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Drug Notebook

FDA Alerts

Special Alerts:

[Posted 02/11/2008] FDA informed healthcare professionals of important warnings and instructions for Heparin Sodium Injection use. There have been reports of serious adverse events including allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension. Most events developed within minutes of heparin initiation although the possibility for a delayed response has not been excluded. The reports have largely involved use of multiple-dose vials. However, there have been several cases in which product from multiple, single-dose vials have been combined to administer a bolus dose. Heparin sodium is an anticoagulant (blood thinner) that is used in patients undergoing kidney dialysis, certain types of cardiac surgery, and treatment or prevention of other serious medical conditions, including deep venous thrombosis and pulmonary emboli. Heparin treatment is initiated using high doses (5000-50,000 units) given directly into the blood stream (intravenously) as a bolus. Serious adverse events have recently been reported in patients who received these higher bolus doses.

The manufacture of multiple-dose vials of heparin sodium has been suspended pending the completion of an extensive ongoing investigation to determine the root cause of the problem. Because heparin sodium is a medically necessary product and serious public health consequences would result if there were a sudden shortage of the drug, the multiple-dose vials of heparin sodium manufactured by Baxter that are currently in distribution will not be recalled. See the FDA Public Health Advisory for Agency recommendations to healthcare professionals on the use of heparin sodium for injection. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#HeparinInj2, http://www.fda.gov/cder/drug/advisory/heparin.htm, http://www.fda.gov/cder/drug/infopage/heparin/heparinQA.htm and http://www.fda.gov/bbs/topics/NEWS/2008/NEW01797.html.

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heparin
(HEP a rin)

What is this medicine?
HEPARIN (HEP a rin) is an anticoagulant. It is used to treat or prevent clots in the veins, arteries, lungs, or heart. It stops clots from forming or getting bigger. This medicine prevents clotting during open-heart surgery, dialysis, or in patients who are confined to bed.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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What is the price of this medication and similar alternatives?

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 11/2009. For the most current and up-to-date pricing information, please visit www.drugstore.com. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Heparin Sodium Porcine) 1000UNIT/ML Solution (APP PHARMACEUTICAL10/$188.99 or 30/$541.97
Heparin Sodium Porcine) 10000UNIT/ML Solution (APP PHARMACEUTICAL125/$660.64 or 375/$1967.96
Heparin Sodium Porcine) 10000UNIT/ML Solution (APP PHARMACEUTICAL25/$259.2 or 75/$673.91

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What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • any sign of bleeding like bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine, bleeding gums, nosebleeds
  • back pain
  • bleeding in the eye
  • breathing problems
  • burning or itching on the bottoms of the feet
  • cold, blue, or painful hands and feet
  • coughing up blood
  • feeling faint or lightheaded, falls
  • fever, chills
  • heavy menstrual bleeding
  • nausea, vomiting
  • stomach pain
  • unusually low blood pressure

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • pain at site where injected

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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How should I use this medicine?
This medicine is given by injection or infusion into a vein. It can also be given by injection of small amounts under the skin. It is usually given by a health care professional in a hospital or clinic setting.

If you get this medicine at home, you will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take it more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

Talk to your pediatrician regarding the use of this medicine in children. While this medicine may be prescribed for children for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

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What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

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What may interact with this medicine?
Do not take this medicine with any of the following medications:

  • aspirin and aspirin-like drugs
  • mifepristone
  • medicines that treat or prevent blood clots like warfarin, enoxaparin, and dalteparin
  • protamine

This medicine may also interact with the following medications:

  • dextran
  • digoxin
  • hydroxychloroquine
  • medicines for treating colds or allergies
  • nicotine
  • NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
  • phenylbutazone
  • tetracycline antibiotics

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

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Who should NOT use this medication?

  • Uncontrollable bleeding, unless such bleeding is secondary to disseminated intravascular coagulation.
  • Severe thrombocytopenia.
  • Inability to perform suitable blood coagulation tests at required intervals in patients receiving full-dose therapy. Lack of such tests generally is not a contraindication for fixed low-dose therapy, since monitoring of coagulation tests usually is not required.
  • Known hypersensitivity to heparin or bisulfites (in certain IV solutions). Hypersensitivity to corn products (solutions containing dextrose). (See Sensitivity Reactions under Cautions.)

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What should I watch for while using this medicine?
While you are taking this medicine, carry an identification card with your name, the name and dose of medicine(s) being used, and the name and phone number of your doctor or health care professional or person to contact in an emergency.

Notify your doctor or health care professional at once if you have cold, blue hands or feet, or any unusual bleeding. Monitor your skin closely for easy bruising or red spots, which can indicate bleeding.

If you are going to have surgery or dental work, tell your doctor or health care professional that you have received this medicine. Be careful brushing and flossing your teeth or using a toothpick while receiving this medicine because you may bleed more easily.

Avoid sports and activities that might cause injury while you are using this medicine. Severe falls or injuries can cause unseen bleeding. Be careful when using sharp tools or knives. Consider using an electric razor.

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What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:

  • bleeding disorders, such as hemophilia or low blood platelets
  • bowel disease or diverticulitis
  • endocarditis
  • high blood pressure
  • liver disease
  • recent surgery or delivery of a baby
  • stomach ulcers
  • an unusual or allergic reaction to heparin, benzyl alcohol, sulfites, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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