Expiration date: 04/2027

Composition

One tablet contains:

Active ingredient: alimemazine (alimemazine tartrate) - 20 mg or 40 mg or 60 mg;

Excipients: microcrystalline cellulose (type 101), hypromellose, colloidal silicon dioxide, magnesium stearate;

Shell: Opadray II 85F230124 (for a dosage of 20 mg), Opadray II 85F230060 (for a dosage of 40 mg), Opadray II 85F265071 (for a dosage of 60 mg): partially hydrolyzed polyvinyl alcohol, titanium dioxide E 171, macrogol-3350, talc, iron oxide yellow E 172, iron oxide red E 172 dye.

Release form

Long-release film-coated tablets, 20 mg, 40 mg and 60 mg. 10 tablets each in a contour cell package made of polyvinyl chloride film and aluminum printed lacquered foil. 3 contour cell packages together with the instructions for use are placed in a pack of cardboard.

Pharmacological action

Pharmacotherapeutic group: Anxiolytic agent. Sedative

ATX: R.06.A.D Phenothiazine derivatives, R.06.A.D.01 Alimemazine

Pharmacodynamics:

It is a derivative of phenothiazine. Alimemazine acts as a mild sedative and anti-anxiety agent, has a positive effect on senestopathy, obsession and phobia. It is used for psychosomatic manifestations developing as a result of neurovegetative disorders, vascular, traumatic and infectious disorders of the central nervous system. The sedative effect helps to normalize sleep in patients of this category. It has antiemetic and antitussive activity.

The sedative and anxiolytic effect is due to the blockade of adrenoreceptors of 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 respiratory tract, and skin itching. Alimemazine is more active in antihistamine and sedation than diprazine. The antipruritic effect is due to the effect on histamine receptors of the first type. 

Pharmacokinetics:

It is rapidly and completely absorbed by any route of administration. The effect of alimemazine begins 15-20 minutes after administration. The maximum concentration (With max) of alimemazine and the area under the pharmacokinetic curve (AUC) for the drug Teraligen® retard linearly depend on the dose taken. The time to reach the maximum concentration of alimemazine (Tmax) for Teraligen® retard is 5-6 hours. The relationship of alimemazine with plasma proteins is 20-30%. It is metabolized in the liver. It is excreted by the kidneys - 70-80% in the form of a metabolite (sulfoxide). The half-life (T1/2) of alimemazine for Teraligen retard is 15-17 hours.

Indications for use

As a sedative (sedative), anxiolytic (anti-anxiety) remedy and a means to improve falling asleep:

• dementia (including dementia due to epilepsy), occurring with manifestations of psychomotor agitation, anxiety affect (as part of combination therapy);
• organic anxiety disorder (in the form of monotherapy or 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 (somatized 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 ineffectiveness of standard therapy;
• unspecified disorder of the autonomic (autonomous) nervous system, other disorders of the autonomic (autonomous) 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, anxiety (evasive, 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 with the ineffectiveness of standard therapy);
• unsocialized behavior disorder (in the form of 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 inorganic etiology (as part of combination therapy with the ineffectiveness of standard therapy).

As an antiallergic agent:

• itching regardless of location and etiology (itching with photo-contact dermatitis and solar urticaria, dermatitis, eczema, urticaria, bites or stings by non-venomous insects or other non-venomous arthropods, chickenpox, measles, Hodgkin's disease, diabetes mellitus, shingles, itching of the anus, itching of the vulva, unspecified anogenital itching) in the form of monotherapy or as part of a combination therapy;
• unspecified allergy (in the form of monotherapy or as part of combination therapy).

Methods of application and dosage

Inside. Without chewing. The effect of the drug is dose-dependent, the doses are selected depending on the goals of therapy. The drug is prescribed in the required dose once a day or twice a day with an interval of 12 hours at the same time.

In order to determine the tolerability of alimemazine, it is possible to use a prolonged form after taking Teraligene preparations in a direct-release dosage form (tablets, solution for intramuscular administration).

To achieve a vegetative stabilizing effect of 20-60 mg / day.

To achieve the anxiolytic effect of 20-80 mg / day.

Hypnotic and sedative effects can be achieved with a single dose of 20-60 mg.

For the symptomatic treatment of allergic reactions, 20-40 mg / day.

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

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

Contraindications

• Hypersensitivity to the components of the drug;
• angle-closure glaucoma;
• prostatic hyperplasia;
• severe hepatic and/or renal insufficiency;
• parkinsonism;
• myasthenia gravis;
• Reye's syndrome;
• simultaneous use of monoamine oxidase inhibitors (MAO);
• pregnancy;
• lactation period;
• children under 18 years of age (for this dosage form).

With caution:

With caution, the drug should be used for alcoholism, if there are indications in the anamnesis of complications with the use of phenothiazine-type drugs; with obstruction of the neck of the bladder; predisposition to urinary retention; with epilepsy; open-angle glaucoma; jaundice; suppression of bone marrow function; arterial hypotension.

Special instructions

Alimemazine can mask the ototoxic effect (tinnitus, dizziness) of drugs used together.

Alimemazine increases the body's need for riboflavin.

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

During the treatment period, false positive results for pregnancy are possible. Alcohol should not be consumed during the treatment period.

Influence on the ability to control transport. cf. and fur.:

Against the background of drug treatment, 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, the work of a dispatcher and operator).

Storage conditions

In the original packaging (in a pack) at a temperature not exceeding 25 ° C. Keep out of reach of children.