Aggrastat

DRUG DESCRIPTION

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:

AGGRASTAT® (TIROFIBAN HYDROCHLORIDE)  Structural Formula Illustration

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 »

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 »


Aggrastat Consumer (continued)

SIDE EFFECTS: Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Consult your pharmacist.


Aggrastat Patient Information Including Side Effects

Brand Names: Aggrastat

Generic Name: tirofiban (Pronunciation: tye roe FYE ban)

  • What is tirofiban (Aggrastat)?
  • What are the possible side effects of tirofiban (Aggrastat)?
  • What is the most important information I should know about tirofiban (Aggrastat)?
  • What should I discuss with my health care provider before receiving tirofiban (Aggrastat)?
  • How is tirofiban given (Aggrastat)?
  • What happens if I miss a dose (Aggrastat)?
  • What happens if I overdose (Aggrastat)?
  • What should I avoid while receiving tirofiban (Aggrastat)?
  • What other drugs will affect tirofiban (Aggrastat)?
  • Where can I get more information?

What is tirofiban (Aggrastat)?

Tirofiban keeps the platelets in your blood from coagulating (clotting) to prevent unwanted blood clots that can occur with certain heart or blood vessel conditions.

Tirofiban is used to prevent blood clots or heart attack in people with severe chest pain or other conditions, and in those who are undergoing a procedure called angioplasty (to open blocked arteries).

Tirofiban may also be used for purposes other than those listed in this medication guide.

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 numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • fever, chills, body aches, flu symptoms; or
  • pale skin, easy bruising or bleeding, weakness, fever, and urinating more or less than usual.

Less serious side effects may also occur, such as:

  • nausea, stomach pain;
  • runny or stuffy nose, cough, sore throat; or
  • mild headache or dizziness.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about tirofiban (Aggrastat)?

Do not receive this medication if you are allergic to tirofiban, or to similar drugs such as abciximab (ReoPro) or eptifibatide (Integrilin).

Do not receive this medication if you have a stomach ulcer or ulcerative colitis, severe liver disease, severe high blood pressure, a bleeding or blood clotting disorder, a history of head injury, brain tumor, or blood clot in the brain (aneurysm), a stroke or any type of bleeding within the past 30 days, or any type of surgery, injury, or medical emergency within the past 6 weeks.

Tirofiban is not expected to be harmful to an unborn baby. However, aspirin is sometimes given with tirofiban, and aspirin can cause bleeding when it is taken during the last 3 months of pregnancy. Aspirin can also cause side effects in a newborn baby.

Tell your doctor if you are pregnant or plan to become pregnant during treatment with tirofiban and aspirin.

Because tirofiban keeps your blood from coagulating (clotting) to prevent unwanted blood clots, it can also make it easier for you to bleed, even from a minor injury. Contact your doctor or seek emergency medical attention if you have bleeding that will not stop.

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