Instructions Riboxin film-coated tablets 200 mg blister No. 50
Composition
active ingredient: inosine;
1 tablet contains 200 mg of inosine in terms of 100% substance;
excipients: potato starch; powdered sugar; calcium stearate; coating mixture "Opadry II Yellow" 33G22623 (hypromellose (hydroxypropylmethylcellulose); lactose, monohydrate; titanium dioxide (E 171); polyethylene glycol (macrogol) 3000; triacetin; quinoline yellow (E 104); sunset yellow FCF (E 110); iron oxide (E 172); indigo carmine (E 132)).
Dosage form
Film-coated tablets.
Main physicochemical properties: film-coated tablets, yellow in color, with a biconvex surface. Two layers are visible on the cross section.
Pharmacotherapeutic group
Cardiological drugs. ATC code C01E B.
Pharmacological properties
Pharmacodynamics. Riboxin has antihypoxic, antiarrhythmic properties, has an anabolic effect. 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 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, increases the activity of a number of enzymes of the Krebs cycle. The drug normalizes myocardial contractility and promotes more complete relaxation of the myocardium in diastole due to the ability to bind calcium ions that have penetrated the cells in the phase of their excitation, activates tissue regeneration (especially the myocardium and the mucous membrane of the digestive tract).
Pharmacokinetics. Riboxin is well absorbed in the digestive tract. With the blood flow it enters the cells, where it can be converted into nucleotides that participate in energy and protein metabolism. Inosine is metabolized in the liver with the formation of glucuronic acid and its subsequent oxidation. It is excreted mainly with urine, to a lesser extent with feces and bile.
Indication
As part of the complex 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 the background of heavy physical exertion, infectious and endocrine genesis), myocarditis, liver diseases (hepatitis, cirrhosis, fatty liver dystrophy), uroproporphyria.
Contraindication
- Hypersensitivity to inosine or to other components of the drug;
- gout;
- hyperuricemia;
- renal failure.
Interaction with other medicinal products and other types of interactions
When used with cardiac glycosides, inosine prevents the development of arrhythmias and enhances the inotropic effect.
Inosine can be used simultaneously with anabolic drugs (potassium orotate, methandrostenolone), nitroglycerin, nifedipine, furosemide, spironolactone.
When inosine is used simultaneously with beta-blockers, the effectiveness of inosine is not reduced.
Riboxin increases the duration of action of heparin.
Forms a precipitate with tannin.
With hypouricemic agents, it weakens the effects of hypouricemic agents.
The dye E 110, which is part of the tablet shell, can cause allergic reactions.
Application features
Inosine should not be used for the urgent correction of cardiac disorders.
If itching and skin hyperemia occur, treatment with the drug should be discontinued.
Riboxin tablets contain lactose. Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
In case of kidney diseases, the drug is prescribed only when, in the opinion of the doctor, the expected effect exceeds the possible risk of use.
With prolonged use of inosine, the concentration of uric acid in the blood and urine should be monitored.
Use during pregnancy or breastfeeding
The efficacy and safety of the drug have not been studied for this group of patients, so it should not be used during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not have a negative effect on the ability to drive a car and work with complex mechanisms.
Method of administration and doses
Tablets should be taken orally, before meals, without chewing and with sufficient water. The daily dose is determined individually and is for adults 600-2400 mg (3-12 tablets). For adults in the first days of treatment, the daily dose is 600-800 mg (1 tablet 3-4 times a day). If the drug is well tolerated, the dose should be increased within 2-3 days from 1200 mg (2 tablets 3 times a day) to 2400 mg.
The duration of the treatment course is from 4 weeks to 1.5-3 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: Should not be used in children due to lack of safety data.
Overdose
Symptoms: increased side effects, allergic reactions, nausea, diarrhea, abdominal pain.
Treatment: discontinuation of the drug and symptomatic therapy.
Adverse reactions
Immune system, skin and subcutaneous tissue disorders: allergic/anaphylactic reactions (including itching, skin hyperemia, urticaria, rashes, anaphylactic shock);
from the side of metabolism and metabolism: hyperuricemia, with prolonged use in high doses, exacerbation of gout is possible;
Cardiovascular system: tachycardia, arterial hypotension, which may be accompanied by headache, shortness of breath, dizziness, nausea, vomiting, sweating;
others: increased uric acid levels in the blood, general weakness.
Expiration date
4 years.
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 blister; 5 blisters in a pack.
Vacation category
According to the recipe.
Manufacturers
PJSC "Kyivmedpreparat", Kyiv.
PJSC "Halychpharm", Lviv.
Location of manufacturers and their business addresses
PJSC "Kyivmedpreparat", Ukraine, 01032, Kyiv, Saksaganskoho St., 139.
PJSC "Halychpharm", Ukraine, 79024, Lviv, Opryshkivska St., 6/8.
Applicant
PJSC "Halychpharm", Lviv.
Applicant's location
PJSC "Halychpharm", Ukraine, 79024, Lviv, Opryshkivska St., 6/8.
