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 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, C_max is 2 hours, T_1/2 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

Open the list of 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 Disclaimer

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

Aminocaproic acid [Avexima Siberia LLC (Russia)]
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.

Aminocaproic acid [Biosintez, PJSC (Russia)]
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.

Aminocaproic acid [Dalkhimpharm, JSC (Russia)]
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.

Aminocaproic acid [Medsintez Plant, LLC (Russia)]
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.

Aminocaproic acid [IST-Pharm, LLC (Russia)]
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.

Aminocaproic acid [Kraspharma, PJSC (Russia)]
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.

Aminocaproic acid [Mosfarm LLC (Russia)]
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.

Aminocaproic acid [N.A. Semashko Moscow Chemical Pharmaceutical Preparations, JSC (Russia)]
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.

Aminocaproic acid [Promomed Rus LLC (Russia)]
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.

Aminocaproic acid [PFC Alium, LLC (Russia)]
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).