Protamine sulfate suspension 10 mg/ml, ampoules 5 ml 5 pcs.

Composition

Solution for injection 1 ml protamine sulfate 10 mg

Pharmacological action

Protamine sulfate is a specific heparin antagonist.1 mg of protamine sulfate neutralizes 80-120 units of heparin in the blood.

Complexation is caused by an abundance of cationic groups (due to arginine) that bind to the anionic centers of heparin.

The effect of the drug after intravenous administration occurs instantly and lasts for 2 hours. After intravenous administration, a protamine-heparin complex is formed, which can be destroyed with the release of heparin.

In case of overdose, it can reduce blood clotting, since protamine sulfate itself shows anticoagulant activity.

Indications

• Bleeding due to an overdose of heparin;
• before surgery in patients who take heparin for therapeutic purposes;
• after operations on the heart and blood vessels with extracorporeal circulation;
• hyperheparinemia.

Contraindications

• Hypersensitivity to the components of the drug;
• idiopathic or congenital hyperheparinemia (in such cases, the drug is not effective and may increase bleeding);
• severe hypotension;
• thrombocytopenia;
• adrenal insufficiency;
• taking patients with insulins containing protamine sulfate, as well as other medications containing protamine sulfate;
• allergic reactions to fish in the anamnesis.

Side effects

From the cardiovascular system: reduced blood pressure, bradycardia.

From the digestive system: nausea, vomiting.

From the immune system: skin rash, pruritus, development of anaphylactoid reactions.

Other services: sensation of heat, hyperemia of the skin, feeling of lack of air (with excessively rapid administration).

Interaction

Incompatible with cephalosporin solutions and penicillin (do not administer simultaneously). There is no data on interaction with other BOS.

How to take, course of administration and dosage

Protamine sulfate solution is administered slowly intravenously by jet or drip.

The rate of administration should not exceed 5 mg per minute (for example,50 mg of the drug should be administered within 10 minutes), since faster administration can cause an anaphylactoid reaction.

The dose of the drug depends on the method of administration of heparin. The calculated dose is dissolved in 300-500 ml of 0.9% sodium chloride solution. Do not administer more than 150 mg of protamine sulfate for 1 hour.

Overdose

It can be accompanied by bleeding, because protamine has its own anticoagulant activity.

Treatment is symptomatic.

Interaction with other medicinal products

Incompatible with cephalosporins and penicillins.

It is an antagonist of low molecular weight heparins. It can increase the intensity and duration of action of non-depolarizing muscle relaxants.

Special instructions

Introduction is carried out under the control of blood clotting. Before administration, make sure that the patient’s blood volume is adequate (hypovolemia increases the risk of collapse).

Form of production

Colorless transparent solution.

Active ingredient

Protamine Sulfate

Conditions of release from pharmacies

By prescription

Dosage form

suspension for injection

Description

For adults as directed by your doctor

Indications

Bleed

Weight

Weight: 57 gr.