Protamine sulfate


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IV Heparin overdosage For heparin administered via IV inj: If only a few min have elapsed since admin, 1 mg for every 100 U of heparin administered; if 30-60 min have elapsed since admin, 0.5-0.75 mg for every 100 U of heparin; and if ≥2 hr have elapsed since admin, 0.25-0.375 mg for every 100 U of heparin. Max: 50 mg/dose. For heparin administered via IV infusion: 25-50 mg via inj after stopping heparin infusion. For heparin administered via SC inj: 1-1.5 mg via IV inj for each 100 U of heparin administered. Alternatively, loading dose of 25-50 mg via slow IV inj and the rest of the dose via continuous IV infusion over 8-16 hr or the expected duration of absorption of heparin. Enoxaparin or dalteparin overdosage For enoxaparin: If ≤8 hr since LMWH dose, 1 mg for every 1 mg of enoxaparin administered; if >8 hr has elapsed since LMWH dose, infuse 0.5 mg per mg of enoxaparin Na administered. For dalteparin: 1 mg per 100 anti-Xa U of dalteparin administered. If aPTT remains prolonged 2-4 hr after the 1st infusion, a 2nd infusion may be given.
Dosage Details
Intravenous
Enoxaparin or dalteparin overdosage
Adult: Dose depends on the administered dose of the LMWH, time elapsed since drug was administered and blood coagulation tests. For enoxaparin: If ≤8 hr since admin, 1 mg for every 1 mg of enoxaparin administered; if >8 hr has elapsed since admin, infuse 0.5 mg for every 1 mg of enoxaparin administered. For dalteparin: 1 mg for every 100 anti-Xa U of dalteparin administered. If aPTT remains prolonged 2-4 hr after the 1st infusion, a 2nd infusion may be given.

Intravenous
Heparin overdosage
Adult: Dosage depends on administered heparin dose, its route of admin, time elapsed since heparin admin, and blood coagulation studies. For heparin administered via IV inj: If only a few min have elapsed since admin, 1 mg for every 100 U of heparin administered; if 30-60 min have elapsed since admin, 0.5-0.75 mg for every 100 U of heparin; and if ≥2 hr have elapsed since admin, 0.25-0.375 mg for every 100 U of heparin. Doses to be given via inj at ≤5 mg/min. Max: 50 mg/dose. For heparin administered via IV infusion: 25-50 mg via inj after stopping heparin infusion. For heparin administered via SC inj: 1-1.5 mg via IV inj for each 100 U of heparin administered. Alternatively, loading dose of 25-50 mg via slow IV inj and the rest of the dose via continuous IV infusion over 8-16 hr or the expected duration of absorption of heparin.
Incompatibility
Some anti-infective agents (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 where protamine is frequently used, diabetics using protamine insulin, allergy to fish, vasectomised or infertile males who may have antibodies to protamine). Pregnancy and lactation.
Adverse Reactions
Hypotension, bradycardia, dyspnoea, warm sensation, transient flushing, nausea, vomiting, back pain, lassitude.
Potentially fatal: Anaphylactoid reactions including circulatory collapse and MI, capillary leak, pulmonary and systemic HTN, angioedema, resp distress syndrome, anaphylaxis. Rarely, noncardiogenic pulmonary oedema w/ prolonged hypotension.
IV/Parenteral: C
MonitoringParameters
Monitor clotting parameters closely esp in prolonged procedures. Monitor aPTT or activated coagulation time, 5-15 min after protamine sulfate admin.
Overdosage
Symptoms: Hypotension, bradycardia, dyspnoea, nausea, vomiting, lassitude, transitory flushing and/or sensation of warmth. Management: Treatment is supportive and symptomatic w/ regular monitoring of coagulation tests and resp ventilation. If bleeding is severe, fresh frozen plasma or fresh whole blood may be used.
Action
Description: Protamine sulfate is prepared from the sperm or mature testes of salmon or related species and is composed of arginine, proline, serine and valine. It combines w/ strongly acidic heparin to form a stable complex, neutralising the anticoagulant activity of both drugs.
Onset: W/in 5 min (heparin neutralisation).
Pharmacokinetics:
Metabolism: Partially metabolised or may be attacked by fibrinolysin, freeing heparin.
Excretion: Elimination half-life: 7.4 min.
Storage
Store between 20-25°C. Do not freeze.
ATC Classification
V03AB14 - protamine ; Belongs to the class of antidotes. Used in the management of heparin overdose.
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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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