Instructions for Ascorutin tablets blister No. 50
Composition
active ingredients: ascorbic acid (vitamin C), rutoside;
1 tablet contains ascorbic acid (vitamin C) calculated as 100% substance 50 mg, rutoside trihydrate calculated as 100% anhydrous substance 50 mg;
excipients: white sugar, potato starch, corn starch, magnesium stearate, talc.
Dosage form
Pills.
Main physical and chemical properties: single-layer tablets, round in shape, light yellow with a greenish tint, the upper and lower surfaces of which are flat, the edges of the surfaces are beveled. Imperfections are allowed on the surface of the tablets. A relatively homogeneous structure is visible on the break under a magnifying glass.
Pharmacotherapeutic group
Capillary stabilizing agents. Bioflavonoids. Rutoside, combinations. ATX code C05C A51.
Pharmacological properties
Pharmacodynamics.
A combined medicinal product, the action of which is due to the effects of the components that make up its composition.
Rutoside (vitamin P) promotes the conversion of ascorbic acid to dehydroascorbic acid and prevents the further transformation of the latter into diketugulonic acid. Therefore, most of the effects of rutoside are mediated by ascorbic acid.
Rutoside in combination with ascorbic acid reduces capillary permeability and fragility, strengthens the cell wall, reduces platelet aggregation, has an anti-inflammatory effect (including by inhibiting hyaluronidase activity), antioxidant properties, and participates in redox processes.
In addition, rutoside is characterized by such effects as reducing the exudation of the liquid part of blood plasma and diapedesis of blood cells through the vascular wall; choleretic and mild antihypertensive effects.
In patients with chronic venous insufficiency, rutoside leads to a decrease in edematous and painful syndromes, trophic disorders, a decrease or disappearance of paresthesias and seizures. It helps to reduce the severity of side effects of radiotherapy (cystitis, enteroproctitis, dysphagia, skin erythema), and also slows down the progression of diabetic retinopathy.
Pharmacokinetics.
Each vitamin included in the composition of the drug undergoes its own transformations. Ascorbic acid is rapidly absorbed mainly in the duodenum and small intestine. 30 minutes after ingestion, the content of ascorbic acid in the blood increases markedly, its uptake by tissues begins, while it is first converted into dehydroascorbic acid, which penetrates cell membranes without energy losses and is quickly restored in the cell. Ascorbic acid in tissues is found almost exclusively intracellularly, determined in three forms - ascorbic, dehydroascorbic acids and ascorbigen (bound ascorbic acid). It is distributed unevenly between organs. A lot of it is found in the endocrine glands, especially in the adrenal glands, less - in the brain, kidneys, liver, in the heart and skeletal muscles. The content of ascorbic acid in leukocytes and platelets is higher than in blood plasma. It is metabolized and excreted by the kidneys up to 90% in the form of oxalate, partly in the free form.
Rutoside, absorbed in the digestive tract, promotes the transport and deposition of ascorbate. It is excreted in the unchanged form of metabolites, mainly with bile and to a lesser extent with urine.
The half-life is 10-25 hours.
Indication
– Deficiency of rutoside and ascorbic acid.
– As part of complex therapy for diseases accompanied by increased vascular permeability.
– Prevention of colds and reduction of flu symptoms.
– To increase immunity.
Contraindication
– Hypersensitivity to any components of the drug.
– Increased blood clotting, thrombophlebitis, tendency to thrombosis.
– Gout, urolithiasis with the formation of urate stones, cystinuria, hypokalemia and hypercalcemia, oxalaturia.
– Diabetes.
– Severe kidney disease.
– Concomitant use with sulfonamides or aminoglycosides.
– Fructose intolerance, glucose-galactose malabsorption syndrome.
Interaction with other medicinal products and other types of interactions
Acetylsalicylic acid, oral contraceptives: reduced absorption of the drug.
Ascorbic acid at a dose of ≥1 g increases the bioavailability of oral contraceptives (estrogens, including ethinyl estradiol), increases the blood concentration of salicylates, enhancing their side effects (risk of crystalluria, effect on the gastric mucosa).
Acetylsalicylic acid, barbiturates, tetracyclines: increased urinary excretion of ascorbic acid.
Desferrioxamine (deferoxamine): increases iron absorption, urinary excretion; increases tissue toxicity of iron, especially cardiotoxicity, which can lead to circulatory decompensation. Cardiac dysfunction (usually reversible after discontinuation of vitamin C) has been reported in patients with idiopathic hemochromatosis and thalassemia who have used desferrioxamine and high doses of ascorbic acid (more than 500 mg per day). Such a combination in this category of patients requires caution and careful monitoring of cardiac function. Ascorbic acid can be taken only 2 hours after the injection of desferrioxamine.
Heparin, indirect anticoagulants, phenothiazines, fluphenazine, sulfonamide drugs, aminoglycoside antibiotics: reduced effectiveness of these drugs.
Cyclosporine A: possible reduction in its bioavailability.
B vitamins: mutual enhancement of therapeutic effects. High doses of ascorbic acid are infused to inhibit the resorption of vitamin B12.
Corticosteroids, paracetamol: the half-life of the latter increases when using high doses of ascorbic acid (this interaction has no clinical consequences when taking therapeutic doses).
Calcitonin: increases the rate of absorption of ascorbic acid.
Amphetamine: its renal excretion increases when high doses of ascorbic acid are used.
Aluminum antacids: it should be noted that ascorbic acid promotes the absorption of aluminum from the intestine, and an increase in the elimination of aluminum in the urine is possible. The combined use of antacids and ascorbic acid is not recommended, especially in patients with renal failure.
With prolonged use (more than 4 weeks), the drug should not be prescribed simultaneously with cardiac glycosides, antihypertensive agents or nonsteroidal anti-inflammatory drugs, as it may enhance their effects.
Ascorbic acid increases the excretion of oxalates in the urine, thus increasing the risk of forming oxalate stones in the urine.
Combined use of very high doses of ascorbic acid with amygdalin (complementary medicine) may increase the risk of cyanide toxicity.
Smoking, alcohol: reduce the concentration of ascorbate in blood plasma.
Disulfiram: long-term administration of large doses of ascorbic acid inhibits the disulfiram-alcohol reaction.
Ascorbic acid in large doses (more than 2 g/day) may affect the results of biochemical determinations of creatinine, uric acid and glucose levels in blood and urine samples, determination of inorganic phosphates, liver enzymes and bilirubin in the blood. The stool screening test for occult blood may be falsely negative.
Simultaneous use with alkaline drinks, consumption of fresh fruit or vegetable juices reduces the absorption of ascorbic acid.
Application features
Simultaneous use of the drug with alkaline drinks, fresh fruit or vegetable juices reduces the absorption of vitamin C. Absorption of ascorbic acid may be impaired in intestinal dyskinesias, enteritis, and achilia.
Since ascorbic acid increases iron absorption, its use in high doses can be dangerous for patients with hemochromatosis, thalassemia, polycythemia, leukemia, and sideroblastic anemia. Patients with high iron levels in the body should use the drug in minimal doses.
Ascorbic acid should be used with caution in the treatment of patients with glucose-6-phosphate dehydrogenase deficiency and patients with a history of kidney disease.
With prolonged use of high doses of ascorbic acid, kidney function, blood pressure, and pancreatic function should be monitored.
In case of urolithiasis, the daily dose of ascorbic acid should not exceed 1 g. Large doses of the drug should not be prescribed to patients with increased blood clotting.
Since ascorbic acid has a mild stimulating effect, it is not recommended to take the medicine at the end of the day.
Due to the content of ascorbic acid in the medicinal product, it may alter the results of a number of laboratory tests (see section “Interaction with other medicinal products and other types of interactions”).
The drug contains sugar, which should be taken into account by patients with diabetes.
Use during pregnancy or breastfeeding
During pregnancy, the drug can be used only after consulting a doctor. The drug is contraindicated in the 1st trimester of pregnancy. In the 2nd–3rd trimesters of pregnancy or during breastfeeding, the drug should be prescribed taking into account the benefit/risk ratio for the woman and the fetus/child, provided that the recommended doses and duration of treatment are strictly observed.
Available clinical data on the use of rutin and vitamin C as separate medicinal products in pregnant women do not indicate any significant risk to the fetus. However, there are no adequate and well-controlled clinical studies of the safety of combined preparations containing vitamin C and rutin in pregnant women.
There are no reports of embryotoxicity of rutin or its penetration into breast milk.
Vitamin C is excreted in breast milk, but doses even 10 times the recommended daily dose did not lead to a significant increase in its concentration in breast milk.
Ability to influence reaction speed when driving vehicles or other mechanisms
There is no data on the effect of Ascorutin on the ability to drive vehicles or work with other mechanisms.
Method of administration and doses
The medicine should be taken orally after meals. The tablets should be swallowed whole with a small amount of water.
For therapeutic purposes, adults are prescribed 1 tablet 2–3 times a day; children aged from
3 years – 1 tablet 2 times a day. As a preventive measure, the recommended dose is: for adults – 1 tablet 2 times a day, for children over 3 years old – 1 tablet 2 times a day.
1 tablet per day.
The duration of the treatment course is 3–4 weeks (depending on the nature of the disease and the effectiveness of the treatment).
Children
The drug is prescribed to children aged 3 years and older.
Overdose
Symptoms: epigastric pain, nausea, vomiting, diarrhea, itching and skin rashes, increased excitability of the nervous system, headache, increased blood pressure, thrombosis. Possible increased manifestations of adverse reactions.
Overdose may lead to changes in renal excretion of ascorbic and uric acids during urine acetylation with the risk of precipitation of oxalate stones.
With prolonged use in large doses, inhibition of the function of the insular apparatus of the pancreas and impaired kidney function are possible.
Ascorbic acid in doses exceeding 3 g/day may cause acidosis or hemolytic anemia in some individuals with glucose-6-phosphate dehydrogenase deficiency.
Treatment: gastric lavage, use of sorbents, symptomatic treatment.
Adverse reactions
From the side of the central nervous system: headache, feeling of fatigue, with prolonged use in high doses - sleep disturbances, increased excitability of the central nervous system.
From the kidneys and urinary tract: acidification of urine, hyperoxaluria in patients at risk at doses exceeding 1 g/day; with prolonged use in high doses - damage to the glomerular apparatus of the kidneys, formation of urate and oxalate stones in the urinary tract, renal failure. Doses of ascorbic acid above 600 mg/day have a diuretic effect.
From the side of the blood system: with prolonged use in high doses - thrombocytosis, hyperprothrombinemia, thrombocytopenia, erythrocytopenia, neutrophilic leukocytosis, hemolytic anemia in some individuals with glucose-6-phosphate dehydrogenase deficiency.
Metabolic: hypervitaminosis C, deterioration of tissue trophism, with prolonged use in high doses - inhibition of the function of the insular apparatus of the pancreas (hyperglycemia, glucosuria) and glycogen synthesis, sodium and fluid retention, impaired zinc and copper metabolism.
From the side of the cardiovascular system: with prolonged use in high doses - myocardial dystrophy, increased blood pressure, development of microangiopathies.
On the part of the digestive tract: with prolonged use in high doses - irritation of the mucous membrane of the digestive tract, heartburn, stomach cramps, nausea, vomiting, diarrhea.
On the part of the immune system: hypersensitivity reactions, including skin hyperemia, skin rashes, eczema, itching, angioedema, urticaria, anaphylactic shock, respiratory hypersensitivity reactions.
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.
10 tablets in a blister; 5 blisters in a pack.
10 tablets in a blister; 80 blisters in a cardboard box.
50 tablets in containers; 1 container in a pack.
Vacation category
Without a prescription.
Producer
Technolog PJSC.
Location of the manufacturer and address of its place of business.
Ukraine, 20300, Cherkasy region, Uman city, Stara Prorizna Street, building 8.
