Rx Item-Aggrastat tirofiban HCl monohydrate 3.75mg Sdv 15ml By Medicure Pharma

Clinical Information
Gen. Code and Des.
76752 tirofiban HCl monohydrate INTRAVEN VIAL 3.75 MG/15
GCN and Des.
42532 tirofiban HCl monohydrate INTRAVEN VIAL 3.75 MG/15
Strength
3.75MG
Dose Form
VIAL (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
20121800 PLATELET-AGGREGATION INHIBITORS
Active Ingredients
7532 tirofiban HCl monohydrate 150915405
Inactive Ingredients
2332 sodium citrate 68042
FDA NDA Approved




Item info. These highlights do not include all the info. needed to use AGGRASTAT? (tirofiban hydrochloride) safely and effectively. See full prescribing info. for AGGRASTAT.
AGGRASTAT? (tirofiban hydrochloride) injection, for intravenous use
Initial U.S. Approval: 1998
RECENT MAJOR CHANGES Dosage and Administration 4/2015
INDICATIONS AND USAGE AGGRASTAT? is 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).
DOSAGE AND ADMINISTRATION Administer intravenously 25 mcg/kg within 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 minutes and then 0.075 mcg/kg/min.
DOSAGE FORMS AND STRENGTHS Intravenous injection premixed: mg/100 mL (50 mcg/mL) and 12.5 mg/250 mL (50 mcg/mL) with sodium chloride.
CONTRAINDICATIONS Known hypersensitivity to any component of AGGRASTAT. History of thrombocytopenia with prior exposure to AGGRASTAT. Active internal bleeding, or history of bleeding diathesis, major surgical procedure or severe physical trauma within the previous month.
WARNINGS AND PRECAUTIONS AGGRASTAT can cause serious bleeding. If bleeding cannot be controlled discontinue AGGRASTAT. Thrombocytopenia: Discontinue AGGRASTAT and heparin.
ADVERSE REACTIONS Bleeding is the most commonly reported adverse reaction.
To report SUSPECTED ADVERSE REACTIONS, contact Medicure at 1-800-509-0544 or FDA at 1-800-FDA-1088 or www.fda.gov/ medwatch. DRUG INTERACTIONS Coadministration of antiplatelet agents, thrombolytics, heparin, or aspirin increases the risk of bleeding.
USE IN SPECIFIC POPULATIONS Renal Insufficiency: Reduce the dose in patients with severe renal insufficiency.
See 17 for PATIENT COUNSELING info. Revised: 4/2015

Rx Item-Aggrastat 3.75mg Sdv 15ml By Med
NDC No.25208-0001-04 25208000104 UPC/GTIN No.325208000103 3-25208-00010-3 325208000103 MPN No. 202 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopa

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NDC No.25208-0001-04 25208000104 UPC/GTIN No.325208000103 3-25208-00010-3 325208000103 MPN No. 202 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopa

TIROFIBAN-0.9% SODIUM CHL
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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