Drugs Details

Drugs Info of Heparin
Drugs Details
  • Drugs Type  : Multum
  • Date : 30th Jan 2015 05:29 am
  • Brand Name : Heparin
  • Generic Name :  heparin (injection) (Pronunciation: HEP a rin)
Descriptions

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) α- L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-α-D-glucose-6-sulfate, (3) β-D-glucuronic acid, (4) 2-acetamido-2-deoxy-α-D-glucose, and (5) α-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 injection ()?

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...

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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: very low platelet count (thrombocytopenia), uncontrollable bleeding, high blood pressure (hypertension), heart problems (such as infection of the heart, heart attack), recent surgery/procedure, cancer, bleeding/clotting disorders (such as hemophilia, antithrombin III deficiency), stomach/intestinal ulcers or tube drainage, liver disease, current/recent bleeding (such as from wounds, menstrual...

Read All Potential Precautions of Heparin »


This monograph has been modified to include the generic and brand name in many instances.

Indications

Heparin sodium is indicated for:

Atrial fibrillation with embolization:

Treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation);
Prevention of clotting in arterial and heart surgery;
Anticoagulant therapy in prophylaxis and treatment of venous thrombosis and its extension;
(In a low-dose regimen) for prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdomino-thoracic surgery or who for other reasons are at risk of developing thromboembolic disease (see DOSAGE AND ADMINISTRATION);
Prophylaxis and treatment of pulmonary embolism;
Prophylaxis and treatment of peripheral arterial embolism.

Dosage Administration

Heparin sodium is not effective by oral administration and should be given by intermittent intravenous injection, after dilution in 50 or 100 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP, or by intravenous infusion.

The dosage of heparin sodium should be adjusted according to the patient's coagulation test results. When heparin is given by continuous intravenous infusion, the coagulation time should be determined approximately every 4 hours in the early stages of treatment. When the drug is administered intermittently by intravenous injection, coagulation tests should be performed before each injection during the early stages of treatment and at appropriate intervals thereafter. Dosage is considered adequate when the activated partial thromboplastin time (APTT) is 1.5 to 2 times normal or when the whole blood clotting time is elevated approximately 2.5 to 3 times the control value.

Periodic platelet counts, hematocrits and tests for occult blood in stool are recommended during the entire course of heparin therapy.

Converting to Oral Anticoagulant

When an oral anticoagulant of the coumarin or similar type is to be begun in patients already receiving heparin sodium, baseline and subsequent tests of prothrombin activity must be determined at a time when heparin activity is too low to affect the prothrombin time. If continuous I.V. heparin infusion is used, prothrombin time can usually be measured at any time.

In converting from heparin to an oral anticoagulant, the dose of the oral anticoagulant should be the usual initial amount and thereafter prothrombin time should be determined at the usual intervals. To ensure continuous anticoagulation, it is advisable to continue full heparin therapy for several days after the prothrombin time has reached the therapeutic range. Heparin therapy may then be discontinued without tapering.

Therapeutic Anticoagulant Effect with Full-Dose Heparin

Although dosage must be adjusted for the individual patient according to the results of suitable laboratory tests, the following dosage schedules may be used as guidelines:

 

Method of Administration Frequency Recommended dose*
Intermittent Intravenous Injection Initial Dose 10,000 Units, in 50—100 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection
  Every 4 to 6 hours 5000—10,000 Units, in 50—100 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection
Continuous Intravenous Infusion Initial Dose 5000 Units by I.V. Injection
Continuous 20,000—40,000 Units/24 hours in 5% Dextrose Injection or 0.9% Sodium Chloride Injection
* Based on 150 lb. (68 kg) patient.

Pediatric Use

There are no adequate and well controlled studies on heparin use in pediatric patients. Pediatric dosing recommendations are based on clinical experience. In general, the following dosage schedule may be used as a guideline in pediatric patients:

Initial Dose: 75 to 100 units/kg (IV bolus over 10 minutes)

Maintenance Dose Infants: 25 to 30 units/kg/hour;

Infants < 2 months have the highest requirements (average 28 units/kg/hour)

Children > 1 year of age: 18 to 20 units/kg/hour;

Older children may require less heparin, similar to weight-adjusted adult dosage

Monitoring

Adjust heparin to maintain a PTT of 60 to 85 seconds, assuming this reflects an anti-Factor Xa level of 0.35 to 0.70.

Surgery of the Heart and Blood Vessels

Patients undergoing total body perfusion for open-heart surgery should receive an initial dose of not less than 150 units of heparin sodium per kilogram of body weight. Frequently, a dose of 300 units per kilogram is used for procedures estimated to last less than 60 minutes or 400 units per kilogram for those estimated to last longer than 60 minutes.

Low-Dose Prophylaxis of Postoperative Thromboembolism

A number of well-controlled clinical trials have demonstrated that low-dose heparin prophylaxis, given just prior to and after surgery, will reduce the incidence of postoperative deep vein thrombosis in the legs (as measured by the I-125 fibrinogen technique and venography) and of clinical pulmonary embolism. The most widely used dosage has been 5,000 units 2 hours before surgery and 5,000 units every 8 to 12 hours thereafter for 7 days or until the patient is fully ambulatory, whichever is longer. A concentrated solution of heparin sodium is recommended. Such prophylaxis should be reserved for patients over the age of 40 who are undergoing major surgery. Patients with bleeding disorders and those having brain or spinal cord surgery, spinal anesthesia, eye surgery, or potentially sanguineous operations should be excluded, as should patients receiving oral anticoagulants or platelet-active drugs (see WARNINGS). The value of such prophylaxis in hip surgery has not been established. The possibility of increased bleeding during surgery or postoperatively should be borne in mind. If such bleeding occurs, discontinuance of heparin and neutralization with protamine sulfate are advisable. If clinical evidence of thromboembolism develops despite low-dose prophylaxis, full therapeutic doses of anticoagulants should be given unless contraindicated. Prior to initiating heparinization the physician should rule out bleeding disorders by appropriate history and laboratory tests, and appropriate coagulation tests should be repeated just prior to surgery. Coagulation test values should be normal or only slightly elevated at these times.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Slight discoloration does not alter potency. See PRECAUTIONS.

Instructions For Use

To Open Diluent Container

Peel overwrap from the corner and remove container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.

To Assemble Vial and Flexible Diluent Container: (Use Aseptic Technique)

1. Remove the protective covers from the top of the vial and the vial port on the diluent container as follows:

a. To remove the breakaway vial cap, swing the pull ring over the top of the vial and pull down far enough to start the opening (see Figure 1.), then pull straight up to remove the cap. (see Figure 2.) NOTE: Once the breakaway cap has been removed, do not access vial with syringe.

Fig. 1

Swing the pull ring - Illustration

Fig. 2

Pull straight up - Illustration

b. To remove the vial port cover, grasp the tab on the pull ring, pull up to break the three tie strings, then pull back to remove the cover. (see Figure 3.)

2. Screw the vial into the vial port until it will go no further. THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. This occurs approximately ½ turn (180°) after the first audible click. (see Figure 4.) The clicking sound does not assure a seal; the vial must be turned as far as it will go. NOTE: Once vial is seated, do not attempt to remove. (see Figure 4.)

3. Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly.

4. Label appropriately

Fig. 3

Pull up to break the three tie strings - Illustration

Fig. 4

Seat the vial securely - Illustration
To Prepare Admixture

1. Squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial.

2. With the other hand, push the drug vial down into the container telescoping the walls of the container. Grasp the inner cap of the vial through the walls of the container. (see Figure 5.)

3. Pull the inner cap from the drug vial. (see Figure 6.) Verify that the rubber stopper has been pulled out, allowing the drug and diluent to mix.

4. Mix container contents thoroughly and use within the specified time.

Fig. 5

Grasp the inner cap of the vial - Illustration

Fig. 6

Pull the inner cap from the drug vial - Illustration
Preparation for Administration (Use Aseptic Technique)
  1. Confirm the activation and admixture of vial contents.
  2. Check for leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired.
  3. Close flow control clamp of administration set.
  4. Remove cover from outlet port at bottom of container.
  5. Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. NOTE: See full directions on administration set carton.
  6. Lift the free end of the hanger loop on the bottom of the vial, breaking the two tie strings. Bend the loop outward to lock it in the upright position, then suspend container from hanger.
  7. Squeeze and release drip chamber to establish proper fluid level in chamber.
  8. Open flow control clamp and clear air from set. Close clamp.
  9. Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture.
  10. Regulate rate of administration with flow control clamp.

WARNING: Do not use flexible container in series connections.

How Supplied

Heparin Sodium Injection, USP is supplied in the ADD-Vantage™ vials as follows:

 

NDC No. Total Volume Total Units Heparin/vial Total mg Sodium Chloride/vial
0409-2581-02 5 mL 10,000 40
0409-2584-02 10 mL 25,000 80

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Caution: Federal (USA) law prohibits dispensing without prescription.

Revised: October, 2011. Hospira, Inc., Lake Forest, IL 60045 USA


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Hemorrhage

Hemorrhage is the chief complication that may result from heparin therapy (see WARNINGS). An overly prolonged clotting time or minor bleeding during therapy can usually be controlled by withdrawing the drug (see OVERDOSAGE). It should be appreciated that gastrointestinal or urinary tract bleeding during anticoagulant therapy may indicate the presence of an underlying occult lesion. Bleeding can occur at any site but certain specific hemorrhagic complications may be difficult to detect:

  1. Adrenal hemorrhage, with resultant acute adrenal insufficiency, has occurred during anticoagulant therapy. Therefore, such treatment should be discontinued in patients who develop signs and symptoms of acute adrenal hemorrhage and insufficiency. Initiation of corrective therapy should not depend on laboratory confirmation of the diagnosis since any delay in an acute situation may result in the patient's death.
  2. Ovarian (corpus luteum) hemorrhage developed in a number of women of reproductive age receiving short- or long-term anticoagulant therapy. This complication if unrecognized may be fatal.
  3. Retroperitoneal hemorrhage.

Hypersensitivity

Generalized hypersensitivity reactions have been reported with chills, fever, and urticaria as the most usual manifestations, and asthma, rhinitis, lacrimation, headache, nausea and vomiting and anaphylactoid reactions, including shock, occurring more rarely. Itching and burning, especially on the plantar site of the feet may occur.

Thrombocytopenia has been reported to occur in patients receiving heparin with a reported incidence of 0 to 30%. While often mild and of no obvious clinical significance, such thrombocytopenia can be accompanied by severe thromboembolic complications such as skin necrosis, gangrene of the extremities that may lead to amputation, myocardial infarction, pulmonary embolism, stroke and possibly death. (See WARNINGS and PRECAUTIONS.)

Certain episodes of painful, ischemic and cyanosed limbs have in the past been attributed to allergic vasospastic reactions. Whether these are in fact identical to the thrombocytopenia associated complications remains to be determined.

Miscellaneous

Osteoporosis following long-term administration of high doses of heparin, cutaneous necrosis after systemic administration, suppression of aldosterone synthesis, delayed transient alopecia, priapism and rebound hyperlipemia on discontinuation of heparin sodium have also been reported.

Significant elevations of aminotransferase (SGOT [S-AST] and SGPT [S-ALT]) levels have occurred in a high percentage of patients (and healthy subjects) who have received heparin.

Read the Heparin (heparin) Side Effects Center for a complete guide to possible side effects

Interactions

Oral anticoagulants

Heparin sodium may prolong the one-stage prothrombin time. Therefore, when heparin sodium is given with dicumarol or warfarin sodium, a period of at least 5 hours after the last intravenous dose should elapse before blood is drawn if a valid PROTHROMBIN time is to be obtained.

Platelet inhibitors

Drugs such as acetylsalicylic acid, dextran, phenylbutazone, ibuprofen, indomethacin, dipyridamole, hydroxychloroquine and others that interfere with platelet aggregation reactions (the main hemostatic defense of heparinized patients) may induce bleeding and should be used with caution in patients receiving heparin sodium.

Other interactions

Digitalis, tetracyclines, nicotine, antihistamines or I.V. nitroglycerin may partially counteract the anticoagulant action of heparin sodium.

Drug/Laboratory Test Interactions

Hyperaminotransferasemia

Significant elevations of aminotransferase (SGOT [S-AST] and SGPT [SALT]) levels have occurred in a high percentage of patients (and healthy subjects) who have received heparin. Since aminotransferase determinations are important in the differential diagnosis of myocardial infarction, liver disease, and pulmonary emboli, rises that might be caused by drugs (like heparin) should be interpreted with caution.


This monograph has been modified to include the generic and brand name in many instances.

Warnings

Heparin is not intended for intramuscular use.

Fatal Medication Errors

Do not use Heparin Sodium Injection as a “catheter lock flush” product. Heparin Sodium Injection is supplied in vials containing various strengths of heparin, including vials that contain a highly concentrated solution of 10,000 units in 1 mL. Fatal hemorrhages have occurred in pediatric patients due to medication errors in which 1 mL Heparin Sodium Injection vials were confused with 1 mL “catheter lock flush” vials. Carefully examine all Heparin Sodium Injection vials to confirm the correct vial choice prior to administration of the drug.

Hypersensitivity

Patients with documented hypersensitivity to heparin should be given the drug only in clearly life-threatening situations.

Hemorrhage

Hemorrhage can occur at virtually any site in patients receiving heparin. An unexplained fall in hematocrit, fall in blood pressure or any other unexplained symptom should lead to serious consideration of a hemorrhagic event.

Heparin sodium should be used with extreme caution in disease states in which there is increased danger of hemorrhage. Some of the conditions in which increased danger of hemorrhage exists are:

Cardiovascular — Subacute bacterial endocarditis. Severe hypertension.

Surgical — During and immediately following (a) spinal tap or spinal anesthesia or (b) major surgery, especially involving the brain, spinal cord or eye.

Hematologic — Conditions associated with increased bleeding tendencies, such as hemophilia, thrombocytopenia, and some vascular purpuras.

Gastrointestinal — Ulcerative lesions and continuous tube drainage of the stomach or small intestine.

Other — Menstruation, liver disease with impaired hemostasis.

Coagulation Testing

When heparin sodium is administered in therapeutic amounts, its dosage should be regulated by frequent blood coagulation tests. If the coagulation test is unduly prolonged or if hemorrhage occurs, heparin sodium should be discontinued promptly (see OVERDOSAGE).

Thrombocytopenia

Thrombocytopenia in patients receiving heparin has been reported at frequencies up to 30%. It can occur 2 to 20 days (average 5 to 9) following the onset of heparin therapy. Obtain platelet counts before and periodically during heparin therapy. Monitor thrombocytopenia of any degree closely. If the count falls below 100,000/mm³ or if recurrent thrombosis develops, promptly discontinue heparin, evaluate for HIT and HITT, and, if necessary, administer an alternative anticoagulant (see Heparin-induced Thrombocytopenia and Heparin-induced Thrombocytopenia and Thrombosis).

Heparin-Induced Thrombocytopenia and Heparin-Induced Thrombocytopenia and Thrombosis

Heparin-induced thrombocytopenia (HIT) is a serious antibody-mediated reaction resulting from irreversible aggregation of platelets. HIT may progress to the development of venous and arterial thromboses, a condition known as heparin-induced thrombocytopenia and thrombosis (HITT).

Thrombotic events may also be the initial presentation for HITT. These serious thromboembolic events include deep vein thrombosis, pulmonary embolism, cerebral vein thrombosis, limb ischemia, stroke, myocardial infarction, mesenteric thrombosis, renal arterial thrombosis, skin necrosis, gangrene of the extremities that may lead to amputation, and possibly death. Monitor thrombocytopenia of any degree closely. If the platelet count falls below 100,000/mm³ or if recurrent thrombosis develops, promptly discontinue heparin, evaluate for HIT and HITT, and, if necessary, administer an alternative anticoagulant.

HIT and HITT can occur up to several weeks after the discontinuation of heparin therapy. Patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin should be evaluated for HIT and HITT.

Precautions

General

Do not administer unless solution is clear and container is intact. Discard unused portion (see DOSAGE AND ADMINISTRATION).

  1. Heparin Resistance
    Increased resistance to heparin is frequently encountered in fever, thrombosis, thrombophlebitis, infections with thrombosing tendencies, myocardial infarction, cancer and in postsurgical patients.
  2. Increased Risk in Older Women
    A higher incidence of bleeding has been reported in women over 60 years of age. Laboratory Tests: Periodic platelet counts, hematocrits and tests for occult blood in stool are recommended during the entire course of heparin therapy (see DOSAGE AND ADMINISTRATION).

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term studies in animals have been performed to evaluate carcinogenic potential of heparin. Also, no reproduction studies in animals have been performed concerning mutagenesis or impairment of fertility.

Pregnancy

Pregnancy Category C: There are no adequate and well-controlled studies on heparin use in pregnant women. In published reports, heparin exposure during pregnancy did not show evidence of an increased risk of adverse maternal or fetal outcomes in humans. Heparin sodium does not cross the placenta, based on human and animal studies. Administration of heparin to pregnant animals at doses higher than the maximum human daily dose based on body weight resulted in increased resorptions. Use heparin sodium during pregnancy only if the potential benefit justifies the potential risk to the fetus.

In a published study conducted in rats and rabbits, pregnant animals received heparin intravenously during organogenesis at a dose of 10,000 units/kg/day, approximately 10 times the maximum human daily dose based on body weight. The number of early resorptions increased in both species. There was no evidence of teratogenic effects.

Nursing Mothers

Due to its large molecular weight, heparin is not likely to be excreted in human milk, and any heparin in milk would not be orally absorbed by a nursing infant. Benzyl alcohol present in maternal serum is likely to cross into human milk and may be orally absorbed by a nursing infant. Exercise caution when administering Heparin Sodium Injection to a nursing mother. Pediatric Use: There are no adequate and well controlled studies on heparin use in pediatric patients. Pediatric dosingrecommendations are based on clinical experience (see DOSAGE AND ADMINISTRATION, Pediatric Use). Carefully examine all Heparin Sodium Injection vials to confirm choice of the correct strength prior to administration of the drug. Pediatric patients, including neonates, have died as a result of medication errors in which HEPARIN SODIUM INJECTION vials have been confused with “catheter lock flush” vials (see WARNINGS, Fatal Medication Errors).


This monograph has been modified to include the generic and brand name in many instances.

OverDose

Symptoms

Bleeding is the chief sign of heparin overdosage. Nosebleeds, blood in urine or tarry stools may be noted as the first sign of bleeding. Easy bruising or petechial formations may precede frank bleeding.

Treatment

Neutralization of heparin effect.

When clinical circumstances (bleeding) require reversal of heparinization, protamine sulfate (1% solution) by slow infusion will neutralize heparin sodium. No more than 50 mg should be administered, very slowly in any 10 minute period. Each mg of protamine sulfate neutralizes approximately 100 USP heparin units. The amount of protamine required decreases over time as heparin is metabolized. Although the metabolism of heparin is complex, it may, for the purpose of choosing a protamine dose, be assumed to have a half-life of about ½ hour after intravenous injection.

Administration of protamine sulfate can cause severe hypotensive and anaphylactoid reactions. Because fatal reactions often resembling anaphylaxis have been reported, the drug should be given only when resuscitation techniques and treatment of anaphylactoid shock are readily available.

For additional information, the labeling of Protamine Sulfate Injection, USP products should be consulted.

ContrainDications

Heparin sodium should not be used in patients:

With severe thrombocytopenia;
In whom suitable blood coagulation tests — e.g., the whole blood clotting time, partial thromboplastin time, etc. — cannot be performed at appropriate intervals (this contraindication refers to full-dose heparin; there is usually no need to monitor coagulation parameters in patients receiving low-dose heparin);
With an uncontrollable active bleeding state (see WARNINGS), except when this is due to disseminated intravascular coagulation.
Intravenous solutions with Heparin Sodium Injection are contraindicated in patients who are hypersensitive to heparin.


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Heparin inhibits reactions that lead to the clotting of blood and the formation of fibrin clots both in vitro and in vivo. Heparin acts at multiple sites in the normal coagulation system. Small amounts of heparin in combination with antithrombin III (heparin cofactor) can inhibit thrombosis by inactivating activated Factor X and inhibiting the conversion of prothrombin to thrombin. Once active thrombosis has developed, larger amounts of heparin can inhibit further coagulation by inactivating thrombin and preventing the conversion of fibrinogen to fibrin. Heparin also prevents the formation of a stable fibrin clot in inhibiting the activation of the fibrin stabilizing factor.

Bleeding time is usually unaffected by heparin. Clotting time is prolonged by full therapeutic doses of heparin; in most cases, it is not measurably affected by low doses of heparin.

Peak plasma levels of heparin are achieved 2 to 4 hours following subcutaneous administration, although there are considerable individual variations. Loglinear plots of heparin plasma concentrations with time for a wide range of dose levels are linear which suggests the absence of zero order processes. Liver and the reticuloendothelial system are the site of biotransformation. The biphasic elimination curve, a rapidly declining alpha phase (t½ = 10') and after the age of 40 a slower beta phase, indicates uptake in organs. The absence of a relationship between anticoagulant half-life and concentration half-life may reflect factors such as protein binding of heparin.

Heparin does not have fibrinolytic activity; therefore, it will not lyse existing clots.


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

HEPARIN - INJECTION

 

(HEP-a-rin)

 

USES: This medication is used to prevent and treat blood clots. It may be used to prevent and treat blood clots in the lungs/legs (including in patients with atrial fibrillation). It may be used to treat certain blood clotting disorders. It may also be used to prevent blood clots after surgery, during dialysis, during blood transfusions, when collecting blood samples, or when a person is unable to move for a long time. Heparin helps to keep blood flowing smoothly by making a certain natural substance in your body (anti-clotting protein) work better. It is known as an anticoagulant.

 

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to prevent blood clots in patients with certain types of heart attack or a certain type of chest pain called unstable angina.

 

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using heparin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into a vein or under the skin as directed by your doctor. Do not inject this medication into a muscle. The dosage and how often you use it are based on your medical condition, weight, and response to treatment.

Heparin comes in many strengths. Serious (sometimes fatal) injuries have occurred when the wrong strength was used. Check that you are using the correct strength and dose before injecting this medication.

If you are injecting heparin into a vein, flush the catheter/line with normal saline before and after infusing drugs that interact with heparin such as doxorubicin, droperidol, ciprofloxacin, and mitoxantrone.

If you are injecting heparin under the skin, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.

Your doctor may direct you to switch to an anticoagulant taken by mouth (such as warfarin). Use this medication and any new medication exactly as directed by your doctor.

Consumer Overview Side Effect

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 its effect on your clotting proteins is too much. Tell your doctor right away 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 you have any very serious side effects, including: 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.

 

Read the Heparin (heparin) Side Effects Center for a complete guide to possible side effects

Learn More »

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.

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

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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 worsen if you have more salt (such as congestive heart failure).

Older adults, especially women over 60 years of age, may be more sensitive to the side effects of this drug, especially bleeding.

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. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

One product that may interact with this drug is: mifepristone.

This medication is sometimes used together with other drugs that have "blood thinning" or anti-platelet effects such as aspirin, clopidogrel, or warfarin. If your doctor prescribes a combination of these drugs, he or she will monitor you closely to minimize your risk of bleeding. Keep all medical and laboratory appointments.

Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (NSAIDs such as ibuprofen, naproxen, or aspirin) that can increase the risk of bleeding when used with heparin. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

Cigarette smoking decreases blood levels of this medication. Tell your doctor if you smoke or if you have recently stopped smoking.

This medication may interfere with certain laboratory tests (including certain liver function tests, prothrombin time), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: easy/unusual bruising, easy/unusual bleeding such as persistent nosebleeds, blood in urine, black stools.

 

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (such as hematocrit, complete blood count, platelet counts, activated partial thromboplastin time, test for blood in stool) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

 

MISSED DOSE: For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule. Do not double the dose to catch up.

 

STORAGE: Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

 

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

 

Information last revised October 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names:

Generic Name: heparin (injection) (Pronunciation: HEP a rin)

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

What is heparin injection ?

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 injection should not be used to flush (clean out) an intravenous (IV) catheter. A separate heparin product is available to use as catheter lock flush.

Heparin may also be used for purposes not listed in this medication guide.

What are the possible side effects of heparin injection ?

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 severe headache, confusion, problems with vision, speech, or balance;
  • chest pain, sudden cough, wheezing, rapid breathing, fast heart rate;
  • pain, swelling, warmth, or redness in one or both legs;
  • trouble breathing;
  • (in an infant) extreme drowsiness, weakness, or gasping for breath; 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.

Read the Heparin (heparin) Side Effects Center for a complete guide to possible side effects

Learn More »

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

Heparin injection should not be used to flush (clean out) an intravenous (IV) catheter. A separate heparin product is available to use as catheter lock flush.

You should not use this medication if you are allergic to heparin, or if you have uncontrolled bleeding or a severe lack of platelets in your blood.

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 (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), nabumetone (Relafen), piroxicam (Feldene), and others.

Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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

Side Effects Centers
  • Heparin

Patient Detailed How Take

What should I discuss with my healthcare provider before using heparin injection ?

You should not use this medication if you are allergic to heparin, or if you have:

  • a severe lack of platelets in your blood; or
  • uncontrolled bleeding.

To make sure you can safely use heparin, tell your doctor if you have any of these other conditions:

  • an infection of the lining of your heart (also called bacterial endocarditis);
  • uncontrolled high blood pressure;
  • a bleeding or blood clotting disorder, such as hemophilia;
  • a stomach or intestinal disorder;
  • liver disease; or
  • if you are having a menstrual period.

FDA pregnancy category C. It is not known whether heparin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Do not use this medication without telling your doctor if you are breast-feeding a baby.

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

How should I use heparin injection ?

Heparin is injected under the skin or into a vein through an IV. You may be shown how to use an IV at home.

Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

You may be switched from injectable heparin to an oral (taken by mouth) blood thinner. Do not stop using the heparin until your doctor tells you to. You may need to use both the injection and the oral forms of heparin for a short time.

Store at room temperature away from moisture and heat.

Side Effects Centers
  • Heparin

Patient Detailed Avoid Taking

What happens if I miss a dose ?

Call your doctor for instructions if you miss a dose of heparin.

What happens if I overdose ?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include easy bruising, nosebleeds, blood in your urine or stools, black or tarry stools, or any bleeding that will not stop.

What should I avoid while using heparin injection ?

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 (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), nabumetone (Relafen), piroxicam (Feldene), and others.

What other drugs will affect heparin injection ?

Tell your doctor about all other medicines you use, especially:

  • another blood thinner, such as warfarin (Coumadin, Jantoven);
  • digoxin (digitalis, Lanoxin, Lanoxicaps);
  • dipyridamole (Persantine);
  • hydroxychloroquine (Plaquenil, Quineprox);
  • ibuprofen (Advil, Motrin);
  • indomethacin (Indocin);
  • nicotine cigarettes, gum, lozenges, or skin patches;
  • nitroglycerin (Nitro Dur, Nitrolingual, Nitrostat, Transderm Nitro, and others);
  • an antibiotic such as demeclocycline (Declomycin), doxycycline (Adoxa, Alodox, Avidoxy, Oraxyl, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn), or tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap);
  • cold, allergy, or sleep medications (Allerest, Benadryl, Chlor-Trimeton, Dimetapp, Sominex, Tylenol PM, and others); or
  • salicylates such as aspirin, Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others.

This list is not complete and other drugs may interact with heparin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about heparin.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 9.01. Revision date: 2/14/2012.

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Side Effects Centers
  • Heparin

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