Heparin Sodium
Generic: HEPARIN SODIUM
Basic Information
Manufacturer
Fresenius Kabi USA, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
ed937dd2-8fab-4875-a1e8-627b71ccb7fb
Indications & Usage
INDICATIONS AND USAGE Heparin Sodium Injection is indicated for: Anticoagulant therapy in prophylaxis and treatment of venous thrombosis and its extension; Low-dose regimen for 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 (see DOSAGE AND ADMINISTRATION ); Prophylaxis and treatment of 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.
Heparin may also be employed as an anticoagulant in blood transfusions, extracorporeal circulation, and dialysis procedures.
Heparin may also be employed as an anticoagulant in blood transfusions, extracorporeal circulation, and dialysis procedures.
Warnings
WARNINGS Heparin is not intended for intramuscular use.
Fatal Medication Errors Do not use Heparin Sodium Injection as a ‘‘catheter lock flush’’ product.
Heparin Sodium Injection is supplied in vials containing various strengths of heparin, including vials that contain a highly concentrated solution of 10,000 units in 1 mL.
Fatal hemorrhages have occurred in pediatric patients due to medication errors in which 1 mL Heparin Sodium Injection vials were confused with 1 mL ‘‘catheter lock flush’’ vials.
Carefully examine all Heparin Sodium Injection vials to confirm the correct vial choice prior to administration of the drug.
Hypersensitivity Patients with documented hypersensitivity to heparin should be given the drug only in clearly life-threatening situations (see ADVERSE REACTIONS , Hypersensitivity ).
Hemorrhage Hemorrhage can occur at virtually any site in patients receiving heparin.
An unexplained fall in hematocrit, fall in blood pressure or any other unexplained symptom should lead to serious consideration of a hemorrhagic event.
Heparin sodium should be used with extreme caution in disease states in which there is increased danger of hemorrhage.
Some of the conditions in which increased danger of hemorrhage exists are: Cardiovascular —Subacute bacterial endocarditis, severe hypertension.
Surgical —During and immediately following (a) spinal tap or spinal anesthesia or (b) major surgery, especially involving the brain, spinal cord, or eye.
Hematologic —Conditions associated with increased bleeding tendencies, such as hemophilia, thrombocytopenia and some vascular purpuras.
Gastrointestinal —Ulcerative lesions and continuous tube drainage of the stomach or small intestine.
Other —Menstruation, liver disease with impaired hemostasis.
Coagulation Testing When heparin sodium is administered in therapeutic amounts, its dosage should be regulated by frequent blood coagulation tests.
If the coagulation test is unduly prolonged or if hemorrhage occurs, heparin sodium should be promptly discontinued (see OVERDOSAGE ).
Thrombocytopenia Thrombocytopenia has been reported to occur in patients receiving heparin with a reported incidence of up to 30%.
Platelet counts should be obtained at baseline and periodically during heparin administration.
Mild thrombocytopenia (count greater than 100,000/mm 3 ) may remain stable or reverse even if heparin is continued.
However, thrombocytopenia of any degree should be monitored closely.
If the count falls below 100,000/mm 3 or if recurrent thrombosis develops (see Heparin-induced Thrombocytopenia and Heparin-induced Thrombocytopenia and Thrombosis ), the heparin product should be discontinued and, if necessary, an alternative anticoagulant administered.
Heparin-induced Thrombocytopenia (HIT) and Heparin-induced Thrombocytopenia and Thrombosis (HITT) Heparin-induced Thrombocytopenia (HIT) is a serious antibody-mediated reaction resulting from irreversible aggregation of platelets.
HIT may progress to the development of venous and arterial thromboses, a condition referred to as Heparin-induced Thrombocytopenia and 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.
Thrombocytopenia of any degree should be monitored closely.
If the platelet count falls below 100,000/mm 3 or if recurrent thrombosis develops, the heparin product should be promptly discontinued and alternative anticoagulants considered, if patients require continued anticoagulation.
Delayed Onset of HIT and HITT Heparin-induced Thrombocytopenia and Heparin-induced Thrombocytopenia and Thrombosis can occur up to several weeks after the discontinuation of heparin therapy.
Patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin should be evaluated for HIT and HITT.
Fatal Medication Errors Do not use Heparin Sodium Injection as a ‘‘catheter lock flush’’ product.
Heparin Sodium Injection is supplied in vials containing various strengths of heparin, including vials that contain a highly concentrated solution of 10,000 units in 1 mL.
Fatal hemorrhages have occurred in pediatric patients due to medication errors in which 1 mL Heparin Sodium Injection vials were confused with 1 mL ‘‘catheter lock flush’’ vials.
Carefully examine all Heparin Sodium Injection vials to confirm the correct vial choice prior to administration of the drug.
Hypersensitivity Patients with documented hypersensitivity to heparin should be given the drug only in clearly life-threatening situations (see ADVERSE REACTIONS , Hypersensitivity ).
Hemorrhage Hemorrhage can occur at virtually any site in patients receiving heparin.
An unexplained fall in hematocrit, fall in blood pressure or any other unexplained symptom should lead to serious consideration of a hemorrhagic event.
Heparin sodium should be used with extreme caution in disease states in which there is increased danger of hemorrhage.
Some of the conditions in which increased danger of hemorrhage exists are: Cardiovascular —Subacute bacterial endocarditis, severe hypertension.
Surgical —During and immediately following (a) spinal tap or spinal anesthesia or (b) major surgery, especially involving the brain, spinal cord, or eye.
Hematologic —Conditions associated with increased bleeding tendencies, such as hemophilia, thrombocytopenia and some vascular purpuras.
Gastrointestinal —Ulcerative lesions and continuous tube drainage of the stomach or small intestine.
Other —Menstruation, liver disease with impaired hemostasis.
Coagulation Testing When heparin sodium is administered in therapeutic amounts, its dosage should be regulated by frequent blood coagulation tests.
If the coagulation test is unduly prolonged or if hemorrhage occurs, heparin sodium should be promptly discontinued (see OVERDOSAGE ).
Thrombocytopenia Thrombocytopenia has been reported to occur in patients receiving heparin with a reported incidence of up to 30%.
Platelet counts should be obtained at baseline and periodically during heparin administration.
Mild thrombocytopenia (count greater than 100,000/mm 3 ) may remain stable or reverse even if heparin is continued.
However, thrombocytopenia of any degree should be monitored closely.
If the count falls below 100,000/mm 3 or if recurrent thrombosis develops (see Heparin-induced Thrombocytopenia and Heparin-induced Thrombocytopenia and Thrombosis ), the heparin product should be discontinued and, if necessary, an alternative anticoagulant administered.
Heparin-induced Thrombocytopenia (HIT) and Heparin-induced Thrombocytopenia and Thrombosis (HITT) Heparin-induced Thrombocytopenia (HIT) is a serious antibody-mediated reaction resulting from irreversible aggregation of platelets.
HIT may progress to the development of venous and arterial thromboses, a condition referred to as Heparin-induced Thrombocytopenia and 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.
Thrombocytopenia of any degree should be monitored closely.
If the platelet count falls below 100,000/mm 3 or if recurrent thrombosis develops, the heparin product should be promptly discontinued and alternative anticoagulants considered, if patients require continued anticoagulation.
Delayed Onset of HIT and HITT Heparin-induced Thrombocytopenia and Heparin-induced Thrombocytopenia and Thrombosis can occur up to several weeks after the discontinuation of heparin therapy.
Patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin should be evaluated for HIT and HITT.
Fatal Medication Errors Do not use Heparin Sodium Injection as a ‘‘catheter lock flush’’ product.
Heparin Sodium Injection is supplied in vials containing various strengths of heparin, including vials that contain a highly concentrated solution of 10,000 units in 1 mL.
Fatal hemorrhages have occurred in pediatric patients due to medication errors in which 1 mL Heparin Sodium Injection vials were confused with 1 mL ‘‘catheter lock flush’’ vials.
Carefully examine all Heparin Sodium Injection vials to confirm the correct vial choice prior to administration of the drug.
Hypersensitivity Patients with documented hypersensitivity to heparin should be given the drug only in clearly life-threatening situations (see ADVERSE REACTIONS , Hypersensitivity ).
Hemorrhage Hemorrhage can occur at virtually any site in patients receiving heparin.
An unexplained fall in hematocrit, fall in blood pressure or any other unexplained symptom should lead to serious consideration of a hemorrhagic event.
Heparin sodium should be used with extreme caution in disease states in which there is increased danger of hemorrhage.
Some of the conditions in which increased danger of hemorrhage exists are: Cardiovascular —Subacute bacterial endocarditis, severe hypertension.
Surgical —During and immediately following (a) spinal tap or spinal anesthesia or (b) major surgery, especially involving the brain, spinal cord, or eye.
Hematologic —Conditions associated with increased bleeding tendencies, such as hemophilia, thrombocytopenia and some vascular purpuras.
Gastrointestinal —Ulcerative lesions and continuous tube drainage of the stomach or small intestine.
Other —Menstruation, liver disease with impaired hemostasis.
Coagulation Testing When heparin sodium is administered in therapeutic amounts, its dosage should be regulated by frequent blood coagulation tests.
If the coagulation test is unduly prolonged or if hemorrhage occurs, heparin sodium should be promptly discontinued (see OVERDOSAGE ).
Thrombocytopenia Thrombocytopenia has been reported to occur in patients receiving heparin with a reported incidence of up to 30%.
Platelet counts should be obtained at baseline and periodically during heparin administration.
Mild thrombocytopenia (count greater than 100,000/mm 3 ) may remain stable or reverse even if heparin is continued.
However, thrombocytopenia of any degree should be monitored closely.
If the count falls below 100,000/mm 3 or if recurrent thrombosis develops (see Heparin-induced Thrombocytopenia and Heparin-induced Thrombocytopenia and Thrombosis ), the heparin product should be discontinued and, if necessary, an alternative anticoagulant administered.
Heparin-induced Thrombocytopenia (HIT) and Heparin-induced Thrombocytopenia and Thrombosis (HITT) Heparin-induced Thrombocytopenia (HIT) is a serious antibody-mediated reaction resulting from irreversible aggregation of platelets.
HIT may progress to the development of venous and arterial thromboses, a condition referred to as Heparin-induced Thrombocytopenia and 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.
Thrombocytopenia of any degree should be monitored closely.
If the platelet count falls below 100,000/mm 3 or if recurrent thrombosis develops, the heparin product should be promptly discontinued and alternative anticoagulants considered, if patients require continued anticoagulation.
Delayed Onset of HIT and HITT Heparin-induced Thrombocytopenia and Heparin-induced Thrombocytopenia and Thrombosis can occur up to several weeks after the discontinuation of heparin therapy.
Patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin should be evaluated for HIT and HITT.
Fatal Medication Errors Do not use Heparin Sodium Injection as a ‘‘catheter lock flush’’ product.
Heparin Sodium Injection is supplied in vials containing various strengths of heparin, including vials that contain a highly concentrated solution of 10,000 units in 1 mL.
Fatal hemorrhages have occurred in pediatric patients due to medication errors in which 1 mL Heparin Sodium Injection vials were confused with 1 mL ‘‘catheter lock flush’’ vials.
Carefully examine all Heparin Sodium Injection vials to confirm the correct vial choice prior to administration of the drug.
Hypersensitivity Patients with documented hypersensitivity to heparin should be given the drug only in clearly life-threatening situations (see ADVERSE REACTIONS , Hypersensitivity ).
Hemorrhage Hemorrhage can occur at virtually any site in patients receiving heparin.
An unexplained fall in hematocrit, fall in blood pressure or any other unexplained symptom should lead to serious consideration of a hemorrhagic event.
Heparin sodium should be used with extreme caution in disease states in which there is increased danger of hemorrhage.
Some of the conditions in which increased danger of hemorrhage exists are: Cardiovascular —Subacute bacterial endocarditis, severe hypertension.
Surgical —During and immediately following (a) spinal tap or spinal anesthesia or (b) major surgery, especially involving the brain, spinal cord, or eye.
Hematologic —Conditions associated with increased bleeding tendencies, such as hemophilia, thrombocytopenia and some vascular purpuras.
Gastrointestinal —Ulcerative lesions and continuous tube drainage of the stomach or small intestine.
Other —Menstruation, liver disease with impaired hemostasis.
Coagulation Testing When heparin sodium is administered in therapeutic amounts, its dosage should be regulated by frequent blood coagulation tests.
If the coagulation test is unduly prolonged or if hemorrhage occurs, heparin sodium should be promptly discontinued (see OVERDOSAGE ).
Thrombocytopenia Thrombocytopenia has been reported to occur in patients receiving heparin with a reported incidence of up to 30%.
Platelet counts should be obtained at baseline and periodically during heparin administration.
Mild thrombocytopenia (count greater than 100,000/mm 3 ) may remain stable or reverse even if heparin is continued.
However, thrombocytopenia of any degree should be monitored closely.
If the count falls below 100,000/mm 3 or if recurrent thrombosis develops (see Heparin-induced Thrombocytopenia and Heparin-induced Thrombocytopenia and Thrombosis ), the heparin product should be discontinued and, if necessary, an alternative anticoagulant administered.
Heparin-induced Thrombocytopenia (HIT) and Heparin-induced Thrombocytopenia and Thrombosis (HITT) Heparin-induced Thrombocytopenia (HIT) is a serious antibody-mediated reaction resulting from irreversible aggregation of platelets.
HIT may progress to the development of venous and arterial thromboses, a condition referred to as Heparin-induced Thrombocytopenia and 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.
Thrombocytopenia of any degree should be monitored closely.
If the platelet count falls below 100,000/mm 3 or if recurrent thrombosis develops, the heparin product should be promptly discontinued and alternative anticoagulants considered, if patients require continued anticoagulation.
Delayed Onset of HIT and HITT Heparin-induced Thrombocytopenia and Heparin-induced Thrombocytopenia and Thrombosis can occur up to several weeks after the discontinuation of heparin therapy.
Patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin should be evaluated for HIT and HITT.
Adverse Reactions
ADVERSE REACTIONS 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.
Hemorrhage Hemorrhage is the chief complication that may result from heparin therapy (see WARNINGS ).
An overly prolonged clotting time or minor bleeding during therapy can usually be controlled by withdrawing the drug (see OVERDOSAGE ).
It should be appreciated that 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: (a) Adrenal hemorrhage, with resultant acute adrenal insufficiency, has occurred during anticoagulant therapy.
Therefore, such treatment should be discontinued in patients who develop signs and symptoms of acute adrenal hemorrhage and insufficiency.
Initiation of corrective therapy should not depend on laboratory confirmation of the diagnosis, since any delay in an acute situation may result in the patient’s death.
(b) Ovarian (corpus luteum) hemorrhage developed in a number of women of reproductive age receiving short- or long-term anticoagulant therapy.
This complication, if unrecognized, may be fatal.
(c) Retroperitoneal hemorrhage.
Thrombocytopenia, Heparin-induced Thrombocytopenia (HIT) and Heparin-induced Thrombocytopenia and Thrombosis (HITT) and Delayed Onset of HIT and HITT See WARNINGS .
Local Irritation Local irritation, erythema, mild pain, hematoma or ulceration may follow deep subcutaneous (intrafat) injection of heparin sodium.
These complications are much more common after intramuscular use, and such use is not recommended.
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 ).
Certain episodes of painful, ischemic and cyanosed limbs have in the past been attributed to allergic vasospastic reactions.
Whether these are in fact identical to the thrombocytopenia-associated complications, remains to be determined.
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.
Significant elevations of aminotransferase (SGOT [S-AST] and SGPT [S-ALT]) levels have occurred in a high percentage of patients (and healthy subjects) who have received heparin.
Hemorrhage Hemorrhage is the chief complication that may result from heparin therapy (see WARNINGS ).
An overly prolonged clotting time or minor bleeding during therapy can usually be controlled by withdrawing the drug (see OVERDOSAGE ).
It should be appreciated that 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: (a) Adrenal hemorrhage, with resultant acute adrenal insufficiency, has occurred during anticoagulant therapy.
Therefore, such treatment should be discontinued in patients who develop signs and symptoms of acute adrenal hemorrhage and insufficiency.
Initiation of corrective therapy should not depend on laboratory confirmation of the diagnosis, since any delay in an acute situation may result in the patient’s death.
(b) Ovarian (corpus luteum) hemorrhage developed in a number of women of reproductive age receiving short- or long-term anticoagulant therapy.
This complication, if unrecognized, may be fatal.
(c) Retroperitoneal hemorrhage.
Thrombocytopenia, Heparin-induced Thrombocytopenia (HIT) and Heparin-induced Thrombocytopenia and Thrombosis (HITT) and Delayed Onset of HIT and HITT See WARNINGS .
Local Irritation Local irritation, erythema, mild pain, hematoma or ulceration may follow deep subcutaneous (intrafat) injection of heparin sodium.
These complications are much more common after intramuscular use, and such use is not recommended.
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 ).
Certain episodes of painful, ischemic and cyanosed limbs have in the past been attributed to allergic vasospastic reactions.
Whether these are in fact identical to the thrombocytopenia-associated complications, remains to be determined.
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.
Significant elevations of aminotransferase (SGOT [S-AST] and SGPT [S-ALT]) levels have occurred in a high percentage of patients (and healthy subjects) who have received heparin.
Hemorrhage Hemorrhage is the chief complication that may result from heparin therapy (see WARNINGS ).
An overly prolonged clotting time or minor bleeding during therapy can usually be controlled by withdrawing the drug (see OVERDOSAGE ).
It should be appreciated that 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: (a) Adrenal hemorrhage, with resultant acute adrenal insufficiency, has occurred during anticoagulant therapy.
Therefore, such treatment should be discontinued in patients who develop signs and symptoms of acute adrenal hemorrhage and insufficiency.
Initiation of corrective therapy should not depend on laboratory confirmation of the diagnosis, since any delay in an acute situation may result in the patient’s death.
(b) Ovarian (corpus luteum) hemorrhage developed in a number of women of reproductive age receiving short- or long-term anticoagulant therapy.
This complication, if unrecognized, may be fatal.
(c) Retroperitoneal hemorrhage.
Thrombocytopenia, Heparin-induced Thrombocytopenia (HIT) and Heparin-induced Thrombocytopenia and Thrombosis (HITT) and Delayed Onset of HIT and HITT See WARNINGS .
Local Irritation Local irritation, erythema, mild pain, hematoma or ulceration may follow deep subcutaneous (intrafat) injection of heparin sodium.
These complications are much more common after intramuscular use, and such use is not recommended.
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 ).
Certain episodes of painful, ischemic and cyanosed limbs have in the past been attributed to allergic vasospastic reactions.
Whether these are in fact identical to the thrombocytopenia-associated complications, remains to be determined.
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.
Significant elevations of aminotransferase (SGOT [S-AST] and SGPT [S-ALT]) levels have occurred in a high percentage of patients (and healthy subjects) who have received heparin.
Hemorrhage Hemorrhage is the chief complication that may result from heparin therapy (see WARNINGS ).
An overly prolonged clotting time or minor bleeding during therapy can usually be controlled by withdrawing the drug (see OVERDOSAGE ).
It should be appreciated that 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: (a) Adrenal hemorrhage, with resultant acute adrenal insufficiency, has occurred during anticoagulant therapy.
Therefore, such treatment should be discontinued in patients who develop signs and symptoms of acute adrenal hemorrhage and insufficiency.
Initiation of corrective therapy should not depend on laboratory confirmation of the diagnosis, since any delay in an acute situation may result in the patient’s death.
(b) Ovarian (corpus luteum) hemorrhage developed in a number of women of reproductive age receiving short- or long-term anticoagulant therapy.
This complication, if unrecognized, may be fatal.
(c) Retroperitoneal hemorrhage.
Thrombocytopenia, Heparin-induced Thrombocytopenia (HIT) and Heparin-induced Thrombocytopenia and Thrombosis (HITT) and Delayed Onset of HIT and HITT See WARNINGS .
Local Irritation Local irritation, erythema, mild pain, hematoma or ulceration may follow deep subcutaneous (intrafat) injection of heparin sodium.
These complications are much more common after intramuscular use, and such use is not recommended.
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 ).
Certain episodes of painful, ischemic and cyanosed limbs have in the past been attributed to allergic vasospastic reactions.
Whether these are in fact identical to the thrombocytopenia-associated complications, remains to be determined.
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.
Significant elevations of aminotransferase (SGOT [S-AST] and SGPT [S-ALT]) levels have occurred in a high percentage of patients (and healthy subjects) who have received heparin.