Solargin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SOLARGIN

Composition:

Active substance: arginine hydrochloride;

1 ml of solution contains arginine hydrochloride 42 mg;

Excipient: water for injections.

Pharmaceutical form. Infusion solution.

Main physico-chemical properties: clear, colorless or slightly yellowish-brown liquid.

Pharmacotherapeutic group. Plasma substitutes and perfusion solutions. Additional solutions for intravenous administration. Amino acids. Arginine hydrochloride. ATC code B05X B01.

Pharmacological Properties

Pharmacodynamics

Arginine (α-amino-δ-guanidinovaleric acid) is an amino acid belonging to the class of conditionally essential amino acids. It acts as an active and versatile cellular regulator of numerous vital functions in the body and exhibits important protective effects under critical conditions.

Arginine hydrochloride demonstrates anti-hypoxic, membrane-stabilizing, cytoprotective, antioxidant, free radical-scavenging, and detoxifying activities. It acts as an active regulator of intermediate metabolism and energy supply processes and plays a role in maintaining hormonal balance in the body. It is known that arginine increases blood levels of insulin, glucagon, growth hormone, and prolactin. It participates in the synthesis of proline, polyamines, and agmatine, is involved in fibrinogenolysis and spermatogenesis, and exerts membrane depolarizing effects.

Arginine is one of the main substrates in the urea cycle for urea synthesis in the liver. The drug's hypoammonemic effect is achieved by enhancing the conversion of ammonia into urea. It exerts hepatoprotective action due to its antioxidant, anti-hypoxic, and membrane-stabilizing properties and positively influences energy supply processes in hepatocytes.

Arginine hydrochloride serves as a substrate for nitric oxide synthase (NOS), the enzyme catalyzing nitric oxide (NO) synthesis in endothelial cells. The drug activates guanylate cyclase and increases the level of cyclic guanosine monophosphate (cGMP) in vascular endothelium. It reduces activation and adhesion of leukocytes and platelets to the vascular endothelium and inhibits the synthesis of adhesion proteins VCAM-1 and MCP-1, thereby preventing the formation and progression of atherosclerotic plaques. It also suppresses the synthesis of endothelin-1, a potent vasoconstrictor and stimulator of vascular smooth muscle cell proliferation and migration. Arginine hydrochloride additionally inhibits the synthesis of asymmetric dimethylarginine—an endogenous stimulator of oxidative stress. The drug stimulates thymus gland activity, which produces T-cells, and regulates blood glucose levels during physical exertion. It exerts an acidifying effect and contributes to the correction of acid-base balance.

Pharmacokinetics

During continuous intravenous infusion, maximum plasma concentration of arginine hydrochloride is reached within 20–30 minutes after the start of administration. Arginine hydrochloride crosses the placental barrier, is filtered in the renal glomeruli, but is almost completely reabsorbed in the renal tubules.

Clinical Characteristics

Indications. Metabolic alkalosis, hyperammonemia, atherosclerosis of the heart and cerebral vessels, peripheral vascular atherosclerosis including manifestations of intermittent claudication, diabetic angiopathy, arterial hypertension, chronic heart failure, hypercholesterolemia, chronic obstructive pulmonary diseases, pulmonary hypertension, fetal growth retardation, and preeclampsia — to be used as part of combination therapy.

Contraindications

Hypersensitivity to the drug. Severe impairment of renal function, hyperchloremic acidosis; history of allergic reactions; concomitant use of potassium-sparing diuretics, including spironolactone. Myocardial infarction (including history of myocardial infarction).

Interaction with other medicinal products and other forms of interaction

When using arginine, it should be considered that it may cause pronounced and persistent hyperkalemia in patients with renal insufficiency who are taking or have taken spironolactone. Prior use of potassium-sparing diuretics may also contribute to increased blood potassium concentration. Concomitant administration with aminophylline may lead to increased blood insulin levels. Arginine is incompatible with thiopental.

Special precautions for use

In patients with renal insufficiency, urine output and plasma potassium levels should be checked before starting infusion, as the medicinal product may promote the development of hyperkalemia. The medicinal product should be used with caution in patients with endocrine gland dysfunction. The medicinal product may stimulate insulin and growth hormone secretion. When dry mouth occurs, blood glucose levels should be checked. Caution is advised in patients with electrolyte metabolism disorders and kidney diseases. If symptoms of asthenia worsen during arginine administration, treatment should be discontinued. The medicinal product should be used with caution in patients with angina pectoris.

Use during pregnancy or breastfeeding

The medicinal product crosses the placenta and therefore may be used during pregnancy only when the expected benefit to the mother outweighs the potential risk to the fetus. There are no data available regarding the use of the medicinal product during breastfeeding.

Ability to affect reaction speed when driving or operating machinery
Caution should be exercised when driving or operating machinery, as the medicinal product may cause dizziness.

Dosage and Administration

The medicinal product is administered intravenously by drip infusion at a rate of 10 drops per minute for the first 10–15 minutes; thereafter, the infusion rate may be increased to 30 drops per minute.

The daily dose of arginine is 100 ml of solution.

In severe circulatory disturbances affecting central and peripheral vessels, as well as in pronounced intoxication, hypoxia, and asthenic conditions, the dose of arginine may be increased up to 200 ml per day.

The maximum infusion rate must not exceed 20 mmol/hour.

For children under 12 years of age, the dose of the medicinal product is 5–10 ml per kg of body weight per day. For the treatment of metabolic alkalosis, the dose can be calculated as follows:

arginine hydrochloride (mmol)

______________________________________ × 0.3 × body weight (kg)

base excess (Be) (mmol/L)

Infusion should begin with half of the calculated dose. Any additional correction should be performed after obtaining updated acid-base balance test results.

Instructions for use.

Do not use if the container seal is broken or if the solution is not clear. Any unused solution must be discarded.

Children. The medicinal product may be administered to children aged 3 years and older.

Overdose

Symptoms: renal failure, hypoglycemia, metabolic acidosis.

Treatment: In case of overdose, infusion of the medicinal product must be discontinued. Physiological responses should be monitored and vital functions supported. If necessary, administer alkalinizing agents and diuretics to restore diuresis, as well as electrolyte solutions (0.9% sodium chloride solution, 5% glucose solution). Symptomatic therapy is recommended.

Adverse Reactions

General disorders: hyperthermia, feeling of warmth, malaise.

Musculoskeletal system: joint pain.

Gastrointestinal tract: dry mouth, nausea, vomiting.

Skin and subcutaneous tissue: injection site reactions, including hyperemia, itching sensation, skin pallor, up to acrocyanosis.

Immune system: anaphylactic shock, hypersensitivity reactions, including rash, urticaria, angioedema.

Respiratory system, thoracic organs and mediastinum: dyspnea.

Cardiovascular system: fluctuations in blood pressure, changes in heart rhythm, chest pain.

Nervous system: headache, dizziness, feeling of fear, weakness, seizures, tremor, more frequently when the infusion rate exceeds recommended.

Laboratory findings: hyperkalemia.

Reporting of suspected adverse reactions

Reporting of adverse reactions after drug registration is important. It allows 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 via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua

Shelf life. 2 years.

Storage conditions

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

Incompatibility. The medicinal product is incompatible with thiopental.

Packaging. 100 ml in a polypropylene container; 1 container per cardboard box.

Prescription status. Prescription only.

Manufacturer. Subsidiary enterprise "Farmatreyd".

Manufacturer's location and address of business activity

85 Sambirska Street, Drohobych, Lviv region, Ukraine.