Theraligeen retard sustained release pills 20mg, 30pcs

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

Pharmacological action

Pharmacotherapeutic group: Anxiolytic agent. Sedative APX: R. 06. A. D Phenothiazine derivatives, R. 06. A. D. 01 Alimemazine 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. Maximum concentration (With max) alimemazine and area under the pharmacokinetic curve (AUC) for the drug Teraligen ® retard linearly depend on the dose taken. Time to reach the maximum concentration of alimemazine (Tmax) for the drug Teraligen ® retard is 5-6 hours. The binding of alimemazine 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). The elimination half-life (T 1/2) of alimemazine for Teraligen retard is 15-17 hours.

Indications

As a sedative (sedative), anxiolytic (anti-anxiety) agent, 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);

– 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 related to the 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).

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;

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

Use during pregnancy and lactation

The use of alimemazine is contraindicated during pregnancy and lactation. 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;

– 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 18 years (for this dosage form).

With caution:

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.

Nervous system disorders:  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 vision (paresis of accommodation), noise or ringing in the ears.

From the cardiovascular system:  dizziness, low 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 services:  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. 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 Teraligen preparations in a direct-release dosage form (tablets, solution for intramuscular use).

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

To achieve an 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 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.

Overdose

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

Treatment: drug withdrawal, symptomatic therapy.

Description

Round biconvex film-coated tablets of light brown color (for a dosage of 20 mg), brown color (for a dosage of 40 mg) and red-brown color (for a dosage of 60 mg). On a cross-section, the core is white or almost white in color.

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 vehicles and 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

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

Storage conditions

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