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Innohep®

Brand Name: Innohep®
Active Ingredient:   tinzaparin sodium
Strength(s): 20,000 IU of anti-Factor Xa per mL
Dosage Form(s):   Subcutaneous injection
Company Name:    DuPont Pharma
Availability:         Prescription only, professional use only
*Dated Approved by FDA:   July 14, 2000
*Approval by FDA does not mean that the drug is available for consumers at this time.




What is Innohep used for?

Innohep is used together with another drug, warfarin, to treat blood clots that have occurred deep in the veins of hospitalized patients who may or may not have also experienced the occurrence of blood clots in their lungs (pulmonary embolism).

Who should not be treated with Innohep?

Innohep should not be given to those who:

  • are currently experiencing major bleeding
  • have a history of heparin causing the blood to have low platelets (thrombocytopenia)
  • are allergic to:
    • heparin
    • sulfites
    • benzyl alcohol
    • pork products

Tell your health care provider if you have any of these conditions.

Special Warning(s) with Innohep:

Using Innohep or other low molecular weight heparins (LMWHs) to reduce the risk of problems from blood clots when epidural/spinal anesthesia or spinal puncture is in use puts patients at risk of developing spinal or epidural injury (hematoma), which can result in long-term or permanent paralysis.

Innohep, like other drugs that prevent the blood from clotting, is given with extreme caution in conditions that increase risk of bleeding, such as:

  • Inflammation of the heart and/or the tissue surrounding the heart
  • severe uncontrolled high blood pressure
  • bleeding disorders, including liver failure and certain protein deposits (amyloidosis)
  • active ulcerative colitis and other disorders in the stomach and intestines
  • bleeding into the brain (hemorrhagic stroke)
  • recent brain, spinal or eye surgery
  • when taking other medications that prevents the blood from clotting.

Innohep contains a sulfite that may cause a severe allergic reaction including life-threatening asthma if you are sensitive to sulfites.

General Precautions with Innohep:

Because certain other medications can increase the risk of bleeding with Innohep, review all medications that you are taking with your health care provider, including those that you take without a prescription. Tell your doctor or health care provider if you are taking:

  • blood thinners
  • salicylates, such as aspirin
  • sulfinpyrazone
  • dextran
  • non-steroidal anti-inflammatory drugs such as ibuprofen (Motrin®), naproxen sodium (Naprosyn® or Alleve®).

What should I tell my doctor or health care provider?

Tell your doctor or health care provider if you have a history of:

  • a tendency to bleed easily
  • uncontrolled high blood pressure
  • recent stomach ulcer
  • eye problems due to diabetes
  • recent bleeding
  • kidney problems
  • hemorrhagic stroke

Because vials of Innohep contain the preservative benzyl alcohol, tell your doctor or health care provider if you are trying to become pregnant, are already pregnant, or are breast-feeding. Benzyl alcohol can and may cross the placenta in pregnant women and cause death in premature babies.

What are some possible side effects of Innohep? (This is NOT a complete list of side effects reported with Innohep. Your health care provider can discuss with you a more complete list of side effects.)  

The most common side effect with Innohep is bleeding.

For more detailed information about Innohep, ask your health care provider.

http://www.fda.gov/cder/foi/label/2000/20484lbl.pdf    Innohep's Approved Label

Date Posted:  6/18/01

 

Back to Drug Side Effects


source: FDA


last update: December 2004





This information is not intended to be a substitute for professional medical advice. You should not use this material to diagnose or treat a health condition or disease without consulting with your healthcare provider.
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