Aminocaproic acid (Solution) Instructions for Use
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, Cmax 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 T1/2 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
| 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 DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
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.
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.
Solution for infusion 50 mg/ml: vial 1 or 35 pcs.
Marketing Authorization Holder
Advanced Pharma, LLC (Russia)
Manufactured By
Advanced Perm, LLC (Russia)
Dosage Form
|
Aminocaproic acid-Edvansd | Solution for infusion 50 mg/ml: vial 1 or 35 pcs. |
Dosage Form, Packaging, and Composition
Solution for infusion in the form of a transparent, colorless liquid.
| 100 ml | |
| Aminocaproic acid | 5 g |
Excipients: sodium chloride – 0.9 g, water for injections – up to 100 ml.
100 ml – bottles (1) – cardboard boxes.
100 ml – bottles (35) – cardboard boxes (for hospitals).
![Aminocaproic acid [Solution] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Aminocaproic acid [Solution] 2")