Sargin

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT SARGIN® (sarGIN)

Composition:

Active substance: L-arginine aspartate;

1 ml of solution contains Arginine aspartate (L-arginine aspartate) – 200 mg;

Excipients: propyl parahydroxybenzoate (E 216), methyl parahydroxybenzoate (E 218), sorbitol (E 420), sodium saccharin (E 954), grape flavoring, purified water.

Pharmaceutical form. Oral solution.

Main physico-chemical properties: liquid, yellowish to yellow-brown in color, with a grape odor.

Pharmacotherapeutic group. Other cardiac preparations. Amino acids.

ATC code C01E.

Pharmacological Properties

Pharmacodynamics

Sargin® exerts anti-hypoxic, cytoprotective, antioxidant, detoxifying, and membrane-stabilizing effects. It plays an important role in ammonia neutralization and enhances its excretion from the body, thereby strengthening the liver's detoxification function. It exerts hepatoprotective action and positively influences energy supply processes in hepatocytes.

As a donor of nitric oxide, Sargin® participates in the body's energy supply processes, reduces activation and adhesion of leukocytes and platelets to the vascular endothelium, thus preventing the 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 contributes to correction of acid-base balance.

Pharmacokinetics

Not studied.

Clinical characteristics.

Indications.

To be used 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 in medical history).

Interaction with other medicinal products and other types 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 insulin blood levels, and concomitant use of spironolactone with arginine – by 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.

The drug should be used with caution in patients with angina pectoris.

The drug should not be taken by patients with hereditary fructose intolerance.

The medicinal product contains sorbitol (E 420). If you have been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicinal product.

The drug contains auxiliary substances methylparahydroxybenzoate (E 218) and propylparahydroxybenzoate (E 216), which may cause allergic reactions (possibly delayed).

This medicinal product contains less than 0.04 mmol (0.95 mg)/dose (5 ml) of sodium, i.e. it is practically sodium-free.

Use during pregnancy or breastfeeding

The drug crosses the placenta and therefore may be used during pregnancy only if the expected benefit to the mother outweighs the potential risk to the fetus.

There are no data available on the use of the drug during breastfeeding.

Ability to influence reaction rate when driving or operating machinery

No effect.

Dosage and Administration.

Oral use, take during meals. For adults with atherosclerosis of the heart and brain vessels, peripheral vascular atherosclerosis – 5 ml 3–8 times daily. For hypercholesterolemia, arterial hypertension – 5 ml 3–6 times daily. For chronic obstructive pulmonary diseases, pulmonary hypertension – 5 ml 3–6 times daily. For asthenic conditions – 5 ml 4–8 times daily. Maximum daily dose – 40 ml (8 g). Treatment duration – 8–15 days; if necessary, the course should be repeated.

Children.

Do not use in patients under 18 years of age.

Overdose.

Symptoms: hypersensitivity reactions, hypoglycemic states.

Treatment. If these symptoms occur, discontinue the drug. Gastric lavage and administration of sorbents are indicated. There is no specific antidote. Symptomatic therapy.

Side effects.

From the musculoskeletal system: joint pain.

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

From the immune system: hypersensitivity reactions, including bronchospasm.

Laboratory findings: hyperkalemia.

Reporting suspected adverse reactions

Reporting suspected adverse reactions after medicinal product registration is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmacy 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 the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

The shelf life of the medicinal product after first opening is 14 days.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

No special storage conditions required.

Keep out of reach of children.

Incompatibility.

Arginine is incompatible with thiopental.

Packaging.

100 ml or 200 ml in a vial. One vial with one dosing spoon or dosing cup or dosing syringe in a carton. Or 5 ml sachets. 20 or 30 sachets per carton.

Availability category. Over-the-counter (without prescription).

Manufacturer.

JSC "Farmak".

Manufacturer's name and address of the place of business.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.