Heparin

DRUG DESCRIPTION

Heparin Sodium Injection, USP is a sterile, nonpyrogenic solution of heparin sodium (derived from porcine intestinal mucosa) in water for injection. Each container contains 10000, 12500, 20000 or 25,000 USP Heparin Units; 40 or 80 mg sodium chloride added to render isotonic (see HOW SUPPLIED section for various sizes and strength). May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. pH 6.0 (5.0 to 7.5).

The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended for use only as a single-dose injection. When smaller doses are required, the unused portion should be discarded.

Heparin sodium in the ADD-Vantage™ system is intended for intravenous administration only after dilution.

Heparin Sodium, USP is a heterogenous group of straight-chain anionic mucopolysaccharides, called glycosamino-glycans having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1) ?- L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-?-D-glucose-6-sulfate, (3) ?-D-glucuronic acid, (4) 2-acetamido-2-deoxy-?-D-glucose, and (5) ?-L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2) > (1) > (4) > (3) > (5), and are joined by glycosidic linkages, forming polymers of varying sizes. Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram.

Structure of Heparin Sodium (representative subunits):

Heparin Sodium Structural Formula Illustration

What are the possible side effects of heparin ()?

Heparin can cause you to have bleeding episodes while you are using it and for several weeks after you stop. Call your doctor at once if you have easy bruising or unusual bleeding, such as a nosebleed, blood in your urine or stools, black or tarry stools, or any bleeding that will not stop.

Get emergency medical help if you have any of these signs of an allergic reaction: nausea, vomiting, sweating, hives, itching, trouble breathing, swelling of your face, lips, tongue, or throat, or feeling like you might pass out..

Some people receiving a...

Read All Potential Side Effects and See Pictures of Heparin »

What are the precautions when taking heparin (Heparin)?

Before using heparin, tell your doctor or pharmacist if you are allergic to it; or to pork products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: very low platelet count (thrombocytopenia), uncontrollable bleeding.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe high blood pressure (hypertension), heart problems (e.g., infection of the heart, heart attack), recent surgery/procedure, cancer, bleeding/clotting disorders (e.g., hemophilia,...

Read All Potential Precautions of Heparin »


Heparin Consumer (continued)

SIDE EFFECTS: Mild pain/redness/irritation at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: swelling at injection site, bone pain, easily broken bones.

This medication can cause bleeding if it has too much effect on your blood. Tell your doctor immediately if you develop any signs of serious bleeding, including unusual pain/swelling/discomfort, prolonged bleeding from cuts or gums, persistent nosebleeds, unusually heavy/prolonged menstrual periods, unusual/easy bruising, dark urine, black stools, severe headache, unusual dizziness.

Some patients can have certain bad reactions to heparin (heparin-induced thrombocytopenia-HIT or heparin-induced thrombocytopenia and thrombosis-HITT). This can occur during treatment and up to several weeks after treatment with heparin has stopped.

Get medical help right away if any of these rare but very serious side effects occur: pain/loss of feeling in the arms/legs, change in color of the arms/legs, chest pain, trouble breathing, confusion, weakness on one side of the body, slurred speech, vision changes.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using heparin, tell your doctor or pharmacist if you are allergic to it; or to pork products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: very low platelet count (thrombocytopenia), uncontrollable bleeding.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe high blood pressure (hypertension), heart problems (e.g., infection of the heart, heart attack), recent surgery/procedure, cancer, bleeding/clotting disorders (e.g., hemophilia, antithrombin III deficiency), stomach/intestinal ulcers or tube drainage, liver disease, kidney disease, current/recent bleeding (e.g., from wounds, menstrual period).

Before having surgery, tell your doctor or dentist that you are using this medication.

This medication contains sodium. Consult your doctor or pharmacist if you are on a salt-restricted diet or if you have a condition that could be worsened by an increase in salt intake (e.g., congestive heart failure).

Adults over 60 years of age, especially women, may be at greater risk for bleeding while using this drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication does not pass into breast milk. However, consult your doctor before breast-feeding.


Heparin Patient Information Including Side Effects

Brand Names:

Generic Name: heparin (Pronunciation: HEP a rin)

  • What is heparin ?
  • What are the possible side effects of heparin ?
  • What is the most important information I should know about heparin ?
  • What should I discuss with my healthcare provider before using heparin ?
  • How should I use heparin ?
  • What happens if I miss a dose ?
  • What happens if I overdose ?
  • What should I avoid while using heparin ?
  • What other drugs will affect heparin ?
  • Where can I get more information?

What is heparin ?

Heparin is an anticoagulant (blood thinner) that prevents the formation of blood clots.

Heparin is used to treat and prevent blood clots in the veins, arteries, or lung. Heparin is also used before surgery to reduce the risk of blood clots.

Heparin may also be used for other purposes other than those listed in this medication guide.

What are the possible side effects of heparin ?

Heparin can cause you to have bleeding episodes while you are using it and for several weeks after you stop. Call your doctor at once if you have easy bruising or unusual bleeding, such as a nosebleed, blood in your urine or stools, black or tarry stools, or any bleeding that will not stop.

Get emergency medical help if you have any of these signs of an allergic reaction: nausea, vomiting, sweating, hives, itching, trouble breathing, swelling of your face, lips, tongue, or throat, or feeling like you might pass out..

Some people receiving a heparin injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel nauseated, light-headed, sweaty, or short of breath during or after a heparin injection.

Stop using heparin and call your doctor at once if you have any of these serious side effects:

  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • pain or swelling in one or both legs;
  • trouble breathing; or
  • fever, chills, runny nose, or watery eyes.

Less serious side effects may include:

  • mild pain, redness, warmth, or skin changes where the medicine was injected;
  • mild itching of your feet; or
  • bluish-colored skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about heparin ?

Before using heparin, tell your doctor if you have high blood pressure, an infection involving your heart, hemophilia or other bleeding disorder, a stomach or intestinal disorder, liver disease, or if you are on your period.

Heparin can cause you to have bleeding episodes while you are using it and for several weeks after you stop. Call your doctor at once if you have easy bruising or unusual bleeding, such as a nosebleed, black or bloody tarry stools, or any bleeding that will not stop.

Certain medicines can increase your risk of bleeding while you are using heparin, such as aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) including ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), diflunisal (Dolobid), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), piroxicam (Feldene), and others.

Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Women over 60 years of age may be more likely to have bleeding episodes while using heparin.

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