Pronunciation:

na-droe-PARE-in

Dosage Forms:

• Solution

Classifications:

Pharmacologic—

Low Molecular Weight Heparin

Uses of This Medicine:

Nadroparin is used to prevent and treat deep vein thrombosis, a condition in which harmful blood clots form in the blood vessels of the legs. These blood clots can travel to the lungs and can become lodged in the blood vessels of the lungs, causing a condition called pulmonary embolism. Nadroparin is used for several days after surgery, while you are unable to walk. Nadroparin also is used to prevent blood clots from forming during hemodialysis.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

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

Older adults—

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Acemetacin
• Alipogene Tiparvovec
• Alteplase, Recombinant
• Amtolmetin Guacil
• Anistreplase
• Antithrombin, Recombinant
• Aspirin
• Bromfenac
• Bufexamac
• Celecoxib
• Choline Salicylate
• Citalopram
• Clonixin
• Collagenase, Clostridium histolyticum
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyridamole
• Dipyrone
• Escitalopram
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Ibuprofen
• Ibuprofen Lysine
• Indomethacin
• Ketoprofen
• Ketorolac
• Levomilnacipran
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Nabumetone
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Paroxetine
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Pranoprofen
• Proglumetacin
• Propyphenazone
• Proquazone
• Reteplase, Recombinant
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sertraline
• Sodium Salicylate
• Streptokinase
• Sulindac
• Tenecteplase
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Urokinase
• Valdecoxib
• Vorapaxar
• Vortioxetine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. 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 cord or
• 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 care professional will teach you how to inject yourself with the medicine. Be sure to follow the directions carefully. Check with your health care professional if you have any problems using the medicine.

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

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• 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-factor Xa International Units (IU) per kilogram (kg) (39.1 anti-factor Xa IU per pound) 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 under the skin once a day beginning two to four hours before surgery and continuing for at least seven days.
    • Children: Use and dose must be determined by your doctor.
  • For prevention of deep vein thrombosis or pulmonary embolism after hip replacement surgery:
    • Adults: The dose is usually 38 anti-factor Xa IU per kg (17.3 anti-factor Xa IU per pound) of body weight injected under the skin twelve hours before surgery, twelve hours after surgery, and once a day for the first three days after surgery. Then, the dose is 57 anti-factor Xa IU per kg (26 anti-factor Xa IU per pound) of body weight injected under the skin once a day from the fourth 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 usually 171 anti-factor Xa IU per kg (77.7 anti-factor Xa IU per pound) of body weight injected under the skin once a day. Or, the dose may be 86 anti-factor Xa IU per kg (39.1 anti-factor Xa IU per pound) of body weight injected under the 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-factor Xa IU per pound) of body weight injected into an artery at the start of each dialysis session.
    • Children: Use and dose must be determined by your doctor.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

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

Side Effects of This Medicine:

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

Stop taking this medicine and get emergency help immediately if any of the following 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

blood in the urine

blue-green to black skin discoloration

bluish discoloration, flushing, or redness of skin

burning, pricking, tickling, or tingling sensation

coughing

difficulty in swallowing

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 spots in the mouth, on the gums, or on the skin

swelling of eyelids, face, or lips

tightness in chest, troubled breathing, and/or wheezing

vomiting of blood or coffee ground–like material

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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