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 agent, fibrinolysis inhibitor
Pharmacological Action
Hemostatic agent, inhibits the conversion of plasminogen to plasmin, apparently by inhibiting the activator of this process, and also has a direct inhibitory effect on plasmin; inhibits the activating effect of streptokinase, urokinase and tissue kinases on fibrinolysis, neutralizes the effects of kallikrein, trypsin and hyaluronidase, reduces capillary permeability.
It has antiallergic activity and improves the antitoxic function of the liver.
Pharmacokinetics
With intravenous administration, the effect appears after 15-20 minutes. Absorption is high, Cmax is 2 hours, T1/2 is 4 hours.
It is excreted by the kidneys – 40-60% unchanged. In case of impaired renal excretory function, the excretion of aminocaproic acid is delayed, as a result of which its concentration in the blood increases sharply.
Indications
Bleeding (hyperfibrinolysis, hypo- and afibrinogenemia), bleeding during surgical interventions and pathological conditions accompanied by increased fibrinolytic activity of the blood (during neurosurgical, intracavitary, thoracic, gynecological and urological operations, including on the prostate gland, lungs, pancreas; tonsillectomy, after dental interventions, during operations using a heart-lung machine).
Diseases of internal organs with hemorrhagic syndrome; premature placental abruption, complicated abortion.
Prevention of secondary hypofibrinogenemia during massive transfusions of preserved blood.
ICD codes
| ICD-10 code | Indication |
| O08 | Complications following abortion and ectopic and molar pregnancy |
| O45 | Premature separation of placenta [abruptio placentae] |
| R58 | Hemorrhage, not elsewhere classified |
| ICD-11 code | Indication |
| JA05.Z | Complications of abortion, ectopic or molar pregnancy, unspecified |
| JA8C.Z | Medical care for mother due to premature placental abruption, unspecified |
| MG27 | Hemorrhage, not elsewhere classified |
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. |
Solution
Intravenous, drip. To achieve a rapid effect (acute hypofibrinogenemia), up to 100 ml of a 50 mg/ml solution is administered at a rate of 50-60 drops per minute for 15-30 minutes.
During the first hour, a dose of 4-5 g (80-100 ml) is administered, and then, if necessary, 1 g (20 ml) every hour for about 8 hours or until the bleeding stops completely.
In case of ongoing or recurrent bleeding, infusions of a 50 mg/ml solution of aminocaproic acid are repeated every 4 hours.
For children, based on 100 mg/kg in the 1st hour, then 33 mg/kg/hour; maximum daily dose is 18 g/sq.m.
The daily dose for adults is 5-30 g. The daily dose for children under 1 year is 3 g; 2-6 years – 3-6 g; 7-10 years – 6-9 g, from 10 years – as for adults.
For acute blood loss: children under 1 year – 6 g, 2-4 years – 6-9 g, 5-8 years – 9-12 g, 9-10 years – 18 g. The duration of treatment is 3-14 days.
Adverse Reactions
Dizziness, tinnitus, headache, nausea, diarrhea, nasal congestion, skin rash, decreased blood pressure, orthostatic hypotension, convulsions, rhabdomyolysis, myoglobinuria, acute renal failure, subendocardial hemorrhage.
Contraindications
Hypersensitivity to the drug, hypercoagulation (thrombosis, thromboembolism), coagulopathy due to diffusion, disseminated intravascular coagulation (DIC syndrome), tendency to thrombosis and thromboembolic diseases, kidney diseases with impaired excretory function, hematuria, cerebrovascular accidents, pregnancy, lactation period.
With caution: arterial hypotension, valvular heart disease, hematuria, bleeding from the upper urinary tract of unknown etiology, hepatic insufficiency, chronic renal failure, children under 1 year of age.
Use in Pregnancy and Lactation
Contraindicated during pregnancy and lactation.
Use in Hepatic Impairment
With caution in hepatic insufficiency. In liver diseases, with intravenous administration, control of the coagulogram is necessary.
Use in Renal Impairment
With caution in chronic renal failure.
Pediatric Use
With caution in children under 1 year of age.
Special Precautions
When prescribing the drug, it is necessary to monitor the fibrinolytic activity of the blood and the fibrinogen content. With intravenous administration, control of the coagulogram is necessary, especially in coronary heart disease, after myocardial infarction, and in liver diseases.
Overdose
Increased side effects (dizziness, nausea, diarrhea, catarrh of the upper respiratory tract) and a sharp inhibition of fibrinolysis.
In case of overdose, activators of plasminogen (streptokinase, urokinase or anistreplase) should be urgently administered.
Drug Interactions
It can be combined with the administration of hydrolysates, glucose solutions (dextrose solutions), and anti-shock solutions.
In acute fibrinolysis, the administration of aminocaproic acid with a fibrinogen content of 2-4 g (maximum – 8 g) must be supplemented with a subsequent infusion.
Antiaggregant effect is reduced with simultaneous use of direct and indirect anticoagulants.
No other medicinal products should be added to the aminocaproic acid solution.
Storage Conditions
In a dry place, protected from light, out of reach of children, at a temperature from 2 to 25°C (77°F).
Shelf Life
Shelf life . 3 years. Do not use after the expiration date printed on the package.
Dispensing Status
The drug is dispensed by prescription.
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 50 mg/ml: 100 ml, 200 ml, 250 ml, 400 ml, 500 ml, or 1000 ml containers 1 pc.
Marketing Authorization Holder
Avexima Siberia LLC (Russia)
Dosage Form
 |
Aminocaproic acid | Infusion solution 50 mg/ml: 100 ml, 200 ml, 250 ml, 400 ml, 500 ml, or 1000 ml containers 1 pc. |
Dosage Form, Packaging, and Composition
Solution for infusion in the form of a colorless, transparent liquid.
| 1 ml | |
| Aminocaproic acid | 50 mg |
Excipients : sodium chloride – 9 mg, water for injection – up to 1 l.
Theoretical osmolarity – 689 mOsm/l.
100 ml – containers (1) – bags.
200 ml – containers (1) – bags.
250 ml – containers (1) – bags.
400 ml – containers (1) – bags.
500 ml – containers (1) – bags.
1000 ml – containers (1) – bags.
Infusion solution 50 mg/ml: 100 ml or 200 ml bottles 1 pc.
Marketing Authorization Holder
Biosintez, PJSC (Russia)
Dosage Form
|
Aminocaproic acid | Infusion solution 50 mg/ml: 100 ml or 200 ml bottles 1 pc. |
Dosage Form, Packaging, and Composition
Solution for infusion in the form of a colorless, transparent liquid.
| 1 ml | |
| Aminocaproic acid | 50 mg |
Excipients : sodium chloride – 9 mg, water for injection – up to 1 ml.
Theoretical osmolarity – 689 mOsm/l.
100 ml – glass bottles (1) – cardboard packs.
200 ml – glass bottles (1) – cardboard packs.
Infusion solution 50 mg/ml: 100 ml or 200 ml bottles
Marketing Authorization Holder
Dalkhimpharm, JSC (Russia)
Dosage Form
|
Aminocaproic acid | Infusion solution 50 mg/ml: 100 ml or 200 ml bottles |
Dosage Form, Packaging, and Composition
Solution for infusion transparent, colorless.
| 1 ml | |
| Aminocaproic acid | 50 mg |
Excipients : sodium chloride – 9 mg, water for injection – up to 1 ml.
Theoretical osmolarity 689 mOsm/l.
100 ml – bottles (1) – cardboard packs.
200 ml – bottles (1) – cardboard packs.
Infusion solution 50 mg/1 ml: containers 100 ml, 250 ml, 500 ml, or 1000 ml
Marketing Authorization Holder
Medsintez Plant, LLC (Russia)
Dosage Form
|
Aminocaproic acid | Infusion solution 50 mg/1 ml: containers 100 ml, 250 ml, 500 ml, or 1000 ml |
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 injection – up to 1 l.
Theoretical osmolarity: 689 mOsmol/l.
100 ml – polymer containers (1) with 2 sterile ports – bags (1) (double sterile vacuum packaging) – cardboard packs.
250 ml – polymer containers (1) with 2 sterile ports – bags (1) (double sterile vacuum packaging) – cardboard packs.
500 ml – polymer containers (1) with 2 sterile ports – bags (1) (double sterile vacuum packaging) – cardboard packs.
1000 ml – polymer containers (1) with 2 sterile ports – bags (1) (double sterile vacuum packaging) – cardboard packs.
Infusion solution 5 g/100 ml: bottles 1, 10, 15, 24, 30, or 36 pcs.
Marketing Authorization Holder
IST-Pharm, LLC (Russia)
Dosage Form
|
Aminocaproic acid | Infusion solution 5 g/100 ml: bottles 1, 10, 15, 24, 30, or 36 pcs. |
Dosage Form, Packaging, and Composition
| Solution for infusion 5% | 1 ml | 1 bottle |
| Aminocaproic acid | 50 mg | 5 g |
100 ml – bottles (1) – cardboard packs.
100 ml – bottles (10) – boxes.
100 ml – bottles (15) – boxes.
100 ml – bottles (24) – boxes.
100 ml – bottles (30) – boxes.
100 ml – bottles (36) – boxes.
Infusion solution 5% (5 g/100 ml): bottles 1 or 48 pcs.
Marketing Authorization Holder
Kraspharma, PJSC (Russia)
Dosage Form
|
Aminocaproic acid | Infusion solution 5% (5 g/100 ml): bottles 1 or 48 pcs. |
Dosage Form, Packaging, and Composition
| Solution for infusion 5% | 1 ml | 1 bottle |
| Aminocaproic acid | 50 mg | 5 g |
100 ml – bottles (for hospitals).
100 ml – bottles (1) – cardboard packs.
100 ml – bottles (48) – cardboard boxes.
Solution for infusion 5 g/100 ml: bot. 1 or 36 pcs.
Marketing Authorization Holder
Mosfarm LLC (Russia)
Dosage Form
|
Aminocaproic acid | Solution for infusion 5 g/100 ml: bot. 1 or 36 pcs. |
Dosage Form, Packaging, and Composition
| Solution for infusion | 1 ml | 1 bottle |
| Aminocaproic acid | 50 mg | 5 g |
100 ml – bottles for blood and blood substitutes (1) – cardboard packs.
100 ml – bottles for blood and blood substitutes (36) – cardboard boxes.
Infusion solution 5 g/100 ml: fl.
Marketing Authorization Holder
N.A. Semashko Moscow Chemical Pharmaceutical Preparations, JSC (Russia)
Dosage Form
|
Aminocaproic acid | Infusion solution 5 g/100 ml: fl. |
Dosage Form, Packaging, and Composition
| Solution for infusion 5% | 1 ml | 1 fl. |
| Aminocaproic acid | 50 mg | 5 g |
100 ml – vials (1) – polyethylene bags.
Infusion solution 50 mg/ml: 100 ml bottles 1 or 56 pcs, pack 56 pcs. 200 ml bottles 1, 24, or 28 pcs., pack 24 or 28 pcs.
Marketing Authorization Holder
Promomed Rus LLC (Russia)
Manufactured By
Biokhimik, JSC (Russia)
Dosage Form
|
Aminocaproic acid | Infusion solution 50 mg/ml: 100 ml bottles 1 or 56 pcs, pack 56 pcs. 200 ml bottles 1, 24, or 28 pcs., pack 24 or 28 pcs. |
Dosage Form, Packaging, and Composition
| Solution for infusion 5% | 1 ml | 1 bottle |
| Aminocaproic acid | 50 mg | 10 g |
200 ml – bottles.
200 ml – bottles (1) – cardboard packs.
200 ml – bottles (28) – cardboard boxes.
Infusion solution 50 mg/1 ml: bottles 100 ml 1, 15, 24, 28, or 36 pcs, bottles 200 ml 1, 15, 24, 28, or 36 pcs.
Marketing Authorization Holder
PFC Alium, LLC (Russia)
Dosage Form
|
Aminocaproic acid | Infusion solution 50 mg/1 ml: bottles 100 ml 1, 15, 24, 28, or 36 pcs, bottles 200 ml 1, 15, 24, 28, or 36 pcs. |
Dosage Form, Packaging, and Composition
Solution for infusion transparent, colorless.
| 1 ml | 1 l | |
| Aminocaproic acid | 50 mg | 50 g |
Excipients : sodium chloride – 9 g, water for injection – up to 1 l.
Theoretical osmolarity – 690 mOsmol/l.
100 ml – plastic bottles (1) – cardboard packs.
250 ml – plastic bottles (1) – cardboard packs.
100 ml – plastic bottles (15) – cardboard boxes (for hospitals).
100 ml – plastic bottles (24) – cardboard boxes (for hospitals).
100 ml – plastic bottles (28) – cardboard boxes (for hospitals).
100 ml – plastic bottles (36) – cardboard boxes (for hospitals).
250 ml – plastic bottles (15) – cardboard boxes (for hospitals).
250 ml – plastic bottles (24) – cardboard boxes (for hospitals).
250 ml – plastic bottles (28) – cardboard boxes (for hospitals).
250 ml – plastic bottles (36) – cardboard boxes (for hospitals).
Infusion solution 5 g/100 ml: containers 100 ml, 250 ml, or 500 ml
Marketing Authorization Holder
Medpolymer Firm, JSC (Russia)
Dosage Form
|
Aminocaproic acid | Infusion solution 5 g/100 ml: containers 100 ml, 250 ml, or 500 ml |
Dosage Form, Packaging, and Composition
| Solution for infusion 5% | 1 ml |
| Aminocaproic acid | 50 mg |
100 ml – polymer containers (1) (for infusion solutions) – laminated aluminum foil bags (for hospitals).
250 ml – polymer containers (1) (for infusion solutions) – laminated aluminum foil bags (for hospitals).
500 ml – polymer containers (1) (for infusion solutions) – laminated aluminum foil bags (for hospitals).
Solution for infusion 5% (5 g/100 ml): bot. 1 pc.
Marketing Authorization Holder
Mir Chemical and Pharmaceutical Concern, LLC (Russia)
Dosage Form
|
Aminocaproic acid | Solution for infusion 5% (5 g/100 ml): bot. 1 pc. |
Dosage Form, Packaging, and Composition
| Solution for infusion 5% | 1 ml | 1 bot. |
| Aminocaproic acid | 50 mg | 5 g |
100 ml – bottles for blood and blood substitutes.
100 ml – bottles for blood and blood substitutes (1) – cardboard packs.
100 ml – bottles for blood and blood substitutes (28) – cardboard boxes.
![Aminocaproic acid [Solution] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Aminocaproic acid [Solution] 2")