- Severe hypotension, cardiovascular collapse, noncardiogenic pulmonary edema, catasphoric pulmonary vasoconstriction and pulmonary hypertension may occur with the use of therapy; avoid over and repeated dosage or administration if current or previous use of protamine containing drugs [US Black Box Warning ]
- Risk factors include allergy to fish, previous vasectomy and severe left ventricular dysfunction and abnormal pre-operative pulmonary hemodynamics [US Black Box Warning ]
- Carefully consider the risk to benefit of administration; in case of severe reaction, vasopressor and resucitation equipment should be immediately available [US Black Box Warning ]
- Avoid use if bleeding occurs without prior heparin use [US Black Box Warning ]
- Inspite of complete neutralization of heparin by adequate doses of protamine sulfate some events of hyperheparinemia or bleeding occurred at the end of the operation. Therefore closely monitor patients after cardiac surgery
- Do not administer rapidly to avoid severe hypotensive and anaphylactoid reactions
- Facilities to treat shock should be available
- Do not give more than 50 mg over a short period
Cautions: Use cautiously in
- Hypersensitivity to fish
- Concurrent or prior protamine insulin use
- Prior protamine use
- Prior vasectomy
- Severe LV dysfunction
- Abnormal preop pulmonary hemodynamics
Pregnancy Category:C
Breastfeeding: Safety unknown. Manufacturer advises caution.
