FDA

Heparin Sodium 2,000 Units in Sodium Chloride 0.9% in Plastic Container

Approved 24 Jul 2020InjectionInjectable

The FDA lists this product in 4 strengths and forms.

Indications

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

Warnings and precautions

Hemorrhage: Fatal hemorrhages 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 ) Thrombocytopenia: Monitor platelet count during therapy; discontinue heparin if HIT or HITT is suspected. ( 5.3 ) Heparin Resistance: Increased resistance to heparin is frequently encountered in fever, thrombosis, thrombophlebitis, infections with thrombosing tendencies, myocardial infarction, cancer and in postsurgical patients.

( 5.4 ) Hypersensitivity Reactions: Use in patients with prior reactions only in life threatening situations. ( 5.5 ) Increased Risk of Bleeding in Older Patients, Especially Women: A higher incidence of bleeding has been reported in patients, particularly women, over 60 years of age. ( 5.6 ) Laboratory Tests: Periodic platelet counts, hematocrits, and tests for occult blood in stool are recommended during the entire course of heparin therapy, regardless of the route of administration.

Contraindications

Warnings and precautions

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 )] Increased Risk of Bleeding in Older Patients, Especially Women [see Warnings and Precautions ( 5.6 )] Most common adverse reactions are: hemorrhage, thrombocytopenia, HIT and HITT, hypersensitivity, and elevations of aminotransferase levels.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 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 - 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.

HIT and HITT, including delayed onset [see Warnings and Precautions ( 5.2 )] 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 - 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 [see Warnings and Precautions ( 5.5 )]. 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 also been reported.

Heparin Sodium 2,000 Units in Sodium Chloride 0.9% in Plastic Container

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

Heparin Sodium 2,000 Units in 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 Reactions Patients

5.6Increased Risk of Bleeding in Older Patients, Especially Women

5.7Laboratory Tests

Interactions

7.1Oral Anticoagulants

7.2Platelet Inhibitors

7.3Other

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Postmarketing Experience

Composition

Strengths and forms

Official product information

At a glance