Aminocaproic acid (Solution) Instructions for Use

Instructions
Dosage forms

ATC Code

B02AA01 (Aminocaproic acid)

Active Substance

Aminocaproic acid (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Hemostatic agent. Fibrinolysis inhibitor – inhibitor of plasminogen to plasmin conversion

Pharmacotherapeutic Group

Hemostatic agents; antifibrinolytic agents; amino acids

Pharmacological Action

Hemostatic agent, fibrinolysis inhibitor. It blocks the action of plasminogen activators, inhibits the action of plasmin, and partially inhibits kinins.

It also has some anti-allergic activity and slightly increases the antitoxic function of the liver.

Pharmacokinetics

After oral administration, it is rapidly absorbed from the gastrointestinal tract, C_max in blood plasma is reached after 2 hours.

It is widely distributed in the body and is rapidly excreted in the urine, mainly unchanged.

The terminal T_1/2 is about 2 hours.

Indications

Stop bleeding during surgical interventions and various pathological conditions accompanied by increased fibrinolytic activity of blood and tissues (after operations on the lungs, prostate, pancreas, and thyroid gland).

Prevention of the development of secondary hyperfibrinogenemia during massive transfusions of preserved blood.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
R58	Hemorrhage, not elsewhere classified
T81.0	Haemorrhage and haematoma complicating a procedure, not elsewhere classified
Z51.3	Blood transfusion (without a specified diagnosis)

ICD-11 code	Indication
MG27	Hemorrhage, not elsewhere classified
NE81.0Z	Hemorrhage or hematoma of other or unspecified sites complicating a procedure, not elsewhere classified
QB98	Blood transfusion without a reported diagnosis

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

For adults, administer orally at 5-30 g/day in 3-6 divided doses. For intravenous use, administer an initial loading dose of 4-5 g in the first hour, followed by a maintenance infusion of 1 g/hour. Do not exceed the maximum daily dose of 30 g.

For pediatric patients, administer intravenously at an initial rate of 100 mg/kg in the first hour, followed by a continuous infusion of 33 mg/kg/hour. The pediatric maximum daily dose is 18 g/m².

Adverse Reactions

From the cardiovascular system, adverse reactions include arterial hypotension, bradycardia, and arrhythmias.

From the digestive system, nausea and diarrhea may occur. Other reported reactions include catarrhal phenomena of the upper respiratory tract and dizziness.

Contraindications

Tendency to thrombosis and embolism.

Impaired renal function.

Hypersensitivity to aminocaproic acid or any component of the formulation.

Use in Pregnancy and Lactation

Use in women to prevent increased blood loss during childbirth is not advisable, as thromboembolic complications may occur.

Use in Renal Impairment

Contraindicated: impaired renal function. Administration of aminocaproic acid is not recommended for hematuria (due to the risk of developing acute renal failure).

Pediatric Use

Children: IV – administered at a rate of 100 mg/kg in the first hour, then 33 mg/kg/hour. Maximum daily dose – 18 g/m².

Special Precautions

Should be used with caution in cases of cerebrovascular accident.

Administration of aminocaproic acid is not recommended for hematuria (due to the risk of developing acute renal failure).

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Aminocaproic acid solution for injections 5% [Repromed, LLC (Russia)]
Infusion solution 5 g/100 ml: bot. 1 or 56 pcs.

Marketing Authorization Holder

Repromed, LLC (Russia)

Dosage Form

Aminocaproic acid solution for injections 5%

Infusion solution 5 g/100 ml: bot. 1 or 56 pcs.

Dosage Form, Packaging, and Composition

Infusion solution 5%	1 ml	1 bottle
Aminocaproic acid	50 mg	5 g

100 ml – polyethylene bottles.

Aminocaproic acid-SOLOpharm [Grotex, LLC (Russia)]
Solution for infusion 50 mg/1 ml: 100 ml or 250 ml fl. or vial.

Marketing Authorization Holder

Grotex, LLC (Russia)

Dosage Form

Aminocaproic acid-SOLOpharm

Solution for infusion 50 mg/1 ml: 100 ml or 250 ml fl. or vial.

Dosage Form, Packaging, and Composition

Solution for infusion in the form of a transparent, colorless liquid.

	1 l
Aminocaproic acid	50 g

Excipients: sodium chloride – 9 g, water for injections – up to 1 l.

Theoretical osmolarity: 689 mOsm/l

100 ml – bottles (1) – cardboard boxes.
100 ml – vials (1) – cardboard boxes.
250 ml – bottles (1) – cardboard boxes.
250 ml – vials (1) – cardboard boxes.

Aminocaproic acid-Edvansd [Advanced Pharma, LLC (Russia)]
Solution for infusion 50 mg/ml: vial 1 or 35 pcs.