Protamine

Generic name
Protamine
Brand name
ATC Code
V03AB14
Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No information

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

No information is present at this moment.

Available formulations

No information is present at this moment.

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

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.

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.

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.

Interactions

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

ALL OTHER THERAPEUTIC PRODUCTS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

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

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

Changes

Therapeutic Drug Monitoring


Overdose