Instructions for Riboxin-Darnitsa film-coated tablets 200 mg No. 50
Composition
active ingredient: inosine;
1 tablet contains riboxin (inosine) 200 mg;
excipients: potato starch, crystalline sugar, methylcellulose, stearic acid, polysorbate 80, tropeolin 0, titanium dioxide (E 171).
Dosage form
Film-coated tablets.
Main physicochemical properties: yellow, film-coated tablets with a biconvex surface. Two layers are visible on the cross-section.
Pharmacotherapeutic group
Cardiological drugs. ATX code C01E B.
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 more complete relaxation of the myocardium in diastole due to the ability to bind calcium ions that have penetrated the cells during their excitation, activates tissue regeneration (especially the myocardium and the mucous membrane of the gastrointestinal tract).
Pharmacokinetics
Well absorbed in the gastrointestinal tract. 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.
Indication
Comprehensive treatment of ischemic heart disease (condition after myocardial infarction, angina pectoris), heart rhythm disturbances, intoxication with cardiac glycoside drugs, treatment of cardiomyopathies of various genesis, myocardial dystrophies (against heavy physical exertion, infectious and endocrine genesis), myocarditis; liver diseases (hepatitis, cirrhosis, fatty liver dystrophy); uroproporphyria.
Contraindication
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 failure.
Interaction with other medicinal products and other types of interactions
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, enhancement of positive inotropic effect;
with hypouricemic agents – weakening of the effects of hypouricemic agents.
When used simultaneously with β-blockers, the effect of Riboxin does not decrease.
Simultaneous use with nitroglycerin, nifedipine, furosemide, spironolactone is possible.
Application features
Riboxin should not be used for the urgent correction of cardiac disorders.
If itching and skin hyperemia occur, treatment with the drug should be discontinued.
During treatment, it is necessary to monitor the level of urea concentration in the blood and urine. A limitation for 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 probable risk.
The medicine contains crystalline sugar, which should be taken into account by patients with diabetes.
Use during pregnancy or breastfeeding
Studies of the efficacy and safety of the drug have not been conducted for this group of patients, therefore the drug should not be used during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or 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.
Method of administration and doses
The drug should be taken by adults orally before meals, without chewing and drinking plenty of water. The daily dose for adults is set individually by the doctor, the dose is 600-2400 mg per 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 should be gradually increased (over 2-3 days) to 1200 mg per day (2 tablets 3 times a day), if necessary - to 2400 mg per day (4 tablets 3 times a day). The duration of the treatment course 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.
Children
The medicine should not be used in children due to the lack of data on safety.
Overdose
There have been no reports of overdose with the drug. If the dose of the drug is exceeded, side effects may be increased.
Treatment: drug withdrawal, symptomatic therapy.
Side effects
From the side of metabolism: hyperuricemia, exacerbation of gout (with prolonged use of high doses).
Cardiovascular system: tachycardia, arterial hypotension, which may be accompanied by headache, shortness of breath, dizziness, nausea, vomiting, sweating.
Immune system disorders: allergic/anaphylactic reactions, including rash, itching, skin hyperemia, urticaria, anaphylactic shock.
General disorders: general weakness.
Laboratory indicators: increased uric acid levels in the blood.
If any adverse reactions occur, the use of the drug should be discontinued.
Expiration date
4 years.
Do not use the medicine 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 contour blister pack; 5 contour blister packs in a pack.
Vacation category
According to the recipe.
Producer
PrJSC "Pharmaceutical Company "Darnitsa".
Address
Ukraine, 02093, Kyiv, Boryspilska St., 13.
