Protamine sulfate

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Protamine sulfate
Clinical data
Trade namesProsulf, others
AHFS/Drugs.comMonograph
Routes of
administration
IV
Legal status
Legal status
ECHA InfoCard
100.113.361 Edit this at Wikidata

Protamine sulfate is a medication that is used to reverse the effects of

injection into a vein.[3] The onset of effects is typically within five minutes.[2]

Common side effects include

allergic reactions, and vomiting.[3] Allergic reactions may be severe and include anaphylaxis.[3] The risk is greater in males who have had a vasectomy.[5] While there is no evidence of harm from using during pregnancy it has not been well studied in this group.[6] Protamine works by binding with heparin.[3]

Protamine sulfate was approved for medical use in the United States in 1969.

Medical uses

Protamine sulfate is usually administered to reverse the large dose of heparin administered during certain surgeries, especially heart surgery where anti-coagulation is necessary to prevent clot formation within the cardiopulmonary bypass pump apparatus. A dose of protamine is given, by drip administered over several minutes, once the patient is off-pump, when extracorporeal circulation and anticoagulation are no longer needed.

It is also used in gene transfer, protein purification and in tissue cultures as a

crosslinker for viral transduction. In gene therapy, protamine sulfate has been studied as a means to increase transduction rates by both viral and nonviral-mediated delivery mechanisms (e.g. utilizing cationic liposomes).[9][10]

Protamine is used in

.

Dosage

Dosage for heparin reversal is 0.5mg to 1.0 mg  mg protamine sulfate IV for every 100 IU of active heparin. Partial thromboplastin time (PTT) should be monitored at 5 to 15 minutes after dose then in 2–8 hours afterward.

Adverse effects

allergic reactions in patients who are allergic to fish, diabetics using insulin preparations containing protamine, and vasectomized or infertile men.[11][12] These occur at rates ranging from 0.28% to 6%.[12][13][14]

Avoiding rapid

steroids may minimize these reactions. A 5 to 10 mg test dose is recommended following pretreatment before administering the full dose.[12]

Mechanism

It is a highly

low molecular weight heparin (LMWH) to form a stable ion pair, which does not have anticoagulant activity. The ionic complex is then removed and broken down by the reticuloendothelial system
. In large doses, protamine sulfate may also have an independent — however weak — anticoagulant effect.

History

Protamine sulfate replaced hexadimethrine bromide (Polybrene), another cationic agent that was the original heparin reversal agent in the early days of heart surgery, until studies in the 1960s suggested that hexadimethrine bromide might cause kidney failure when used in doses in excess of its therapeutic range.[15]

References

  1. FDA
    . Retrieved 22 Oct 2023.
  2. ^ a b "Prosulf 10mg/ml Solution for Injection - Summary of Product Characteristics (SPC) - (eMC)". www.medicines.org.uk. Archived from the original on 20 December 2016. Retrieved 14 December 2016.
  3. ^ a b c d e f g h "Protamine Sulfate". The American Society of Health-System Pharmacists. Archived from the original on 6 November 2016. Retrieved 8 December 2016.
  4. ^ "Protamine sulfate". www.drugbank.ca. Retrieved 14 February 2019.
  5. .
  6. ^ "Protamine Use During Pregnancy". Drugs.com. Archived from the original on 21 December 2016. Retrieved 14 December 2016.
  7. . WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
  8. .
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External links