Ascorbic acid with glucose (Tablets) Instructions for Use

Marketing Authorization Holder

Lumi, LLC (Russia)

ATC Code

A11GB (Ascorbic acid (vitamin C) in combination with other drugs)

Active Substances

Ascorbic acid (Rec.INN WHO registered)

Dextrose (Ph.Eur. European Pharmacopoeia)

Dosage Form

Ascorbic acid with glucose

Tablets 100 mg+877 mg: 10, 20, 40, 60, 100, 200, or 500 pcs.

Dosage Form, Packaging, and Composition

10 pcs. – non-cell contour packs (1) – cardboard packs.
10 pcs. – blister contour packs (1) – cardboard packs.
10 pcs. – non-cell contour packs (2) – cardboard packs.
10 pcs. – non-cell contour packs (4) – cardboard packs.
10 pcs. – non-cell contour packs (6) – cardboard packs.
10 pcs. – non-cell contour packs (10) – cardboard packs.
10 pcs. – blister contour packs (2) – cardboard packs.
10 pcs. – blister contour packs (4) – cardboard packs.
10 pcs. – blister contour packs (6) – cardboard packs.
10 pcs. – blister contour packs (10) – cardboard packs.
10 pcs. – blister contour packs (10) – bags.
10 pcs. – blister contour packs (5) – bags.
10 pcs. – blister contour packs (20) – bags.
10 pcs. – blister contour packs (50) – bags.
10 pcs. – blister contour packs (100) – bags.
10 pcs. – blister contour packs (500) – bags.
10 pcs. – blister contour packs (600) – bags.
10 pcs. – blister contour packs (400) – bags.

Clinical-Pharmacological Group

Vitamin preparation

Pharmacotherapeutic Group

Vitamin

Pharmacological Action

Ascorbic acid plays an important role in the regulation of redox processes, carbohydrate metabolism, blood coagulation, tissue regeneration, and helps to increase the body’s resistance. Ascorbic acid (vitamin C) is not produced in the human body and comes only with food. With a balanced and adequate diet, a person does not experience a deficiency of vitamin C.

Dextrose is involved in various metabolic processes in the body, enhances redox processes in the body, and improves the antitoxic function of the liver. It is completely absorbed by the body and is not excreted by the kidneys (its appearance in urine is a pathological sign).

Indications

Meeting the increased need of the body for vitamin C during periods of intensive growth, pregnancy, breastfeeding, with increased physical and mental stress, stressful conditions, during the recovery period after prolonged and severe illnesses.

ICD codes

Dosage Regimen

The drug is taken orally, after meals.

For prophylactic purposes, the following is prescribed:

• Adults: 50-100 mg/day;
• Children from 6 to 14 years old – 50 mg/day, from 14 to 18 years old – 75 mg/day;
• During pregnancy and lactation: 300 mg/day for 10-15 days, then 100 mg/day.

For therapeutic purposes, the following is prescribed:

• Adults: 50-100 mg 3-5 times a day;
• Children: 50-100 mg 2-3 times a day.

The maximum daily dose for adults is 1000 mg, for children – 500 mg.

The duration of treatment depends on the nature and course of the disease and is recommended by the doctor.

Adverse Reactions

Allergic reactions to the components of the drug, irritation of the gastrointestinal mucosa (nausea, vomiting, diarrhea, gastrointestinal spasm); inhibition of the function of the pancreatic islet apparatus (hyperglycemia, glucosuria); when used in high doses – hyperoxaluria and nephrocalcinosis (oxalate). Changes in laboratory parameters: thrombocytosis, hyperprothrombinemia, erythrocytopenia, neutrophilic leukocytosis, hypokalemia.

Contraindications

Hypersensitivity to the components of the drug. Large doses should not be prescribed to patients with increased blood clotting, thrombophlebitis and a tendency to thrombosis, as well as in diabetes mellitus and conditions accompanied by increased blood sugar levels. Children under 6 years of age.

With caution Glucose-6-phosphate dehydrogenase deficiency; when used in large doses – hemochromatosis, sideroblastic anemia, thalassemia, hyperoxaluria, nephrourolithiasis.

Use in Pregnancy and Lactation

Use is possible according to the dosing regimen.

Use in Renal Impairment

Use with caution in hyperoxaluria, nephrourolithiasis. Due to the stimulating effect of ascorbic acid on the formation of corticosteroid hormones, it is necessary to monitor renal function.

Pediatric Use

Contraindicated in children under 6 years of age. For children over 6 years of age, use is possible according to the dosing regimen.

Special Precautions

Due to the stimulating effect of ascorbic acid on the formation of corticosteroid hormones, it is necessary to monitor renal function and blood pressure.

With long-term use of large doses, inhibition of the function of the pancreatic islet apparatus is possible, so it must be regularly monitored during treatment.

In patients with increased iron content in the body, ascorbic acid should be used in minimal doses.

Prescription of ascorbic acid to patients with rapidly proliferating and intensively metastasizing tumors may exacerbate the course of the process.

Ascorbic acid as a reducing agent can distort the results of various laboratory tests (blood glucose, bilirubin, activity of “liver” transaminases and LDH).

Patients with diabetes should take into account that 1 tablet contains about 0.08 XE (bread units), and the daily dose (5 tablets) contains about 0.4 XE.

Effect on the ability to drive vehicles and mechanisms. No data available.

Overdose

Symptoms when using more than 1 g – headache, increased excitability of the central nervous system, insomnia, nausea, vomiting, diarrhea, hyperacid gastritis, ulceration of the gastrointestinal mucosa, inhibition of the function of the pancreatic islet apparatus (hyperglycemia, glucosuria), hyperoxaluria, nephrolithiasis (from calcium oxalate), damage to the glomerular apparatus of the kidneys, moderate pollakiuria (when taking a dose of more than 600 mg/day). Decreased capillary permeability (possible deterioration of tissue trophism, increased blood pressure, hypercoagulation, development of microangiopathies).

Drug Interactions

Ascorbic acid increases the concentration of benzylpenicillin and tetracycline in the blood.

It improves the absorption of iron preparations.

It slows down the renal excretion of acids and increases the excretion of drugs with an alkaline reaction (including alkaloids).

It increases the total clearance of ethanol, which in turn reduces the concentration of ascorbic acid in the body.

Drugs of the quinoline series, calcium chloride, glucocorticosteroids with long-term use deplete the reserves of ascorbic acid.

With simultaneous use, it reduces the chronotropic effect of isoprenaline.

With long-term use or use in high doses, it may disrupt the disulfiram-ethanol interaction.

In high doses, it increases the renal excretion of mexiletine. Barbiturates and primidone increase the excretion of ascorbic acid in the urine. It reduces the therapeutic effect of antipsychotic drugs (neuroleptics) – phenothiazine derivatives, tubular reabsorption of amphetamine and tricyclic antidepressants.

Storage Conditions

In a dry place protected from light at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life. 2 years. Do not use after the expiration date.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.