Larginus

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT LARGINUS (LARGINUS)

Composition:

Active substance: arginine aspartate;

1 ml of solution contains arginine aspartate 200 mg;

Excipients: sorbitol (E 420), sodium saccharin (E 954), methylparahydroxybenzoate (E 218), propylparahydroxybenzoate (E 216), food flavoring "Caramel", purified water.

Pharmaceutical form. Oral solution.

Main physicochemical properties: yellowish liquid with a caramel odor.

Pharmacotherapeutic group. Other cardiac preparations. Amino acids.

ATC Code C01E.

Pharmacological Properties

Pharmacodynamics. Larginus exerts anti-hypoxic, cytoprotective, antioxidant, detoxifying, and membrane-stabilizing effects. It plays an important role in neutralizing ammonia and stimulating its elimination from the body, enhances the liver's detoxification function. Exerts hepatoprotective action and positively influences energy supply processes in hepatocytes.

As a donor of nitric oxide, Larginus participates in the body's energy supply processes, reduces activation and adhesion of leukocytes and platelets to vascular endothelium, thus preventing formation and progression of atherosclerotic plaques, and is involved in fibrinogenolysis and spermatogenesis.

The medicinal product exerts a moderate anabolic effect, stimulates thymus gland activity, promotes insulin synthesis, regulates blood glucose levels during physical exertion, and helps correct acid-base balance.

Pharmacokinetics. Not studied.

Clinical characteristics

Indications. Use in the complex therapy of atherosclerosis of heart and brain vessels, arterial hypertension, peripheral vascular atherosclerosis; chronic heart failure; hypercholesterolemia; chronic obstructive pulmonary diseases, pulmonary hypertension; asthenic conditions.

Contraindications. Hypersensitivity, severe renal function impairment. Myocardial infarction (including history of).

Interaction with other medicinal products and other forms of interactions. When using arginine aspartate, it should be taken into account that concomitant use of aminophylline with arginine may be accompanied by an increase in blood insulin levels, and concomitant use of spironolactone with arginine may lead to an increase in blood potassium levels.

Arginine is incompatible with thiopental.

Special precautions for use

The drug should be used with caution in patients with electrolyte imbalance or kidney diseases. During treatment, a balanced regimen of sleep and rest should be maintained, and consumption of alcohol, nicotine, and psychostimulants should be avoided. If symptoms of asthenia worsen during treatment, the drug should be discontinued.

Use with caution in patients with angina pectoris.

The drug should not be administered to patients with hereditary fructose intolerance.

"Larginus" contains sorbitol (E 420). Patients with known sugar intolerance should consult their physician before taking this medicinal product.

The medicinal product contains auxiliary substances methylparaben (E 218) and propylparaben (E 216), which may cause allergic reactions (possibly delayed).

This medicinal product contains less than 0.02 mmol (0.47 mg) of sodium per dose (5 ml), i.e. it is practically sodium-free.

Use during pregnancy or breastfeeding. The drug crosses the placental barrier; therefore, it should be used during pregnancy only when the expected benefit to the mother outweighs the potential risk to the fetus.

There is no available data regarding use of the drug during lactation.

Effect on ability to drive or operate machinery. No effect.

Method of Administration and Dosage

Oral administration. Take during meals.
For adults:

• In case of atherosclerosis of heart and brain vessels, peripheral vascular atherosclerosis — 5 ml (1 measuring spoon — 1 g of the drug) 3–8 times daily.
• In case of hypercholesterolemia, arterial hypertension — 5 ml 3–6 times daily.
• In case of chronic obstructive pulmonary diseases, pulmonary hypertension — 5 ml 3–6 times daily.
• In case of asthenic conditions — 5 ml 4–8 times daily.

Maximum daily dose — 8 g.
Duration of treatment course — 8–15 days; if necessary, the course may be repeated.

Children. Do not use in patients under 18 years of age.

Overdose

Symptoms: hypersensitivity reactions, hypoglycemic states.

Treatment. If the above symptoms occur, discontinue the drug. Gastric lavage and administration of sorbents are indicated. No antidote is available. Symptomatic therapy should be provided.

Adverse Reactions

Musculoskeletal system: joint pain.

Gastrointestinal tract: rarely – mild discomfort in the stomach and intestine, nausea immediately after administration of the medicinal product, which resolve spontaneously.

Immune system: hypersensitivity reactions, including bronchospasm.

Laboratory parameters: hyperkalemia.

Reporting of adverse reactions after medicinal product registration is of great importance. This enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmacy professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy of the medicinal product via the automated pharmacovigilance information system at: https://aisf.dec.gov.ua

Shelf life. 2 years.

Shelf life after opening the bottle – 14 days.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach and sight of children. Do not freeze.

Incompatibility. Arginine is incompatible with thiopental.

Packaging. 100 ml in a bottle or 200 ml in a flask; 1 bottle or 1 flask with a measuring spoon in a cardboard box.

Supply category. Over-the-counter.

Manufacturer. JSC "Tekhnolohiya".

Manufacturer's address and place of business. 8 Stara Prorizna Street, City of Uman, Cherkasy Region, 20300, Ukraine.