Protamine sulfate: description and instructions

What is a drug substance like protamine sulfate? Instructions for its use, as well as the form and indications of this tool will be indicated below.

Composition, description, form

What is Protamin Sulfate? It is a solution, issued as a yellowish or colorless transparent liquid, intended for intravenous administration. The drug on the basis of this drug substance is of the same name and additionally contains water for injection.

The sale of "Protamine sulphate" comes in ampoules, which are placed in contour cells made of PVC film, which are packaged in cardboard packs. Also, the package contains instructions for use and an ampoule knife.

Action of the medicinal product

What is protamine sulfate? The instruction reports that this is a heparin antagonist (specific). 1 mg of this substance is capable of neutralizing about 80-115 units of heparin in the patient's blood.

The effect of the agent under consideration after intravenous injection occurs instantaneously and lasts about two hours. Complexation of this drug is due to the abundance of cationic groups that bind to the anionic centers of heparin.

According to the instructions of protamine, sulfate in the human body forms a protamine-heparin complex, which breaks down with the release of the latter.

In case of an overdose with this remedy, blood coagulability can be significantly reduced in the patient, since the active substance of the drug in question shows a high anticoagulant activity.

Pharmacokinetics of the agent

What are the kinetic properties of protamine sulfate heparin? According to experts, the pharmacokinetic characteristics of this drug have not been studied. Therefore, they are not represented in the instruction.

Indication for the purpose of the solution

In what cases can an intravenous solution of "Protamine sulfate" be prescribed to a patient? Application of this tool is shown:

• Before the operation of people taking heparin with a therapeutic purpose;
• With hypergeparinemia;
• With bleeding caused by an overdose of heparin;
• After the operation on the blood vessels and the heart with an extracorporeal circulation.

Prohibitions to the appointment of a solution

The drug "Protamine sulfate" (prescription for its purchase should be prescribed only by a doctor) is contraindicated for use in the following cases:

• With thrombocytopenia;
• High sensitivity to the elements of the drug;
• Severe arterial hypotension;
• Congenital or idiopathic hypergeparinemia (in this condition, the medication is ineffective, and can also significantly increase bleeding);
• Taking insulin and other medicines containing protamine sulfate;
• Allergic reactions to fish products, including in the anamnesis;
• Insufficiency of the adrenal cortex.

One can not help saying that the experience of medical use of this drug in children is limited.

During pregnancy and feeding, "Protamine sulphate" can be used. However, this should be done only if the expected effect of treatment significantly exceeds the likely risk to the fetus or child.

The drug "Protamine sulfate": instructions for use

The solution in question should be administered slowly intravenously by drip or jetting. The rate of administration should not be higher than 5 mg per minute. A faster administration of the drug may cause the patient to have an anaphylactoid reaction.

The dosage of this medication depends on the method of administration. The calculated dose should be dissolved in 300-500 ml of a 0.9% solution of sodium chloride. It is strictly forbidden to administer more than 150 mg of the drug within 60 minutes.

• With bolus injections, the dosage of protamine sulfate decreases, depending on the time that elapsed from the administration of heparin. This is due to the fact that the latter is continuously removed from the human body.
• If heparin is injected intravenously, it is necessary to stop its infusion and use about 20-30 mg of protamine sulfate.
• When injecting heparin subcutaneously, the dosage of protamine sulfate is 1-1.5 mg per 100 IU of heparin. The first 25-50 mg should be injected slowly intravenously, and the remaining amount - drip intravenously for 8-17 hours. A fractional administration is also possible, but this will require strict control of the APTTV.
• In case of an operation with extracorporeal circulation, the dosage of the solution in question is 1.5 mg per 100 IU of heparin.

The maximum duration of therapy is 3 days.

Side effect

Can protamine sulfate cause side effects? The instruction states that in general this preparation is relatively well tolerated by patients. However, in some cases it can still cause negative effects on the part of the immune, cardiovascular and digestive systems, as well as skin:

• Bradycardia, lowering blood pressure;
• Vomiting and nausea;
• Itching, skin rash, the development of anaphylactoid reactions;
• A feeling of heat, a feeling of lack of air and hyperemia of the skin.

Cases of overdose and interaction with other drugs

This solution, intended for intravenous administration, is incompatible with penicillins and cephalosporins. In view of the fact that it is an antagonist of low molecular weight heparins, this medication can prolong the duration and intensity of the action of nondepolarizing muscle relaxants.

An overdose of the drug may be accompanied by bleeding. This is due to the fact that the substance in question has a high anticoagulant activity. In this case, symptomatic treatment is required.

Special Information

What should you know before you enter a solution such as protamine sulfate? Experts argue that the use of this drug should be strictly controlled by a doctor who is obliged to regularly monitor the coagulability of the patient's blood.

Before the introduction of this medication it is necessary to make sure of adequate blood volume of the patient. This is due to the fact that hypovolemia significantly increases the risk of collapse.

Storage conditions, leave from pharmacies, expiration date

Is the preparation "Protamine sulfate" available for sale in pharmacies? The prescription in Latin or Russian should be presented to the pharmacist, otherwise the medication will not be released.

Store the substance in question in a place inaccessible to children and protected from sunlight, where the temperature of the air is from 4 to 10 degrees. It should also be noted that the intravenous solution of "Protamine sulphate" should not be frozen in any case.

Shelf life of this medication is 4 years from the date of manufacture. Do not use it after this period.

Analogs of the drug and reviews about it

There are not many analogues for the drug in question. Intravenous solution can be replaced with such drugs as "Protamine" and "Protamine-Feren".

As for consumer feedback, almost all of them are positive. "Protamine sulfate" is a very effective and effective remedy available to everyone. This is the opinion most patients adhere to. They argue that this medication does not allow heparin to inhibit the process of blood coagulability, improving the patient's condition with severe bleeding.

Also to the merits of this drug is its fast and long-lasting effect. In addition, to achieve therapeutic effect, the patient does not need to undergo long-term treatment. The maximum period of use of this drug is three days.