RIBOXIN-DARNITSA

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT RIBOXIN-DARNITSA (RIBOXIN-DARNITSA)

Composition:

Active substance: inosine;

1 tablet contains 200 mg of riboxin (inosine);

Excipients: potato starch, crystalline sugar, methylcellulose, stearic acid, polysorbate 80, tropaeolin 0, titanium dioxide (E 171).

Pharmaceutical form. Coated tablets.

Main physicochemical properties: yellow coated tablets with a biconvex surface. Two layers are visible in cross-section.

Pharmacotherapeutic group. Cardiological preparations. ATC code C01EB.

Pharmacological Properties

Pharmacodynamics

Riboxin is an anabolic medicinal agent with anti-hypoxic and antiarrhythmic effects.

It is a precursor of ATP and directly participates in glucose metabolism, promoting metabolic activation under conditions of hypoxia and in the absence of ATP. The drug activates metabolism of pyruvic acid to ensure normal tissue respiration and promotes activation of xanthine dehydrogenase. Riboxin positively influences myocardial metabolism, in particular improves cellular energy balance, stimulates nucleotide synthesis, and enhances the activity of several enzymes in the Krebs cycle. The agent normalizes myocardial contractile function and promotes more complete myocardial relaxation in diastole due to its ability to bind calcium ions entering the cells during excitation. It also activates tissue regeneration (particularly of the myocardium and gastrointestinal mucosa).

Pharmacokinetics

Well absorbed in the gastrointestinal tract. Metabolized in the liver with formation of glucuronic acid and its subsequent oxidation. Excreted predominantly in urine; in insignificant amounts – in feces and bile.

Clinical characteristics.

Indications.

Complex treatment of ischemic heart disease (post-myocardial infarction condition, angina pectoris), cardiac arrhythmias, intoxication with cardiac glycosides, treatment of cardiomyopathies of various etiologies, myocardial dystrophies (against the background of severe physical exertion, infectious and endocrine causes), myocarditis; liver diseases (hepatitis, liver cirrhosis, fatty liver dystrophy); uroporphyrinuria.

Contraindications.

Hypersensitivity to the active substance or to other components of the drug; gout; hyperuricemia. Renal insufficiency is a limitation for the use of the drug.

Interaction with other medicinal products and other types of interactions.

Possible interactions when used concomitantly with other medicinal products:

with heparin – enhancement of heparin effects, prolonged duration of action;

with cardiac glycosides – prevention of arrhythmias, enhancement of positive inotropic effect;

with hypouricemic agents – weakening of hypouricemic effects.

The effect of riboxin is not reduced when used concomitantly with β-adrenoblockers.

Simultaneous use with nitroglycerin, nifedipine, furosemide, and spironolactone is possible.

Special precautions for use.

Riboxin should not be used for emergency correction of cardiac dysfunction.

If itching or skin hyperemia occurs, treatment with the drug should be discontinued.

During treatment, it is necessary to monitor blood and urine urea levels. Renal insufficiency is a limitation for the use of this medicinal product. The administration of the drug in patients with renal insufficiency is advisable only if, in the opinion of the physician, the expected benefit outweighs the potential risk.

The medicinal product contains crystalline sugar, which should be taken into account in patients with diabetes mellitus.

Use during pregnancy or breastfeeding.

Studies on the efficacy and safety of the drug in this patient group have not been conducted; therefore, the drug should not be used during pregnancy or breastfeeding.

Ability to influence reaction rate when driving or operating machinery.

The drug does not affect neuromuscular conduction speed; it can be used at recommended doses by individuals who drive vehicles or operate complex machinery.

Method of administration and dosage.

The medicinal product should be administered orally to adults before meals, without chewing, and taken with sufficient amount of water. The daily dose for adults is determined individually by a physician and ranges from 600–2400 mg per day. At the beginning of treatment, the medicinal product is usually prescribed at a daily dose of 600–800 mg (1 tablet 3–4 times daily). If the medicinal product is well tolerated, the dose may be gradually increased (over 2–3 days) to 1200 mg daily (2 tablets 3 times daily), and if necessary, up to 2400 mg daily (4 tablets 3 times daily). The duration of treatment course is 1–3 months.

In case of uroporphyrinuria, the daily dose is 800 mg (1 tablet 4 times daily), and the duration of treatment course is 1–3 months.

Children.

The medicinal product must not be used in children due to lack of safety data.

Overdose.

There have been no reports of overdose with this medicinal product. In case of exceeding the recommended dose, adverse effects may be intensified.

Treatment: discontinue the medicinal product, symptomatic therapy.

Adverse Reactions.

Metabolic and nutritional disorders: hyperuricemia, exacerbation of gout (with prolonged use of high doses).

Cardiovascular system disorders: tachycardia, arterial hypotension, which may be accompanied by headache, dyspnea, dizziness, nausea, vomiting, sweating.

Immune system disorders: allergic/anaphylactic reactions, including rash, itching, skin hyperemia, urticaria, anaphylactic shock.

General disorders: general weakness.

Laboratory findings: increased blood uric acid levels.

If any adverse reactions occur, discontinue use of the medicinal product.

Shelf life. 4 years.

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

Storage conditions.

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

Keep out of reach of children.

Packaging.

10 tablets in a blister pack; 5 blister packs in a carton.

Prescription status. Prescription only.

Manufacturer. JSC "Pharmaceutical company "Darnytsia".

Manufacturer's address and place of business.

13, Borispilska Street, Kyiv, 02093, Ukraine.