Heparin Injection
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Heparin Injection
(hep' a rin)
(hep' a rin)
[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.
Pending revision, the material in this section should be considered in light of more recently available information in the
MedWatch notification at the beginning of this monograph.
Heparin is used to prevent blood clots from forming in in people who have certain medical conditions or who are undergoing
certain medical procedures that increase the chance that clots will form. Heparin is also used to stop the growth of clots
that have already formed in the blood vessels, but it cannot be used to decrease the size of clots that have already formed.
Heparin is also used in small amounts to prevent blood clots from forming in catheters (small plastic tubes through which
medication can be administered or blood drawn) that are left in veins over a period of time. Heparin is in a class of medications
called anticoagulants ('blood thinners'). It works by decreasing the clotting ability of the blood.
Pending revision, the material in this section should be considered in light of more recently available information in the
MedWatch notification at the beginning of this monograph.
Heparin comes as a solution (liquid) to be injected intravenously (into a vein) or deeply under the skin and as a dilute (less
concentrated) solution to be injected into intravenous catheters. Heparin should not be injected into a muscle. Heparin is
sometimes injected 1-6 times a day and sometimes given as a slow, continuous injection into the vein. When heparin is used
to prevent blood clots from forming in intravenous catheters, it is usually used when the catheter is first put in place,
and every time that blood is drawn out of the catheter or medication is given through the catheter.
Heparin may be given to you by a nurse or other health care provider, or you may be told to inject the medication by yourself
at home. If you will be injecting heparin yourself, a health care provider will show you how to inject the medication. Ask
your doctor, nurse, or pharmacist if you do not understand these directions or have any questions about where on your body
you should inject heparin, how to give the injection, or how to dispose of used needles and syringes after you inject the
medication.
If you will be injecting heparin yourself, follow the directions on your prescription label carefully, and ask your doctor
or pharmacist to explain any part you do not understand. Use heparin exactly as directed. Do not use more or less of it or
use it more often than prescribed by your doctor.
Heparin solution comes in different strengths, and using the wrong strength may cause serious problems. Before giving an injection
of heparin, check the package label to make sure it is the strength of heparin solution that your doctor prescribed for you.
If the strength of heparin is not correct do not use the heparin and call your doctor or pharmacist right away.
Your doctor may increase or decrease your dose during your heparin treatment. If you will be injecting heparin yourself, be
sure you know how much medication you should use.
Pending revision, the material in this section should be considered in light of more recently available information in the
MedWatch notification at the beginning of this monograph.
Heparin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- redness, pain, bruising, or sores at the spot where heparin was injected
- hair loss
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
- unusual bruising or bleeding
- vomit that is bloody or looks like coffee grounds
- stool that contains bright red blood or is black and tarry
- blood in urine
- excessive tiredness
- nausea
- vomiting
- chest pain, pressure, or squeezing discomfort
- discomfort in the arms, shoulder, jaw, neck, or back
- coughing up blood
- excessive sweating
- sudden severe headache
- lightheadedness or fainting
- sudden loss of balance or coordination
- sudden trouble walking
- sudden numbness or weakness of the face, arm or leg, especially on one side of the body
- sudden confusion, or difficulty speaking or understanding speech
- difficulty seeing in one or both eyes
- purple or black skin discoloration
- pain and blue or dark discoloration in the arms or legs
- itching and burning, especially on the bottoms of the feet
- chills
- fever
- hives
- rash
- wheezing
- shortness of breath
- difficulty breathing or swallowing
- hoarseness
- painful erection that lasts for hours
Heparin may cause osteoporosis (condition in which the bones become weak and may break easily), especially in people who use
the medication for a long time. Talk to your doctor about the risks of using this medication.
Heparin may cause other side effects. Call your doctor if you have any unusual problems while using this medication.
Pending revision, the material in this section should be considered in light of more recently available information in the
MedWatch notification at the beginning of this monograph.
- tell your doctor and pharmacist if you are allergic to heparin, any other medications, beef products,pork products, or any of the ingredients in heparin injection. Ask your doctor or pharmacist for a list of the ingredients.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: other anticoagulants such as warfarin (Coumadin); antihistamines (in many cough and cold products); antithrombin III (Thrombate III); aspirin or aspirin-containing products and other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); dextran; digoxin (Digitek, Lanoxin); dipyridamole (Persantine, in Aggrenox); hydroxychloroquine (Plaquenil); indomethacin (Indocin); phenylbutazone (Azolid) (not available in the US); quinine; and tetracycline antibiotics such as demeclocycline (Declomycin), doxycycline (Monodox, Vibramycin), minocycline (Dynacin, Minocin) and tetracycline (Bristacycline, Sumycin). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have a low level of platelets (type of blood cells needed for normal clotting) in your blood and if you have heavy bleeding that cannot be stopped anywhere in your body. Your doctor may tell you not to use heparin.
- tell your doctor if you are currently experiencing your menstrual period; if you have a fever or an infection; and if you have recently had a a spinal tap (removal of a small amount of the fluid that bathes the spinal cord to test for infection or other problems), spinal anesthesia (administration of pain medication in the area around the spine), surgery, especially involving the brain, spinal cord or eye; or a heart attack. Also tell your doctor if you have or have ever had a bleeding disorder such as hemophilia (condition in which the blood does not clot normally), antithrombin III deficiency (condition that causes blood clots to form), blood clots in the legs, lungs, or anywhere in the body, unusual bruising or purple spots under the skin, cancer, ulcers in the stomach or intestine, a tube that drains the stomach or intestine, high blood pressure, or liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using heparin, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are using heparin.
- tell your doctor if you smoke or use tobacco products and if you stop smoking at any time during your treatment with heparin. Smoking may decrease the effectiveness of this medication.
Unless your doctor tells you otherwise, continue your normal diet.
If you will be injecting heparin yourself at home, talk to your doctor about what you should do if you forget to inject a
dose.
Heparin is also sometimes used alone or in combination with aspirin to prevent pregnancy loss and other problems in pregnant
women who have certain medical conditions and who have experienced these problems in their earlier pregnancies. Talk to your
doctor or pharmacist about the risks of using this medication to treat your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
If you will be injecting heparin at home, your health care provider will tell you how to store the medication. Follow these
directions carefully. Be sure to keep this medication in the container it came in, tightly closed, and out of reach of children.
Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not freeze heparin. Throw away
any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing,
call local emergency services at 911.
Symptoms of overdose may include:
- nosebleed
- blood in urine
- black, tarry stools
- easy bruising
- unusual bleeding
- red blood in stools
- vomit that is bloody or looks like coffee grounds
Pending revision, the material in this section should be considered in light of more recently available information in the
MedWatch notification at the beginning of this monograph.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response
to heparin. Your doctor may ask you to check your stool for blood using an at-home test.
Before having any laboratory test, tell your doctor and the laboratory personnel that you are using heparin.
Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines
you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list
with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with
you in case of emergencies.
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