Tivortin® aspartate

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT TIVORTIN® ASPARTATE (TIVORTIN ASPARTATE)

Composition:

Active substance: L-arginine aspartate;

1 ml of solution contains L-arginine aspartate 200 mg;

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

Pharmaceutical form. Oral solution.

Main physico-chemical properties: clear, slightly opalescent yellowish solution with a caramel odor.

Pharmacotherapeutic group. Other cardiac preparations. Amino acids.

ATC code C01E.

Pharmacological Properties

Pharmacodynamics

Tivortin® aspartate exerts anti-hypoxic, cytoprotective, antioxidant, detoxifying, and membrane-stabilizing effects. It plays an important role in ammonia detoxification and stimulation of its excretion from the body, enhances hepatic detoxification function. It exerts hepatoprotective action and positively influences energy supply processes in hepatocytes.

As a nitric oxide donor, Tivortin® aspartate participates in the body's energy metabolism, 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 processes.

The drug 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.

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

Contraindications.

Hypersensitivity, severe renal function disorders. 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 blood insulin levels, and concomitant use of spironolactone with arginine – by an increase in blood potassium levels.

Arginine is incompatible with thiopental.

Special precautions for use.

Use with caution in patients with electrolyte metabolism disorders and 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 medication should be discontinued.

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

The drug should not be administered to 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 the following excipients: 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)/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.

Effect on ability to drive or operate machinery.

No effect.

Dosage and Administration

Administer orally, during meals. For adults with atherosclerosis of the heart and cerebral vessels, peripheral vascular atherosclerosis – 5 mL (1 measuring spoon – 1 g of the drug) 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 – 8 g. Treatment duration – 8–15 days; if necessary, the course may be repeated.

Children

Not recommended for 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. 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.

Shelf life. 2 years.

Shelf life after opening the vial – 14 days.

Storage conditions.

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

Incompatibility.

Arginine is incompatible with thiopental.

Packaging.

100 ml or 200 ml in a vial; 1 vial with a measuring spoon in a cardboard box.

Availability.

Over-the-counter.

Manufacturer/Applicant.

TOV "Yuria-Pharm".

Manufacturer's address and location of business activity.

108, Kobzarska St., Cherkasy, Cherkasy region, 18030, Ukraine. Tel.: (044) 281-01-01.