INSTRUCTION
on the medical use of the medicinal product
Riboksin-Darnitsa
(Riboxin-Darnitsa)
Composition:
active substance: inosine;
1 ml of solution contains riboxin (inosine) 20 mg;
excipients: sodium hydroxide, water for injection.
Dosage form. Injection.
Basic physical and chemical properties: clear, colorless liquid.
Pharmacotherapeutic group. Cardiac drugs. ATX code С01Е B.
Pharmacological properties.
Pharmacodynamics.
Riboxin is an anabolic drug that has antihypoxic and antiarrhythmic effects.
It is a precursor of ATP, is directly involved in glucose metabolism and promotes the activation of metabolism under 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, it increases the energy balance of cells, stimulates the synthesis of nucleotides, and 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 into cells when they are excited, activates tissue regeneration (especially the myocardium and the mucous membrane of the alimentary canal).
Pharmacokinetics.
When administered intravenously, riboxin is rapidly distributed in tissues. It is metabolized in the liver, where it is completely utilized in the biochemical reactions of the body. In small amounts, it is excreted mainly in the urine.
Clinical characteristics.
Indications.
Complex treatment of ischemic heart disease (condition after myocardial infarction, angina pectoris), cardiac arrhythmias, intoxication with drugs of cardiac glycosides.
Treatment of cardiomyopathies of various origins, myocardial dystrophies (against the background of heavy physical exertion, infectious and endocrine genesis), myocarditis.
Treatment of liver diseases (hepatitis, liver cirrhosis, fatty liver).
Prevention of radiation leukopenia.
Improvement of visual function in open-angle glaucoma with normalized intraocular pressure.
Contraindications.
Increased individual sensitivity to the active substance or to other components of the drug; gout; hyperuricemia. The limitation to the use of the drug is renal failure.
Interaction with other medicinal products and other types of interactions.
With the simultaneous use of the drug with other drugs, it is possible:
with heparin - strengthening the effects of heparin, increasing the duration of its action;
with cardiac glycosides - prevention of arrhythmias, enhancement of positive inotropic action.
With simultaneous use with β-blockers, the effect of riboxin does not decrease.
Possible simultaneous use with nitroglycerin, nifedipine, furosemide, spironolactone.
Incompatible in the same container with alkaloids, acids, alcohols, heavy metal salts, tannin, vitamin B6 (pyridoxine hydrochloride).
Features of the application.
When itching and flushing of the skin appears, treatment with the drug should be canceled.
During treatment, it is necessary to monitor the level of uric acid in the blood and urine.
The limitation to the use of the drug is renal failure. In renal failure, prescribing a drug is advisable only when, in the opinion of the doctor, the expected effect outweighs the possible risk during use.
Application during pregnancy or lactation.
The study of the efficacy and safety of the drug for this group of patients has not been carried out, therefore it is not used during pregnancy or lactation.
The ability to influence the reaction rate when driving or driving 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 dosage.
The drug is used for adults in a stream 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 a 2% solution) is administered once a day; subsequently, with good tolerance, the dose can be increased to 400 mg (20 ml of a 2% solution) 1-2 times a day. The course of treatment is determined individually, on average - 10-15 days.
Jet injection is possible in acute cardiac arrhythmias in a single dose of 200–400 mg (10–20 ml of a 2% solution).
Children
The drug is not used in children due to the lack of data on the safety of use.
Overdose.
An increase in the manifestations of symptoms of adverse reactions is possible.
Treatment. Cancellation of the drug, symptomatic therapy.
Adverse reactions.
From the side of the cardiovascular system: tachycardia, arterial hypotension, which may be accompanied by headache, dizziness, nausea, vomiting, sweating.
From the immune system: allergic / anaphylactic reactions, including rash, itching, skin flushing, urticaria, anaphylactic shock.
From the side of metabolism, metabolism: hyperuricemia, exacerbation of gout (with prolonged use of high doses).
General disorders and reactions at the injection site: general weakness, changes at the injection site (including hyperemia, itching).
Shelf life. 4 years.
Do not use the medicinal product after the expiration date indicated on the package.
Storage conditions.
Store in its original packaging at a temperature not exceeding 25 ° C. Do not freeze. Keep out of the reach of children.
Incompatibility.
Do not mix in the same syringe or infusion set with other medicines. Use only recommended solvents (see section "Method of administration and dosage").
Packaging.
5 ml in ampoule; 5 ampoules in a blister strip; 2 contour cell packs in a pack.
10 ml in an ampoule; 5 ampoules in a blister strip; 2 contour cell packs in a pack.
Vacation category. On prescription.
Manufacturer's location and address of the place of business.
PJSC "Pharmaceutical company" Darnitsa ".
Location.
Ukraine, 02093, Kiev, st. Boryspil, 13.
