Danaparoid (Subcutaneous Route)

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. Danaparoid is used for several days after hip replacement surgery, while you are unable to walk. It is during this time that blood clots are most likely to form . Danaparoid also may be used for other conditions as determined by your doctor .

Danaparoid was available only with your doctor`s prescription.

Organon, Inc. discontinued manufacturing OrgaranA® (danaparoid) on August 14, 2002 .

This product is available in the following dosage forms:

• Solution

Before Using

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.

Pediatric

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

Geriatric

Many medicines have not been studied specifically in older people . Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people . There is no specific information comparing use of danaparoid in the elderly with use in other age groups.

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

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.

• Abciximab


• Aceclofenac


• Acemetacin


• Acenocoumarol


• Alclofenac


• Alteplase, Recombinant


• Anisindione


• Anistreplase


• Apazone


• Ardeparin


• Argatroban


• Benoxaprofen


• Bivalirudin


• Bromfenac


• Bufexamac


• Carprofen


• Certoparin


• Chamomile


• Cilostazol


• Citalopram


• Clometacin


• Clonixin


• Clopidogrel


• Dalteparin


• Danaparoid


• Defibrotide


• Dermatan Sulfate


• Desirudin


• Desvenlafaxine


• Dexketoprofen


• Diclofenac


• Dicumarol


• Diflunisal


• Dipyrone


• Droxicam


• Duloxetine


• Enoxaparin


• Eptifibatide


• Escitalopram


• Etodolac


• Etofenamate


• Felbinac


• Fenbufen


• Fenoprofen


• Fentiazac


• Floctafenine


• Flufenamic Acid


• Fluoxetine


• Flurbiprofen


• Fluvoxamine


• Fondaparinux


• Garlic


• Ginkgo


• Heparin


• Ibuprofen


• Indomethacin


• Indoprofen


• Isoxicam


• Ketoprofen


• Ketorolac


• Lamifiban


• Lornoxicam


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Milnacipran


• Nabumetone


• Nadroparin


• Naproxen


• Niflumic Acid


• Nimesulide


• Oxaprozin


• Oxyphenbutazone


• Papaya


• Parnaparin


• Paroxetine


• Phenindione


• Phenprocoumon


• Phenylbutazone


• Pirazolac


• Piroxicam


• Pirprofen


• Propyphenazone


• Proquazone


• Reteplase, Recombinant


• Reviparin


• Sertraline


• Sibrafiban


• St John`s Wort


• Streptokinase


• Sulindac


• Suprofen


• Tan-Shen


• Tenecteplase


• Tenidap


• Tenoxicam


• Tiaprofenic Acid


• Tinzaparin


• Tirofiban


• Tolmetin


• Urokinase


• Venlafaxine


• Warfarin


• Xemilofiban


• Zomepirac

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aspirin


• Avocado


• Benorilate


• Choline Salicylate


• Chondroitin


• Coenzyme Q10


• Curcumin


• Dong Quai


• Ginger


• Green Tea


• Magnesium Salicylate


• Mesalamine


• Olsalazine


• Salicylamide


• Salicylic Acid


• Salsalate


• Sodium Salicylate


• Sodium Thiosalicylate


• Trolamine Salicylate


• Vitamin A

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:

• Bleeding problems or


• Heart infection or


• High blood pressure (hypertension) or


• Kidney disease or


• Stomach or intestinal ulcer (active) or


• Strokea€”The risk of bleeding may be increased .

Also, tell your doctor if you have received danaparoid before and had a reaction to it called thrombocytopenia (a low platelet count in the blood), or if new blood clots formed while you were receiving the medicine.

In addition, tell your doctor if you have recently had medical surgery. This may increase the risk of serious bleeding when you are taking danaparoid.

Proper Use

If you are using danaparoid 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 prevention of deep venous thrombosis (leg clots) and pulmonary embolism (lung clots):
    
    
    
    • Adultsa€”750 anti-factor Xa units, injected under the skin, two times a day for up to fourteen days after surgery.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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.

Precautions

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

Check with your doctor immediately if you notice any of the following side effects:

• Bruising or bleeding, especially bleeding that is hard to stop. Bleeding inside the body sometimes appears as bloody or black, tarry stools, or faintness.


• Back pain; burning, pricking, tickling, or tingling sensation; leg weakness; numbness; paralysis; or problems with bowel or bladder function .

Side Effects

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:

Less common

• Bleeding gums


• Coughing up blood


• Difficulty in breathing or swallowing


• Dizziness


• Headache


• Increased menstrual flow or vaginal bleeding


• Nosebleeds


• Paralysis


• Prolonged bleeding from cuts


• Red or black, tarry stools


• Red or dark brown urine


• Shortness of breath


• Unexplained pain, swelling, or discomfort, especially in the chest, abdomen, joints, or muscles


• Unusual bruising


• Vomiting of blood or coffee grounda€“like material; weakness

Rare

• Back pain


• Burning, pricking, tickling, or tingling sensation


• Leg weakness


• Numbness


• Problems with bowel or bladder function

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

• Fever

Rare

• Skin rash

Some side effects may occur that usually do not need medical attention . These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Pain at injection site

Less common

• Constipation


• Nausea

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.