Deacura®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DEACURE®

Composition:

Active substance: biotin;

1 tablet contains 5 mg of biotin;

Excipients: lactose monohydrate, microcrystalline cellulose, povidone, crospovidone, magnesium stearate.

Pharmaceutical form. Tablets.

Main physicochemical properties: white-colored, round, flat on both sides, with beveled edges and a cross-shaped score line on one side.

Pharmacotherapeutic group. Simple vitamin preparations. Biotin.

ATC code: A11H A05.

Pharmacological properties.

Pharmacodynamics.

Biotin (vitamin H, vitamin B7) is essential for cellular development and growth. As a coenzyme, it plays a crucial role in gluconeogenesis, lipogenesis, propionate biotransformation, and leucine catabolism.

Biotin deficiency may occur in cases of unbalanced nutrition, prolonged diets, and consumption of raw egg white; during parenteral nutrition; in malabsorption syndrome or after resection of the small intestine; in biotin-dependent multiple carboxylase deficiency; and in patients undergoing hemodialysis.

Biotin acts synergistically with other B-group vitamins. It functions as a coenzyme for carboxylases, exerts insulin-like effects, and participates in gluconeogenesis (by promoting glucokinase synthesis), thereby contributing to blood glucose stabilization and improved nervous system function. There is evidence of biotin's involvement in purine nucleotide synthesis. Biotin also serves as a source of sulfur, which participates in protein synthesis—particularly collagen—and thus positively affects the structure of skin and its appendages (hair, nails).

Pharmacokinetics.

Absorption of unbound biotin occurs in the upper segments of the small intestine, with the biotin molecule crossing the intestinal wall unchanged. Absorption occurs primarily via diffusion. Recent studies have also demonstrated active transport mediated by a biotin-sodium cotransport complex.

Up to 80% of biotin binds to plasma proteins. Free or partially bound biotin levels in blood typically range from 200 to 1200 ng/L. Biotin is excreted in urine (6 to 50 µg per day) and feces. Approximately half of biotin is excreted unchanged, and the other half as biologically inactive metabolites. The optimal plasma concentration has not been precisely defined. However, in healthy individuals, it may be around 400 ng/L. The elimination half-life is dose-dependent and is approximately 26 hours after oral administration of high doses of biotin (100 µg per kg body weight). In patients with biotinidase deficiency, the half-life following the same dose is reduced to 10–14 hours.

Clinical characteristics.

Indications.

Treatment and prevention of diseases caused by biotin deficiency: skin, nails, and hair disorders.

Treatment of genetically determined enzyme deficiencies associated with biotin (multiple carboxylase deficiency).

Contraindications.

Hypersensitivity to biotin or to other components of the drug.

Interaction with other medicinal products and other forms of interaction.

When used with anticonvulsant drugs, a decreased plasma biotin level may occur due to increased urinary excretion. Valproic acid reduces biotinidase activity, impairing mitochondrial functions in the liver.

Pantothenic acid in high doses competes with biotin; therefore, simultaneous use should be avoided.

Special precautions for use.

Raw egg white contains the protein avidin, which interacts with biotin; therefore, simultaneous intake of these substances should be avoided.

Consuming large quantities of raw eggs over a period of 2–3 weeks may lead to biotin deficiency.

The product contains lactose and therefore should not be used in patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.

Effect on clinical laboratory test results.

Biotin may interfere with laboratory tests based on biotin/streptavidin interaction, leading to falsely low or falsely high test results, depending on the assay type. The likelihood of obtaining inaccurate results increases in children and patients with impaired renal function, as well as with high-dose biotin use. The potential influence of biotin should be considered when interpreting laboratory test results, especially when results are inconsistent with clinical findings (e.g., thyroid function test results suggestive of Graves' disease in asymptomatic patients taking biotin, or falsely negative troponin test results in patients with myocardial infarction receiving biotin). In cases where biotin interference is suspected, alternative testing methods not sensitive to biotin should be used whenever possible. Laboratory personnel should be consulted prior to ordering tests for patients being treated with biotin.

Use during pregnancy or breastfeeding.

There is no experience with the use of this medicinal product during pregnancy or breastfeeding.

Ability to influence reaction rate while driving or operating machinery.

There are no study data indicating that the product affects the ability to drive or operate machinery.

Dosage and Administration.

The recommended dose for adults in the treatment of biotin deficiency (nail, hair, and skin disorders) is 2.5–5 mg of biotin per day.

For the treatment of genetically determined biotin-associated enzymopathies (multiple carboxylase deficiency), up to 10 mg of biotin per day may be administered.

Tablets should be taken before meals, without chewing, with sufficient liquid.

The duration of treatment depends on the nature and course of the disease.

Children.

Data on use in children are lacking.

Overdose.

Biotin has a wide therapeutic range. Cases of poisoning or overdose have not been reported.

Side effects.

Immune system disorders: allergic reactions, including chest pain, shortness of breath, urticaria, skin rashes.

If any adverse reactions occur, it is recommended to discontinue treatment and consult a physician.

Shelf life. 3 years. After opening the bottle – 9 months.

Storage conditions.

Store in a place inaccessible to children, in the original packaging, at a temperature not exceeding 25 °C.

Packaging.

Glass bottle containing 50 or 100 tablets in a cardboard box with instructions for medical use.

Availability. Over-the-counter (without prescription).

Manufacturer.

mibe GmbH Arzneimittel.

Manufacturer's address.

Muenchenersstrasse 15, Brehna, Saxony-Anhalt, 06796, Germany.