Instructions for use Natubiotin tablets 10 mg blister No. 30
Composition
active ingredient: biotin;
1 tablet contains 5 mg or 10 mg of biotin;
Excipients: microcrystalline cellulose; lactose monohydrate; povidone K30; crospovidone; magnesium stearate.
Dosage form
Pills.
Main physicochemical properties: round, white or almost white tablets.
Pharmacotherapeutic group
Simple vitamin preparations. ATX code A11H A05.
Pharmacological properties
Pharmacodynamics.
Biotin is a prosthetic group for various enzymes in numerous carboxylation and decarboxylation reactions. Thus, biotin plays an important role in gluconeogenesis, lipogenesis, fatty acid synthesis, propionate biotransformation, and leucine cleavage.
Prevalence in nature and daily requirement of the body
Biotin, which is widely distributed in the diet, is mostly bound to protein and occurs in the form of biocytin (food products of animal origin) and is rapidly reabsorbed after hydrolysis in the small intestine. In plants, biotin is partially present in free form. Since biotin is synthesized by the intestinal microflora, only the daily requirement of the human body can be estimated. An amount of 50 μg to 200 μg per day, which is obtained with a normal balanced diet, is considered sufficient. Taking even fairly high single doses of biotin does not cause any pharmacological effects.
Symptoms of biotin deficiency
Biotin deficiency is very rare. However, eating very large amounts of raw egg white can cause dermatitis, the so-called egg white lesion. Egg white contains the glycoprotein avidin, which forms a stable complex with biotin that is not broken down in the gastrointestinal tract. Thus, biotin cannot be available to the body and a biotin deficiency can develop. In addition, in biotin-associated multiple carboxylase deficiency, the need for biotin is increased due to a genetic defect. The deficiency is manifested by a reaction on the skin and its appendages, and specific mental symptoms and gastrointestinal disorders can result.
Pharmacokinetics.
Absorption of free biotin begins in the upper part of the small intestine. Here, the biotin molecule penetrates the intestinal wall unchanged. Absorption occurs mainly by diffusion. Recent studies also indicate active transport of the substance using the biotin-sodium carrier complex.
The degree of binding of biotin to blood plasma proteins is 80%.
The concentration of free or only weakly bound biotin in the blood is usually from 200 to 1200 μg/l. Biotin is excreted in the urine (from 6 to 50 μg per day) and feces. Biotin is excreted unchanged (about 50%) and half as biologically inactive metabolites. The optimal concentration in blood plasma is not exactly known. The half-life depends on the dose and is almost 26 hours after oral administration of 100 μg per kilogram of body weight. In patients with biotinidase deficiency, the half-life after the same dose is reduced to 10-14 hours.
Indication
Treatment and prevention of diseases caused by biotin deficiency: skin, nail, and hair diseases.
Treatment of genetically determined biotin-associated enzymopathies (multiple carboxylase deficiencies).
Contraindication
Hypersensitivity to biotin or to other components of the drug.
Special safety precautions
Raw egg white contains the protein avidin, which interacts with biotin, so you should avoid taking them simultaneously.
Eating a large amount of raw eggs for 2-3 weeks can cause biotin deficiency.
The drug contains lactose, therefore patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome should not use the drug.
Interaction with other medicinal products and other types of interactions
When using biotin with anticonvulsants, a decrease in the concentration of biotin in the blood plasma is possible due to increased urinary excretion. Valproic acid reduces the activity of biotinidase, reducing the function of mitochondria in the liver.
Pantothenic acid in large doses competes with biotin, so their simultaneous use should be avoided.
Application features
Impact on clinical laboratory tests.
When interpreting laboratory test results, the possible influence of biotin should be considered, especially if there is a lack of agreement with the clinical picture (e.g., thyroid test results mimicking Graves' disease in asymptomatic patients taking biotin, or false-negative troponin test results in patients with myocardial infarction taking biotin). When interference is suspected, alternative tests that are immune to biotin interference should be used.
When ordering laboratory tests, patients taking biotin should consult with laboratory personnel.
Use during pregnancy or breastfeeding
According to generally accepted principles, Natubiotin should be used during pregnancy or breastfeeding only if the expected benefit to the woman outweighs the potential risk to the fetus/child.
There is no information yet on the negative effects of the drug during pregnancy or breastfeeding. Biotin crosses the placenta and enters breast milk. Breast milk usually contains 7-13 mcg of biotin/l.
Ability to influence reaction speed when driving vehicles or other mechanisms
No effect.
Method of administration and doses
The recommended dose for adults in the treatment of biotin deficiency (diseases of nails, hair, skin) is 1 tablet of 5 mg per day.
For the treatment of genetically determined enzymopathies associated with biotin (multiple carboxylase deficiency), 1-2 tablets are prescribed (daily dose – 10 mg of biotin).
Take the tablets before meals, without chewing, with sufficient liquid.
The duration of the treatment course depends on the nature and course of the disease.
Children
Due to limited experience, the drug is not used in children under 12 years of age.
Children over 12 years of age should use the drug as prescribed by a doctor; there are no dosage recommendations due to limited data.
Overdose
To date, there have been no reports of biotin overdose.
Adverse reactions
On the part of the immune system: very rarely (˂ 1/10,000) - 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 doctor.
Reporting of adverse reactions
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report to doctors all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the automated pharmacovigilance information system at the link: https://aisf.dec.gov.ua.
Expiration date
5 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.
Packaging
30 tablets in a blister; 1 or 2 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Dr. Gustav Klein GmbH & Co. KG / Dr. Gustav Klein GmbH & Co. KG.
Location of the manufacturer and address of its place of business
Steinenfeld 3, 77736 Zell am Harmersbach, Germany/Steinenfeld 3, 77736 Zell am Harmersbach, Germany.
Address
Steinenfeld 3, 77736 Zell am Harmersbach, Germany/Steinenfeld 3, 77736 Zell am Harmersbach, Germany.
