Teraligen valenta 5 mg 100 pcs. film-coated tablets

Pharmacodynamics and pharmacokinetics

Teraligen is an antipsychotic (antipsychotic) that has serotonin-blocking , antispasmodic and antihistamine effects, as well as hypnotic , antiemetic , antitussive and sedative effects.

You can observe the effect after taking it within 10-15 minutes, its duration of action is from 6 to 8 hours.

The drug has low antipsychotic activity , so it is ineffective in the acute stage of psychotic conditions .

It is also used for the treatment of elderly people, as well as children and adolescents, as the drug is well tolerated.

Absorbed completely, quickly, the maximum concentration in plasma can be observed after administration after 1-2 hours. Within 2 days it is excreted as a metabolite by the kidneys (70-80%).

Teraligen® Valenta

In adults and children from 7 years of age

:

As a sedative (calming), anxiolytic (anti-anxiety) and sleep aid

:

— dementia

(including dementia due to epilepsy), occurring with manifestations of psychomotor agitation, anxiety affect (as part of combination therapy);

— organic anxiety disorder

(as monotherapy or as part of combination therapy);

— schizophrenia

(with a predominance of neurosis-like disorders, as part of combination therapy);

— mood disorders

(affective disorders) - as part of combination therapy;

— generalized anxiety disorder

(as part of combination therapy);

— obsessive-compulsive disorder

(as part of combination therapy);

— reaction to severe stress and adaptation disorders

(acute stress reaction, post-traumatic stress disorder, unspecified reaction to severe stress, other reactions to severe stress) - as part of combination therapy;

— dissociative (conversion) disorders

(as part of combination therapy
);
- somatoform disorders

(somatization disorder, undifferentiated somatoform disorder, hypochondriacal disorder, somatoform dysfunction of the autonomic nervous system, persistent somatoform pain disorder, unspecified somatoform disorder, other somatoform disorders) - as part of combination therapy for severe anxiety or when standard therapy is ineffective;

— unspecified autonomic nervous system disorder, other autonomic nervous system disorders

(as part of combination therapy);

— anorexia nervosa

(as part of combination therapy);

— emotionally unstable personality disorder (impulsive and borderline types)

- as part of combination therapy;

— histrionic personality disorder, anxious (avoidant) personality disorder

(as part of combination therapy);

— persistent personality changes after experiencing a disaster

(as part of combination therapy);

— hyperkinetic behavior disorder

(as part of combination therapy);

— family-confined conduct disorder

(as part of combination therapy when standard therapy is ineffective);

— unsocialized behavior disorder

(as monotherapy or as part of combination therapy);

— restlessness, agitation and other symptoms and signs related to emotional state

(as part of combination therapy);

- other neurotic disorders
(neurasthenia, unspecified neurotic disorder)
- as part of combination therapy;

— insomnia of non-organic etiology

(as part of combination therapy when standard therapy is ineffective);

— emotional disorders whose onset is specific to childhood

(phobic anxiety disorder in childhood, social anxiety disorder in childhood, sibling rivalry disorder, unspecified emotional disorder in childhood, other emotional disorders in childhood) - as part of combination therapy.

As an antiallergic agent

:

— itching regardless of location and etiology

(pruritus of the anus, pruritus of the vulva, unspecified anogenital pruritus, pruritus due to photocontact dermatitis and solar urticaria, dermatitis, eczema, urticaria, bites or stings from non-venomous insects or other non-venomous arthropods, chickenpox, measles, Hodgkin's disease, diabetes mellitus, shingles lichen) in the form of monotherapy or as part of combination therapy;

— asthma, hay fever, whooping cough

(as part of complex therapy as an antiallergic agent to relieve cough, shortness of breath and asthma attacks);

— unspecified allergy

(as monotherapy or as part of combination therapy).

In children from 3 years old

:

As an antiallergic agent

:

— itching regardless of location and etiology

(itching from photocontact dermatitis and solar urticaria, dermatitis, eczema, urticaria, bites or stings from non-venomous insects or other non-venomous arthropods, chickenpox, measles, Hodgkin's disease, diabetes mellitus, herpes zoster, anal itching, vulvar itching, unspecified anogenital itching) as monotherapy or as part of combination therapy.

As a sedative (calming) agent

:

— during medicinal preparation for surgery

(for the purpose of sedation before surgery).

Indications for use

This medicine is used to treat the following diseases:

• sleep disorders;
• senestopathic depression;
• in case of somatic diseases, a state of anxiety and excitement;
• psychopathy with psychoasthenic and asthenic disorders;
• somatized mental disorders;
• neuroses and neurosis-like conditions of organic or endogenous origin with hypochondriacal , psychovegetative , senestopathic and phobic disorders ;
• allergic reactions;
• anxiety-depressive diseases (with vascular and borderline diseases).

TERALIGEN VALENTA

Indications

As a sedative (calming), anxiolytic (anti-anxiety) and hypnotic:
- dementia (in

including dementia due to epilepsy), occurring with manifestations of psychomotor agitation, anxiety affect (as part of combination therapy);

— organic anxiety disorder

(as monotherapy or as part of combination therapy);

— schizophrenia

(with a predominance of neurosis-like disorders, as part of combination therapy);

— mood disorders

(affective disorders) - as part of combination therapy;

— generalized anxiety disorder

(as part of combination therapy);

— obsessive-compulsive disorder

(as part of combination therapy);

— reaction to severe stress and adaptation disorders (acute

stress reaction, post-traumatic stress disorder, unspecified reaction to severe stress, other reactions to severe stress) - as part of combination therapy;

— dissociative (conversion) disorders

(as part of combination therapy);

— somatoform disorders

(somatization disorder, undifferentiated, somatoform disorder, hypochondriacal disorder, somatoform dysfunction of the autonomic nervous system, persistent somatoform pain disorder, unspecified somatoform disorder, other somatoform disorders) - as part of combination therapy for severe anxiety or when standard therapy is ineffective;

— unspecified autonomic nervous system disorder, other autonomic nervous system disorders

(as part of combination therapy);

— anorexia nervosa

(as part of combination therapy);

— emotionally unstable personality disorder

(impulsive and borderline types) - as part of combination therapy;

- histrionic personality disorder, anxious (avoidant, avoidant) personality disorder

(as part of combination therapy);

— persistent personality changes after experiencing a disaster

(as part of combination therapy);

— hyperkinetic behavior disorder

(as part of combination therapy);

— family-confined conduct disorder

(as part of combination therapy when standard therapy is ineffective);

— unsocialized behavior disorder

(as monotherapy or as part of combination therapy);

— restlessness, agitation and other symptoms and signs related to emotional state

(as part of combination therapy);

— other neurotic disorders

(neurasthenia, unspecified neurotic disorder) - as part of combination therapy;

— insomnia of non-organic etiology

(as part of combination therapy when standard therapy is ineffective);

— emotional disorders whose onset is specific to childhood

(phobic anxiety disorder in childhood, social anxiety disorder in childhood, sibling rivalry disorder, unspecified emotional disorder in childhood, other emotional disorders in childhood) - as part of combination therapy.

As an antiallergic agent:

- itching regardless of location and etiology (anal itching, vulvar itching, unspecified anogenital itching, itching with photocontact dermatitis and solar urticaria, dermatitis, eczema, urticaria, bites or stings from non-venomous insects or other non-venomous arthropods, chickenpox, measles, Hodgkin's disease , diabetes mellitus, herpes zoster) as monotherapy or as part of combination therapy;

— asthma, hay fever, whooping cough

(as part of complex therapy as an antiallergic agent to relieve cough, shortness of breath and asthma attacks);

— unspecified allergy (in

as monotherapy or as part of combination therapy).

Contraindications

Teraligen has a number of contraindications:

• children under 7 years old;
• hypersensitivity to any ingredient of the drug;
• myasthenia gravis;
• pregnancy;
• prostatic hyperplasia;
• taking MAO inhibitors ;
• lactation;
• parkinsonism;
• angle-closure glaucoma;
• Reye's syndrome;
• kidney and liver diseases (severe stage).

The drug is prescribed with caution in the following cases: bone marrow suppression , epilepsy , arterial hypotension , chronic alcoholism, jaundice , predisposition to urinary retention, open-angle glaucoma , bladder neck obstruction .

Teraligen valenta 5 mg 100 pcs. film-coated tablets

pharmachologic effect

Antipsychotic (neuroleptic).

Composition and release form Teraligen valenta 5 mg 100 pcs. film-coated tablets

Tablets - 1 tablet:

• active ingredient: alimemazine tartrate - 5.0 mg or 10.0 mg;
• excipients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide (aerosil), croscarmellose sodium, magnesium stearate;
• shell composition: Opadry II 85F34655: partially hydrolyzed polyvinyl alcohol, macrogol-3350, talc, titanium dioxide E 171, carmine red dye E 120, aluminum varnish based on sunset yellow dye E 110, aluminum varnish based on indigo carmine E 132.

Film-coated tablets, 5 mg and 10 mg.

25 tablets in a blister pack or in a blister pack with perforation made of polyvinyl chloride film and printed varnished aluminum foil.

1, 2 or 4 contour packages along with instructions for use are placed in a pack.

Description of the dosage form

Dark pink film-coated tablets with an embossed symbol on one side and a stripe on the other.

Directions for use and doses

Inside. Without chewing. The effect of the drug is dose-dependent; doses are selected depending on the goals of therapy.

For adults

To achieve a vegetative stabilizing effect, 15-60 mg/day.

To achieve an anxiolytic effect, 20-80 mg/day.

To achieve a sedative and/or hypnotic effect, 5-10 mg once (20-30 minutes before bedtime).

For the symptomatic treatment of allergic reactions, 10-40 mg/day.

The course of treatment should begin with 2.5-5 mg in the evening with a gradual increase in the daily dose until the desired effect. The daily dose can be divided into 3-4 doses. The duration of the course of treatment can be from 2 to 6 or more months and is determined by the doctor.

The highest dose for adults is 500 mg/day, for elderly people (over 60 years old) - 200 mg/day.

Children from 7 years of age are prescribed according to the following scheme (depending on age and body weight).

To achieve an anxiolytic effect, 20-40 mg/day.

The course of treatment should begin with 2.5-5 mg with a gradual increase in the daily dose until the desired effect. The daily dose can be divided into 3-4 doses.

To achieve a sedative and/or hypnotic effect, 2.5-5 mg once (20-30 minutes before bedtime).

To achieve a sedative effect in behavioral disorders in psychotic conditions, it is possible to increase the daily dose to 60 mg/day.

For the symptomatic treatment of allergic reactions, 5-20 mg/day.

The duration of the course of treatment can be from 2 to 6 or more months and is determined by the doctor.

Children from 3 years old

For the symptomatic treatment of allergic reactions, 2.5-5 mg 3-4 times a day. The duration of the course of treatment can be from 2 to 6 or more months and is determined by the doctor.

For the purpose of sedation before surgery, children from 3 to 7 years old are prescribed at the rate of 2 mg/kg 1-2 hours before surgery. The maximum daily dose is 2 mg/kg.

Pharmacodynamics

It is a phenothiazine derivative.

Alimemazine acts as a mild sedative and anti-anxiety agent, has a positive effect on senesthopathy, obsession and phobia.

It is used for psychosomatic manifestations that develop as a result of neurovegetative disorders, vascular, traumatic and infectious disorders of the central nervous system. The sedative effect helps normalize sleep in patients in this category.

Has antiemetic and antitussive activity.

The sedative and anxiolytic effect is due to the blockade of adrenergic receptors in the reticular formation of the brain stem. The antiemetic and vegetative-stabilizing effect is due to the blockade of dopamine D2 receptors in the trigger zone of the vomiting center.

Due to its antihistamine activity, alimemazine is used for allergic diseases, especially the respiratory tract, and for itchy skin.

Alimemazine is more active in antihistamine and sedative action than diprazine. The antipruritic effect is due to the effect on type 1 histamine receptors.

Pharmacokinetics

Quickly and completely absorbed by any route of administration. The effect of alimemazine begins 15-20 minutes after administration and lasts 6-8 hours. The binding to plasma proteins is 20-30%. Metabolized in the liver. Excreted by the kidneys - 70-80% in the form of a metabolite (sulfoxide).

Indications for use Teraligen valenta 5 mg 100 pcs. film-coated tablets

In adults and children from 7 years of age

As a sedative (calming), anxiolytic (anti-anxiety) and sleep aid:

• dementia (including dementia due to epilepsy), occurring with manifestations of psychomotor agitation, anxiety affect (as part of combination therapy);
• organic anxiety disorder (as monotherapy or as part of combination therapy);
• schizophrenia (with a predominance of neurosis-like disorders, as part of combination therapy);
• mood disorders (affective disorders) - as part of combination therapy;
• generalized anxiety disorder (as part of combination therapy);
• obsessive-compulsive disorder (as part of combination therapy);
• reaction to severe stress and adaptation disorders (acute reaction to stress, post-traumatic stress disorder, unspecified reaction to severe stress, other reactions to severe stress) - as part of combination therapy;
• dissociative (conversion) disorders (as part of combination therapy);
• somatoform disorders (somatization disorder, undifferentiated somatoform disorder, hypochondriacal disorder, somatoform dysfunction of the autonomic nervous system, persistent somatoform pain disorder, unspecified somatoform disorder, other somatoform disorders) - as part of combination therapy for severe anxiety or when standard therapy is ineffective;
• unspecified disorder of the autonomic nervous system, other disorders of the autonomic nervous system (as part of combination therapy);
• anorexia nervosa (as part of combination therapy);
• emotionally unstable personality disorder (impulsive and borderline types) - as part of combination therapy;
• hysterical personality disorder, anxious (avoidant, avoidant) personality disorder (as part of combination therapy);
• persistent personality change after experiencing a disaster (as part of combination therapy);
• hyperkinetic behavior disorder (as part of combination therapy);
• behavioral disorder limited to the family (as part of combination therapy when standard therapy is ineffective);
• unsocialized behavior disorder (as monotherapy or as part of combination therapy);
• anxiety, agitation and other symptoms and signs related to the emotional state (as part of combination therapy);
• other neurotic disorders (neurasthenia, unspecified neurotic disorder) - as part of combination therapy;
• insomnia of non-organic etiology (as part of combination therapy when standard therapy is ineffective);
• emotional disorders whose onset is specific to childhood (phobic anxiety disorder of childhood, social anxiety disorder of childhood, sibling rivalry disorder, unspecified emotional disorder of childhood, other emotional disorders of childhood) - as part of combination therapy.

As an antiallergic agent:

• itching regardless of location and etiology (anal itching, vulvar itching, unspecified anogenital itching, itching due to photocontact dermatitis and solar urticaria, dermatitis, eczema, urticaria, bites or stings from non-venomous insects or other non-venomous arthropods, chicken pox, measles, Diseases Hodgkin's disease, diabetes mellitus, herpes zoster) as monotherapy or as part of combination therapy;
• asthma, hay fever, whooping cough (as part of complex therapy as an antiallergic agent to relieve cough, shortness of breath and asthma attacks);
• unspecified allergy (as monotherapy or as part of combination therapy).

In children from 3 years old

As an antiallergic agent:

• itching regardless of location and etiology (itching due to photocontact dermatitis and solar urticaria, dermatitis, eczema, urticaria, bites or stings from non-venomous insects or other non-venomous arthropods, chickenpox, measles, Hodgkin's disease, diabetes mellitus, shingles, itching of the anus, itching vulva, unspecified anogenital itching) as monotherapy or as part of combination therapy.

As a sedative (calming agent):

• during medicinal preparation for surgery (for the purpose of sedation before surgery).

Contraindications

• Hypersensitivity to the components of the drug;
• lactose intolerance, lactase deficiency, glucose-galactose malabsorption;
• angle-closure glaucoma;
• prostatic hyperplasia;
• severe liver and/or kidney failure;
• parkinsonism;
• myasthenia gravis;
• Reye's syndrome;
• simultaneous use of monoamine oxidase inhibitors (MAO);
• pregnancy;
• lactation period;
• children up to 3 years of age when used as an antiallergic agent and for sedation before surgery, up to 7 years for other indications.

Carefully

The drug should be used with caution in case of alcoholism if there is a history of complications when using phenothiazine drugs; with obstruction of the bladder neck; predisposition to urinary retention; for epilepsy; open-angle glaucoma; jaundice; suppression of bone marrow function; arterial hypotension.

Application of Teraligen valenta 5 mg 100 pcs. film-coated tablets during pregnancy and breastfeeding

Contraindicated for use during pregnancy and lactation (breastfeeding). If pregnancy occurs during treatment, the drug should be discontinued.

If it is necessary to use the drug during lactation, breastfeeding should be stopped.

special instructions

Alimemazine may mask the ototoxic effect (tinnitus, dizziness) of co-administered drugs.

Alimemazine increases the body's need for riboflavin.

To prevent distortion of the results of skin prick tests for allergens, the drug should be discontinued 72 hours before allergy testing.

During treatment, false positive results for pregnancy are possible.

During treatment you should not drink alcohol.

Impact on the ability to drive vehicles and operate machinery

During treatment with the drug, you should not engage in activities that require increased concentration of attention and speed of psychomotor reactions (driving a car and other vehicles, working with moving mechanisms, working as a dispatcher and operator).

Overdose

Symptoms: increased manifestations of the described side effects, with the exception of allergic reactions.

Treatment: drug withdrawal, symptomatic therapy.

Side effects Teraligen valenta 5 mg 100 pcs. film-coated tablets

Side effects are extremely rare and mild.

From the nervous system: drowsiness, lethargy, fatigue (occurs mainly in the first days of use and rarely requires discontinuation of the drug), paradoxical reaction (anxiety, agitation, nightmares, irritability); confusion, extrapyramidal disorders (hypokinesia, akathisia, tremor).

From the senses: blurred visual perception (accommodation paresis), noise or ringing in the ears.

From the cardiovascular system: dizziness, decreased blood pressure (BP), tachycardia.

From the digestive system: dryness of the oral mucosa, atony of the gastrointestinal tract, constipation, loss of appetite.

From the respiratory system: dry nose, throat, increased viscosity of bronchial secretions.

From the urinary system: bladder atony, urinary retention.

Other: allergic reactions, inhibition of bone marrow hematopoiesis, increased sweating, muscle relaxation, photosensitivity.

Drug interactions

Alimemazine enhances the effects of narcotic analgesics, hypnotics, anxiolytic (tranquilizers) and antipsychotic (neuroleptic) drugs (drugs), as well as drugs for general anesthesia, m-anticholinergic drugs and antihypertensive drugs (dose adjustment required).

Tricyclic antidepressants and anticholinergic drugs enhance the m-anticholinergic activity of alimemazine.

With the simultaneous use of alimemazine with ethanol, increased depression of the central nervous system is possible.

Alimemazine weakens the effect of phenamine derivatives, m-cholinomimetics, ephedrine, guanethidine, levodopa, dopamine.

When alimemazine is used together with antiepileptic drugs and barbiturates, the threshold for convulsive activity is reduced (dose adjustment required).

When alimemazine is used together with beta-blockers, a pronounced decrease in blood pressure and arrhythmias are possible.

Alimemazine weakens the effect of bromocriptine.

With simultaneous use in nursing mothers, an increase in the concentration of prolactin in the blood serum is possible.

With the simultaneous use of alimemazine and MAO inhibitors (simultaneous use is not recommended) and alimemazine and phenothiazine derivatives, the risk of arterial hypotension and extrapyramidal disorders increases.

With the simultaneous use of alimemazine with drugs that inhibit bone marrow hematopoiesis, the risk of myelosuppression increases.

The combined use of phenothiazine derivatives (which includes alimemazine) with hepatotoxic drugs may enhance the manifestations of hepatotoxicity of the latter.

Side effects

Teraligen tablets are well tolerated and rarely cause side effects.

The following side effects are possible:

• tachycardia , decreased blood pressure , dizziness ;
• accommodation paresis , ringing, tinnitus;
• increased viscosity of bronchial secretions, dry throat and nose;
• lethargy, drowsiness, fatigue (these symptoms usually occur in the first days and do not require discontinuation of the drug), nightmares, anxiety, irritability, agitation; in rare cases, hypokinesia , confusion, tremor , akathisia , and in children - increased convulsive activity;
• urinary retention, bladder atony ;
• loss of appetite, constipation , gastrointestinal atony, dry mouth;
• muscle relaxation , inhibition of hematopoiesis in the bone marrow, photosensitivity , allergic reactions, increased sweating.

Instructions for use of Teraligen (Method and dosage)

The tablets are intended for oral administration.

To obtain a hypnotic effect, adults need to take 5-10 mg per day, an anxiolytic effect - 60-80 mg, and in a psychotic state - 0.2-0.4 g.

Instructions for Tiralijen for children (over 7 years old): to achieve a hypnotic effect - 2.5-5 mg, anxiolytic effect - 20-40 mg, for the treatment of allergic reactions - 5-20 mg. The daily dose for a psychotic state can be increased to 60 mg.

The daily dose should be divided into 3-4 doses.

Psychotropic drugs with multireceptor activity, in particular traditional minor neuroleptics, have firmly won their place not only in psychiatry, but also in many other areas of medicine. However, today there is a tendency to give preference to modern atypical psychotropic drugs due to their greater selectivity of action and better tolerability. But, as practice shows, not all “new” drugs can demonstrate high efficiency, and in turn, not all “old” drugs are characterized by a high severity of adverse effects and can successfully compete with modern drugs in terms of effectiveness. Teraligen (alimemazine) occupies a special place in the group of traditional minor antipsychotics. Alimemazine is one of the phenothiazine derivatives - 10-(3-dimethylamino-2-methylpropyl)-phenothiazine hydrotartrate - and is close in chemical structure to diprazine and levomepromazine. This drug was synthesized in France in the laboratory in 1958 and quickly found its use as a strong “neurostatic, antihistamine and vegetotropic drug” [17]. It is distributed under the trade names: Panectyl - in Canada, Repeltin - in Germany, Temaril - in the USA, Theralen - in France and Italy, Vallergan - in England, etc.

Currently, in Russia, alimemazine exists under the commercial name “Teraligen” and is produced.

The pharmacological properties of alimemazine were first studied by S. Courvoisier [17], I. Rosenblum [24] and A. Fernandez-Zoila [18]. In comparative studies, these authors found that alimemazine has a less pronounced adrenolytic effect than chlorpromazine and is inferior to it in the severity of its antiemetic and general depressive effects, but is superior to it in its effect on the general tone of the autonomic nervous system and in its antispasmodic effect on smooth muscles , as well as antihistamine and antiserotonin effects. Subsequently, many researchers turned to the study of alimemazine, finding new facets of the use of the drug. It was found that alimemazine combines neuroleptic and anxiolytic properties and has significantly less parkinsonian and hypotensive effects than other phenothiazine derivatives. According to the results of early [16, 21, 22, 23] and more modern studies [5, 6, 8] of the mechanism of action of alimemazine, it was found that it has antihistamine, antispasmodic, serotonin-blocking, moderate α-adrenergic blocking, as well as antiemetic, hypnotic, sedative and antitussive actions. The antipsychotic effect is due to the blockade of dopamine D2 receptors of the mesolimbic and mesocortical systems and is implemented in a dose of 200 mg/day, according to the instructions. The vegetative stabilizing effect is associated with the blockade of noradrenergic receptors. Sedative and hypotensive effects are caused by blockade of adrenergic receptors of the reticular formation of the brain stem; sleeping pills and antihistamines - with blockade of histamine receptors; anxiolytic effect - with blockade of serotonin and adrenergic receptors; the antispasmodic effect is associated with blocking cholinergic and noradrenergic receptors; antiemetic effect - with blockade of D2 receptors of the trigger zone of the vomiting center; hypothermic effect - with blockade of dopamine receptors of the hypothalamus. The effect of the drug begins 15–20 minutes after taking it, and the duration of action is 6–8 hours.

Due to its properties, alimemazine quickly found application in a variety of areas of clinical medicine. As a drug that has an antiallergic effect and affects the general tone of the autonomic nervous system [1, 3, 12], the drug began to be used in the practice of treating skin diseases (pruritic and allergic dermatoses) [13, 20] and internal diseases (for dyspneic disorders), otorhinolaryngology (Meniere's disease and Meniere-like attacks), various allergic diseases [5, 21]. In addition, alimemazine is used during the preparation of patients for such painful and complex procedures and studies as esophagoscopy, gastroscopy, etc. In gastroenterology, it is also used to relieve pain in peptic ulcers and chronic colitis [5, 8]. In gynecological practice, the drug is used for premenstrual syndrome, dysmenorrhea, chronic inflammatory processes in the pelvis, lumbodynia, etc. [23].

Being an antipsychotic, Teraligen (alimemazine) has found its widest use in psychiatry and neurology. According to A. Fernandez-Zoila [18], who studied the drug in outpatient practice, Teraligen has pronounced tranquilizing and hypnotic effects. In the treatment of psychotic disorders, it can soften the manifestations of states of psychomotor agitation, hallucinations and normalize sleep. According to various authors [4, 11, 14, 15, 16], Teraligen occupies one of the most important places among anxiolytics, and combination treatment in combination with antidepressants, depending on the characteristics of the structure of the psychopathological syndrome, significantly increases its therapeutic effect in the treatment of affective and neurotic disorders.

Today, in practical psychiatry, Teraligen is equally widely used in hospitals and in outpatient care, both as the main therapeutic drug and in combination with other psychotropic drugs, incl. and neuroleptics. Most often, Teraligen is prescribed for the treatment of borderline and neurotic disorders, in particular hypochondriacal and somatoform conditions with gastrointestinal dysfunction. Clinical example: patient T., 53 years old. Diagnosis: post-traumatic stress disorder, somatoform disorder (ICD-10 code F43.1, F45.32). Nurse, married, has an adult son. Throughout her life she was extremely responsible, efficient, and anxious. After the death of her mother 3 years ago, she grieved the loss, regretted that she might not have done what she could, and felt a sense of guilt. Night sleep was permanently disturbed. Later, about two years ago, she began to notice dyspeptic disorders, mainly in the form of diarrhea after any stressful situations for herself. Subsequently, I almost constantly felt discomfort in the intestinal area, rumbling in the stomach, frequent bowel movements, was fixated on my sensations, and could not fully work. I consulted a gastroenterologist and took treatment that did not bring much effect or the effect was short-lived. I felt disappointed, confused, and suspected an incurable disease. She visited a psychiatrist with complaints of anxiety and insomnia. According to the Hamilton HARS scale, the level of anxiety disorders corresponded to 28 points (high level of anxiety). A β-blocker, an antidepressant from the group of serotonin reuptake inhibitors and Teraligen were prescribed with a gradual increase in the daily dose to 20 mg per day. For the first 3–4 days, the patient experienced severe drowsiness and lethargy. Then she became somewhat more active. During the first five days, the patient's fixation on unpleasant bodily sensations decreased, the feeling of rumbling and bloating decreased, the urge to defecate began to decrease, and falling asleep improved. When assessed on the Hamilton HARS scale, a decrease in the level of anxiety was revealed to 19 points (average level, closer to high). Subsequently, after about 10–14 days, discomfort in the intestinal area decreased significantly and stool returned to normal.

In the treatment of this patient, Teraligen was used as an anti-anxiety, antidepressant, vegetostabilizing, antispasmodic and hypnotic agent. All this was achieved due to the multireceptor effect of the drug associated with the blockade of noradrenergic, histamine, serotonin receptors, as well as cholinergic and adrenergic receptors.

Teraligen is effective in the treatment of panic disorders, incl. with respiratory dysfunction. Clinical example: patient A. 28 years old. Diagnosis: panic disorder in a hysterical personality, adaptation disorder in the form of a mixed anxious and depressive reaction (F41.1, F60.4, F43.22). Middle manager, divorced, has an 8-year-old son. She complained of periodic panic attacks with palpitations, a feeling of suffocation, and fear of death. Such attacks usually occur in transport, closed, crowded spaces. The patient is forced to leave the place where the attack occurs and tries to avoid crowds of people. The attacks last from 40 minutes to an hour, then gradually pass after a change of environment. Subsequently, the patient experiences weakness, lethargy, and tearfulness. Previously, such episodes were noted several times in adolescence, but then spontaneously - without special treatment - stopped. The current deterioration of her condition arose against the background of the divorce process, which the patient perceives extremely painfully, considering herself to be the disadvantaged, offended party. Outside of attacks, the patient experiences a depressed mood with anxiety about the future, often cries, cannot fully engage with her child, lies a lot, demands the attention of relatives and friends, and experiences a constant feeling of lack of air. Night sleep is not disturbed. At the appointment she is capricious, demonstrative, demanding of the doctor, and talks about the real risk of “dying of fear.” During the conversation he sobs noisily, but afterwards he calms down and agrees with the proposed treatment. When assessing the state on the Hamilton HARS scale, a high level of anxiety was revealed, corresponding to 38 points. Prescribed: β-blockers, an antidepressant from the group of serotonin reuptake inhibitors, Teraligen with a gradual increase in dose to 30 mg per day. During the first week of treatment, general anxiety decreased somewhat, but drowsiness was noted during the day. Starting from the 8th–9th day of admission, the patient became more active, began to go outside, and her mood improved. When assessing the condition on the HARS scale, 19 points were noted (the average level is closer to high). After 14 days from the start of treatment, the patient was able to travel several stops on the subway. While on the road, I experienced tension associated with the expectation of a possible attack, but there was no pronounced panic with palpitations and a feeling of lack of air. Subsequently, during the month of taking the prescribed therapy, she regularly used transport and visited shops. She noted minor discomfort, which she dealt with. I was critical of my feelings. On the HARS scale, the level of anxiety disorders corresponded to 13 points (average level). In the treatment of this patient, Teraligen was also used as an anti-anxiety, antidepressant, vegetative stabilizing and antispasmodic agent. Accordingly, clinical effects were achieved through effects on noradrenergic, serotonin, cholinergic and adrenergic receptors.

Teraligen is effective in the treatment of somatoform autonomic dysfunction of the cardiovascular system. Clinical example: patient I., 63 years old, pensioner. Diagnosis: adaptation disorder in the form of a mixed anxiety and depressive reaction, somatoform disorder (F43.22, F45.30). The patient complained of increased nervousness and anxiety, usually associated with solving real pressing problems. Lately he has noticed a decrease in emotional stability even to minor problems. I began to notice similar phenomena after menopause. About 10 years ago, he was diagnosed with hypertension, is being seen by a therapist, and is receiving appropriate treatment. But in emotionally significant situations, he notes an increase in blood pressure, palpitations, increased heart rate, tremor of the fingers, and sometimes a feeling of coldness in the extremities. Periodically experiences difficulty falling asleep, usually associated with emotional stress. On the Hamilton scale, the level of anxiety corresponded to 23 points (medium level of anxiety, closer to high). Prescribed: an antidepressant from the group of serotonin and norepinephrine reuptake inhibitors, Teraligen at a dose of up to 15 mg daily. During the first 3 days of treatment, during the treatment, she noted some lethargy and a feeling of dullness in the morning. Then gradually over the next 4 days these phenomena were reduced. She became more active and noted greater resistance to emotional stress. Episodes of high blood pressure have become much less frequent. In special situations, the patient independently resorts to a one-time additional dose of Teraligen in the amount of 2.5 mg, notifying the doctor. The level of anxiety on the Hamilton scale corresponds to 10 points (medium level, closer to low). As in the two previous cases, Teraligen was prescribed to this patient for vegetostabilizing hypotensive purposes as an anti-anxiety drug and as a means of improving night sleep. The clinical effect was achieved due to the effect of the drug on noradrenergic, histamine, serotonin and adrenergic receptors.

Teraligen is effective in the treatment of asthenic disorders associated with tension and insomnia. Clinical example: patient P., 42 years old. Diagnosis: neurasthenia (F.48.0). I went to see a psychiatrist for the first time. All his life he was an active, active person. Successfully moved up the career ladder. Currently he is the head of a large enterprise, with more than 100 people subordinate to him. Married, has children. After an unfavorable period associated with work, against the background of increased physical and mental stress, in the last 2–3 months I began to notice rapid fatigue, a difficult feeling of internal tension to overcome, irritability directed mainly at loved ones, difficulty falling asleep and a lack of feeling of rest in the morning. On the Hamilton scale, the level of anxiety corresponded to 12 points (average level, closer to low). Was prescribed: nootropic therapy, Teraligen up to 7.5 mg per day. During the first 2–3 days, I began to notice an improvement in falling asleep, and after 5–7 days of use, irritability significantly decreased, self-control improved, and the feeling of internal tension disappeared. At this point, there was a reduction on the Hamilton scale and the level of anxiety corresponded to 6 (medium level, closer to low). In the treatment of this patient, Teraligen primarily served as a sedative and anxiolytic agent for the purpose of correcting behavior and increasing stress resistance, and also as a hypnotic. A quick effect was achieved thanks to Teraligen's effect on histamine, serotonin and adrenergic receptors in the form of their blockade.

As already mentioned, Teraligen is used in the complex treatment of endogenous mental disorders, usually in combination with other antipsychotics and antidepressants to reduce the level of agitation, anxiety and tension, which are often observed as part of affective-delusional attacks and major depressive episodes, as well as other affective disorders, continuous schizophrenia and personality disorders. In both cases, Teraligen does not act as the main therapeutic drug, but is often indispensable due to its effectiveness and lack of side effects. Clinical example: patient M., 26 years old. Diagnosis: schizotypal disorder (F21). Programmer, single, lives with parents. Over the course of 10 years, periodic depression has been observed, characterized by low mood with a feeling of inner emptiness, a dull perception of the surrounding life, lack of awareness of one’s feelings and thoughts, and other depersonalization and derealization disorders, which are present to one degree or another outside depressive episodes. Several times he suffered short-term subpsychotic episodes against the background of stressful situations and exogenous hazards. The personality of a patient of the schizoid type with the phenomena of psychophysical juvenileism, with isolation and elements of eccentricity, with unusual hobbies. As preventive and maintenance therapy, the patient takes an atypical antipsychotic with an antidepressant from the serotonin reuptake inhibitor group. During the period of remission, the patient successfully works and studies. With increased workload, the patient experienced asthenic phenomena in the form of increased nervousness, feelings of internal tension, periodic agitation, and difficulty falling asleep. The level of anxiety assessed on the Hamilton HARS scale corresponded to 17 points (average level, closer to high). At that time, a nootropic drug and Teraligen at a dose of 5 mg in the evening were added to the main maintenance regimen. The dose was selected empirically, based on the patient's subjective feelings. While taking Teraligen, already in the first 2-3 days the patient’s sleep improved at night, the feeling of internal tension in the evening significantly decreased, and his mood evened out. After re-evaluation a week later, the level of anxiety underwent a reduction and corresponded to 4 points, i.e. was absent. In this case, Teraligen was used as an adjunctive sedative-hypnotic, and the corresponding effects were associated with effects on histamine and adrenergic receptors. The rapid effect obtained as a result of the use of such small doses was made possible due to the mutually potentiating effect when using various psychotropic drugs.

In all the described cases, the effective dosage was selected individually by titration, and, as can be seen, in a number of cases the drug was effective even in small doses (2.5–5.0 mg/day). None of the described patients had adverse extrapyramidal effects. As is known from general information about the drug, Teraligen is taken orally. The daily dose can be divided into 3-4 doses. Adult patients take 2.5–5.0–10.0 mg per day (hypnotic effect) and more - up to 60–80 mg per day (anxiolytic effect). In a psychotic state, dosages of up to 0.2–0.4 g per day can be used. According to the instructions, drowsiness is observed in the first 3 days of use (regardless of the patient’s age). But it should be noted that the identification of different types of dosing is very arbitrary, because dosage selection is carried out individually. The drug is prescribed to children from 7 years of age [19]. Due to the very wide range of receptor effects and clinical use of Teraligen, the issue of interaction with other drugs becomes relevant [5, 8, 9].

Analysis of the characteristics of the drug’s action allows us to conclude that Teraligen:

• enhances the effect of narcotic analgesics, ethanol, hypnotics, anxiolytic (tranquilizers) and antipsychotic drugs (neuroleptics), as well as drugs for general anesthesia, m-anticholinergic blockers, β-blockers and antihypertensive drugs (dose adjustment required);
• weakens the effect of amphetamine derivatives, m-anticholinergic stimulants, ephedrine, guanethidine, levodopa, dopamine, as well as bromocriptine and increases the concentration of prolactin in the blood serum;
• the use of Teraligen with antiepileptic drugs and barbiturates reduces the threshold of convulsive activity (dose adjustment required);
• tricyclic antidepressants and anticholinergic drugs enhance the m-anticholinergic activity of Teraligen;
• monoamine oxidase inhibitors (simultaneous administration with Teraligen is not recommended) and phenothiazine derivatives increase the risk of arterial hypotension and extrapyramidal disorders;
• when Teraligen is co-administered with drugs that inhibit bone marrow hematopoiesis, the risk of myelosuppression increases;
• hepatotoxic drugs increase the manifestations of hepatotoxicity of the drug Teraligen.

An objective assessment of the effectiveness of the drug is impossible without comparison with other drugs with similar indications for use. Compared to benzodiazepines, Teraligen has an undeniable advantage in the absence of the formation of drug dependence and, therefore, wider possibilities for long-term use [2]. Compared to diphenylmethane derivatives and fabomotizole, Teraligen demonstrates more pronounced anxiolytic activity and the rate of onset of the positive effect [7, 10]. When compared with drugs from the group of minor neuroleptics (periciazine, thioridazine, sulpiride), Teraligen is not inferior to them in terms of the level of sedation and significantly benefits in terms of the virtual absence of side extrapyramidal disorders, in contrast to the above-mentioned drugs, which have quite pronounced side effects [9]; in addition, thioridazine has severe cardiotoxicity, and sulpiride can cause hyperprolactinemia. These undesirable effects are not characteristic of Teraligen. Summarizing all of the above, Teraligen can be characterized as a drug with a wide range of clinical applications not only in psychiatry, but also in neurology and other areas of medicine for the treatment of somatoform, psychosomatic and somatic diseases, incl. and as part of complex therapy. Due to the wide range of dosages, good tolerability and the possibility of long-term use, Teraligen is not only an effective drug, but also extremely convenient to use for both the doctor and the patient.

Interaction

The drug can enhance the effect of anxiolytics , hypnotics , antipsychotics , narcotic analgesics , general anesthesia , antihypertensive drugs and m-anticholinergic drugs . In such cases, it is necessary to adjust the dose.

Teraligen reduces the effectiveness of m-cholinergic stimulants , dopamine , ephedrine , amphetamine , levodopa , guanethidine . Significant depression of the central nervous system is observed when taken simultaneously with drugs that suppress central nervous system functions and ethanol . Combination with barbiturates and antiepileptic drugs leads to a decrease in the threshold of convulsive readiness.

An increase in the plasma concentration of alimemazine is caused by beta-blockers , which can lead to the development of arrhythmia and a decrease in blood pressure.

Teraligen increases the level of prolactin in the blood and reduces the effectiveness of bromocriptine .

The M-anticholinergic activity of alimemazine increases while taking anticholinergics and tricyclic antidepressants .

The risk of extrapyramidal disorders and arterial hypotension increases when taking MAO inhibitors and phenothiazine derivatives .

Reviews of Teraligen

The overall rating given by buyers on the forums is 3.8 out of 5 points. Many patients write about the effectiveness of the drug, its rapid action and the absence of side effects. In addition, there are reviews from customers for whom the drug did not help, and many also write about severe side effects, in particular weakness, drowsiness, and dizziness. Regarding its use for children, reviews are positive. This drug is safe for children as it is very well tolerated.

Doctors' reviews of Teraligen are positive, however, they note that the drug should not be taken without a prescription, as this can only worsen the patient's condition.

There is no data on this drug in the Wikipedia encyclopedia.

Teraligen price, where to buy

In Russia, the average price for a package of 25 tablets is 282 rubles, for 50 tablets - 465 rubles.

• Online pharmacies in RussiaRussia

ZdravCity

• Teraligen tab.
  p/o captivity. 100 pcs JSC Valenta Pharmaceuticals 1521 rub. order
• Teraligen tablets p.p.o. 5mg 50 pcs. JSC Valenta Pharmaceuticals

  RUB 845 order

• Teraligen solution for intramuscular injection. input 5mg/ml amp. 5 ml 10 pcs. Federal State Budgetary Institution "RKNPK" of the Ministry of Health of Russia - EPMBP

  RUB 1,077 order

• Teraligen tab. p/o captivity. 25pcs JSC Valenta Pharmaceuticals

  RUR 678 order