Protamine Side Effects, and Drug Interactions - Protamines

Protamine Side Effects, and Drug Interactions - Protamines

SIDE EFFECTS

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, circulatory 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 thromboxane 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.

Drug Interactions Protamine sulfate has been shown to be incompatible with certain antibiotics, including several of the cephalosporins and penicillins ( see Dosage and Administration).