PROSULF Solution for injection Ref.[9525] Active ingredients: Protamine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, U.K

Pharmacodynamic properties

Although protamine is a potent antidote for heparin, its precise mechanism of action is unknown. However, when the strongly basic protamine combines with the strongly acid heparin, a stable salt is formed lacking in anticoagulant activity. 1mg of protamine sulfate neutralises between 80 and 120 units of heparin. However, methods of standardisation and the use of heparin from different sources (mucosal, lung) may produce different responses to protamine.

Pharmacokinetic properties

The onset of action of protamine occurs within five minutes following intravenous administration. The fate of the protamine-heparin complex is unknown, but it may be partially degraded, thus freeing heparin.

Preclinical safety data

No data are available.

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