RIBOXIN-BHPHZ

INSTRUCTIONS
for medical use of medicinal product

RIBOXIN-BCPP
(RIBOXIN-BCPP)

Composition:

active substance: inosine;

1 tablet contains inosine (calculated as 100% dry substance) – 200 mg;

excipients: microcrystalline cellulose, magnesium stearate.

Film coating: hydroxypropyl methylcellulose, copovidone, polyethylene glycol, medium-chain triglycerides, polydextrose, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172).

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: tablets are round-shaped with a biconvex surface, film-coated, yellow to brownish-yellow in color.

Pharmacotherapeutic group. Cardiological agents. Inosine. ATC code C01EB.

Pharmacological properties.

Pharmacodynamics.

Inosine belongs to anabolic substances and is a purine nucleoside, a precursor in the synthesis of adenosine triphosphoric acid. It exhibits anti-hypoxic and antiarrhythmic properties and exerts an anabolic effect.

Inosine positively affects metabolism in the myocardium, increases cellular energy balance, stimulates nucleotide synthesis, and enhances the activity of certain enzymes in the Krebs cycle. The drug increases the force of cardiac contractions and promotes more complete relaxation of the myocardium during diastole due to its ability to bind calcium ions that enter the cells during excitation. As a result, stroke volume increases, myocardial blood supply improves, including coronary circulation.

Inosine accelerates oxygen dissociation from oxyhemoglobin, thereby improving tissue oxygenation and enhancing coronary blood flow. The drug normalizes liver function by improving energy processes in hepatocytes, participates in glucose metabolism, and promotes activation of glucose metabolism under hypoxia. Inosine intensifies pyruvic acid metabolism and increases xanthine dehydrogenase activity. The drug also reduces platelet aggregation and activates tissue regeneration (especially myocardium and gastrointestinal mucosa).

Pharmacokinetics.

After oral administration, inosine is well absorbed in the gastrointestinal tract. It is metabolized in the liver to form glucuronic acid with subsequent oxidation. A small amount is excreted in urine.

Clinical characteristics.

Indications.

• As part of complex therapy for ischemic heart disease (after myocardial infarction, angina pectoris), cardiac arrhythmias, intoxication with cardiac glycosides, treatment of cardiomyopathies of various etiologies, myocardial dystrophies (caused by physical exertion, infections, or endocrine disorders), myocarditis;
• urocoporphyrinuria; liver diseases (hepatitis, liver cirrhosis, fatty liver dystrophy).

Contraindications.

• Hypersensitivity to inosine or other components of the drug;
• hyperuricemia;
• renal failure;
• gout.

Interaction with other medicinal products and other types of interactions.

When used with cardiac glycosides, inosine prevents the development of arrhythmias and enhances positive inotropic effects.

Inosine can be used concomitantly with anabolic agents (potassium orotate, methandrostenolone), nitroglycerin, nifedipine, furosemide, spironolactone.

When used concomitantly with beta-adrenergic blockers, the efficacy of inosine is not reduced.

Riboxin prolongs the duration of action of heparin.

Forms a precipitate with tannins.

When used with uric acid-lowering agents, it reduces the effects of uric acid-lowering agents.

Special precautions.

Inosine should not be used for emergency correction of cardiac function disorders.

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

In patients with kidney disease, the drug should be prescribed only when, in the physician’s opinion, the expected benefit outweighs the potential risk.

During prolonged use of inosine, serum and urinary uric acid levels should be monitored.

Use during pregnancy or breastfeeding.

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

Ability to affect reaction rate when driving or operating machinery.

The drug does not affect the ability to drive or operate machinery.

Method of administration and dosage.

Tablets should be taken orally, before meals, without chewing, and with sufficient fluid. The daily dose is determined individually and ranges from 600–2400 mg (3–12 tablets) for adults.

For adults, the initial daily dose during the first days of treatment is 600–800 mg (1 tablet 3–4 times daily). If the drug is well tolerated, the dose may be increased over 2–3 days from 1200 mg (2 tablets 3 times daily) up to 2400 mg.

The duration of treatment course is from 4 weeks to 1.5–3 months.

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

Children.

Should not be used in children due to lack of safety data.

Overdose.

Symptoms: increased adverse effects, allergic reactions, nausea, diarrhea, abdominal pain.

Treatment: discontinue the drug and provide symptomatic therapy.

Adverse reactions.

Immune system, skin and subcutaneous tissue: allergic/anaphylactic reactions (including itching, skin hyperemia, urticaria, rash, anaphylactic shock).

Metabolism and nutrition: hyperuricemia; prolonged use in high doses may provoke gout flare-ups.

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

Others: increased blood uric acid levels, general weakness.

Shelf life. 3 years.

Storage conditions. In original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 10 tablets in a blister, 5 blisters in a carton.

Prescription status. Prescription only.

Manufacturer.

Public Joint-Stock Company "Scientific and Production Center "Borshchagov Chemical and Pharmaceutical Plant".

Manufacturer's address and place of business.

17 Miru Street, Kyiv, 03134, Ukraine.

INSTRUCTIONS

for medical use of medicinal product

RIBOXIN-BCPP

(RIBOXIN-BCPP)

Composition:

active substance: inosine;

1 tablet contains inosine (calculated as 100% dry substance) – 200 mg;

excipients: microcrystalline cellulose, magnesium stearate.

Film coating: hydroxypropylmethylcellulose, copovidone, polyethylene glycol, medium-chain triglycerides, polidextrose, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172).

Pharmaceutical form. Film-coated tablets.

Basic physicochemical properties: round, biconvex, film-coated tablets of yellow to brownish-yellow color.

Pharmacotherapeutic group. Cardiology drugs. Inosine.

ATC code C01EB.

Pharmacological properties.

Pharmacodynamics.

Inosine belongs to anabolic agents and is a purine nucleoside, a precursor in the synthesis of adenosine triphosphoric acid. It exhibits anti-hypoxic and antiarrhythmic properties and exerts an anabolic effect.

Inosine positively affects myocardial metabolism, improves cellular energy balance, stimulates nucleotide synthesis, and increases the activity of certain enzymes in the Krebs cycle. The drug enhances myocardial contractility and promotes more complete myocardial relaxation during diastole by binding calcium ions that enter cells during excitation. As a result, cardiac stroke volume increases, and myocardial blood supply, including coronary circulation, improves.

Inosine accelerates oxygen dissociation from oxyhemoglobin, thereby improving tissue oxygenation and enhancing coronary blood flow. The drug normalizes liver function by improving energy processes in hepatocytes, participates in glucose metabolism, and promotes glucose metabolism activation under hypoxia. Inosine intensifies pyruvic acid metabolism and increases xanthine dehydrogenase activity. The drug also reduces platelet aggregation and stimulates tissue regeneration (especially myocardium and gastrointestinal mucosa).

Pharmacokinetics.

After oral administration, inosine is well absorbed in the gastrointestinal tract. It is metabolized in the liver to form glucuronic acid, which is subsequently oxidized. A small amount is excreted in urine.

Clinical characteristics.

Indications.

• In complex therapy of ischemic heart disease (after myocardial infarction, angina pectoris), cardiac arrhythmias, cardiac glycoside intoxication, treatment of cardiomyopathies of various etiologies, myocardial dystrophies (caused by physical exertion, infections, or endocrine disorders), myocarditis;
• urocoporphyrinuria; liver diseases (hepatitis, liver cirrhosis, fatty liver dystrophy).

Contraindications.

• Hypersensitivity to inosine or other components of the drug;
• hyperuricemia;
• renal failure;
• gout.

Interaction with other medicinal products and other types of interactions.

When used with cardiac glycosides, inosine prevents the development of arrhythmias and enhances positive inotropic effects.

Inosine can be used concomitantly with anabolic agents (potassium orotate, methandienone), nitroglycerin, nifedipine, furosemide, spironolactone.

Concomitant use of inosine with beta-blockers does not reduce its efficacy.

Riboxin prolongs the action of heparin.

Forms a precipitate with tannin.

Reduces the effects of uric acid-lowering agents.

Special precautions.

Inosine should not be used for emergency correction of cardiac disorders.

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

In patients with kidney diseases, the drug should be prescribed only when, in the physician’s opinion, the expected benefit outweighs the potential risk.

During prolonged inosine use, serum and urinary uric acid concentrations should be monitored.

Use during pregnancy or breastfeeding.

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

Ability to affect reaction rate when operating vehicles or other machinery.

The drug does not affect the ability to drive vehicles or operate machinery.

Method of administration and dosage.

Tablets should be taken orally, before meals, without chewing, and with sufficient water. The daily dose is individually determined and ranges from 600–2400 mg (3–12 tablets) for adults.

For adults, initial daily dose during the first days of treatment is 600–800 mg (1 tablet 3–4 times daily). If the drug is well tolerated, the dose may be increased over 2–3 days from 1200 mg (2 tablets 3 times daily) up to 2400 mg.

Treatment duration ranges from 4 weeks to 1.5–3 months.

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

Children.

Should not be used in children due to lack of safety data.

Overdose.

Symptoms: increased adverse effects, allergic reactions, nausea, diarrhea, abdominal pain.

Treatment: discontinue the drug and provide symptomatic therapy.

Adverse reactions.

Immune system, skin and subcutaneous tissue: allergic/anaphylactic reactions (including itching, skin hyperemia, urticaria, rash, anaphylactic shock).

Metabolism and nutrition: hyperuricemia; prolonged use in high doses may exacerbate gout.

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

Other: increased serum uric acid levels, general weakness.

Shelf life. 3 years.

Storage conditions. Store in original packaging at temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 10 tablets in a blister, 5 blisters per pack.

Prescription status. Prescription only.

Manufacturer.

Public Joint-Stock Company "Scientific and Production Center "Borshchahivskiy Chemical-Pharmaceutical Plant".

Manufacturer's location and address of operations.

17 Myru Street, Kyiv, 03134, Ukraine.