AGGRASTAT (tirofiban hydrochloride), a non-peptide antagonist of the platelet
glycoprotein (GP) IIb/IIIa receptor, inhibits platelet aggregation.
Tirofiban hydrochloride monohydrate, a non-peptide molecule, is chemically
described as N(butylsulfonyl)-O-[4-(4-piperidinyl)butyl]-L-tyrosine
monohydrochloride monohydrate.
Its molecular formula is C22H36N2O5S•
HCI• 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 (tirofiban) 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.
AGGRASTAT (tirofiban) Injection is a sterile concentrated solution for intravenous infusion
after dilution and is supplied in a 50 mL vial. Each mL of the solution contains
0.281 mg of tirofiban hydrochloride monohydrate equivalent to 0.25 mg of tirofiban
and the following inactive ingredients: 0.16 mg citric acid anhydrous, 2.7 mg
sodium citrate dihydrate, 8 mg sodium chloride, and water for injection. The
pH ranges from 5.5 to 6.5 and may have been adjusted with hydrochloric acid
and/or sodium hydroxide.
What are the possible side effects of tirofiban (Aggrastat)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- nosebleed or other bleeding that will not stop;
- black, bloody, or tarry stools;
- coughing up blood or vomit that looks like coffee grounds;
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- sudden...
Read All Potential Side Effects and See Pictures of Aggrastat »
What are the precautions when taking tirofiban (Aggrastat)?
Consult your...
Read All Potential Precautions of Aggrastat »
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1998 Copyright used under license. All rights reserved.
What are the possible side effects of tirofiban (Aggrastat)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- nosebleed or other bleeding that will not stop;
- black, bloody, or tarry stools;
- coughing up blood or vomit that looks like coffee grounds;
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- sudden...
Read All Potential Side Effects and See Pictures of Aggrastat »
What are the precautions when taking tirofiban (Aggrastat)?
Consult your...
Read All Potential Precautions of Aggrastat »
Last reviewed on RxList: 6/13/2008
This monograph has been modified to include the generic and brand name in many instances.