Protamine Sulfate
Generic: PROTAMINE SULFATE
Basic Information
Manufacturer
Fresenius Kabi USA, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
8df0a819-9e1a-44ce-97a6-3ea82c867d44
Indications & Usage
INDICATIONS AND USAGE: Protamine Sulfate Injection, USP is indicated in the treatment of heparin overdosage.
Warnings
WARNINGS: Hyperheparinemia or bleeding has been reported in experimental animals and in some patients 30 minutes to 18 hours after cardiac surgery (under cardiopulmonary bypass) in spite of complete neutralization of heparin by adequate doses of protamine sulfate at the end of the operation.
It is important to keep the patient under close observation after cardiac surgery.
Additional doses of protamine sulfate should be administered if indicated by coagulation studies, such as the heparin titration test with protamine and the determination of plasma thrombin time.
Too-rapid administration of protamine sulfate can cause severe hypotensive and anaphylactoid reactions (see DOSAGE AND ADMINISTRATION and WARNINGS ).
Facilities to treat shock should be available.
It is important to keep the patient under close observation after cardiac surgery.
Additional doses of protamine sulfate should be administered if indicated by coagulation studies, such as the heparin titration test with protamine and the determination of plasma thrombin time.
Too-rapid administration of protamine sulfate can cause severe hypotensive and anaphylactoid reactions (see DOSAGE AND ADMINISTRATION and WARNINGS ).
Facilities to treat shock should be available.
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.
The intravenous administration of protamine sulfate may cause a sudden fall in blood pressure and bradycardia.
Other reactions include transitory flushing and feeling of warmth, dyspnea, nausea, vomiting and lassitude.
Back pain has been reported in conscious patients undergoing such procedures as cardiac catheterization.
Severe adverse reactions have been reported including: (1) Anaphylaxis that resulted in severe respiratory distress, circulation collapse and capillary leak (see PRECAUTIONS ).
Fatal anaphylaxis has been reported in one patient with no prior history of allergies; (2) Anaphylactoid reactions with circulatory collapse, capillary leak, and noncardiogenic pulmonary edema; acute pulmonary hypertension.
Complement activation by the heparin-protamine complexes, release of lysosomal enzymes from neutrophils, and prostaglandin and thomboxane generation have been associated with the development of anaphylactoid reactions.
Severe and potentially irreversible circulatory collapse associated with myocardial failure and reduced cardiac output can also occur.
The mechanism(s) of this reaction and the role played by concurrent factors are unclear.
High-protein, noncardiogenic pulmonary edema associated with the use of protamine has been reported in patients on cardiopulmonary bypass who are undergoing cardiovascular surgery.
The etiologic role of protamine in the pathogenesis of this condition is uncertain, and multiple factors have been present in most cases.
The condition has been reported in association with administration of certain blood products, other drugs, cardiopulmonary bypass alone, and other etiologic factors.
It is difficult to treat, and it can be life-threatening.
Because fatal anaphylactic and anaphylactoid reactions have been reported after the administration of protamine sulfate, the drug should be given only when resuscitation techniques and treatment of anaphylactic and anaphylactoid shock are readily available.
The intravenous administration of protamine sulfate may cause a sudden fall in blood pressure and bradycardia.
Other reactions include transitory flushing and feeling of warmth, dyspnea, nausea, vomiting and lassitude.
Back pain has been reported in conscious patients undergoing such procedures as cardiac catheterization.
Severe adverse reactions have been reported including: (1) Anaphylaxis that resulted in severe respiratory distress, circulation collapse and capillary leak (see PRECAUTIONS ).
Fatal anaphylaxis has been reported in one patient with no prior history of allergies; (2) Anaphylactoid reactions with circulatory collapse, capillary leak, and noncardiogenic pulmonary edema; acute pulmonary hypertension.
Complement activation by the heparin-protamine complexes, release of lysosomal enzymes from neutrophils, and prostaglandin and thomboxane generation have been associated with the development of anaphylactoid reactions.
Severe and potentially irreversible circulatory collapse associated with myocardial failure and reduced cardiac output can also occur.
The mechanism(s) of this reaction and the role played by concurrent factors are unclear.
High-protein, noncardiogenic pulmonary edema associated with the use of protamine has been reported in patients on cardiopulmonary bypass who are undergoing cardiovascular surgery.
The etiologic role of protamine in the pathogenesis of this condition is uncertain, and multiple factors have been present in most cases.
The condition has been reported in association with administration of certain blood products, other drugs, cardiopulmonary bypass alone, and other etiologic factors.
It is difficult to treat, and it can be life-threatening.
Because fatal anaphylactic and anaphylactoid reactions have been reported after the administration of protamine sulfate, the drug should be given only when resuscitation techniques and treatment of anaphylactic and anaphylactoid shock are readily available.