FDA

Heparin Sodium

Approved 30 Jun 2010InjectionInjectable

The FDA lists this product in 60 strengths and forms.

Indications

Heparin Sodium Injection is indicated for: Prophylaxis and treatment of venous thrombosis and pulmonary embolism Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease Atrial fibrillation with embolization Treatment of acute and chronic consumptive 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 Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease Atrial fibrillation with embolization Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation) Prevention of clotting in arterial and cardiac surgery Prophylaxis and treatment of peripheral arterial embolism Use as an anticoagulant in blood transfusions, extracorporeal circulation, and dialysis procedures

Contraindications

The use of heparin sodium is contraindicated in patients with the following conditions: History of heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis [see Warnings and Precautions ( 5.3 )] Known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see Adverse Reactions ( 6.1 )] 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) An uncontrolled active bleeding state [see Warnings and Precautions ( 5.4 )] , except when this is due to disseminated intravascular coagulation Severe thrombocytopenia ( 4 ) When suitable blood coagulation tests, e.g., the whole blood clotting time, partial thromboplastin time, etc., cannot be performed at appropriate intervals ( 4 ) An uncontrolled active bleeding state, except when this is due to disseminated intravascular coagulation ( 4 )

Warnings and precautions

Fatal Medication Errors: Confirm choice of correct strength prior to administration ( 5.1 ) Hemorrhage: Fatal cases have occurred. Use caution in conditions with increased risk of hemorrhage ( 5.2 ) HIT and HITTS: Monitor for signs and symptoms and discontinue if indicative of HIT and HITTS ( 5.3 ) Benzyl Alcohol Toxicity: Do not use this product in neonates and infants. ( 5.4 ) Monitoring: Blood coagulation tests guide therapy for full-dose heparin.

At a glance

Brand name: Heparin Sodium
Route: Injection
Dosage form: Injectable
Applicant: Sagent Pharms
Status: Prescription
FDA approval: 30 Jun 2010
Application: ANDA090808-002

Indications

Contraindications

Warnings and precautions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

There are no available data on heparin sodium use in pregnant women to inform 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 reproduction 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 45,000 units/ day [see Data ] .

Consider the benefits and risks of heparin sodium for the mother and possible risks to the fetus when prescribing heparin sodium to a pregnant woman. If available, preservative-free heparin sodium 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 Warnings and Precautions ( 5.4 )].

The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 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 ( 5.5 )] Heparin Resistance [see Warnings and Precautions ( 5.7 )] Hypersensitivity [see Warnings and Precautions ( 5.8 )] 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 Sagent Pharmaceuticals, Inc. at 1-866-625-1618 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. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 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: 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 may follow deep subcutaneous (intrafat) injection of heparin sodium. Because these complications are much more common after intramuscular use, the intramuscular route is not recommended. Histamine-like reactions – Such reactions have been observed at the site of injections. 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, and asthma, rhinitis, lacrimation, headache, nausea and vomiting, and anaphylactoid reactions, including shock, occurring less frequently. Itching and burning, especially on the plantar side of the feet, may occur. [see Warnings and Precautions ( 5.8 )] . Elevations of aminotransferases – Significant elevations of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels have occurred in patients who have received heparin [see Drug Interactions (7.4)] .

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.

Heparin Sodium

Indications

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

Heparin Sodium

Indications

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

5.1Fatal Medication Errors Do

5.2Hemorrhage

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

5.4Risk of Serious Adverse Reactions in Infants Due to Benzyl Alcohol Preservative Serious

5.5Thrombocytopenia Thrombocytopenia

5.6Coagulation Testing and Monitoring

5.7Heparin Resistance Resistance

5.8Hypersensitivity Patients

Interactions

7.1Oral Anticoagulants

7.2Platelet Inhibitors

7.3Other Interactions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Postmarketing Experience

Composition

Strengths and forms

Official product information