Protamine Sulfate^®

Protamine Sulfate

Generic Name: Protamine Sulfate
Dosage Form: 5 mL of solution for injection containing 10 mg of protamine sulfate per mL
Pharmacological Category: Antidote

Indications: This drug is used to neutralize the effects of heparin.

Protamine
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.

Indications for Protamine

• Neutralization of heparin and low molecular weight heparin (enoxaparin)

Dosage Form of Protamine
5 mL of solution for injection containing 10 mg of protamine sulfate per mL.

Preparation of Protamine
The vial contains a ready-to-use solution and requires no preparation. If dilution is necessary for infusion, protamine is compatible with 0.9% sodium chloride and 5% dextrose.

Method and Dosage of Injection
Protamine is administered only intravenously and should be injected slowly (50 mg over 10 minutes).

Monitoring Requirements During Protamine Use

• Coagulation tests

hemodynamics during administration

Contraindications for Protamine

• History of hypersensitivity to protamine or any of its components

Warnings and Precautions

• Heparin rebound associated with anticoagulation and bleeding has been reported to occur occasionally; symptoms typically appear 8-9 hours after protamine administration, but may occur as long as 18 hours later.
• Protamine may cause hypersensitivity reaction in patients (have appropriate treatment available).

Too rapid administration can cause severe hypotensive and anaphylactoid-like reactions.

Protamine Use During Pregnancy and Breastfeeding
As the safety of protamine during pregnancy and breastfeeding has not been studied, it is recommended to use protamine cautiously and according to the physician's advice.

Side Effects of Protamine
Like any drug, protamine can cause side effects, though not everyone will experience them. Common side effects may include:

• Weakness and fatigue
• Flushing
• Nausea and vomiting
• Shortness of breath

Drug Interactions with Protamine
Consult with a doctor or pharmacist before using protamine with other medications or supplements.

Packaging
Each package contains 10 vials.

Storage Conditions

• Store the drug at temperatures below 25°C, away from light, moisture, and freezing.
• The drug is usable until the end of the month stated in the expiration date. Avoid using expired drugs.
• Keep the drug out of the reach of children.
• Store the drug in its original packaging until use.