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Hypotension; Pulmonary Hypertension; Risk Factors

• Protamine sulfate can cause severe hypotension, cardiovascular collapse, noncardiogenic pulmonary edema, catastrophic pulmonary vasocontriction, and pulmonary hypertension.
• Risk factors include high dose or overdose, rapid administration (See WARNINGS and DOSAGE AND ADMINISTRATION), repeated doses, previous administration of protamine, and current or previous use of protamine-containing drugs (NPH insulin, protamine zinc insulin, and certain beta-blockers).
• Allergy to fish, previous vasectomy, and severe left ventricular dysfunction and abnormal preoperative pulmonary hemodynamics also may be risk factors. In patients with any of these risk factors, the risk to benefit of administration of protamine sulfate should be carefully considered. Vasopressors and resuscitation equipment should be immediately available in case of a severe reaction to protamine.
• Protamine should not be given when bleeding occurs without prior heparin use.