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protamine (Rx)Brand and Other Names:

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

IV solution

  • 10 mg/mL
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Heparin Neutralization

1-1.5 mg per 100 USP units of heparin; not to exceed 50 mg

Monitor APTT 5-15 min after dose then in 2-8 hr

In accidental overdoses of heparin, consider t1/2 heparin 60-90 min

In setting without bleeding complications, consider observation, rather than reversal of anticoagulation with protamine (avoids ADR's)

Complex of protamine and heparin may degrade over time requiring further doses

Dalteparin or Tinzaparin Overdose

1 mg protamine for 100 units dalteparin or tinzaparin; if PTT prolonged 4hr after protamine overdose administer 0.5 mg per 100 units of dalteparin or tinzaparin

Enoxaparin Overdose

1 mg per mg enoxaparin (if enoxaparin overdose given within 8 hr); if >8 hr of overdose or bleeding continues after 4 hr after first dose, give 0.5 mg protamine per mg enoxaparin

Time Elapsed Since Heparin Dose

Dose of protamine (mg) to neutralize 100 units of heparin

  • <1/2 hr: 1-1.5 mg/100 units of heparin
  • 30-120 min: 0.5-0.75 mg/100 units of heparin
  • >2 hr: 0.25-0.375 mg/100 units of heparin

Dosage Forms & Strengths

IV solution

  • 10 mg/mL
more...

Heparin Neutralization (Off-label)

~1 mg protamine neutralizes 100 units of heparin; not to exceed 50 mg/dose

Monagle P, et al. Chest 2008:133(6 Suppl):S887-S968

Time elapsed since heparin dose

  • Protamine dose to neutralize 100 units of heparin
  • <1/2 hr: 1 mg
  • 30-120 min: 0.5-0.75 mg
  • >2 hr: 0.25-0.375 mg
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Interactions

Interaction Checker

protamine and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Frequency Not Defined

            Anaphylaxis

            Hypotension

            N/V

            Decreased O2 consumption

            Flushing

            Pulmonary hypertension

            Uncontrollable bleeding

            Circulatory collapse

            Pulmonary edema

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            Warnings

            Black Box Warnings

            Protamine sulfate can cause severe hypotension, cardiovascular collapse, noncardiogenic pulmonary edema, catastrophic pulmonary vasoconstriction, and pulmonary hypertension

            Risk factors include high dose or overdose, rapid administration, repeated doses, previous administration of protamine, and current or previous use of protamine-containing drugs (NPH insulin, protamine zinc insulin, and certain beta-blockers).

            Allergy to fish, previous vasectomy, severe left ventricular dysfunction, and abnormal preoperative pulmonary hemodynamics also may be risk factors. In patients with any of these risk factors, the risk to benefit of administration of protamine sulfate should be carefully considered. Vasopressors and resuscitation equipment should be immediately available in case of a severe reaction to protamine.

            Protamine should not be given when bleeding occurs without prior heparin use

            Contraindications

            Hypersensitivity

            Cautions

            Heparin rebound causing bleeding may occur 8-9 hr after protamine administration

            May be ineffective in cardiac surgery patients despite adequate dose

            Rapid infusion reactions can cause severe hypotensive reactions

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: not known if excreted in breast milk

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Protamine that is strongly basic combines with acidic heparin forming a stable complex and neutralizes the anticoagulant activity of both drugs

            Pharmacokinetics

            Half-life elimination: 7 min

            Onset: 5 min

            Duration: 2 hr

            Vd: 5.4 L

            Metabolism: Unknown

            Clearance: 1.4 L/min

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            Administration

            IV Incompatibilities

            Additive: cephalosporins, penicillins

            Syringe: diatrizoate meglumine 52%, diatrizoate sodium, ioxaglate meglumine 39.3%, ioxaglate sodium 19.6%

            IV Preparation

            Reconstitute with 5 mL sterile water

            Resulting solution equals 10 mg/mL

            IV Administration

            Inject without further dilution over 1-3 min; maximum of 50 mg in any 10 min period

            For IV use only

            Administer slow IVP (50 mg over 10 min)

            Rapid IV infusion causes hypotension

            Storage

            Refrigerate

            Avoid freezing

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            Images

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            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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