Registration number: Р N003744/01
Trade name: Biotredin®
International non-proprietary name: pyridoxine + threonine.
Dosage form: sublingual tablets.
Ingredients per 1 tablet: active ingredients: threonine – 100 mg, pyridoxine hydrochloride – 5 mg; excipients: povidone (K17) – 3.51 mg, citric acid monohydrate – 0.59 mg, lactose monohydrate – 6.73 mg, magnesium stearate – 1.17 mg.
Appearance: round flat beveled cylindrical tablets, white to cream-white colour.
Therapeutic category: B vitamins, other combinations.
ATC code: A11JC.
Biotredin® is a regulator of tissue metabolism, increases mental efficiency, has a therapeutic effect on alcohol withdrawal symptoms, reduces craving for alcohol.
Threonine in the presence of pyridoxine (vitamin B6) breaks down into the amino acid glycine and acetaldehyde, which stimulate inhibition processes and redox reactions, respiration process and synthesis of adenosine triphosphate (ATP) in cells, due to which the drug is capable to:
- improve short and long term memory;
- improve mental efficiency;
- reduce psycho-emotional stress;
- increase and normalize the level of endogenous acetaldehyde and, thereby, reduce the alcohol withdrawal syndrome and craving for alcohol.
The effect of Biotredin® appears in 10–20 minutes after sublingual administration.
Pharmacokinetics: threonine and pyridoxine are completely metabolized to final products. There is no accumulation of chemicals in the body.
Indications for use
Indications for use: The medicine is prescribed for children, adolescents and adults with a decrease in mental efficiency and concentration.
The medicine is also prescribed to persons with alcohol abuse, patients with chronic alcoholism in a period of actualization of a pathological craving, combined with affective (irritability, low mood, internal discomfort), sensory (hunger) and ideational (thoughts about alcohol) disorders, with alcohol withdrawal syndrome, and also to maintain remission.
Contraindications: alcohol intoxication, the simultaneous administration of drugs that depress the central nervous system (anxiolytics, antipsychotics (neuroleptics), antidepressants, etc.), hypersensitivity to vitamin B6.
The medicine is not recommended for use in congenital galactosemia, glucose malabsorption syndrome and congenital lactase deficiency, as it contains lactose.
Precautions for use: does not require special precautions.
Dosage and administration
Administration of the drug during pregnancy and breastfeeding: no specific studies have been conducted. Not recommended for use during pregnancy and breastfeeding.
In case of alcohol abuse and alcoholism the drug can be used during pregnancy and during breastfeeding, if the expected therapeutic effect outweighs the risk of possible side effects.
Dosage and administration: the drug is administered sublingually or as a powder after crushing the tablet. The greatest effect of Biotredin® is achieved when combined with Glycine. 1 tablet (100 mg) of Glycine can be taken sublingually 10-15 minutes before Biotredin®.
To enhance concentration, mental efficiency in children, adolescents and adults: 1 tablet 2-3 times a day for 3-10 days. If necessary, the medication can be repeated 3-4 times or more during a year.
Treatment of alcohol withdrawal syndrome: 1-4 tablets 3-4 times at first day (daily dose – 3-16 tablets), further 1-2 tablets 2-3 times a day (daily dose 3-6 tablets) for 21-28 days. The medication can be shortened to 10-14 days.
Patients with chronic alcoholism and alcohol abuse: 1-3 tablets 2-3 times a day for 4-5 days. If necessary, courses are repeated 5-10 times a year.
During the period of remission to reveal the latent craving for alcohol: 2-3 tablets fasted. In case there is a slight dizziness, calming effect, facial redness or sweating in 10–20 minutes after intake, hidden craving can be considered as existing. In that case, a 5-10-day treatment by Biotredin® together with Glycine is recommended: 1-2 tablets of Biotredin® 2-3 times a day; and 1 tablet (100 mg) of Glycine sublingually, 10-15 minutes before each intake of Biotredin®.
Side effects: dizziness, sweating, allergic reactions to vitamin B6.
Overdose: no cases of overdose have been identified.
Drug interactions: incompatible with antipsychotic drugs, antidepressants, anxiolytics, barbiturates. Weakens the effect of antipsychotics (neuroleptics), antidepressants, barbiturates and other drugs that depress the central nervous system.
Possible effects on ability to drive vehicles or use potentially dangerous machines: does not affect.
Special warnings: is not recommended to use during the period of alcohol intoxication, because the therapeutic effect of the drug can be decreased in this period. The drug contains lactose, therefore, it is not recommended for patients with congenital galactosemia, glucose malabsorption syndrome or congenital lactase deficiency.
Package: sublingual tablets, 5 mg +100 mg. 30 tablets in a blister made of polyvinyl chloride film and aluminum foil. 1 blister together with instructions for use in a cardboard box.
Storage conditions: in a dark place at a temperature not exceeding 25 С°.
Keep out of the reach of children.
Shelf life: 3 years.
Do not use after labeled expiration date.
Prescription status: no prescription required.
Name and address of manufacturer/company which accepts customer complaints: LLC “Medical Scientific and Production Complex “BIOTIKI”. Russia, 115404, Moscow, 6th Radialnaya st., 24, bldg. 1, 2, 14, 15.
Phone: +7 (495) 327-86-30
Toll-free hotline in Russia: 8-800-100-32-22