Heparin Sodium 5,000 Units and Sodium Chloride 0.9% in Plastic Container

Approved 28 Apr 1982InjectionInjectable

Indications

Heparin Sodium in Sodium Chloride Injection at a concentration of 2 units/mL is indicated as an anticoagulant to maintain catheter patency. Heparin Sodium in Sodium Chloride Injection at a concentration of 2 units/mL is indicated as an anticoagulant to maintain catheter patency. ( 1 )

Contraindications

The use of Heparin Sodium in Sodium Chloride Injection is contraindicated in patients with the following conditions:

Uncontrollable active bleeding state, except when this is due to disseminated intravascular coagulation [see Warnings and Precautions (5.1) ]
History of heparin-induced thrombocytopenia (HIT) and heparin-induced thrombocytopenia with thrombosis (HITT) [see Warnings and Precautions (5.2) ]
Severe thrombocytopenia [see Warnings and Precautions (5.2 , 5.3) ]
Known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see Adverse Reactions (6.1) ] Heparin Sodium in Sodium Chloride Injection is contraindicated in patients with the following conditions: ( 4 )
With an uncontrollable active bleeding state, except when this is due to disseminated intravascular coagulation ( 5.1 )
With a history of heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia with thrombosis (HITT) ( 5.2 )
With severe thrombocytopenia ( 5.2 , 5.3 )
Known hypersensitivity to heparin or pork products ( 5.5 )

Warnings and precautions

Hemorrhage : Fatal cases have occurred. Monitor for signs of bleeding and manage promptly. ( 5.1 )
HIT and HITT : Monitor for signs and symptoms and discontinue if indicative of HIT or HITT. ( 5.2 )
Hyperkalemia: Measure plasma potassium in patients at risk of hyperkalemia before starting heparin therapy and periodically in all patients. ( 5.6 )
Elevations of serum aminotransferases: Interpret elevation of these enzymes with caution. ( 5.7 )

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5.2Heparin-Induced Thrombocytopenia and Heparin-Induced Thrombocytopenia with Thrombosis

Heparin-induced thrombocytopenia (HIT) is a serious immune-mediated reaction. HIT occurs in patients treated with heparin and is due to the development of antibodies to a platelet Factor 4-heparin complex that induce in vivo platelet aggregation. HIT may progress to the development of venous and arterial thromboses, a condition referred to as heparin-induced thrombocytopenia with 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. Once HIT or HITT is diagnosed or strongly suspected, discontinue all heparin sources (including heparin flushes) and use an alternative anticoagulant.

Immune-mediated HIT is diagnosed based on clinical findings supplemented by laboratory tests confirming the presence of antibodies to heparin, or platelet activation induced by heparin. Obtain platelet counts at baseline and periodically during heparin administration. A drop in platelet count greater than 50% from baseline is considered indicative of HIT. Platelet counts begin to fall 5 to 10 days after exposure to heparin in heparin–naive individuals and reach a threshold by days 7 to 14.

In contrast, “rapid onset” HIT can occur very quickly (within 24 hours following heparin initiation), especially in patients with a recent exposure to heparin (i.e., previous 3 months). Thrombosis development shortly after documenting thrombocytopenia is a characteristic finding in almost half of all patients with HIT. Monitor any degree of thrombocytopenia 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 or HITT can occur up to several weeks after the discontinuation of heparin therapy. Evaluate patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin sodium for HIT or HITT.

Adverse reactions

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

Hemorrhage [see Warnings and Precautions (5.1) ]
Heparin-Induced Thrombocytopenia and Heparin-Induced Thrombocytopenia with Thrombosis [see Warnings and Precautions (5.2) ]
Thrombocytopenia [see Warnings and Precautions (5.3) ]
Heparin Resistance [see Warnings and Precautions (5.4) ]
Hypersensitivity [see Warnings and Precautions (5.5) ]
Hyperkalemia [see Warnings and Precautions (5.6) ]
Elevations of Serum Aminotransferases [see Warnings and Precautions (5.7) ] Most common adverse reactions are: hemorrhage, thrombocytopenia, HIT and HITT, hypersensitivity, and elevations of aminotransferase levels. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at 1-866-888-2472 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 the 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 (5.1) ]. An overly prolonged clotting time or minor bleeding during therapy can usually be controlled by withdrawing the drug [see Overdosage (10) ].

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 during anticoagulant therapy, including fatal cases.
Ovarian (corpus luteum) hemorrhage developed in a number of women of reproductive age receiving short or long-term anticoagulant therapy.
Retroperitoneal hemorrhage Vascular Disorders : Contusion, Vasospastic reactions (including episodes of painful, ischemic, and cyanosed limbs). HIT and HITT, including delayed onset cases, Thrombocytopenia [see Warnings and Precautions (5.2 , 5.3) ]. 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. Hypersensitivity : General 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 [see Warnings and Precautions (5.5) ]. Musculoskeletal, Connective Tissue and Bone Disorders: Osteoporosis with long-term administration of heparin. Metabolism and Nutrition Disorders : Hyperkalemia. General Disorders and Administration Site Conditions: Erythema, mild pain, ulceration. Elevations of serum aminotransferases : Significant elevations of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels have occurred patients who have received heparin. Others: Cutaneous necrosis after systemic administration, delayed transient alopecia, priapism, and rebound hyperlipemia on discontinuation of heparin sodium have also been reported.

Heparin Sodium 5,000 Units and Sodium Chloride 0.9% in Plastic Container

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

5.1Hemorrhage

5.2Heparin-Induced Thrombocytopenia and Heparin-Induced Thrombocytopenia with Thrombosis

5.3Thrombocytopenia Thrombocytopenia

5.4Heparin Resistance

5.5Hypersensitivity

5.6Hyperkalemia

5.7Elevations of Serum Aminotransferases

5.8Laboratory Tests

Interactions

7.1Oral Anticoagulants

7.2Platelet Inhibitors

7.3Other

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Postmarketing Experience

Composition

Official product information

At a glance

Guidelines