Protamine Sulfate^®

Protamine is a protein molecule. When Protamine is administered in the presence of heparin, a stable salt is formed and the anticoagulant activity of heparin is neutralized.

Neutralization of heparin and low-molecular-weight heparin, such as enoxaparin.

Injectable solution containing 10 mg Protamine sulfate per mL

The Protamine vial contains a ready-to-inject solution and does not require preparation.

If dilution is needed for infusion, Protamine is compatible with 0.9% sodium chloride and 5% dextrose.

Protamine can only be used intravenously and must be injected slowly: 50 mg over 10 minutes.

• Blood coagulation tests
• Activated partial thromboplastin time, aPTT
• Activated clotting time, ACT
• Cardiac function and blood pressure monitoring

History of hypersensitivity to Protamine or any component of its formulation.

• Avoid rapid injection of Protamine because of the increased risk of severe hypotension.
• The risk of severe hypersensitivity reactions is higher in patients receiving high doses of Protamine or in Protamine overdose, repeated dosing, history of Protamine use or use of Protamine-containing medicines such as NPH insulin, fish allergy, vasectomy, severe left ventricular dysfunction, and abnormal pulmonary hemodynamics. In these patients, the benefits and risks of Protamine administration should be carefully evaluated.
• Injection of this medicine may cause hypersensitivity reactions; therefore, epinephrine and resuscitation equipment must be available during administration.

Since the safety of Protamine during pregnancy and breastfeeding has not been evaluated, it is recommended that Protamine be used during these periods with caution and according to the physician’s judgment.

Like all medicines, alongside its desired therapeutic effects, this medicine may cause some unwanted side effects; however, these effects do not occur in everyone. Some of the more common possible side effects of this medicine include:

• Feeling weak and debilitated
• Hot flashes
• Nausea and vomiting
• Shortness of breath

Consult your doctor or pharmacist regarding the use of Protamine together with other medicines or supplements.

Each package contains 10 vials.

• Store the medicine below 25°C, away from light, moisture, and freezing.
• The medicine may be used until the end of the month stated in the expiration date on the package. Avoid using or keeping expired medicines.
• Keep the medicine out of the reach of children.
• Keep the medicine in its original packaging until use.

1. Protamine sulfate: Drug information, UpToDate
2. EMC SmPC source listed on the original page.