tirofiban hydrochloride

tirofiban hydrochloride

Aggrastat

Pharmacologic class: Glycoprotein (GP IIb/IIIa)-receptor inhibitor

Therapeutic class: Platelet aggregation inhibitor

Pregnancy risk category B

Action

Inhibits reversible platelet aggregation by binding to GP IIb/IIIa receptor on platelets

Availability

Injection: 25-ml and 50-ml vials (250 mcg/ml), 100-ml and 250-ml premixed vials (50 mcg/ml)

Indications and dosages

Acute coronary syndrome (given with heparin); patients undergoing percutaneous transluminal coronary angioplasty (PTCA) or atherectomy

Adults: Loading dose of 0.4 mcg/kg/minute I.V. for 30 minutes, followed by continuous I.V. infusion of 0.1 mcg/kg/minute for 48 to 108 hours in patients being managed medically. Continue infusion for 12 to 24 hours after PTCA or atherectomy.

Dosage adjustment

• Renal insufficiency

Contraindications

• Hypersensitivity to drug or its components

• Active internal bleeding or history of bleeding diathesis within past 30 days

• Cerebrovascular accident (CVA) within past 30 days, or history of hemorrhagic CVA

• History of intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation, aneurysm, or thrombocytopenia after previous tirofiban use

• History, symptoms, or findings that suggest aortic dissection

• Severe hypertension

• Acute pericarditis

• Major surgery or severe trauma within past 30 days

• Concurrent use of other parenteral GP IIb/IIIa inhibitors

Precautions

Use cautiously in:

• renal disease

• elderly patients

• pregnant or breastfeeding patients

• children younger than age 18 (safety not established).

Administration

Know that drug comes both in premixed vials of 50 mcg/ml and injection concentrate of 250 mcg/ml.

• Dilute injection concentrate to same concentration as premixed vial (50 mcg/ml) by withdrawing and discarding 50 ml of solution from 250-ml plastic bag of normal saline solution or dextrose 5% in water, or by withdrawing and discarding 100 ml of solution from 500-ml plastic bag of same solution and replacing with equal volume of concentrated drug form.

• Mix I.V. solution well and inspect visually before administering.

• Squeeze plastic bag and check for leaks; discard if it has leaks.

• Don't use drug in series connections with other plastic bags. Don't add other drugs to bag containing tirofiban.

Adverse reactions

CNS: headache, dizziness, spinal-epidural hematoma, intracranial hemorrhage

CV: vasovagal reaction, bradycardia, hemopericardium, coronary artery dissection

GI: nausea, vomiting, occult bleeding, hematemesis, retroperitoneal hemorrhage

GU: pelvic pain, hematuria

Hematologic: bleeding, thrombocytopenia

Musculoskeletal: leg pain

Respiratory: pulmonary hemorrhage

Skin: diaphoresis

Other: infusion site bleeding, chills, fever, edema, allergic reactions, anaphylaxis

Interactions

Drug-drug. Clopidogrel, dipyridamole, nonsteroidal anti-inflammatory drugs, oral anticoagulants (such as thrombolytics, ticlopidine, warfarin), other drugs affecting hemostasis: increased risk of bleeding

Levothyroxine, omeprazole: increased renal clearance of tirofiban

Vitamin A: increased risk of bleeding

Drug-diagnostic tests. Hematocrit, hemoglobin, platelets: decreased values

Drug-herbs. Alfalfa, anise, arnica, astragalus, bilberry, black currant seed oil, bladderwrack, bogbean, boldo (with fenugreek), borage oil, buchu, capsaicin, cat's claw, celery, chaparral, chincona bark, clove oil, dandelion, dong quai, evening primrose oil, fenugreek, feverfew, garlic, ginger, ginkgo, guggul, papaya extract, red clover, rhubarb, safflower oil, skullcap, tan-shen: increased risk of bleeding

Patient monitoring

Monitor CBC, platelet count, and coagulation studies. Assess stool for occult blood.

• Watch for bleeding at puncture sites, especially at cardiac catheterization access site. Immobilize access site to reduce bleeding risk.

Monitor for signs and symptoms of bleeding in cranium and other body systems (especially respiratory, GI, and GU).

• Monitor vital signs and ECG.

Assess cardiovascular status. Stay alert for signs and symptoms of coronary artery dissection or hemopericardium.

Patient teaching

Teach patient to recognize and immediately report serious adverse reactions.

• Tell patient he will be closely monitored and undergo regular blood testing during therapy.

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The Company's portfolio of approved and marketed brands includes: Xydalba (dalbavancin hydrochloride), for the treatment of acute bacterial skin and skin structure infections; Zevtera/Mabelio (ceftobiprole medocaril sodium), a cephalosporin antibiotic for the treatment of community- and hospital-acquired pneumonia (CAP, HAP); Brinavess (vernakalant IV) for the rapid conversion of recent onset atrial fibrillation to sinus rhythm and Aggrastat (tirofiban hydrochloride) for the reduction of thrombotic cardiovascular events in patients with acute coronary syndrome.
Canada-based Cardiome Pharma has submitted a supplemental new drug submission for Aggrastat (tirofiban hydrochloride) to Health Canada's Therapeutic Products Directorate.
The Company's portfolio of approved and marketed brands includes: Xydalba (dalbavancin hydrochloride), for the treatment of acute bacterial skin and skin structure infections (ABSSSI); Zevtera /Mabelio (ceftobiprole medocaril sodium), a cephalosporin antibiotic for the treatment of community- and hospital-acquired pneumonia (CAP, HAP); Brinavess (vernakalant IV) for the rapid conversion of recent onset atrial fibrillation to sinus rhythm and Aggrastat (tirofiban hydrochloride) for the reduction of thrombotic cardiovascular events in patients with acute coronary syndrome.