Akk®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT AKK® (AKK)

Composition:

Active substance: aminocaproic acid;

1 ml of solution contains aminocaproic acid 50 mg;

Excipients: sodium chloride, water for injections.

Pharmaceutical form. Solution.

Main physicochemical properties: colorless transparent liquid.

Pharmacotherapeutic group. Antihemorrhagic agents. Fibrinolysis inhibitors. Amino acids. ATC code B02A A01.

Pharmacological properties.

Pharmacodynamics.

Aminocaproic acid exerts antiallergic and antiviral effects and enhances the liver's detoxifying function. It inhibits proteolytic activity associated with the influenza virus. Aminocaproic acid exerts an inhibitory effect on the early stages of virus interaction with susceptible cells and also suppresses the proteolytic activity of hemagglutinin. As a result, a functionally active protein of the influenza virus, which ensures its infectious activity, is not formed, and the amount of progeny infectious virus is reduced.

Two independent in vitro studies conducted on Caco-2 and Calu-3 cell cultures (first study) and A549 and VeroE6 cell cultures (second study) confirmed that aminocaproic acid exhibits antiviral activity against SARS-CoV-2 (coronavirus), the causative agent of coronavirus disease COVID-19. The range of effective concentrations (EC50) was 2.2–20.5 mg/mL in the first study and 1.44–24.5 mg/mL in the second study.

Aminocaproic acid not only demonstrates antiviral activity but also affects certain cellular and humoral parameters of specific and non-specific body defense during respiratory viral infections.

Pharmacokinetics.

When administered locally, pharmacokinetics has not been studied.

Clinical characteristics.

Indications.

Treatment and prevention of influenza and acute respiratory viral infections (ARVI) in children and adults.

Contraindications.

Hypersensitivity to the drug. Predisposition to thrombosis and thromboembolic disorders; coagulopathy due to disseminated intravascular coagulation; kidney diseases with impaired renal function; thromboembolism, renal failure, hematuria, childbirth; pregnancy or breastfeeding; severe form of ischemic heart disease, cerebral circulation disorders.

Interaction with other medicinal products and other types of interactions.

The effect of the drug is reduced by anticoagulants and direct and indirect-acting antiplatelet agents.

Concomitant use with estrogen-containing contraceptives and coagulation factor IX increases the risk of thromboembolism.

Use with caution in patients taking retinoids (including tretinoin).

Special precautions for use.

Use with caution in patients with heart diseases. If it is necessary to administer the drug to patients with cardiac diseases, monitoring of creatine phosphokinase levels in blood plasma is recommended.

Administration of the drug is contraindicated in cases of hematuria due to the risk of developing acute renal failure (see section "Contraindications"). A fatty diet should be avoided during treatment with this drug.

Any unused portions of the drug should be disposed of properly.

This medicinal product contains 3.85 mmol (or 88.5 mg)/25 ml dose of sodium. Caution is advised when administering to patients on a sodium-restricted diet.

Use during pregnancy or breastfeeding.

The drug is contraindicated during pregnancy and breastfeeding.

If it is necessary to use the drug, breastfeeding should be discontinued.

Ability to affect reaction speed when driving or operating machinery.

During treatment, patients should refrain from driving and performing potentially hazardous activities due to possible adverse reactions affecting the central nervous system.

Method of Administration and Dosage.

For the prevention and treatment of influenza and acute respiratory viral infections, the drug is administered locally (0.5–1.0 mL into the nose 3–4 times daily) and orally.

For local administration, it is recommended to insert cotton swabs moistened with 5% aminocaproic acid solution into the nasal passages every 3–4 hours for 5–10 minutes, or to instill (administer by drops) 3–5 drops of the solution into each nostril at the same intervals.

Aminocaproic acid, if necessary, may be used in combination with other antiviral drugs, interferon, and its inducers.

Intranasal instillations of aminocaproic acid (3–4 times daily) are advisable during the influenza epidemic period for prophylaxis; in case of contact with an infected person, this should be supplemented with enteral (as in treatment) administration of the drug within infection foci.

For oral administration, aminocaproic acid in 100 mL bottles is recommended.

Oral dosage for children:

• Children under 2 years of age – 1–2 g (20–40 mL of 5% solution per day), divided into 4 doses of 1–2 teaspoons daily (0.02–0.04 g/kg as a single dose); may be added to food or drinks;
• Children aged 2 to 6 years – 2–4 g (40–80 mL of 5% solution per day), administered as 2–4 teaspoons or 1 tablespoon 4 times daily, or dividing the daily dose into 4 doses;
• Children aged 7 years and older, and adults – 4–5 g (80–100 mL of 5% solution per day), divided into 4 doses. Take 20 or 25 mL per dose, i.e., 4 or 5 containers.

For more accurate dosing of the solution, it is advisable to use a 10 or 20 mL syringe without a needle.

The duration of oral administration of aminocaproic acid in influenza and acute respiratory viral infections is 3–7 days.

The treatment duration depends on the severity of the disease and is determined individually by the physician. The physician may also adjust the dosage and prescribe a repeated course of treatment.

Children.

There are no data indicating restrictions on the use of the drug in children.

Overdose.

Sudden reduction in fibrinolytic activity of blood. Pronounced side effects: dizziness, nausea, diarrhea, skin rash, orthostatic hypotension, seizures, headache, nasal congestion, acute renal failure, rhabdomyolysis, myoglobinuria. Increased adverse reactions and formation of thromboembolic clots. Hemorrhages may occur with prolonged use (more than 6 days) of high doses (over 24 g per day in adults).

Treatment. In case of overdose, discontinue administration of the drug and provide appropriate symptomatic therapy.

Adverse reactions.

Cardiovascular system: orthostatic hypotension, bradycardia, arrhythmias.

Gastrointestinal system: nausea, vomiting, diarrhea.

Hematological system: impaired blood coagulation; with prolonged use (more than 6 days) of high doses (in adults – more than 24 g per day) – hemorrhages.

Central nervous system: headache, dizziness, tinnitus, seizures.

Immune system: hypersensitivity reactions, including allergic reactions, skin rash, nasal congestion, catarrhal symptoms of the upper respiratory tract.

Urinary system: myoglobinuria, acute renal failure.

Other: rhabdomyolysis.

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C in the original packaging. Keep out of reach of children.

Packaging.

2 ml in single-dose polymer containers.

10 containers in a cardboard box.

Prescription status. Over-the-counter.

Manufacturer.

LLC "Yuria-Pharm".

Manufacturer's address and place of business.

108, Kozbarna St., Cherkasy, Cherkasy region, 18030, Ukraine.

Tel.: (044) 281-01-01.