RIBOXIN-DARNITSA

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

Composition:

Active substance: inosine;

1 ml of solution contains 20 mg of riboxine (inosine);

Excipients: sodium hydroxide, water for injections.

Pharmaceutical form. Injection solution.

Main physicochemical properties: transparent, colorless liquid.

Pharmacotherapeutic group. Cardiological agents. ATC code C01EB.

Pharmacological Properties

Pharmacodynamics

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

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

Pharmacokinetics

After intravenous administration, riboxin rapidly distributes into tissues. It is metabolized in the liver, where it is completely utilized in the body's biochemical reactions. A negligible amount is excreted, predominantly in the urine.

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 severe physical exertion, infectious and endocrine causes), myocarditis.

Treatment of liver diseases (hepatitis, liver cirrhosis, fatty liver dystrophy). Prevention of leukopenia during irradiation.

Improvement of visual function in open-angle glaucoma with normalized intraocular pressure.

Contraindications.

Increased individual sensitivity to the active substance or to other components of the drug; gout; hyperuricemia. A limitation for the use of the drug is renal insufficiency.

Interaction with other medicinal products and other types of interactions.

Concomitant use of the drug with other medicinal products may result in:

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

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

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

Concomitant use with nitroglycerin, nifedipine, furosemide, spironolactone is possible.

Incompatible in the same container with alkaloids, acids, alcohols, heavy metal salts, tannin, vitamin B6 (pyridoxine hydrochloride).

Special precautions for use.

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

During treatment, it is necessary to monitor blood and urine urea levels. A contraindication for using the drug is renal insufficiency. Administration of the drug in cases of renal insufficiency is advisable only when, in the physician's opinion, the expected benefit outweighs the potential risk of use.

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 is not used during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

The drug has no negative effect on the ability to drive a vehicle or operate complex machinery.

Administration and Dosage

The medicinal product is administered intravenously, either as a bolus or by infusion (slowly) at a rate of 40–60 drops per minute in adults.

For intravenous infusion, the medicinal product should be diluted in 5% glucose solution or 0.9% sodium chloride solution (up to 250 ml). At the beginning of treatment, 200 mg (10 ml of a 2% solution) is administered once daily. Subsequently, if well tolerated, the dose may be increased to 400 mg (20 ml of a 2% solution) 1–2 times daily. The duration of treatment is determined individually; on average, it is 10–15 days.

Bolus administration is possible in acute cardiac rhythm disorders at a single dose of 200–400 mg (10–20 ml of a 2% solution).

Children

The medicinal product is not used in children due to lack of safety and efficacy data.

Overdose

An overdose may intensify the manifestations of adverse reactions.

Treatment: Discontinuation of the medicinal product and symptomatic therapy.

Adverse reactions.

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

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

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

General disorders and administration site conditions: general weakness, injection site reactions (including hyperemia, itching).

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. Do not freeze. Keep out of reach of children.

Incompatibility.

Do not mix in the same syringe or in the same infusion system with other medicinal products. Use only the recommended solvents (see section "Instructions for use and dosage").

Packaging.

5 ml in a vial; 5 vials in a blister pack; 2 blister packs in a carton.

10 ml in a vial; 5 vials in a blister pack; 2 blister packs in a carton.

Prescription status. Prescription only.

Manufacturer's name and address.

JSC "Pharmaceutical company "Darnytsia".

Location.

02093, Kyiv, Borispilska St., 13, Ukraine.