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Protamine Sulfate is used to reverse the anticoagulant effect of heparin. Doctors give it before surgery, after renal dialysis and after open-heart surgery. It is also used if excessive bleeding occurs, and when an overdose of heparin has been given by mistake.
Pharmacology
Protamine sulfate is a fairly strong basic protein, and it is used as an antidote to heparin. It binds with heparin, which is strongly acidic, and the two form a stable, inactive complex (a salt). This complex cancels the anticoagulant effect of both the protamine on its own and the heparin. That is how protamine sulfate reverses heparin's activity, and why it is useful for treating haemorrhage caused by severe overdosage of heparin or low-molecular weight heparin. Protamine sulfate is also often used in the same way to neutralize the effect of heparin given before surgery and during extracorporeal circulation procedures, such as those done in hemodialysis or cardiac surgery.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Protamine Sulfate should be given as a slow intravenous injection over about 10 minutes. No more than 50 mg should be given in any one dose. The dose depends on the amount and type of heparin to be neutralised, the route it was given by, and the time since the last dose, because heparin is continuously being excreted. Ideally, the dose needed to neutralise heparin should be guided by blood coagulation studies or calculated from a protamine neutralisation test. In gross excess, protamine itself acts as an anticoagulant.
Neutralisation of unfractionated (UF) heparins: 1 mg of protamine sulfate will usually neutralise at least 100 international units of mucous heparin or 80 units of lung heparin. The dose should be reduced if more than 15 minutes have passed since the intravenous injection. For example, if 30 to 60 minutes have passed since heparin was injected intravenously, 0.5 to 0.75 mg of protamine sulfate per 100 units of mucous heparin is recommended. If two hours or more have passed, give 0.25 to 0.375 mg per 100 units of mucous heparin. If the patient is on an intravenous infusion of heparin, stop the infusion and give 25 to 50 mg of protamine sulfate by slow intravenous injection. If the heparin was given subcutaneously, give 1 mg of protamine sulfate per 100 units of mucous heparin. Of this, 25 to 50 mg is given by slow intravenous injection and the balance by intravenous infusion over 8 to 16 hours. To reverse UF heparin after cardiopulmonary bypass, either a standard dose of protamine may be given as above, or the dose may be titrated against the activated clotting time. Patients should be monitored carefully, using either the activated partial thromboplastin time or the activated clotting time, checked 5 to 15 minutes after protamine sulfate is given. Further doses may be needed, because protamine is cleared from the blood more rapidly than heparin.
Neutralisation of low molecular weight (LMW) heparins: A dose of 1 mg per 100 units is usually recommended, but the manufacturer's own guidelines should be consulted. The anti-Xa activity of LMW heparins may not be completely reversible with protamine sulfate and may persist for up to 24 hours after administration. LMW heparins also have a longer half-life (about twice that of UF heparin), and this should be borne in mind when estimating the protamine sulfate dose against the time since the last heparin dose. In theory, the dose of protamine sulfate should be halved once one half-life has passed since the last LMW heparin dose. For LMW heparin given subcutaneously, intermittent injections or a continuous infusion of protamine sulfate have been recommended, since absorption may continue from the subcutaneous depot. Patients should be monitored carefully. Further doses may be needed because protamine is cleared from the blood more rapidly than heparin, especially low molecular weight heparin.
Elderly: There is no current evidence that the recommended dose needs to change.
Children: Safety and efficacy in children have not been established. Not recommended.
Side Effects
Protamine Sulfate can cause blood and lymphatic system problems, mainly an anticoagulant effect of its own when the dose is higher than what is needed to neutralise the anticoagulant effect of heparin. Immune system disorders have also been reported. These are hypersensitivity reactions, including angioedema, anaphylactoid reactions and fatal anaphylaxis. Among cardiac disorders, bradycardia can occur. The vascular disorders are a sudden fall in blood pressure, pulmonary and systemic hypertension, transitory flushing and a feeling of warmth, and severe, acute pulmonary vasoconstriction with cardiovascular collapse. Respiratory, thoracic and mediastinal disorders include dyspnoea. There have been rare instances of noncardiogenic pulmonary oedema with prolonged hypotension, with significant morbidity and mortality. Gastrointestinal disorders are nausea and vomiting. Back pain is listed under musculoskeletal and connective tissue disorders. Lassitude is listed under general disorders and administration site conditions.
Cautions & Contraindications
Warnings & Precautions
If Protamine Sulfate is given too rapidly, it may cause severe hypotension and anaphylactoid reactions. Facilities for resuscitation and treatment of shock should be available. Protamine Sulfate is not suitable for reversing the effects of oral anticoagulants. Take care when giving it to patients who may be at increased risk of allergic reaction to protamine. These include patients who have previously had procedures that may involve protamine, such as coronary angioplasty or cardio-pulmonary by-pass, and diabetics who have been treated with protamine insulin. Patients who are allergic to fish are also at risk, as are men who have had a vasectomy or are infertile and may have antibodies to protamine. Where a procedure is prolonged and repeated doses of protamine are needed, clotting parameters should be monitored carefully. A rebound bleeding effect may occur up to 18 hours post-operatively, and it responds to further doses of protamine.
Pregnancy & Breastfeeding
Like most medicines, Protamine Sulfate should be used in pregnancy only when it is clearly needed. During breastfeeding, use it with caution.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Drug Interactions
Common questions about Prosulf 10 mg/ml
What is Prosulf 10 mg/ml IV Injection?
Prosulf 10 mg/ml IV Injection is a medicine that contains Protamine Sulfate. It is made by Radiant Pharmaceuticals Ltd. It belongs to the Anti-coagulants group of medicines.
What is Prosulf used for?
Protamine Sulfate is used to reverse the anticoagulant effect of heparin. Doctors give it before surgery, after renal dialysis and after open-heart surgery.
What are the side effects of Prosulf?
Protamine Sulfate can cause blood and lymphatic system problems, mainly an anticoagulant effect of its own when the dose is higher than what is needed to neutralise the anticoagulant effect of heparin. Immune system disorders have also been reported.
Can I take Prosulf during pregnancy or while breastfeeding?
Like most medicines, Protamine Sulfate should be used in pregnancy only when it is clearly needed. During breastfeeding, use it with caution. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Can I take other medicines with Prosulf?
Some medicines can interact with Protamine Sulfate, for example: Dobutamine Hydrochloride, Pancuronium Bromide. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Prosulf?
Prosulf is a prescription (Rx) medicine. Take it as your doctor advises.