NADROPARIN (Systemic)*

Some commonly used brand names are:

In Canada?

• Fraxiparine
• Fraxiparine Forte

* Not commercially available in the U.S.

Category

• Anticoagulant
• antithrombotic

Description

Nadroparin ( na-dro-PA-rin)is used to prevent and treat deep vein thrombosis, a conditionin which harmful blood clots form in the blood vessels of the legs. Theseblood clots can travel to the lungs and can become lodged in the blood vesselsof the lungs, causing a condition called pulmonary embolism. Nadroparin isused for several days after surgery, while you are unable to walk. Nadroparinalso is used to prevent blood clots from forming during hemodialysis.

This medicine is available only with your doctor's prescription, in thefollowing dosage form:

Parenteral
• Injection (Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of usingthe medicine must be weighed against the good it will do. This is a decisionyou and your doctor will make. For nadroparin, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to nadroparin. Also tell your health care professionalif you are allergic to any other substances, such as foods, preservatives,or dyes.

Pregnancy? Nadroparin has not been shown to cause birth defectsor other problems in humans or animals. However, before taking this medicine,make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding?It is not known whether nadroparin passes intobreast milk. However, mothers receiving nadroparin should avoid breast-feeding.

Children?Studies on this medicine have been done only inadult patients and there is no specific information comparing use of nadroparinin children with use in other age groups.

Older adults? This medicine has been tested and has not beenshown to cause different side effects or problems in older people than itdoes in younger adults.

Other medicines?Although certain medicines should not be used together at all, in other casestwo different medicines may be used together even if an interaction mightoccur. In these cases, your doctor may want to change the dose, or other precautionsmay be necessary. When you are taking nadroparin, it is especially importantthat your health care professional know if you are taking any of the following:

• Abciximab (e.g., ReoPro) or
• Anagrelide (e.g., Agrylin) or
• Calcium channel blocking agents (bepridil [e.g., Vascor], diltiazem[e.g., Cardizem], felodipine [e.g., Plendil], flunarizine [e.g., Sibelium],nicardipine [e.g., Cardene], nifedipine [e.g., Procardia], nimodipine [e.g.,Nimotop], verapamil [e.g., Calan]) or
• Clopidogril (e.g., Plavix) or
• Dipyridamole (e.g., Persantine) or
• Divalproex (e.g., Depakote) or
• Epoprostenol (e.g., Flolan) or
• Eptifibatide (e.g., Integrilin) or
• Inflammation or pain medicine, except narcotics or
• Mezlocillin (e.g., Mezlin) or
• Pentoxifylline (e.g., Trental) or
• Piperacillin (e.g., Pipracil) or
• Plicamycin (e.g., Mithracin) or
• Sulfinpyrazone (e.g., Anturane) or
• Ticarcillin (e.g., Ticar) or
• Ticlopidine (e.g., Ticlid) or
• Tirofiban (e.g., Aggrastat) or
• Valproic acid (e.g., Depakene)?Using any of these medicinestogether with nadroparin may increase the risk of bleeding

Other medical problems?The presence of other medical problems may affect the use of nadroparin.Make sure you tell your doctor if you have any other medical problems, especially:

• Abortion (risk of) or
• Bleeding problems or
• Eye problems caused by diabetes or high blood pressure or
• Heart infection or
• High blood pressure or
• Injury or surgery involving the brain, ears, eyes, or spinal cordor
• Liver disease or
• Low blood platelet count or
• Stomach or intestinal ulcer or
• Stroke?The risk of bleeding may be increased

• Kidney disease?Nadroparin is removed from the body by the kidneys;patients with kidney disease may need to receive a lower dose of nadroparin

Proper Use of This Medicine

If you are using nadroparin at home, your health careprofessional will teach you how to inject yourself with the medicine. Be sure to follow the directions carefully. Check with yourhealth care professional if you have any problems using the medicine.

Put used syringes in a puncture-resistant, disposablecontainer or dispose of them as directed by your health care professional.

Dosing?The doseof nadroparin will be different for different patients. Follow your doctor's orders or the directions on the label. The followinginformation includes only the average doses of nadroparin. If your dose is different, do not change it unless your doctor tellsyou to do so.

The number of milliliters (mL) of nadroparin that you take depends on thestrength of the medicine. Also, the number of doses youtake each day, the time allowed between doses, and the length of time youtake the medicine depend on the medical problem for which you are taking nadroparin:

• For injection dosage form:
  • For unstable angina or certain types of heart attacks:
    • Adults: The dose is based on body weight. It is usually 86 anti-factorXa International Units (IU) per kilogram (kg) (39.1 anti-factor Xa IU perpound) of body weight injected under the skin every twelve hours for six days.
    • Children: Use and dose must be determined by your doctor.
  • For prevention of deep vein thrombosis (blood clots in the legs)or pulmonary embolism (blood clots in the lungs) after general surgery:
    • Adults: The dose is usually 2850 anti-factor Xa IU injected underthe skin once a day beginning two to four hours before surgery and continuingfor at least seven days.
    • Children: Use and dose must be determined by your doctor.
  • For prevention of deep vein thrombosis or pulmonary embolism afterhip replacement surgery:
    • Adults: The dose is usually 38 anti-factor Xa IU per kg (17.3 anti-factorXa IU per pound) of body weight injected under the skin twelve hours beforesurgery, twelve hours after surgery, and once a day for the first three daysafter surgery. Then, the dose is 57 anti-factor Xa IU per kg (26 anti-factorXa IU per pound) of body weight injected under the skin once a day from thefourth through the tenth days after surgery.
    • Children: Use and dose must be determined by your doctor.
  • For treatment of deep vein thrombosis:
    • Adults:
      • Patients weighing less than 40 kg (88 pounds) or more than 100 kg(220 pounds): Dose must be determined by your doctor.
      • Patients weighing 40 to 100 kg (88 to 220 pounds): The dose is usually171 anti-factor Xa IU per kg (77.7 anti-factor Xa IU per pound) of body weightinjected under the skin once a day. Or, the dose may be 86 anti-factor XaIU per kg (39.1 anti-factor Xa IU per pound) of body weight injected underthe skin two times a day.
    • Children: Use and dose must be determined by your doctor.
  • For prevention of blood clots during hemodialysis (kidney dialysis):
    • Adults: The dose is usually 65 anti-factor Xa IU per kg (29.5 anti-factorXa IU per pound) of body weight injected into an artery at the start of eachdialysis session.
    • Children: Use and dose must be determined by your doctor.

Storage?To store this medicine:

• Keep out of the reach of children.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Ask yourhealth care professional how you should dispose of any medicine you do notuse. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Tell all of your medical doctorsand dentists that you are using this medicine.

Side Effects of This Medicine

Along with its needed effects, a medicinemay cause some unwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.

Stop using this medicine and checkwith your doctor immediately if any of the following side effects occur:

More common

Deep, dark purple bruise, pain, or swelling at place of injection

Rare

Back pain; black, tarry stools; bleeding from the mouth or gums; bloodin the urine; blue-green to black skin discoloration; bluish discoloration, flushing, or redness of skin; burning, pricking, tickling, or tingling sensation; coughing; difficulty inswallowing; dizziness or feeling faint; fever; hives; itching; leg weakness; nosebleed; numbness; paralysis; problems with bladder or bowel function; redness or sloughing of skin at place of injection; skin rash; small purple or red spotsin the mouth, on the gums, or on the skin; swellingof eyelids, face, or lips; tightness in chest, troubledbreathing, and/or wheezing; vomiting of blood orcoffee ground-like material

Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.