FDA

Heparin Sodium

Approved 21 Jul 2011InjectionInjectable

The FDA lists this product in 60 strengths and forms.

Official labelAsk Osler about it

Indications

HEPARIN SODIUM INJECTION is indicated for:

Prophylaxis and treatment of venous thrombosis and pulmonary embolism;
Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation;
Treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation);
Prevention of clotting in arterial and cardiac surgery;
Prophylaxis and treatment of peripheral arterial embolism;
Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. HEPARIN SODIUM INJECTION is an anticoagulant indicated for ( 1 ):
Prophylaxis and treatment of venous thrombosis and pulmonary embolism
Prophylaxis and treatment of the thromboembolic complications associated with atrial fibrillation
Treatment of acute and chronic consumption coagulopathies
Prevention of clotting in arterial and cardiac surgery
Prophylaxis and treatment of peripheral arterial embolism
Anticoagulant use in transfusion, extracorporeal circulation, and dialysis procedures

Contraindications

The use of HEPARIN SODIUM INJECTION is contraindicated in patients:

History of heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis
History of thrombocytopenia with pentosan polysulfate
Known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see Adverse Reactions (6.1) ]
In whom suitable blood coagulation tests (e.g., whole-blood clotting time, partial thromboplastin time) cannot be performed at appropriate intervals. This contraindication refers to full-dose heparin regimens only; there is usually no need to monitor coagulation parameters in patients receiving low-dose heparin
An uncontrollable bleeding state [see Warnings and Precautions (5.2) ] , except when this is due to disseminated intravascular coagulation
History of heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis (HITTS) ( 4 )
History of thrombocytopenia with pentosan polysulfate ( 4 )
Known hypersensitivity to heparin or pork products ( 4 )
In whom suitable blood coagulation tests cannot be performed at appropriate intervals ( 4 )
An uncontrollable bleeding state, except when this is due to disseminated intravascular coagulation ( 4 )

At a glance

Brand name: Heparin Sodium
Route: Injection
Dosage form: Injectable
Applicant: Pfizer
Status: Discontinued
FDA approval: 21 Jul 2011
Application: NDA201370-003

Indications

HEPARIN SODIUM INJECTION is indicated for:

Prophylaxis and treatment of venous thrombosis and pulmonary embolism;
Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation;
Treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation);
Prevention of clotting in arterial and cardiac surgery;
Prophylaxis and treatment of peripheral arterial embolism;
Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. HEPARIN SODIUM INJECTION is an anticoagulant indicated for ( 1 ):
Prophylaxis and treatment of venous thrombosis and pulmonary embolism
Prophylaxis and treatment of the thromboembolic complications associated with atrial fibrillation
Treatment of acute and chronic consumption coagulopathies
Prevention of clotting in arterial and cardiac surgery
Prophylaxis and treatment of peripheral arterial embolism
Anticoagulant use in transfusion, extracorporeal circulation, and dialysis procedures

Contraindications

The use of HEPARIN SODIUM INJECTION is contraindicated in patients:

History of heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis
History of thrombocytopenia with pentosan polysulfate
Known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see Adverse Reactions (6.1) ]
In whom suitable blood coagulation tests (e.g., whole-blood clotting time, partial thromboplastin time) cannot be performed at appropriate intervals. This contraindication refers to full-dose heparin regimens only; there is usually no need to monitor coagulation parameters in patients receiving low-dose heparin
An uncontrollable bleeding state [see Warnings and Precautions (5.2) ] , except when this is due to disseminated intravascular coagulation
History of heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis (HITTS) ( 4 )
History of thrombocytopenia with pentosan polysulfate ( 4 )
Known hypersensitivity to heparin or pork products ( 4 )
In whom suitable blood coagulation tests cannot be performed at appropriate intervals ( 4 )
An uncontrollable bleeding state, except when this is due to disseminated intravascular coagulation ( 4 )

Interactions

Drugs that interfere with coagulation, platelet aggregation or drugs that counteract coagulation may induce bleeding ( 7.2 )
Andexanet alfa may reduce the efficacy of heparin when used concomitantly ( 7.3 )

7.1Oral 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 or 24 hours after the last subcutaneous dose should elapse before blood is drawn if a valid prothrombin time is to be obtained.

7.2Platelet Inhibitors

Drugs such as NSAIDs (including salicylic acid, ibuprofen, indomethacin, and celecoxib), dextran, phenylbutazone, thienopyridines, dipyridamole, hydroxychloroquine, glycoprotein IIb/IIIa antagonists (including abciximab, eptifibatide, and tirofiban), 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.

7.3Unresponsiveness to Heparin with Concomitant Use with Andexanet Alfa

Andexanet binds to heparin-bound antithrombin III (ATIII) and may reduce the anticoagulant effect of heparin. Unresponsiveness to unfractionated heparin may lead to serious and life-threatening thrombotic events. Use of andexanet alfa as an antidote for heparin has not been established. Avoid use of heparin after use of andexanet alfa for the reversal of direct Factor Xa inhibitors (apixaban and rivaroxaban). If anticoagulation is needed, use an alternative anticoagulant to heparin [see Warnings and Precautions (5.5) ] .

7.4Other Interactions

Digitalis, tetracyclines, nicotine, or antihistamines, or intravenous (IV) nitroglycerin may partially counteract the anticoagulant action of heparin sodium. Antithrombin III (human) – The anticoagulant effect of heparin is enhanced by concurrent treatment with antithrombin III (human) in patients with hereditary antithrombin III deficiency. To reduce the risk of bleeding, a reduced dosage of heparin is recommended during treatment with antithrombin III (human).

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

There are no available data on heparin sodium use in pregnant women to infor a drug associated risk of major birth defects and miscarriage. In published reports, heparin exposure during pregnancy did not show evidence of an increased risk of adverse maternal or fetal outcomes in humans. No teratogenicity, but early embryo-fetal death was observed in animal reproductive studies with administration of heparin sodium to pregnant rats and rabbits during organogenesis at doses approximately 10 times the maximum recommended human dose (MRHD) of 40,000 USP units/24 hours infusion (see Data ) .

Consider the benefits and risks of HEPARIN SODIUM INJECTION to a pregnant woman and possible risks to the fetus when prescribing HEPARIN SODIUM INJECTION to a pregnant woman. If available, preservative-free HEPARIN SODIUM INJECTION is recommended when heparin therapy is needed during pregnancy. There are no known adverse outcomes associated with fetal exposure to the preservative benzyl alcohol through maternal drug administration; however, the preservative benzyl alcohol can cause serious adverse events and death when administered intravenously to neonates and infants [see Use in Specific Populations (8.4) ].

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Data Human Data The maternal and fetal outcomes associated with uses of heparin via various dosing methods and administration routes during pregnancy have been investigated in numerous studies.

These studies generally reported normal deliveries with no maternal or fetal bleeding and no other complications. Animal Data 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.

Adverse reactions

The following clinically significant adverse reactions are described elsewhere in the labeling:

Hemorrhage [see Warnings and Precautions (5.2) ]
Heparin-Induced Thrombocytopenia and Heparin-Induced Thrombocytopenia and Thrombosis [see Warnings and Precautions (5.3) ]
Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative [see Warnings and Precautions (5.4) ]
Thrombocytopenia [see Warnings and Precautions (5.6) ]
Heparin Resistance [see Warnings and Precautions (5.8) ]
Hypersensitivity [see Warnings and Precautions (5.9) ]
Hyperkalemia [see Warnings and Precautions (5.10) ] Most common adverse reactions are hemorrhage, thrombocytopenia, HIT and HITTS, injection site irritation, general hypersensitivity reactions, and elevations of aminotransferase levels. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Postmarketing Experience

The following adverse reactions have been identified during post approval use of HEPARIN SODIUM INJECTION. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.

Hemorrhage – Hemorrhage is the chief complication that may result from heparin therapy [see Warnings and Precautions (5.2) ] . 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 including: - Adrenal hemorrhage, with resultant acute adrenal insufficiency, has occurred with heparin therapy, including fatal cases. - Ovarian (corpus luteum) hemorrhage developed in a number of women of reproductive age receiving short- or long-term heparin therapy. - Retroperitoneal hemorrhage.
HIT and HITT, including delayed onset cases [see Warnings and Precautions (5.3) ] .
Local irritation – Local irritation, erythema, mild pain, hematoma, or ulceration have occurred following deep subcutaneous (intrafat) injection of heparin sodium. Because such reactions occur more frequently after intramuscular administration, the IM route is not recommended.
Histamine-like reactions – Such reactions have been observed at the site of injection. Necrosis of the skin has been reported at the site of subcutaneous injection of heparin, occasionally requiring skin grafting [see Warnings and Precautions (5.3) ] .
Hypersensitivity – Generalized hypersensitivity reactions have been reported with chills, fever, and urticaria as the most usual manifestations; asthma, rhinitis, lacrimation, headache, nausea and vomiting, and anaphylactoid reactions, including shock, occur less frequently. Itching and burning, especially on the plantar site of the feet, may occur.
Metabolism and Nutrition Disorders – Hyperkalemia.
Elevations of serum aminotransferases – Significant elevations of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels have occurred in patients who have received heparin.
Others – 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 been reported.

Heparin Sodium

Indications

Contraindications

At a glance

Two medicines in one question?

Heparin Sodium

Indications

Contraindications

At a glance

Two medicines in one question?

Warnings and precautions

5.1Fatal Medication Errors Do

5.2Hemorrhage

5.3Heparin-Induced Thrombocytopenia and Heparin-Induced Thrombocytopenia and Thrombosis

5.5Unresponsiveness to Heparin with Concomitant Use with Andexanet Alfa Unresponsiveness

5.6Thrombocytopenia Thrombocytopenia

5.7Coagulation Testing and Monitoring

5.8Heparin Resistance Resistance

5.9Hypersensitivity Patients

5.10Hyperkalemia

Interactions

7.1Oral Anticoagulants

7.2Platelet Inhibitors

7.3Unresponsiveness to Heparin with Concomitant Use with Andexanet Alfa

7.4Other Interactions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Postmarketing Experience

Composition

Strengths and forms

Official product information