Aggrastat
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
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).
History
There is currently no drug history available for this drug.
Other Information
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 N(butylsulfonyl)-O-[4-(4-piperidinyl)butyl]-L-tyrosine monohydrochloride monohydrate.
Its molecular formula is C22H36N2O5S•HCl•H2O 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 only, in plastic containers of 100 mL or 250 mL. Each 100 mL of the premixed, iso-osmotic 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, iso-osmotic 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.
The pH of the solution ranges from 5.5 to 6.5 and may have been adjusted with hydrochloric acid and/or sodium hydroxide. The flexible container is manufactured from a specially designed multilayer plastic (PL 2408). Solutions in contact with the plastic container leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.
Sources
Aggrastat Manufacturers
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Medicure International Inc
![Aggrastat (Tirofiban) Injection, Solution [Medicure International Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Aggrastat | Medicure International Inc
Administer intravenously 25 mcg/kg within 5 minutes and then 0.15 mcg/kg/min (or 0.075 mcg/kg/min for patients with creatinine clearance ≤60 mL/min), for up to 18 hours. This is not the regimen that was used in studies that established effectiveness of AGGRASTAT [see Clinical Studies (14)].
The instructions by weight and creatinine clearance (CrCl) are tabulated in Table 1.
Table 1 Dosing by Weight and CrClWeight
(kg)Within 5 min
All Patients
(mL)Maintenance Infusion Rate
(mL/hr.)CrCl >60 mL/min
CrCl ≤60 mL/min
30-37
17
6
3
38-45
21
7.5
3.75
46-54
25
9
4.5
55-62
29
10.5
5.25
63-70
33
12
6
71-79
37.5
13.5
6.75
80-87
42
15
7.5
88-95
46
16.5
8.25
96-104
50
18
9
105-112
54
19.5
9.75
113-120
58
21
10.5
121-128
62
22.5
11.25
129-137
66.5
24
12
138-145
71
25.5
12.75
146-153
75
27
13.5
Important Administration Instructions
To open the container, 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. Suspend the container from its eyelet support, remove the plastic protector from the outlet port, and attach a conventional administration set. You may administer AGGRASTAT in the same intravenous line as atropine sulfate, dobutamine, dopamine, epinephrine hydrochloride (HCl), famotidine injection, furosemide, lidocaine, midazolam HCl, morphine sulfate, nitroglycerin, potassium chloride, and propranolol HCl. Do not administer AGGRASTAT through the same IV line as diazepam. Do not add other drugs or remove solution directly from the bag with a syringe. Do not use plastic containers in series connections; such use can result in air embolism by drawing air from the first container if it is empty of solution. Discard any unused portion left in the bag.
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