Teraligen pills 5mg, 25pcs

Composition

One tablet contains:

Active ingredient:

alimemazine tartrate – 5.0 mg;

excipients:

lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide (aerosil), croscarmellose sodium, magnesium stearate.

shell composition:

Opadray II 85F34655: partially hydrolyzed polyvinyl alcohol, macrogol-3350, talc, titanium dioxide E 171, carmine red dye E 120, aluminum varnish based on sunny sunset yellow dye E 110, aluminum varnish based on indigo carmine E 132.

Pharmacological action

An anxiolytic agent. A sedative.

ATX code: [R06AD01].

Pharmacological properties

Pharmacodynamics

It is a phenothiazine derivative. 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 that develop as a result of neurovegetative disorders, vascular, traumatic and infectious disorders of the central nervous system.

The sedative effect contributes to the normalization of sleep in patients of this category. It has antiemetic and antitussive activity. Sedative and anxiolytic effects are caused by 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 of the trigger zone of the emetic center.

Due to its antihistamine activity, alimemazine is used for allergic diseases, especially of the respiratory tract, and for itching of the skin. Alimemazine is more active in antihistamines and sedatives 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 use. The effect of alimemazine begins 15-20 minutes after use and lasts 6-8 hours. Binding to plasma proteins is 20-30%. It is metabolized in the liver. Excreted by the kidneys-70-80% in the form of a metabolite (sulfoxide).

Indications

For adults and children over 7 years of age:

As a sedative (sedative), anxiolytic (anti-anxiety), and sleep-enhancing agent:

dementia (including dementia in connection with epilepsy), occurring with symptoms of psychomotor agitation, of the affect of anxiety (as part of combination therapy);

– organic anxiety disorder (as monotherapy or in combination therapy);

– schizophrenia (with the prevalence of neurosis-like disorders, as part of combination therapy);

– mood disorders (affective disorders) in the combination therapy;

generalized anxiety disorder (as part of combination therapy);

– obsessive-compulsive disorder (as part of combination therapy);

– reaction to severe stress and adjustment disorders (acute stress reaction, post-traumatic stress disorder, unspecified reaction to severe stress, and other reactions to severe stress) in combination therapy;

and dissociative (conversion) disorder (as part of combination therapy);

– somatoform disorders (somatized distress, undifferentiated somatoform disorder hypochondriacal disorder, somatoform dysfunction of the autonomic nervous system, steady somatoform pain disorder, unspecified somatoform disorder other somatoform disorders) in combination therapy in severe anxiety or after failure of standard therapy;

– unspecified disorder of vegetative (Autonomous) nervous system and other disorders of the vegetative (Autonomous) nervous system (in combination therapy);

– anorexia nervosa (as part of combination therapy);

– emotionally unstable personality disorder (impulsive and borderline types) in the combination therapy;

– the hysterical personality disorder, anxiety (evading, avoidant) personality disorder (as part of combination therapy);

– resistant personality change after catastrophe experience (as part of combination therapy);

– hyperkinetic conduct disorder (as part of combination therapy);

– behavior disorder, limited the scope of the family (in a combination therapy after failure of standard therapy);

– nesotsializirovannyh a conduct disorder (as monotherapy or in combination therapy);

– anxiety, agitation and other symptoms and signs involving emotional state (as part of combination therapy);

– other neurotic disorders (neurosis, neurotic disorder, unspecified) in the combination therapy;

– insomnia inorganic etiology (in a combination therapy after failure of standard therapy);

– emotional disorders, which are specific to childhood (phobic anxiety disorder in children, social anxiety disorder in childhood, the disorder due to the sibling (with brothers and sisters) rivalry, unspecified emotional disorder in childhood, other emotional disorders in childhood) in the combination therapy.

As an anti-allergic agent:

– itching regardless of the location and etiology (itching of the anus, itching of the vulva, unspecified anogenital itching, itching in photocontact dermatitis and solar urticaria, dermatitis, eczema, hives, bites or Galiani non-poisonous insects or other nonpoisonous arthropods, chickenpox, measles, Hodgkin’s Disease, diabetes, shingles) as monotherapy or in combination therapy;

– asthma, hay fever, whooping cough (in the complex therapy as antiallergic drugs for the relief of cough, shortness of breath and asthma attacks);

– unspecified Allergy (as monotherapy or in combination therapy).

For children from 3 years of age:

As an anti-allergic agent:

– itching regardless of the location and etiology (itching when photocontact dermatitis and solar urticaria, dermatitis, eczema, hives, bites or Galiani non-poisonous insects or other nonpoisonous arthropods, chickenpox, measles, Hodgkin’s Disease, diabetes, shingles, itching of the anus, itching of the vulva, unspecified anogenital itching) as monotherapy or in combination therapy.

As a sedative (sedative) agent:

– during medical preparation for surgery (for the purpose of sedation before surgery).

Use during pregnancy and lactation

It is contraindicated for use during pregnancy and lactation (breastfeeding). If pregnancy occurs during the treatment period, the drug should be discontinued. If it is necessary to use the drug during lactation, stop breastfeeding.

Contraindications

– hypersensitivity to the components of the drug;

– lactose intolerance, lactase deficiency, glucose-galactose malabsorption;

– closure glaucoma;

– hyperplasia of the prostate;

– severe hepatic and/or renal failure;

– parkinsonism;

– myasthenia gravis;

– Reye’s syndrome;

– concomitant use of monoamine oxidase inhibitors (MAOIS);

– pregnancy;

– lactation period;

– children’s age up to 3 years if used as antiallergic drugs for sedation before surgery up to 7 years for other reasons.

Precautions for use

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

Side effects

Side effects are extremely rare and mild.

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

From the side of the senses: blurred visual perception (paresis of accommodation), 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, decreased appetite.

Respiratory system disorders: dryness in the nose, pharynx, increased viscosity of bronchial secretions.

From the urinary system: atony of the bladder, urinary retention.

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

Interaction

Alimemazine enhances the effects of narcotic analgesics, sleeping pills, anxiolytic (tranquilizers) and antipsychotic (neuroleptics) drugs, as well as drugs for general anesthesia, m-holinoblockers and antihypertensive drugs (dose adjustment is required). Tricyclic antidepressants and anticholinergic drugs enhance the m-holinoblocking activity of alimemazine. Simultaneous use of alimemazine with ethanol may increase central nervous system depression.

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

The combined use of alimemazine with antiepileptic drugs and barbiturates reduces the threshold of convulsive activity (dose adjustment is required).

With the combined use of alimemazine 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.

Concomitant use of alimemazine and MAO inhibitors (concomitant use is not recommended) and alimemazine and phenothiazine derivatives increases the risk of hypotension and extrapyramidal disorders.

Simultaneous use of alimemazine with drugs that inhibit bone marrow hematopoiesis increases the risk of myelosuppression.

The combined use of phenothiazine derivatives (including alimemazine) with hepatotoxic drugs may increase the manifestations of hepatotoxicity of the latter.

How to take, course of use and dosage

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 of 15-60 mg / day.

To achieve an anxiolytic effect of 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.

Course treatment should begin with taking 2.5-5 mg in the evening with a gradual increase in the daily dose to 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 months or more and is determined by the doctor.

The highest dose for adults is 500 mg / day, for the elderly (over 60 years) – 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 of 20-40 mg / day.

The course of treatment should begin with taking 2.5-5 mg with a gradual increase in the daily dose to 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 violation of behavior in psychotic states, 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 months or more and is determined by the doctor.

Children from 3 years of age

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 months or more and is determined by the doctor.

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

Overdose

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

Treatment: drug withdrawal, symptomatic therapy.

Description

Round biconvex tablets, coated with a dark pink color with a risk; two layers are visible on the cross section: the shell is dark pink and the core is white.

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 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.

Do not drink alcohol during the treatment period.

Influence on the ability to drive motor vehicles and manage mechanisms:

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).

Form of production

Film-coated tablets,5 mg and 10 mg. 25 tablets in a contour cell package or in a contour cell package with perforation made of polyvinyl chloride film and aluminum foil printed varnished. 1,2 or 4 contour packages together with the instructions for use are placed in a pack.

Storage conditions

Store in a dark place at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Shelf

life is 3 years.

Do not use after the expiration date indicated on the package.

Active ingredient

Alimemazine

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Mental Disorders