Mebicar^® (Tablets) Instructions for Use

Instructions
Dosage forms

ATC Code

N06BX21 (Temgicoluril)

Active Substance

Temgicoluril (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Anxiolytic (tranquilizer)

Pharmacotherapeutic Group

Psychoanaleptics; psychostimulants, agents used in attention deficit hyperactivity disorder, and nootropic agents; other psychostimulants and nootropic agents

Pharmacological Action

Anxiolytic agent, tetramethyltetraazabicyclooctanedione. It also has an anticonvulsant effect. Without having a direct hypnotic effect, it regulates disturbed night sleep. It does not exhibit central or peripheral cholinoblocking properties. The anxiolytic effect is not accompanied by muscle relaxation and impaired coordination of movements.

Pharmacokinetics

It is excreted by the kidneys within 24 hours after administration.

Indications

Neuroses and neurosis-like states (irritability, emotional lability, anxiety, fear). Anxious-paranoid syndrome in schizophrenia, involutional and vascular psychoses. Chronic verbal hallucinosis of organic genesis. Complex therapy for the treatment of patients with cardialgia, coronary artery disease and rehabilitation after myocardial infarction. Reduction of craving for tobacco smoking, ethanol, psychoactive substances; improvement of tolerance to neuroleptics and tranquilizers.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
F06.0	Organic hallucinosis
F10	Mental and behavioral disorders due to alcohol use
F11	Mental and behavioral disorders due to opioid use
F13	Mental and behavioral disorders due to use of sedatives or hypnotics
F17	Mental and behavioural disorders due to use of tobacco
F20	Schizophrenia
F21	Schizotypal disorder
F22	Chronic delusional disorders
F23	Acute and transient psychotic disorders
F25	Schizoaffective disorders
F29	Unspecified nonorganic psychosis
F40	Phobic anxiety disorders (including agoraphobia, social phobias)
F41.0	Panic disorder [episodic paroxysmal anxiety]
F41.1	Generalized anxiety disorder
F41.2	Mixed anxiety and depressive disorder
F41.9	Anxiety disorder, unspecified
F45.3	Somatoform dysfunction of the autonomic nervous system
F48.0	Neurasthenia
F48.9	Unspecified neurotic disorder
I20	Angina pectoris
I21	Acute myocardial infarction
R07.2	Pain in the heart region
Y49.3	Phenothiazine antipsychotics and neuroleptics
Y49.4	Butyrophenone and thioxanthene derivative neuroleptics
Y49.5	Other antipsychotics and neuroleptics

ICD-11 code	Indication
6A20.Z	Schizophrenia, unspecified episode
6A21.Z	Schizoaffective disorder, unspecified
6A22	Schizotypal disorder
6A23.Z	Acute and transient psychotic disorder, unspecified
6A24.Z	Delusional disorder, unspecified
6A2Z	Schizophrenia or other primary psychotic disorders, unspecified
6A73	Mixed depressive and anxiety disorder
6A8Z	Affective disorders, unspecified
6B00	Generalized anxiety disorder
6B01	Panic disorder
6B0Z	Anxiety or fear-related disorders, unspecified
6B6Z	Dissociative disorders, unspecified
6C20.Z	Bodily distress disorder, unspecified
6C40.Z	Disorders due to alcohol use, unspecified
6C43.Z	Disorders due to opioid use, unspecified
6C44.Z	Disorders due to use of sedatives, hypnotics or anxiolytics, unspecified
6C4A.Z	Disorders due to nicotine use, unspecified
6C9Z	Disruptive behavior or dissocial disorders, unspecified
6E61.0	Secondary psychotic syndrome, with hallucinations
BA40.Z	Angina pectoris, unspecified
BA41.Z	Acute myocardial infarction, unspecified
MC86	Precordial pain
PL00	Drugs, medicaments or biological substances causing injury or harm in therapeutic use

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer Mebicar^® orally, regardless of food intake.

For adults, the typical dosage is 300 mg to 900 mg taken two to three times daily.

Do not exceed a maximum single dose of 3 grams.

Do not exceed a maximum daily dose of 10 grams.

For the management of neuroses, anxiety, and adjunct therapy in cardiac conditions, treatment duration typically ranges from several days to two to three months.

For chronic mental illnesses, such as schizophrenia, treatment courses may extend up to six months.

Adhere strictly to the dosage and duration prescribed by the physician.

Individualize the dosage based on the specific indication and patient response.

Adverse Reactions

Possible allergic reactions (skin itching), decreased blood pressure, hypothermia (by 1-1.5°C (29.3°F)), dyspepsia.

Contraindications

Hypersensitivity to temgicoluril.

Special Precautions

Decreased blood pressure and body temperature are not a reason to discontinue therapy and normalize on their own.

Influence on the ability to drive vehicles and mechanisms

During the treatment period, caution must be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

It enhances the effect of hypnotic agents.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.

Medical Disclaimer