Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Protamine

Generic name
Protamine
Brand name
ATC Code
V03AB14

Pharmacokinetics in children

No information

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

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Available formulations

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Dosages

Heparin or LMWH overdose
  • Intravenous
    • 1 month up to 18 years
      [1]

      • (Protamine sulphate or protamine hydrochloride): The maximum infusion rate is 5 mg/min, max 50 mg/dose

        HEPARIN: Assess based on the aPTT.  The dosage depends on the dose and time of the previous administration of heparin (see general comments): 
         

        Time since the previous administration of heparin (in min)  Dose of protamine (mg) to neutralize 100 units of heparin
         < 30  1
         30-60  0.5–0.75
         60-120  0.375-0.5
         > 120  0.25-0.375
        • The dosage of protamine is the same after both subcutaneous and intravenous heparin. Part can be given as a slow infusion and the rest then over 8-16 hours.
        • Repeated dosing might be needed as protamin disappears from the blood more rapidly than heparin. The prolonged absorption after s.c. administration of heparin also indicates a need for repeated dosing

        LMWH:

        • In general 1 mg of protamine sulphate neutralizes 100 antifactor Xa units of LMWH.
        • Within 4 hours after administration of LMWH, the aim is to neutralize complete dose.
        • 4-8 hours after LMWH administration: Neutralize 50% of the dose.
        • For information on the protamine dose for neutralising LMWH, see the warnings in the relevant LMWH monograph.
        • Repeated dosing might be needed as protamin disappears from the blood more rapidly than  LMWH. The prolonged absorption after s.c. administration of LMWH also indicates a need for repeated dosing

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Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects

No information is present at this moment.

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions

No information available on specific warnings and precautions in children.

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Antidotes
V03AB15
Iron chelating agents
V03AC03
V03AC02
V03AC01
Detoxifying agents for antineoplastic treatment
V03AF03
V03AF01
V03AF07
Drugs for treatment of hypoglycemia
V03AH01
DETOXIFYING AGENTS FOR ANTINEOPLASTIC TREATMENT
V03AF03
V03AF01
V03AF07

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References

  1. Monagle P, et al, Antithrombotic Therapy in Neonates and Children: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines, Chest., 2012, https://doi.org/10.1378/chest.11-2308
  2. Nederlandse Vereniging voor Kindergeneeskunde, sectie kinderhematologie, Richtlijn Diagnostiek en behandeling van veneuze trombo-embolische complicaties bij neonaten en kinderen tot 18 jaar, https://hematologienederland.nl/kwaliteit/werkboek-kinderhematologie/, 2020, Jan , Revisie 1

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Changes

Changes