Tirofiban Hydrochloride 50 ug/mL
Tirofiban Hydrochloride · INJECTION · Nexus Pharmaceuticals LLC
Tirofiban Hydrochloride is an injectable medication given through an IV that helps prevent blood clots in patients undergoing certain heart procedures or those with acute coronary syndrome. It works by blocking platelet aggregation, which reduces the risk of heart attack and stent thrombosis in at-risk patients.
Key Facts
- Brand Name
- Tirofiban Hydrochloride
- Generic Name
- Tirofiban Hydrochloride
- NDC Code (Product)
14789-101- Manufacturer
- Nexus Pharmaceuticals LLC
- Strength
- 50 ug/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA213947
- Marketing Start
- 09/25/2023
Recall History
Eugia US LLC
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Eugia US LLC
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Tirofiban hydrochloride injection is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS). Tirofiban hydrochloride injection is a platelet aggregation inhibitor indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS). ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Administer intravenously 25 mcg/kg within 5 minutes and then 0.15 mcg/kg/min for up to 18 hours. In patients with creatinine clearance ≤ 60 mL/min, give 25 mcg/kg within 5 minutes and then 0.075 mcg/kg/min. ( 2 ) 2.1 Recommended Dosage The recommended dosage is 25 mcg/kg administered intravenously within 5 minutes and then 0.15 mcg/kg/min for up to 18 hours. 2.2 Administration For intravenous use only. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. To open the 250 mL premixed bag, first tear off its foil overpouch. The plastic may be somewhat opaque because of moisture absorption during sterilization; the opacity will diminish gradually. Check for leaks by squeezing the inner bag firmly; if any leaks are found or sterility is suspect then the solution should be discarded. Do not use unless the solution is clear and the seal is intact. Administration Instructions The bolus dose of tirofiban hydrochloride injection may be administered from the 250 mL premixed bag. Do not dilute. Administer the bolus dose within 5 minutes via IV pump. Immediately …
Contraindications
4 CONTRAINDICATIONS Tirofiban hydrochloride injection is contraindicated in patients with: Severe hypersensitivity reaction to tirofiban hydrochloride injection (i.e., anaphylactic reactions) [see Adverse Reactions ( 6.2 )] . A history of thrombocytopenia following prior exposure to tirofiban hydrochloride injection [see Adverse Reactions ( 6.1 )] . Active internal bleeding or a history of bleeding diathesis, major surgical procedure or severe physical trauma within the previous month [see Adverse Reactions ( 6.1 )] . Known hypersensitivity to any component of tirofiban hydrochloride injection. ( 4 ) History of thrombocytopenia with prior exposure to tirofiban hydrochloride injection. ( 4 ) Active internal bleeding, or history of bleeding diathesis, major surgical procedure or severe physical trauma within the previous month. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Concomitant use of fibrinolytics, anticoagulants and antiplatelet drugs increases the risk of bleeding. Coadministration of fibrinolytics, anticoagulants and antiplatelet agents, increases the risk of bleeding. ( 7 )
Adverse Reactions
6 ADVERSE REACTIONS Bleeding is the most commonly reported adverse reaction. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In the PRISM (Platelet Receptor Inhibition for Ischemic Syndrome Management), PRISM-PLUS (Platelet Receptor Inhibition for Ischemic Syndrome Management — Patients Limited by Unstable Signs and Symptoms) and RESTORE (Randomized Efficacy Study of Tirofiban for Outcomes and Restenosis) trials, 1946 patients received tirofiban hydrochloride injection in combination with heparin and 2002 patients received tirofiban hydrochloride injection alone for about 3 days. Forty-three percent of the population was > 65 years of age and approximately 30% of patients were female. In clinical studies with the recommended regimen (25 mcg/kg bolus followed by a 0.15 mcg/kg/min maintena…
Frequently Asked Questions
What is Tirofiban Hydrochloride used for?
Tirofiban Hydrochloride is an injectable medication given through an IV that helps prevent blood clots in patients undergoing certain heart procedures or those with acute coronary syndrome. It works by blocking platelet aggregation, which reduces the risk of heart attack and stent thrombosis in at-risk patients.
Is Tirofiban Hydrochloride a controlled substance?
Tirofiban Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Tirofiban Hydrochloride?
The generic name for Tirofiban Hydrochloride is Tirofiban Hydrochloride. There are no other listed brand versions of Tirofiban Hydrochloride.
What is the NDC code for Tirofiban Hydrochloride 50 ug/mL?
The NDC (National Drug Code) for Tirofiban Hydrochloride 50 ug/mL is 14789-101, listed by Nexus Pharmaceuticals LLC.
Other Tirofiban Hydrochloride Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)