Heparin Sodium in Sodium Chloride
Generic: HEPARIN SODIUM IN SODIUM CHLORIDE
Basic Information
Manufacturer
B. Braun Medical Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
8b030692-fc66-4c53-85aa-6f865e635618
Indications & Usage
1 INDICATIONS AND USAGE Heparin Sodium in 0.45% Sodium Chloride 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 is indicated for: (1) 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 is indicated for: (1) 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.
Adverse Reactions
6 ADVERSE REACTIONS The following serious 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) ] Thrombocytopenia [ see Warnings and Precautions (5.4) ] Heparin Resistance [ see Warnings and Precautions (5.6) ] Hypersensitivity [ see Warnings and Precautions (5.7) ] Hyperkalemia [see Warnings and Precautions (5.8) ] Elevations of Serum Aminotransferases [see Warnings and Precautions (5.9) ] Most common adverse reactions are: hemorrhage, thrombocytopenia, HIT or HITT, hypersensitivity reactions, heparin resistance, hyperkalemia, and elevations of aminotransferase levels.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact B.
Braun Medical Inc.
at 1-800-227-2862 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Postmarketing 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.
Hemorrhage – Hemorrhage is the chief complication that may result from heparin therapy [ see Warnings and Precautions (5.2) ] .
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 with heparin 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, and Thrombocytopenia – [ see Warnings and Precautions (5.3 and 5.4) ] 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 (5.7) ] .
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 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.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact B.
Braun Medical Inc.
at 1-800-227-2862 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Postmarketing 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.
Hemorrhage – Hemorrhage is the chief complication that may result from heparin therapy [ see Warnings and Precautions (5.2) ] .
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 with heparin 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, and Thrombocytopenia – [ see Warnings and Precautions (5.3 and 5.4) ] 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 (5.7) ] .
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 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.