Tirofiban Hydrochloride
Generic Name: tirofiban hydrochloride
Brand Names:
Tirofiban Hydrochloride
11 DESCRIPTION Tirofiban Hydrochloride Injection contains tirofiban hydrochloride, a non-peptide antagonist of the platelet GP IIb/IIIa receptor, which inhibits platelet aggregation. Tirofiban hydrochloride monohydrate is chemically described as N- (butylsulfonyl)- O -[4-(4-piperidinyl)butyl]-L-tyrosine monohydrochloride monohydrate.
Overview
11 DESCRIPTION Tirofiban Hydrochloride Injection contains tirofiban hydrochloride, a non-peptide antagonist of the platelet GP IIb/IIIa receptor, which inhibits platelet aggregation. Tirofiban hydrochloride monohydrate is chemically described as N- (butylsulfonyl)- O -[4-(4-piperidinyl)butyl]-L-tyrosine monohydrochloride monohydrate.
Uses
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
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 100 mL or the 250 mL premixed bag, first tear off its foil overpouch and remove inner overwrap.
Side Effects
6 ADVERSE REACTIONS Bleeding is the most commonly reported adverse reaction. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lambda Therapeutics Limited at 1-855-642-2594 or the 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.
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 )
Warnings
5 WARNINGS AND PRECAUTIONS Tirofiban Hydrochloride Injection can cause serious bleeding. If bleeding cannot be controlled discontinue Tirofiban Hydrochloride Injection. ( 5.1 ) Thrombocytopenia: Discontinue Tirofiban Hydrochloride Injection and heparin. ( 5.2 ) 5.1 General Risk of Bleeding Bleeding is the most common complication encountered during therapy with Tirofiban Hydrochloride Injection. Most bleeding associated with Tirofiban Hydrochloride Injection occurs at the arterial access site for cardiac catheterization. Minimize the use of traumatic or potentially traumatic procedures such as arterial and venous punctures, intramuscular injections, nasotracheal intubation, etc. Concomitant use of fibrinolytics, anticoagulants and antiplatelet drugs increases the risk of bleeding. 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 )] .
Pregnancy
8.1 Pregnancy Risk Summary While published data cannot definitively establish the absence of risk, available published case reports have not established an association with tirofiban use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes. Untreated myocardial infarction can be fatal to the pregnant woman and fetus (see Clinical Considerations ).
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Tirofiban Hydrochloride Injection is supplied as a clear, non-preserved, colorless, isosmotic, sterile premixed solution with sodium chloride for tonicity adjustment.
Frequently Asked Questions
What is Tirofiban Hydrochloride used for?▼
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 )
What are the side effects of Tirofiban Hydrochloride?▼
6 ADVERSE REACTIONS Bleeding is the most commonly reported adverse reaction. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lambda Therapeutics Limited at 1-855-642-2594 or the 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.
Can I take Tirofiban Hydrochloride during pregnancy?▼
8.1 Pregnancy Risk Summary While published data cannot definitively establish the absence of risk, available published case reports have not established an association with tirofiban use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes. Untreated myocardial infarction can be fatal to the pregnant woman and fetus (see Clinical Considerations ).
What are the important warnings for Tirofiban Hydrochloride?▼
5 WARNINGS AND PRECAUTIONS Tirofiban Hydrochloride Injection can cause serious bleeding. If bleeding cannot be controlled discontinue Tirofiban Hydrochloride Injection. ( 5.1 ) Thrombocytopenia: Discontinue Tirofiban Hydrochloride Injection and heparin. ( 5.2 ) 5.1 General Risk of Bleeding Bleeding is the most common complication encountered during therapy with Tirofiban Hydrochloride Injection. Most bleeding associated with Tirofiban Hydrochloride Injection occurs at the arterial access site for cardiac catheterization. Minimize the use of traumatic or potentially traumatic procedures such as arterial and venous punctures, intramuscular injections, nasotracheal intubation, etc. Concomitant use of fibrinolytics, anticoagulants and antiplatelet drugs increases the risk of bleeding. 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 )] .
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.