Protamine sulfate


Generic Medicine Info
Indications and Dosage
Intravenous
Heparin overdosage
Adult: Dosage is individualised depending on the quantity and type of heparin to be neutralised, the route it was given, and the time elapsed since the last administration. Unfractionated heparin neutralisation: 1 mg of protamine will normally neutralise approx 80 international units (lung heparin) or 100 international units (mucous heparin), respectively. Dose may be reduced if >15 minutes have passed since IV administration. If the patient is receiving IV heparin: 25-50 mg via slow IV infusion. If the patient is receiving SC heparin: 25-50 mg via slow IV infusion, then the balance by IV infusion over 8-16 hours. Max: 50 mg. Neutralisation of LMWH: 1 mg will normally neutralise 100 international units of LMWH. Doses are given via intermittent IV inj. Max: 50 mg.
Reconstitution
May be further diluted in NaCl 0.9% or dextrose 5% in water.
Incompatibility
Incompatible with certain antibiotics (e.g. cephalosporins, penicillins).
Special Precautions
Patient at risk of developing hypersensitivity to protamine (e.g. previous history of procedures such as coronary angioplasty or cardiopulmonary bypass surgery which may include protamine use, diabetics using protamine insulin, allergy to fish, men who are infertile or have had a vasectomy and may have antibodies to protamine). Severe left ventricular dysfunction. Abnormal pulmonary haemodynamics. Not indicated for reversing the effects of oral anticoagulants. Pregnancy and lactation.
Adverse Reactions
Significant: Heparin rebound; hypersensitivity reactions, hypotension, cardiovascular collapse, noncardiogenic pulmonary oedema, pulmonary vasoconstriction, pulmonary hypertension; severe hypotension and anaphylactoid-like reactions (rapid administration).
General disorders and administration site conditions: Lassitude, sensation of warmth.
Gastrointestinal disorders: Nausea, vomiting.
Musculoskeletal and connective tissue disorders: Back pain.
Respiratory, thoracic and mediastinal disorders: Dyspnoea.
Vascular disorders: Flushing.
IV/Parenteral: C
Monitoring Parameters
Monitor coagulation tests, aPTT, or activated coagulation time; cardiac monitor and blood pressure (particularly during administration).
Overdosage
Symptoms: Bleeding, hypotension, bradycardia, dyspnoea, nausea, vomiting, lassitude, transitory flushing and/or sensation of warmth. Management: Symptomatic treatment. Monitor coagulation tests and respiratory ventilation. Give fresh frozen plasma or fresh whole blood to combat bleeding problems. May consider fluids, epinephrine, dobutamine, or dopamine to treat hypotension.
Action
Description:
Mechanism of Action: Protamine sulfate is a highly alkaline protein. Its exact mechanism as an antidote for heparin is unknown; however, its combination with the highly acidic heparin leads to the formation of a stable salt lacking in anticoagulant activity.
Onset: Heparin neutralisation: Approx 5 minutes (IV).
Pharmacokinetics:
Metabolism: Protamine in the heparin-protamine complex may be partially metabolised or attacked by fibrinolysin, freeing heparin.
Excretion: Elimination half-life: Approx 7 minutes.
Storage
Store between 15-25°C. Do not refrigerate.
MIMS Class
Antidotes & Detoxifying Agents
ATC Classification
V03AB14 - protamine ; Belongs to the class of antidotes. Used in the management of heparin overdose.
References
Anon. Protamine Sulfate. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 31/03/2023.

Anon. Protamine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 31/03/2023.

Artex Ltd. Protamine Sulphate Injection 1% BP data sheet 04 May 2018. Medsafe. http://www.medsafe.govt.nz. Accessed 31/03/2023.

Buckingham R (ed). Protamine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 31/03/2023.

Joint Formulary Committee. Protamine Sulfate. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 24/05/2023.

Prosulf 10 mg/mL Solution for Injection (Antah Pharma Sdn). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 31/03/2023.

Prosulf 10 mg/mL Solution for Injection (Wockhardt UK Ltd). MHRA. https://products.mhra.gov.uk. Accessed 31/03/2023.

Protamine Sulfate 10 mg/mL Solution for Injection (Wockhardt UK Ltd). MHRA. https://products.mhra.gov.uk. Accessed 31/03/2023.

Protamine Sulfate Injection, Solution (Fresenius Kabi USA, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 31/03/2023.

Taminfate (Ain Medicare Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 31/03/2023.

Disclaimer: This information is independently developed by MIMS based on Protamine sulfate from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com
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