Riboxin-Darnitsa solution for injection 20 mg/ml ampoule 5 ml No. 10




Pharmacological properties
Pharmacodynamics. Riboxin is an anabolic drug that has antihypoxic and antiarrhythmic effects.
It is a precursor of ATP, takes a direct part in glucose metabolism and promotes the activation of metabolism in conditions of hypoxia and in the absence of ATP. The drug activates the metabolism of pyruvic acid to ensure the normal process of tissue respiration, and also promotes the activation of xanthine dehydrogenase. Riboxin has a positive effect on the metabolism in the myocardium, in particular, increases the energy balance of cells, stimulates the synthesis of nucleotides, enhances the activity of a number of enzymes of the Krebs cycle. The drug normalizes the contractile activity of the myocardium and promotes a more complete relaxation of the myocardium in diastole due to the ability to bind calcium ions that have penetrated the cells during excitation, activates tissue regeneration (especially the myocardium and the mucous membrane of the gastrointestinal tract).
Pharmacokinetics. Well absorbed in the gastrointestinal tract when taken orally. Metabolized in the liver with the formation of glucuronic acid and its subsequent oxidation. Excreted mainly with urine, in small quantities with feces and bile.
When administered intravenously, Riboxin is rapidly distributed in tissues. It is metabolized in the liver, where it is completely utilized in biochemical reactions of the body. In small quantities, it is excreted mainly with urine.
Indication
Comprehensive treatment for coronary heart disease (condition after myocardial infarction, angina pectoris), heart rhythm disturbances, intoxication with cardiac glycosides, cardiomyopathy of various genesis, myocardial dystrophy (against heavy physical exertion, infectious and endocrine genesis), myocarditis; liver diseases (hepatitis, cirrhosis, fatty liver dystrophy); uroproporphyria. Prevention of leukopenia during irradiation. Improvement of visual function in open-angle glaucoma with normalized intraocular pressure.
Application
Tablets. The drug is taken orally with meals, without chewing, with a sufficient amount of water. The daily dose for adults is set by the doctor individually, the dose is 600-2400 mg/day. At the beginning of treatment, the drug should usually be prescribed in a daily dose of 600-800 mg (1 tablet 3-4 times a day). If the drug is well tolerated, the dose is gradually increased (within 2-3 days) to 1200 mg/day (2 tablets 3 times a day), if necessary - to 2400 mg/day (4 tablets 3 times a day). The duration of the course of treatment is 1-3 months.
For uroproporphyria, the daily dose is 800 mg (1 tablet 4 times a day), the duration of the treatment course is 1-3 months.
Solution. The drug is administered to adults intravenously or drip (slowly) at a rate of 40-60 drops per minute.
For intravenous drip administration, the drug is 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 2% solution) is administered once a day, then, with good tolerability, the dose can be increased to 400 mg (20 ml of 2% solution) 1-2 times a day. The course of treatment is determined individually, on average - 10-15 days.
Jet injection is possible for acute heart rhythm disturbances in a single dose of 200-400 mg (10-20 ml of 2% solution).
Contraindication
Hypersensitivity to the active substance or to other components of the drug; gout; hyperuricemia. Renal failure is a limitation to the use of the drug.
Side effects
From the side of metabolism: hyperuricemia, exacerbation of gout (with prolonged use in high doses).
Cardiovascular system: tachycardia, arterial hypotension, may be accompanied by headache, shortness of breath, dizziness, nausea, vomiting, increased sweating.
Immune system disorders: allergic/anaphylactic reactions including rash, itching, redness of the skin, urticaria, anaphylactic shock.
General disorders and administration site conditions: general weakness, changes at the injection site (including hyperemia, itching).
Laboratory indicators: increased uric acid levels in the blood.
If any adverse reactions occur, the use of the drug should be discontinued.
Special instructions
Riboxin-Darnitsa should not be used for the urgent correction of heart disorders.
If itching and skin hyperemia occur, treatment with the drug should be discontinued.
During therapy, it is necessary to monitor the level of uric acid concentration in the blood and urine.
A limitation to the use of the drug is renal failure. In renal failure, the drug should be prescribed only if, in the opinion of the doctor, the expected effect of the use exceeds the possible risk.
The medicine contains crystalline sugar, which should be taken into account by patients with diabetes.
Use during pregnancy and breastfeeding. Studies of the efficacy and safety of the drug for this group of patients have not been conducted, therefore the drug should not be used during pregnancy and breastfeeding.
Children. The drug should not be used in children due to the lack of data on safety.
The ability to influence the speed of reactions when driving vehicles or working with other mechanisms. The drug does not affect the speed of neuromuscular conduction, in recommended doses it can be used by people who drive vehicles and work with complex mechanisms.
When using the drug simultaneously with other medications, it is possible:
with heparin - enhancing the effects of heparin, increasing the duration of its action;
with cardiac glycosides - prevention of arrhythmias, increased expression of positive inotropic action;
with hypouricemic agents - weakening of the effects of hypouricemic agents.
With simultaneous use of the drug with β-adrenergic blockers, the effectiveness of Riboxin does not decrease.
Simultaneous use with nitroglycerin, nifedipine, furosemide, spironolactone is possible.
In the form of a solution, it is incompatible in the same container with alkaloids, acids, alcohols, salts of heavy metals, tannin, vitamin B6 (pyridoxine hydrochloride).
Overdose
There have been no reports of overdose of the drug. If the dose of the drug is exceeded, side effects may be increased.
Treatment: drug withdrawal, symptomatic therapy.
Storage conditions
In the original packaging at a temperature not exceeding 25 °C. Do not freeze the solution.
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