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AGGRASTAT
Overview
What is AGGRASTAT?
AGGRASTAT 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 (butylsulfonyl)--[4-(4-piperidinyl)butyl]-L-tyrosine monohydrochloride monohydrate.
Its molecular formula is CHNOS•HCl•HO and its structural formula is:
Tirofiban hydrochloride monohydrate is a white to off-white, non-hygroscopic, free-flowing powder, with a molecular weight of 495.08. It is very slightly soluble in water.
AGGRASTAT Injection Premixed is supplied as a sterile solution in water for injection, for intravenous use. The pH of the solution ranges from 5.5 to 6.5 adjusted with hydrochloric acid and/or sodium hydroxide.
Each 100 mL of the premixed, isosmotic intravenous injection contains 5.618 mg tirofiban hydrochloride monohydrate equivalent to 5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 0.9 g sodium chloride, 54 mg sodium citrate dihydrate, and 3.2 mg citric acid anhydrous.
Each 250 mL of the premixed, isosmotic intravenous injection contains 14.045 mg tirofiban hydrochloride monohydrate equivalent to 12.5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, and 8 mg citric acid anhydrous.
AGGRASTAT Injection Premixed Bolus Vial is supplied as a sterile, isosmotic, concentrated solution for intravenous bolus injection, in 15 mL vials. No dilution is required. Each 15 mL of the premixed, isosmotic intravenous injection bolus vial contains 4.215 mg of tirofiban hydrochloride monohydrate equivalent to 3.75 mg of tirofiban and the following inactive ingredients: 120 mg sodium chloride, 40.5 mg sodium citrate dihydrate, and 2.4 mg citric acid anhydrous and water for injection.
What does AGGRASTAT look like?
What are the available doses of AGGRASTAT?
AGGRASTAT is a clear, non-preserved, colorless, isosmotic, sterile premixed injection with sodium chloride for tonicity adjustment available in the following presentations:
What should I talk to my health care provider before I take AGGRASTAT?
How should I use AGGRASTAT?
AGGRASTAT 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).
What interacts with AGGRASTAT?
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What are the warnings of AGGRASTAT?
Sorry No Records found
What are the precautions of AGGRASTAT?
Sorry No Records found
What are the side effects of AGGRASTAT?
Sorry No records found
What should I look out for while using AGGRASTAT?
AGGRASTAT is contraindicated in patients with:
What might happen if I take too much AGGRASTAT?
In clinical trials, inadvertent overdosage with AGGRASTAT occurred in doses up to 2 times the recommended dose for initial infusion doses. Inadvertent overdosage occurred in doses up to 9.8 times the 0.15 mcg/kg/min maintenance infusion rate.
The most frequently reported manifestation of overdosage was bleeding, primarily minor mucocutaneous bleeding events and minor bleeding at the sites of cardiac catheterization
Overdosage of AGGRASTAT should be treated by assessment of the patient’s clinical condition and cessation or adjustment of the drug infusion as appropriate.
AGGRASTAT can be removed by hemodialysis.
How should I store and handle AGGRASTAT?
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Protect from moisture, freezing and excessive heat.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Protect from moisture, freezing and excessive heat.AGGRASTAT is supplied as a clear, non-preserved, colorless, isosmotic, sterile premixed solution with sodium chloride for tonicity adjustment. FOR INTRAVENOUS USE ONLYStore AGGRASTAT at controlled room temperature, 25°C (77°F) with excursions permitted between 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light during storage.AGGRASTAT is supplied as a clear, non-preserved, colorless, isosmotic, sterile premixed solution with sodium chloride for tonicity adjustment. FOR INTRAVENOUS USE ONLYStore AGGRASTAT at controlled room temperature, 25°C (77°F) with excursions permitted between 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light during storage.AGGRASTAT is supplied as a clear, non-preserved, colorless, isosmotic, sterile premixed solution with sodium chloride for tonicity adjustment. FOR INTRAVENOUS USE ONLYStore AGGRASTAT at controlled room temperature, 25°C (77°F) with excursions permitted between 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light during storage.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
AGGRASTAT is a reversible antagonist of fibrinogen binding to the GP IIb/IIIa receptor, the major platelet surface receptor involved in platelet aggregation. When administered intravenously, AGGRASTAT inhibits platelet aggregation in a dose- and concentration-dependent manner.
When given according to the PRISM-PLUS regimen of 0.4 mcg/kg/min over 30 minutes followed by a 0.1 mcg/kg/min maintenance infusion, >90% inhibition of platelet aggregation is attained by the end of the 30-minute infusion. When given according to the recommended regimen of 25 mcg/kg followed by a 0.15 mcg/kg/min maintenance infusion, >90% inhibition of platelet aggregation is attained within 10 minutes. Platelet aggregation inhibition is reversible following cessation of the infusion of AGGRASTAT.
Non-Clinical Toxicology
AGGRASTAT is contraindicated in patients with:Due to the potential for additive effects, caution and careful titration are warranted in patients receiving diltiazem concomitantly with other agents known to affect cardiac contractility and/or conduction (see ). Pharmacologic studies indicate that there may be additive effects in prolonging AV conduction when using beta-blockers or digitalis concomitantly with diltiazem (see ).
As with all drugs, care should be exercised when treating patients with multiple medications. Diltiazem is both a substrate and an inhibitor of the cytochrome P-450 3A4 enzyme system. Other drugs that are specific substrates, inhibitors, or inducers of this enzyme system may have a significant impact on the efficacy and side effect profile of diltiazem. Patients taking other drugs that are substrates of CYP450 3A4, especially patients with renal and/or hepatic impairment, may require dosage adjustment when starting or stopping concomitantly administered diltiazem in order to maintain optimum therapeutic blood levels.
Anesthetics:
Benzodiazepines:
Beta-blockers:
Administration of diltiazem hydrochloride concomitantly with propranolol in five normal volunteers resulted in increased propranolol levels in all subjects and bioavailability of propranolol was increased approximately 50%. , propranolol appears to be displaced from its binding sites by diltiazem. If combination therapy is initiated or withdrawn in conjunction with propranolol, an adjustment in the propranolol dose may be warranted (see ).
Buspirone:
Carbamazepine:
Cimetidine:
Clonidine:
Cyclosporine:
The effect of cyclosporine on diltiazem plasma concentrations has not been evaluated.
Quinidine:
Rifampin:
Statins:
In a healthy volunteer cross-over study (N=10), coadministration of a single 20 mg dose of simvastatin at the end of a 14 day regimen with 120 mg BID diltiazem sustained-release resulted in a 5-fold increase in mean simvastatin AUC versus simvastatin alone. Subjects with increased average steady-state exposures of diltiazem showed a greater fold increase in simvastatin exposure. Computer-based simulations showed that at a daily dose of 480 mg of diltiazem, an 8- to 9-fold mean increase in simvastatin AUC can be expected. If coadministration of simvastatin with diltiazem is required, limit the daily doses of simvastatin to 10 mg and diltiazem to 240 mg.
In a ten-subject randomized, open label, 4-way cross-over study, coadministration of diltiazem (120 mg BID diltiazem sustained-release for 2 weeks) with a single 20 mg dose of lovastatin resulted in 3- to 4-fold increase in mean lovastatin AUC and C versus lovastatin alone. In the same study, there was no significant change in 20 mg single dose pravastatin AUC and C during diltiazem coadministration. Diltiazem plasma levels were not significantly affected by lovastatin or pravastatin.
Bleeding is the most common complication encountered during therapy with AGGRASTAT. Most bleeding associated with AGGRASTAT 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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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