ASCORBIC ACID WITH GLUCOSE

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ASCORBIC ACID WITH GLUCOSE

Composition:

Active substances: 1 tablet contains ascorbic acid 100 mg; glucose monohydrate 877 mg;

Excipients: potato starch, talc, calcium stearate, stearic acid.

Pharmaceutical form. Tablets.

Main physicochemical properties: flat cylindrical tablets with beveled edges and a score line, white or almost white. Marbling on the tablet surface is permissible.

Pharmacotherapeutic group. Simple ascorbic acid (vitamin C) preparations. Ascorbic acid (vitamin C). ATC code A11G A01.

Pharmacological Properties

Pharmacodynamics

Ascorbic acid (vitamin C) has pronounced reducing properties. It belongs to the group of water-soluble vitamins. It participates in redox reactions, regulation of carbohydrate metabolism, influences the metabolism of aromatic amino acids, thyroxine metabolism, biosynthesis of catecholamines, steroid hormones and insulin. It is essential for blood coagulation, synthesis of collagen and procollagen, and regeneration of connective and bone tissues. It improves capillary permeability. It promotes iron absorption in the intestine and participates in hemoglobin synthesis. It enhances the body's nonspecific resistance and has antidotal properties. Vitamin C deficiency in the diet leads to the development of hypovitaminosis and avitaminosis C, since this vitamin is not synthesized in the body.

Pharmacokinetics

Absorption of ascorbic acid occurs mainly in the small intestine. The absorption process may be impaired in intestinal dyskinesias, enteritis, achylia, helminthic invasion, giardiasis, as well as with consumption of alkaline beverages, fresh fruit and vegetable juices. Maximum plasma concentration of the drug after oral administration is reached within 4 hours. It readily penetrates leukocytes and platelets, and then into all tissues; it accumulates in the posterior pituitary, adrenal cortex, ocular epithelium, interstitial cells of the testes, ovaries, liver, brain, spleen, pancreas, lungs, kidneys, intestinal wall, heart, muscles, and thyroid gland. It is predominantly metabolized in the liver to dehydroascorbic acid, and further to oxalic acid and diketogulonic acid. Unchanged ascorbate and metabolites are excreted in urine and feces; they also pass into breast milk. When high doses are administered, and plasma concentration exceeds 1.4 mg/dL, excretion is markedly enhanced, and increased excretion may persist after discontinuation of administration.

Clinical characteristics.

Indications.

Prevention and treatment of vitamin C deficiency.

Meeting increased body requirements for vitamin C during periods of growth, pregnancy or breastfeeding, during high physical and mental stress, in infectious diseases and intoxications, hemorrhagic diatheses, in complex therapy of hemorrhages (nasal, pulmonary, uterine), in radiation sickness, Addison's disease, anticoagulant overdose, soft tissue injuries and slowly healing infected wounds, bone fractures.

Contraindications.

Hypersensitivity to ascorbic acid or to any of the excipients of the medicinal product. Thrombosis, predisposition to thrombosis, thrombophlebitis, diabetes mellitus, severe kidney diseases. Urolithiasis – when doses exceeding 1 g per day are used. Fructose intolerance, glucose-galactose malabsorption syndrome, various conditions accompanied by hyperglycemia, children under 3 years of age.

Interaction with other medicinal products and other types of interactions.

Oral administration of ascorbic acid enhances the absorption of penicillin, tetracycline, and iron; promotes intestinal absorption of aluminum, which should be considered during concomitant treatment with antacids containing aluminum.

Concomitant use of vitamin C and deferoxamine increases tissue toxicity of iron, especially in the myocardium, which may lead to circulatory decompensation. Vitamin C may be administered only 2 hours after deferoxamine injection.

Prolonged use of high doses by patients undergoing disulfiram treatment inhibits the disulfiram-alcohol reaction.

High doses of the drug reduce the effectiveness of tricyclic antidepressants, phenothiazine derivative neuroleptics, tubular reabsorption of amphetamine, impair renal excretion of mexiletine, and affect vitamin B12 resorption.

Ascorbic acid increases the total clearance of ethanol. When ascorbic acid is used in high doses and alcohol is consumed simultaneously, disulfiram-like reactions may develop.

The medicinal product reduces the toxicity of sulfonamide drugs, decreases the effectiveness of heparin and indirect anticoagulants.

Vitamin C enhances oxalate excretion with urine, thereby increasing the risk of calcium oxalate stone formation in urine, and increases the risk of crystalluria during treatment with salicylates.

Acetylsalicylic acid (aspirin) may reduce the absorption of ascorbic acid.

Concomitant use of salicylates with ascorbic acid may increase renal excretion of ascorbic acid.

Medicinal products of the quinoline series, calcium chloride, salicylates, and corticosteroids, when used long-term, reduce ascorbic acid reserves in the body.

Absorption of ascorbic acid is reduced when used concomitantly with oral contraceptives, consumption of fruit or vegetable juices, or alkaline drinks.

Special precautions for use

When high doses of the medicinal product are used or it is administered for prolonged periods, kidney function, arterial pressure, and pancreatic function should be monitored. The medicinal product should be used with caution in patients with a history of kidney disease.

In patients with urolithiasis, the daily dose of ascorbic acid should not exceed 1 g.

The medicinal product should not be prescribed in high doses to patients with increased blood coagulation.

Since ascorbic acid enhances iron absorption, its use in high doses may be hazardous for patients with hemochromatosis, thalassemia, polycythemia, leukemia, or sideroblastic anemia. Patients with high iron levels in the body should receive the medicinal product in minimal doses.

Concurrent use of the medicinal product with alkaline beverages reduces the absorption of ascorbic acid; therefore, it should not be taken with alkaline mineral water. In addition, absorption of ascorbic acid may be impaired in intestinal dyskinesia, enteritis, and achylia.

Use with caution in the treatment of patients with glucose-6-phosphate dehydrogenase deficiency.

As a reducing agent, ascorbic acid may interfere with laboratory test results, for example, in determining blood levels of glucose, bilirubin, and activities of transaminases and lactate dehydrogenase.

Since ascorbic acid has a mild stimulating effect, it is not recommended to administer the medicinal product late in the day. Due to the stimulatory effect of ascorbic acid on corticosteroid hormone production, kidney function and arterial pressure should be monitored when high doses of the medicinal product are used.

The medicinal product is not recommended for patients with impaired glucose tolerance. Blood glucose levels should be monitored during prolonged use of high doses of the medicinal product.

Ascorbic acid should be used with caution in patients with progressive malignant disease, as its use may aggravate the course of the disease.

The preparation may be harmful to teeth.

Use during pregnancy or breastfeeding

The medicinal product may be used during pregnancy or breastfeeding when the potential benefit to the mother outweighs the possible risk to the fetus, according to dosage recommendations and under medical supervision. Recommended doses should be strictly followed and not exceeded.

Effect on the ability to drive or operate machinery

When used at therapeutic doses, the medicinal product does not affect reaction speed.

Dosage and Administration

The medicinal product should be taken orally after meals.

For prophylactic purposes, adults and children aged 14 years and older should take ½–1 tablet (50–100 mg) daily; children aged 3 to 14 years should take ½ tablet (50 mg) daily.

Therapeutic doses:

• For children aged 14 years and older and adults: ½–1 tablet (50–100 mg) 3–5 times daily.
• For children aged 3 to 7 years: ½–1 tablet (50–100 mg) 2–3 times daily.
• For children aged 7 to 10 years: 1 tablet (100 mg) 2–3 times daily.
• For children aged 10 to 14 years: 1–1½ tablets (100–150 mg) 2–3 times daily.

Pregnant women, postpartum women, and those with low vitamin C levels in breast milk should take 3 tablets (300 mg) daily for 10–15 days, followed by 1 tablet (100 mg) daily for prophylaxis throughout the entire breastfeeding period.

The duration of treatment depends on the nature and course of the disease and is determined individually by the physician.

Children. The medicinal product is indicated for children aged 3 years and older.

Overdose.

Ascorbic acid is well tolerated. It is a water-soluble vitamin, and any excess is excreted in the urine.

Symptoms. Prolonged use of high doses of vitamin C may lead to suppression of the pancreatic islet apparatus function, requiring monitoring of pancreatic status. Overdose may alter renal excretion of ascorbic and uric acids during urine acidification, increasing the risk of precipitation of oxalate calculi.

Administration of high doses of the medicinal product may cause vomiting, nausea, or diarrhea, which resolve after discontinuation of the drug. Abdominal bloating may also occur with excessive intake.

Treatment. Symptomatic therapy.

Adverse reactions.

Gastrointestinal disorders: when administered at doses exceeding 1 g per day – gastrointestinal mucosa irritation, heartburn, nausea, vomiting, diarrhea.

Renal and urinary system disorders: glomerular apparatus damage, crystalluria, formation of urate, cystine and/or oxalate concretions in kidneys and urinary tract, renal failure.

Immune system disorders: allergic reactions, angioedema, occasionally anaphylactic shock in case of sensitization.

Skin and subcutaneous tissue disorders: skin rashes, pruritus, urticaria, eczema.

Endocrine system disorders: damage to the islet apparatus of the pancreas (hyperglycemia, glucosuria) and impaired glycogen synthesis up to the development of diabetes mellitus.

Cardiovascular system disorders: arterial hypertension, myocardial dystrophy.

Blood and lymphatic system disorders: thrombocytosis, hyperprothrombinemia, thrombosis, erythrocytopenia, neutrophilic leukocytosis; in patients with glucose-6-phosphate dehydrogenase deficiency of blood cells may cause erythrocyte hemolysis, hemolytic anemia (in patients with glucose-6-phosphate dehydrogenase deficiency).

Nervous system disorders: increased excitability, sleep disturbances, headache, sensation of heat, fatigue.

Metabolic and nutrition disorders: disturbances in zinc and copper metabolism.

Shelf life. 3 years.

Storage conditions.

Store in original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

10 tablets in blisters.

10 tablets per blister; 3 blisters per carton.

Availability category. Over-the-counter.

Manufacturer. JSC "KYIV VITAMIN PLANT".

Manufacturer's address and location of business activity.

38 Kopilivska St., Kyiv, 04073, Ukraine.

Web-site: www.vitamin.com.ua