LYSINATE

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT LIZINAT (LISINAT)

Composition:

Active substance: escin salt of 2,6-diaminohexanoic acid;

1 ml of injection solution contains 1 mg of escin salt of 2,6-diaminohexanoic acid;

Excipients: ethanol 96%, propylene glycol, water for injections.

Pharmaceutical form. Injection solution.

Main physicochemical properties: clear, colorless or slightly yellow liquid.

Pharmacotherapeutic group. Vasoprotectives. Capillary stabilizing agents. Other capillary stabilizing agents. ATC code C05CX.

Pharmacological Properties

Pharmacodynamics. The medicinal product exerts anti-inflammatory, anti-edematous, and analgesic effects. Aescin reduces the activity of lysosomal hydrolases, thereby preventing the breakdown of mucopolysaccharides in the walls of capillaries and in the surrounding connective tissue, which in turn normalizes increased vascular-tissue permeability, demonstrating anti-exudative (anti-edematous), anti-inflammatory, and analgesic actions. The drug increases vascular tone and exhibits moderate immunomodulatory and hypoglycemic effects.

Pharmacokinetics. Not studied.

Clinical Characteristics

Indications

Use as part of complex therapy for cerebral edema of traumatic, non-traumatic, and postoperative origin, particularly with intracranial hemorrhages, increased intracranial pressure, and signs of edema-swelling.

Spinal cord edema of traumatic, non-traumatic, and postoperative origin.

Cerebrospinal fluid-venous circulation disorders in chronic cerebral circulation disorders (CCCD) and vegetative-vascular dystonia.

Edema of soft tissues involving the musculoskeletal system, accompanied by local disturbances in blood supply and pain syndrome; edema-pain syndromes of the spine and limbs; severe venous circulation disorders in lower limbs during acute thrombophlebitis accompanied by edema-inflammatory syndrome.

Contraindications

Hypersensitivity to escin salt of 2,6-diaminohexanoic acid and/or other components of the drug;

active ongoing bleeding associated with hemodynamic instability;

severe renal function impairment;

severe hepatic function impairment.

Interaction with other medicinal products and other forms of interaction

Lizynat can be co-administered with other medicinal products as indicated (anti-inflammatory agents, analgesics, antimicrobials).

The drug should not be used simultaneously with aminoglycosides, as this may increase their nephrotoxicity. In cases of prior prolonged anticoagulant therapy or when concomitant use of Lizynat and anticoagulants is necessary, dosage adjustment of the latter (dose reduction) and monitoring of prothrombin index are required.

Protein binding of escin in plasma is impaired when cephalosporin antibiotics are used concomitantly, which may increase free escin concentration in blood, increasing the risk of adverse effects.

Special precautions for use

In some patients with hepatoholangeitis, short-term increases in transaminase activity and bilirubin (direct fraction) may occur during treatment with this medicinal product. This does not pose a threat to patients and does not require discontinuation of the drug.

This medicinal product contains 20 vol.% of 96% ethanol (alcohol), i.e. 1000 mg of 96% ethanol in one 5 ml ampoule, or 960 mg of absolute ethanol in one 5 ml ampoule. It is harmful for patients suffering from alcoholism. Caution should be exercised when administering to children, patients with liver disorders, and patients with epilepsy.

Use during pregnancy or breastfeeding

The use of this medicinal product during pregnancy or breastfeeding is contraindicated. Breastfeeding should be discontinued during treatment.

Ability to influence reaction speed when driving or operating machinery
There are no reports to date; however, when using this medicinal product, the possibility of expected adverse reactions affecting the nervous system should be taken into account.

Administration and Dosage

The medicinal product should be administered intravenously or by intravenous infusion.

Intra-arterial administration of the drug is strictly contraindicated!

The medicinal product is recommended to be administered by slow intravenous infusion after dilution of the recommended single dose to a volume of 15–50 ml with 0.9% sodium chloride solution.

The optimal recommended duration of treatment course is 5–10 days of daily administration of the drug.

The maximum daily dose of the medicinal product Lysinat for adults is 25 ml (5 vials).

Recommended Daily Doses

For Adults

The recommended daily dose of the medicinal product Lysinat is 5–10 ml (1–2 vials).

In life-threatening conditions, the daily dose may be increased to 20 ml, divided into two administrations; the treatment course lasts up to 8 days.

In cases of liquor-venous disturbances in chronic pyelonephritis (CPN) and vegetative-vascular dystonia — 10 ml per day; the treatment course lasts 10 days.

For Children

Single dose:

for children aged 1–5 years — 0.22 mg of the medicinal product Lysinat per 1 kg of body weight;

for children aged 5–10 years — 0.18 mg/kg;

for children aged 10 years and older — 0.15 mg/kg.

The drug should be administered twice daily. The duration of treatment course is from 2 to 8 days depending on the patient's condition and therapeutic response.

Children. The medicinal product is contraindicated in children under 1 year of age.

Overdose

Symptoms: sensation of heat, tachycardia, menorrhagia, nausea, heartburn, epigastric pain.

Treatment: symptomatic therapy.

Side effects

In patients with individual hypersensitivity to escin, the following may occur:

Allergic reactions: skin rash (papular, petechial, erythematous), pruritus, skin hyperemia, hyperthermia, urticaria; in isolated cases—Quincke's edema, anaphylactic shock;

Central and peripheral nervous system: headache, dizziness, tremor, paresthesia; in isolated cases—unsteady gait, loss of balance, transient loss of consciousness;

Hepatic and biliary system: increased levels of transaminases and bilirubin;

Gastrointestinal tract: nausea; in isolated cases—vomiting, diarrhea, abdominal pain;

Cardiovascular system: arterial hypotension, arterial hypertension, tachycardia, chest pain;

Respiratory system: in isolated cases—sensation of air hunger, dyspnea, bronchial obstruction, dry cough;

Local reactions: burning along the vein during administration, phlebitis, pain and swelling at the injection site;

Other: general weakness, chills, feeling of warmth, back pain, sweating.

Reporting suspected adverse reactions

Reporting suspected adverse reactions after drug registration is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.

Shelf life. 18 months.

Storage conditions. Keep out of reach of children. No special storage conditions required.

Packaging. 5 mL in an ampoule, 5 ampoules in a blister pack, 2 blisters per carton.

Prescription status. Prescription only.

Manufacturer. JSC "Farmak".

Manufacturer's name and address of place of business.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.