, strokes, and other thrombotic events.
  • Enhanced Cardiovascular Care: Tirofiban is a valuable tool in the management of acute coronary syndromes, including unstable angina and myocardial infarction (heart attack). It helps maintain blood flow in the coronary arteries, minimizing damage to heart muscle tissue.
  • Safer Percutaneous Coronary Interventions (PCI): During PCI procedures like angioplasty and stent placement, Tirofiban is used to prevent clot formation around the catheter and stent, reducing the risk of complications and ensuring the success of the procedure.

Side Effects of Tirofiban Hydrochloride I.V. Injection:

It’s important to note that while Tirofiban offers significant benefits in preventing clot-related events, it can also have side effects. Common side effects may include:

  • Bleeding: Tirofiban’s primary mode of action is to inhibit platelet aggregation, which can lead to an increased risk of bleeding. Patients receiving Tirofiban need to be carefully monitored for signs of bleeding, such as easy bruising, nosebleeds, or gastrointestinal bleeding.
  • Thrombocytopenia: In some cases, Tirofiban can cause a decrease in the number of platelets in the blood, a condition known as thrombocytopenia. This can further increase the risk of bleeding.
  • Allergic Reactions: Although rare, allergic reactions to Tirofiban can occur. Symptoms may include skin rash, itching, swelling, or difficulty breathing. Immediate medical attention is necessary if these symptoms occur.
  • Low Blood Pressure: Tirofiban can cause a drop in blood pressure in some individuals. This is typically monitored during administration.
  • Headache and Nausea: Some patients may experience mild headaches or nausea as a side effect of Tirofiban.
  • Other Side Effects: Other less common side effects may include back pain, fever, and infusion site reactions.

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 primarily used to prevent excessive platelet aggregation and blood clot formation, particularly in situations like acute coronary syndromes (ACS) and during percutaneous coronary interventions (PCI) such as angioplasty and stent placement.

How does Tirofiban work?

Tirofiban works by inhibiting glycoprotein IIb/IIIa receptors on platelets, preventing them from sticking together and forming clots. This reduces the risk of thrombotic events.

When is Tirofiban administered?

Tirofiban is typically administered intravenously (IV) in hospital settings during PCI procedures, in patients with ACS, or in other situations where there is a high risk of blood clot formation.

What are the potential side effects of Tirofiban?

Common side effects include bleeding, thrombocytopenia, allergic reactions, low blood pressure, headache, and nausea. It’s essential to be aware of these potential side effects and report any unusual symptoms to your healthcare provider.

Who should not use Tirofiban?

Tirofiban is not suitable for everyone. Patients with a history of bleeding disorders, recent surgery or trauma, certain medical conditions, or those taking anticoagulant medications may not be candidates for Tirofiban. Your healthcare provider will assess your individual situation.

How is Tirofiban dosed and administered?

Dosage and administration are determined by healthcare professionals based on the patient’s condition and the specific procedure or situation. It is administered as an intravenous infusion.

Is Tirofiban safe during pregnancy and breastfeeding?

Tirofiban’s safety during pregnancy and breastfeeding is not well established. It should be used during pregnancy or breastfeeding only if the potential benefits outweigh the risks and under the guidance of a healthcare provider.

Can I drink alcohol while taking Tirofiban?

Alcohol can increase the risk of bleeding when combined with Tirofiban. It’s advisable to avoid alcohol during treatment with this medication.

How long will I need to take Tirofiban?

The duration of Tirofiban treatment varies based on the specific medical condition. Your healthcare provider will determine the appropriate duration of treatment.

What should I do if I experience bleeding while on Tirofiban?

If you experience unusual bleeding, such as nosebleeds, blood in the urine or stool, or easy bruising, contact your healthcare provider immediately.

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 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, 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)
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