Protamin solution for injections 1000ME/ml. 5 ml. vial №5


Use to neutralize excessive undesirable anticoagulant action of heparin : in case of overdose , before and after operations on the background of heparin therapy, after operations on the heart and blood vessels using extracorporeal circulation during hemodialysis using heparin.



The drug Protamin is a colorless injection solution that is produced in the form of a clear liquid, without visible particles.
The active ingredient in the composition of the drug is protamine hydrochloride 10 mg (1000 IU), as auxiliary substances it contains: g-cresol, hydrochloric acid, sodium chloride, water for injection.

Release form
One carton contains 5 ampoules, each of them contains 5 ml.

Pharmacological properties
Protamin is a drug that has a specific antihemorrhagic effect in bleeding caused by an overdose of heparin.

The drug Protamin is used if there is a need to neutralize the effect of an excessive amount of exogenous heparin (heparin overdose, hemodialysis, as well as after operations with heparin and extracorporeal circulation).

The drug is contraindicated in people who have hypersensitivity (allergy) regarding the constituent components, as well as with thrombocytopenia, congenital and idiopathic hyperheparinemia, hypovolemia, severe arterial hypotension, adrenal cortex insufficiency and in childhood.

It is not used in pediatrics.

Application during pregnancy and lactation
Taking Protamin to women during pregnancy is possible only if the intended benefit to the mother significantly outweighs the risk to the fetus. The use of the drug is contraindicated for lactating women.

Method of administration and dosage
The drug Protamin is administered very slowly intravenously or intramuscularly. The dose of the solution depends on the level of heparin circulating in the blood. Since heparin has a short half-life, the dose of protamine that is required to neutralize it is reduced according to the time elapsed from the moment of administration.
If 15-30 minutes have passed since the injection of heparin, then the dose of protamine is 100-150 IU (1-1.5 mg);
If 30-60 minutes have passed since the injection of heparin, then the dose of protamine is 50-75 IU (0.5-0.75 mg);
If more than 2 hours have passed since the injection of heparin, then the dose of protamine is 25-37.5 IU (0.25-0.375 mg).
Usually, to stop bleeding (caused by heparin), the dose of the drug is half (50%) of the last dose of heparin (in IU) given. If heparin was injected intravenously, then the dose of Protamine Sulfate 2500-3000 IU must also be administered intravenously very slowly, over 2-5 minutes. If heparin was injected subcutaneously, a smaller part of protamine (2500-5000 IU) is injected intravenously very slowly, most of the drug (5000 IU) is injected intramuscularly for 8-16 hours.
When the level of heparin is not known, it is recommended to start the administration of 1 ml of solution (1000 U) intravenously slowly.
The use of the drug requires monitoring of blood clotting (thrombin time, partial thromboplastic time). If necessary, the introduction is repeated after 15 minutes. The maximum permissible dose is 150 mg per hour.
In cases of bleeding, the daily dose of the drug is 5 – 8 mg per kg of body weight, which is administered intravenously drip in 2 doses, the interval between injections is 6 hours. The duration of therapy should not exceed 3 days.

Overdose symptoms of Protamin are bleeding. In this situation, it is necessary to prescribe heparin until the blood coagulation readings return to normal.

Side effects
If Protamine is administered intravenously too quickly, side effects may occur: nausea, shortness of breath, pulmonary edema, noncardiogenic pulmonary edema, bronchospasm, hot flashes, vomiting, general heart failure with pulmonary hypertension or left ventricular heart failure, bradycardia, leukopenia, severe thrombocytopenia or hypotension. Very rarely, manifestations of allergic reactions, including shock states, can be observed, people who are allergic to fish are most susceptible to such reactions, suffer from vasectomy, and treatment with protamine to inactivate heparin or protamine-zinc insulin can also be a risk factor.

Storage conditions and periods
Store at temperatures between + 2 ° C and + 8 ° C (do not freeze), away from children.
The shelf life of the tablets is 5 years.