Riboxin
Ukraine
Table of Contents
INSTRUCTIONS for medical use of the medicinal product RIBOXIN (RIBOXIN)
Composition:
Active substance: inosine;
1 ml of solution contains inosine 20 mg;
Excipients: hexamethylenetetramine, water for injections.
Pharmaceutical form. Solution for injection.
Main physicochemical properties: clear colorless liquid.
Pharmacotherapeutic group. Cardiological preparations. ATC code C01EB.
Pharmacological properties.
Pharmacodynamics.
Riboxin is an anabolic agent exerting anti-hypoxic and antiarrhythmic effects.
It is a precursor of ATP, directly participates in glucose metabolism, and promotes 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 promotes activation of xanthine dehydrogenase. Riboxin exerts a beneficial effect on myocardial metabolism, in particular increases cellular energy balance, stimulates nucleotide synthesis, and enhances the activity of certain enzymes of the Krebs cycle. The drug normalizes myocardial contractile activity 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 (especially of the myocardium and mucous membrane 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; liver diseases (hepatitis, liver cirrhosis, fatty liver dystrophy); prevention of leukopenia during radiation exposure; improvement of visual function in open-angle glaucoma with normalized intraocular pressure.
Contraindications.
- Hypersensitivity to inosine or to other components of the drug;
- hyperuricemia;
- renal failure;
- gout.
Interaction with other medicinal products and other types of interactions.
When used concomitantly with other medicinal products, the following interactions are possible:
with heparin – enhancement of heparin's effects, prolongation of its duration of 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, and 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. Renal insufficiency is a limitation for the use of the drug. Administration of the drug in renal insufficiency should be considered only if, in the physician's opinion, the expected benefit outweighs the potential risk.
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 while 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 drug should be 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 drug should be diluted in 5% glucose solution or 0.9% sodium chloride solution (up to 250 ml). At the beginning of treatment, administer 200 mg (10 ml of 2% solution) once daily. Subsequently, if well tolerated, the dose may be increased to 400 mg (20 ml of 2% solution) 1–2 times daily. The duration of treatment is determined individually, on average 10–15 days.
Bolus administration is possible in acute cardiac arrhythmias at a single dose of 200–400 mg (10–20 ml of 2% solution).
Children.
The drug is not used in children due to lack of safety and efficacy data.
Overdose.
May result in intensification of adverse reaction symptoms.
Treatment: discontinue the drug, symptomatic therapy.
Side effects.
Immune system, skin and subcutaneous tissue disorders: allergic/anaphylactic reactions, including rash, itching, skin hyperemia, urticaria, anaphylactic shock.
Cardiovascular system disorders: tachycardia, arterial hypotension, which may be accompanied by headache, dizziness, nausea, vomiting, sweating.
Metabolism and nutrition disorders: hyperuricemia, exacerbation of gout (with prolonged use of high doses).
General disorders: general weakness, injection site reactions (including hyperemia, itching).
Shelf life. 4 years.
Storage conditions. In the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.
Incompatibility.
The drug must not be mixed with other medicinal products in the same syringe or infusion system.
Use only recommended solvents (see section "Administration and dosage").
Packaging. 5 ml or 10 ml in an ampoule; 5 ampoules in a blister pack; 2 blister packs in a carton; 5 ml or 10 ml in an ampoule; 10 ampoules in a box.
Prescription status. Prescription only.
Manufacturer. JSC "Galichfarm".
Manufacturer's address and place of business. Ukraine, 79024, Lviv, Opryshkivska St., 6/8.
INSTRUCTION
for medical use of medicinal product
RIBOXIN
(RIBOXIN)
Composition:
active substance: inosine;
1 ml of solution contains inosine 20 mg;
excipients: hexamethylenetetramine, water for injections.
Pharmaceutical form. Injection solution.
Main physicochemical properties: clear, colorless liquid.
Pharmacotherapeutic group. Cardiology drugs. ATC code C01EB.
Pharmacological properties.
Pharmacodynamics.
Riboxin is an anabolic agent with anti-hypoxic and antiarrhythmic effects. It is a precursor of ATP and directly participates in glucose metabolism, promoting metabolic activation under hypoxic conditions and in the absence of ATP. The drug activates pyruvate metabolism to ensure normal tissue respiration and promotes activation of xanthine dehydrogenase. Riboxin positively influences myocardial metabolism, particularly by improving cellular energy balance, stimulating nucleotide synthesis, and enhancing the activity of several enzymes in the Krebs cycle. The drug normalizes myocardial contractile function and promotes complete myocardial relaxation during diastole due to its ability to bind calcium ions that enter cells during excitation. It also stimulates tissue regeneration (especially myocardium and mucous membranes of the digestive 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. Excretion occurs in insignificant amounts, mainly with 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, myocardiodystrophies (due to heavy physical exertion, infections, or endocrine disorders), myocarditis; liver diseases (hepatitis, liver cirrhosis, fatty liver dystrophy); prevention of leukopenia during radiation; improvement of visual function in open-angle glaucoma with normalized intraocular pressure.
Contraindications.
- Hypersensitivity to inosine or any other component of the drug;
- hyperuricemia;
- renal failure;
- gout.
Interaction with other medicinal products and other types of interactions.
Possible interactions when used concomitantly with other medicinal products:
with heparin: enhanced heparin effects and prolonged duration of action;
with cardiac glycosides: prevention of arrhythmias, enhancement of positive inotropic effect.
The effect of riboxin is not reduced when used concomitantly with β-blockers.
Concomitant use with nitroglycerin, nifedipine, furosemide, and spironolactone is possible.
Incompatible in the same container with alkaloids, acids, alcohols, heavy metal salts, tannin, and vitamin B6 (pyridoxine hydrochloride).
Special precautions.
If itching or skin hyperemia occurs, treatment with the drug should be discontinued.
During treatment, blood and urine urea levels should be monitored. Renal failure is a limitation for the use of the drug. In cases of renal failure, the drug should be prescribed only when, in the physician’s opinion, the expected benefit outweighs the potential risk.
Use during pregnancy or breastfeeding.
Efficacy and safety studies in this patient group have not been conducted; therefore, the drug should not be used during pregnancy or breastfeeding.
Effect on ability to drive or operate machinery.
The drug does not have a negative effect on the ability to drive or operate complex machinery.
Administration and dosage.
For intravenous use in adults, either as a slow bolus or by infusion (40–60 drops per minute).
For intravenous infusion, dilute the drug in 5% glucose solution or 0.9% sodium chloride solution (up to 250 ml). Initially, administer 200 mg (10 ml of 2% solution) once daily. With good tolerance, the dose may be increased to 400 mg (20 ml of 2% solution) 1–2 times daily. The duration of treatment is determined individually, on average 10–15 days.
Bolus injection may be used in acute cardiac rhythm disorders at a single dose of 200–400 mg (10–20 ml of 2% solution).
Children.
The drug should not be used in children due to lack of safety data.
Overdose.
May result in increased severity of adverse reaction symptoms.
Treatment: Discontinue the drug; symptomatic therapy.
Side effects.
Immune system, skin and subcutaneous tissue disorders: allergic/anaphylactic reactions, including rash, itching sensation, skin hyperemia, urticaria, anaphylactic shock.
Cardiovascular system disorders: tachycardia, arterial hypotension, which may be accompanied by headache, dizziness, nausea, vomiting, sweating.
Metabolism and nutrition disorders: hyperuricemia, exacerbation of gout (with prolonged use of high doses).
General disorders: general weakness, injection site reactions (including hyperemia, itching).
Shelf life. 4 years.
Storage conditions. In the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.
Incompatibility.
The drug must not be mixed with other medicinal products in the same syringe or infusion system.
Use only recommended solvents (see section "Administration and dosage").
Packaging. 5 ml or 10 ml in an ampoule; 5 ampoules in a blister pack; 2 blister packs in a carton; 5 ml or 10 ml in an ampoule; 10 ampoules in a box.
Prescription status. Prescription only.
Manufacturer. JSC "Galichfarm".
Manufacturer's address and place of business. Ukraine, 79024, Lviv, Opryshkivska St., 6/8.