Tivomax® a

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT TIVOMAX® A (TIVOMAX A)

Composition:

Active substance: L-arginine L-aspartate;

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

Excipients: sorbitol (E 420), methylparahydroxybenzoate (E 218), propylparahydroxybenzoate (E 216), sodium saccharin (E 954), caramel flavor, purified water.

Pharmaceutical form. Oral solution.

Main physicochemical properties: slightly yellowish liquid with a caramel odor.

Pharmacotherapeutic group. Other cardiac preparations. Amino acids.

ATC code C01E.

Pharmacological properties.

Pharmacodynamics.

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

As a nitric oxide donor, Tivomax® A participates in the body's energy supply processes, reduces activation and adhesion of leukocytes and platelets to 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 complex therapy of atherosclerosis of heart and cerebral vessels, arterial hypertension, peripheral vascular atherosclerosis; chronic heart failure; hypercholesterolemia; chronic obstructive pulmonary diseases, pulmonary hypertension; asthenic conditions.

Contraindications.

Hypersensitivity to the active substance or to any of the excipients of the medicinal product. Severe renal function impairment. Myocardial infarction (including history of).

Interaction with other medicinal products and other forms of interaction.

When using arginine aspartate, it should be taken into account that concomitant use of aminophylline with arginine may be accompanied by increased blood insulin levels; spironolactone with arginine — by increased blood potassium levels. Arginine is incompatible with thiopental.

Special precautions for use.

The drug should be used with caution in patients with electrolyte imbalance and kidney diseases. During treatment, a balanced regimen of sleep and rest should be maintained, and 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 administered to patients with hereditary fructose intolerance.

The drug contains sorbitol (E 420). If a patient has known sugar intolerance, medical advice should be sought before taking this product.

The drug contains methylparahydroxybenzoate (E 218) and propylparahydroxybenzoate (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 placenta and therefore may be used during pregnancy only if the expected benefit to the mother outweighs the potential risk to the fetus.

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

Ability to affect 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 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 lung diseases, pulmonary hypertension — 5 ml 3–6 times daily.
For 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 children (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.

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 possible allergic reactions, bronchospasm.

The medicinal product contains auxiliary substances such as methylparahydroxybenzoate and propylparahydroxybenzoate, which may cause allergic reactions (possibly delayed), and in individual cases — bronchospasm.

Laboratory findings: hyperkalemia.

Reporting suspected adverse reactions.

Reporting suspected adverse reactions after medicinal product registration is important. 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, should report all cases of suspected adverse reactions and/or lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 1.5 years.

Shelf life after opening the bottle — 14 days.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Do not freeze.

Keep out of reach of children.

Packaging.

100 ml or 200 ml in a bottle; 1 bottle with a measuring spoon or measuring cup in a carton.

Supply category. Over-the-counter.

Manufacturer. JSC "Pharmaceutical Company "Darnytsia".

Manufacturer's address and place of business.

13 Borispilska Street, Kyiv, 02093, Ukraine.