Glycine

INSTRUCTION for medical use of the medicinal product Glycine (Glycinе)

Composition:

Active ingredient: glycine;

1 sublingual tablet contains glycine 100 mg;

Excipients: povidone, glycol montan wax, ammonium methacrylate copolymer (type A), calcium stearate.

Pharmaceutical form. Sublingual tablets.

Main physicochemical properties: white tablets with a bevel and a score line.

Pharmacotherapeutic group. Agents acting on the nervous system.

ATC code N07XX.

Pharmacological Properties.

Pharmacodynamics.

Glycine belongs to the group of non-essential amino acids. Glycine readily penetrates into most biological fluids and tissues of the body, including the brain, undergoes metabolism; its accumulation in tissues does not occur. It is rapidly degraded in the liver by glycine oxidase into water and carbon dioxide.

Pharmacokinetics.

Glycine is a central neurotransmitter that regulates metabolism; it normalizes and activates protective inhibition processes in the central nervous system. It improves metabolic processes in brain tissues and exerts antidepressant and sedative effects. Glycine produces glycine-ergic and GABA-ergic actions, α1-adrenoblocking, antioxidant, and antitoxic effects; it regulates the activity of glutamatergic (NMDA) receptors, thereby reducing psychoemotional tension, aggression, and conflict behavior; enhances social adaptation, improves mood; facilitates falling asleep and normalizes sleep, increases mental performance, and reduces the severity of vegetative-vascular disorders.

L-glycine (glycocoll) participates in the synthesis of the most important substances for the body: nucleic acids, glutathione, bile acids, etc. Glycine is used in the synthesis of porphyrin—the precursor of heme in the hemoglobin molecule—as well as purine bases, which are essential components of nucleic acids. Glycine is part of glutathione-containing compounds, playing a significant role in the body's antioxidant defense system.

Glycine participates in detoxification reactions by becoming a component of hippuric acid, as well as in the synthesis of bile acids (glycocholic acid). In addition, glycine is important for the biosynthesis processes of oxalic acid.

Clinical characteristics.

Indications.

Reduced mental performance. In stressful situations and psychoemotional strain (during examination periods, in conflict situations). Deviant forms of behavior in children and adults.
Functional and organic disorders of the nervous system (neuroses, neurosis-like conditions, vegetative-vascular dystonia, sequelae of neuroinfection and traumatic brain injury, perinatal and other forms of encephalopathy, including those of alcoholic origin), accompanied by increased excitability, emotional instability, reduced mental performance, and sleep disturbances.

Ischemic stroke and cerebral circulation disorders.

As an auxiliary agent in the treatment of alcoholism.

Contraindications.

Individual intolerance to the drug and hypersensitivity to its individual components; arterial hypotension. Children under 3 years of age.

Special precautions.

Patients with a tendency to arterial hypotension should have their arterial pressure monitored, and if necessary, the drug dosage should be adjusted: Glycine should be administered in lower doses, with regular monitoring of arterial pressure. If arterial pressure values fall below the normal level, administration of the drug should be discontinued.

Interaction with other medicinal products and other types of interactions.

Glycine reduces the toxicity of anticonvulsants, antipsychotics, antidepressants, and antiseizure agents. When combined with sedatives, tranquilizers, and antipsychotic drugs, the inhibitory effect on the central nervous system is enhanced.

Special precautions for use.

Use during pregnancy or breastfeeding.

The effect of Glycine on the body during pregnancy or breastfeeding has not been thoroughly studied; therefore, the use of the drug is not recommended.

Ability to influence reaction rate when driving or operating machinery.

Caution should be exercised when driving or operating machinery, as well as during potentially hazardous activities.

Method of Administration and Dosage

Glycine is administered transbuccally or sublingually (in tablet form, the tablet may be crushed into powder before use).

Children from 3 years of age, adolescents, and adults: For decreased mental performance, memory, attention, mental retardation, psychoemotional stress, and deviant behavioral patterns, Glycine is prescribed at 1 tablet (100 mg) 2–3 times daily for 14–30 days.

Maximum daily dose: 300 mg.

Children from 3 years of age and adults: For functional and organic disorders of the nervous system (neuroses, neurosis-like conditions, vegetative-vascular dystonia, sequelae of neuroinfections and traumatic brain injury, perinatal and other forms of encephalopathy), the recommended dose is 1 tablet 2–3 times daily for 7–14 days. If necessary, the treatment course may be repeated.

For sleep disorders, 50–100 mg should be administered 20 minutes before bedtime or immediately before sleep.

In ischemic stroke and cerebral circulation disorders: 1 g of the drug is administered transbuccally or sublingually (the tablet may be crushed if necessary) within the first 3–6 hours after stroke onset, followed by 1 g daily for the next 1–5 days, and then 1–2 tablets 3 times daily for days 6–30.

In the treatment of alcoholism: the drug is used as an adjunctive therapy at 1 tablet 2–3 times daily for 14–30 days. If necessary, treatment courses may be repeated 4–6 times per year.

Children

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

Overdose

There is no reported clinical data on symptoms of overdose.

Side effects.

In individual cases, with increased individual sensitivity, allergic reactions may develop, namely: rhinitis, conjunctivitis, urticaria, throat irritation, weakness.

Gastrointestinal side effects may include dyspeptic symptoms such as epigastric pain and nausea. Isolated cases of nervous system-related adverse events have been observed, including impaired concentration, headache, tension, and irritability.

Shelf life.

3 years. Do not use after the expiry date.

Storage conditions.

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

Packaging.

50 sublingual tablets in a blister pack. 1 blister pack in a cardboard box.

Availability.

Over-the-counter (without prescription).

Manufacturer.

LLC "Arpimed".

Manufacturer's address and place of business.

Building 19, 2nd microdistrict, city of Abovyan, Kotayk region, Republic of Armenia.