HEPARIN SODIUM IN SODIUM CHLORIDE
Generic: HEPARIN SODIUM IN SODIUM CHLORIDE
Basic Information
Manufacturer
HF Acquisition Co LLC, DBA HealthFirst
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
c72b193e-0687-e002-e053-2995a90a7182
Indications & Usage
1 INDICATIONS & USAGE Heparin sodium is indicated for: Prophylaxis and treatment of venous thromboembolism and pulmonary embolism; 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.
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 (HIT) and Heparin-Induced Thrombocytopenia and Thrombosis (HITT) [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 )] 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 )].
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.
HIT and HITT, including delayed onset cases [see Warnings and Precautions ( 5.3 and 5.4 )].
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 side of the feet, may occur [see Warnings and Precautions ( 5.7 )].
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.
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: – 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.
HIT and HITT, including delayed onset cases [see Warnings and Precautions ( 5.3 and 5.4 )].
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 side of the feet, may occur [see Warnings and Precautions ( 5.7 )].
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.