Hanlim Protamine Sulfate Injection

Key information summary

Efficacy & effects

It is important to neutralize the effects of heparin overdose to prevent side effects such as bleeding. Additionally, after procedures that circulate blood outside the body, such as hemodialysis, cardiopulmonary bypass, or selective brain cooling, neutralizing the remaining heparin action ensures patient safety. This drug is used to effectively eliminate heparin's anticoagulant effects in such situations.

Dosage

For every 1,000 IU of heparin, administer 1 to 1.5 mL (10 to 15 mg) of protamine sulfate. The dosage is determined by the neutralization test with protamine. Dilute less than 5 mL (50 mg) of this drug in 100 to 200 mL of normal saline or 5% dextrose injection and slowly administer intravenously over more than 10 minutes.

Precautions

This drug is provided in the form of an ampoule injection. Care must be taken while cutting the glass container, as glass fragments may cause side effects. Special caution is needed when used in children or the elderly. Patients who have had allergic reactions to this drug's components must not use it. Patients who have undergone procedures related to this drug, diabetic patients with a history of insulin treatment, individuals allergic to fish, males who have undergone vasectomy or are infertile, and patients with antibodies to this drug require careful consideration before administration. Rarely, shock may occur when administering this drug; thus, patients should be closely monitored, and the administration should be stopped immediately if symptoms appear, with appropriate treatment initiated. Symptoms of pulmonary hypertension, such as elevated pulmonary arterial pressure, may occur. If abnormal symptoms appear, administration should be stopped immediately and treated. Rapid injection may lead to side effects such as hypotension, bradycardia, dyspnea, skin flushing, and nausea, so it should be administered slowly. Additionally, systemic hypertension, back pain, vascular edema, and severe allergic reactions have been reported, requiring caution. Post-administration, a blood coagulation test should be performed to confirm that sufficient heparin neutralization has occurred. Patients using this drug repeatedly should closely monitor coagulation test results, as the risk of bleeding from overdose may persist for up to 18 hours after surgery. This drug should preferably not be used with certain antibiotics, and pregnant women or those who could become pregnant should use it only when the benefits of treatment outweigh the risks. Nursing mothers should avoid administration if possible, and if administration is necessary, it is advisable to cease breastfeeding. Safety and efficacy in children have not been sufficiently established, hence it is not recommended. In cases of overdose, blood coagulation tests and respiratory status should be carefully monitored, and treatment such as fresh frozen plasma or whole blood transfusion may be required. This drug has anticoagulant effects, so it should not be administered in amounts exceeding the neutralizing quantities of heparin and dextran sulfate. During blood dialysis or cardiopulmonary bypass, it is safer to administer small amounts gradually to reduce the risk of bleeding.

Side effects

Shock, pulmonary hypertension, dyspnea, life-threatening anaphylaxis, non-cardiogenic pulmonary edema

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