Effient

DRUG DESCRIPTION

Effient contains prasugrel, a thienopyridine class inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP receptor. Effient is formulated as the hydrochloride salt, a racemate, which is chemically designated as 5-[(1RS)-2-cyclopropyl-1-(2fluorophenyl)-2-oxoethyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate hydrochloride. Prasugrel hydrochloride has the empirical formula C20H20FNO3S•HCl representing a molecular weight of 409.90. The chemical structure of prasugrel hydrochloride is:

EFFIENT (prasugrel) Structural Formula Illustration

Prasugrel hydrochloride is a white to practically white solid. It is soluble at pH 2, slightly soluble at pH 3 to 4, and practically insoluble at pH 6 to 7.5. It also dissolves freely in methanol and is slightly soluble in 1- and 2-propanol and acetone. It is practically insoluble in diethyl ether and ethyl acetate.

Effient is available for oral administration as 5 mg or 10 mg elongated hexagonal, film-coated, non-scored tablets, debossed on each side. Each yellow 5 mg tablet is manufactured with 5.49 mg prasugrel hydrochloride, equivalent to 5 mg prasugrel and each beige 10 mg tablet with 10.98 mg prasugrel hydrochloride, equivalent to 10 mg of prasugrel. During manufacture and storage, partial conversion from prasugrel hydrochloride to prasugrel free base may occur. Other ingredients include mannitol, hypromellose, croscarmellose sodium, microcrystalline cellulose, and vegetable magnesium stearate. The color coatings contain lactose, hypromellose, titanium dioxide, triacetin, iron oxide yellow, and iron oxide red (only in Effient 10 mg tablet).

What are the possible side effects of prasugrel (Effient)?

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:

  • unusual bleeding such as nosebleeds, bleeding gums, or any bleeding that will not stop;
  • pale skin, fever, easy bruising, purple or red spots under your skin;
  • jaundice (yellowing of the skin or eyes);
  • unexpected vaginal bleeding;
  • feeling very weak or...

Read All Potential Side Effects and See Pictures of Effient »

What are the precautions when taking prasugrel tablets (Effient)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: cancer, diabetes, tumors, hypothalamus or pituitary gland problems (such as due to head injury, pituitary tumor/surgery).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication must not be used during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant,...

Read All Potential Precautions of Effient »


Effient Consumer (continued)

SIDE EFFECTS: Redness, itching, pain, irritation, or bruising at the injection site may occur. Muscle aches may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: muscle/joint pain or stiffness, numbness/tingling/swelling in your arms or legs.

This medication may infrequently make your blood sugar level rise, which can cause or worsen diabetes. Tell your doctor immediately if you develop symptoms of high blood sugar, such as increased thirst and urination. If you already have diabetes, be sure to check your blood sugars regularly. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or 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: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: cancer, diabetes, tumors, hypothalamus or pituitary gland problems (such as due to head injury, pituitary tumor/surgery).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication must not be used during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately.

It is unknown if this drug passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.


Effient Patient Information Including Side Effects

Brand Names: Effient

Generic Name: prasugrel (Pronunciation: PRA soo grel)

  • What is prasugrel (Effient)?
  • What are the possible side effects of prasugrel (Effient)?
  • What is the most important information I should know about prasugrel (Effient)?
  • What should I discuss with my healthcare provider before taking prasugrel (Effient)?
  • How should I take prasugrel (Effient)?
  • What happens if I miss a dose (Effient)?
  • What happens if I overdose (Effient)?
  • What should I avoid while taking prasugrel (Effient)?
  • What other drugs will affect prasugrel (Effient)?
  • Where can I get more information?

What is prasugrel (Effient)?

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

Prasugrel is used to prevent blood clots in people with acute coronary syndrome who are undergoing a procedure after a recent heart attack or stroke, and in people with certain disorders of the heart or blood vessels.

Prasugrel may also be used for other purposes not listed in this medication guide.

What are the possible side effects of prasugrel (Effient)?

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:

  • unusual bleeding such as nosebleeds, bleeding gums, or any bleeding that will not stop;
  • pale skin, fever, easy bruising, purple or red spots under your skin;
  • jaundice (yellowing of the skin or eyes);
  • unexpected vaginal bleeding;
  • feeling very weak or dizzy;
  • blood in your urine or stools, black 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; or
  • sudden headache, confusion, problems with vision, speech, or balance.

Less serious side effects may include:

  • mild headache or dizziness;
  • back pain, minor chest pain;
  • cough;
  • nausea; or
  • tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about prasugrel (Effient)?

Prasugrel keeps your blood from coagulating (clotting) to prevent unwanted blood clots that can occur with certain heart or blood vessel conditions. Because of this drug action, prasugrel can 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.

You may also have bleeding on the inside of your body, such as in your stomach or intestines. Call your doctor at once if you have black or bloody stools, or if you cough up blood or vomit that looks like coffee grounds. These could be signs of bleeding in your digestive tract.

If you need to have any type of surgery or dental work, tell the surgeon or dentist ahead of time that you are using prasugrel. You may need to stop using the medicine for at least 7 days before surgery to prevent excessive bleeding.

While you are taking prasugrel, do not take NSAIDs (non-steroidal anti-inflammatory drugs) without your doctor's advice. NSAIDs include ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), diflunisal (Dolobid), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), piroxicam (Feldene), and others.

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