Teraligen tablets p / o 5mg, No. 50

Neuroses and neurosis-like states of endogenous and organic genesis with a predominance of senestopathic, hypochondriacal, phobic and psychovegetative disorders; psychopathy with asthenic and psychoasthenic disorders; anxiety-depressive states in the framework of borderline endogenous and vascular diseases; senestopathic depression, somatized mental disorders; states of excitement and anxiety in case of somatic diseases; sleep disorders of various origins, allergic reactions (symptomatic treatment).

Inside. The daily dose is divided into 3-4 doses.
Adults 5-10 mg / day (hypnotic effect); 60-80 mg / day (anxiolytic effect). In psychotic conditions - 0.2-0.4 g / day.
Children from 7 years of age are prescribed according to the following scheme (depending on age and body weight):
2.5-5 mg / day (hypnotic effect)
5-20 mg / day (as a symptomatic treatment of allergic reactions)
20-40 mg / day (anxiolytic effect)
In psychotic conditions, it is possible to increase the daily dose to 60 mg / day.

One tablet contains:
Active ingredient: alimemazine tartrate 5 mg
Excipients: milk sugar (lactose), colloidal silicon dioxide, refined sugar (sucrose), wheat starch, tapioca (tapioca starch), talc, magnesium stearate.

The shell of one tablet contains:
hypromellose, macrogol 6000, titanium dioxide, pink Osprey R110 dye, talc.

Hypersensitivity, angle-closure glaucoma, prostatic hyperplasia, severe liver and kidney disease, parkinsonism, myasthenia gravis, Reye's syndrome, simultaneous use of MAO inhibitors, pregnancy, lactation; children up to age 7 years.

With care: xp. alcoholism, if there are indications of complications in the history of the use of drugs of the phenothiazine series; obstruction of the bladder neck, predisposition to urinary retention, epilepsy, open-angle glaucoma, jaundice, bone marrow suppression, arterial hypotension.

Trade name: TeraligenЃ.

International non-proprietary name:

alimemazine.

Dosage form:

film-coated tablets.

Composition:

One tablet contains:
Active ingredient: alimemazine tartrate 5 mg
Excipients: milk sugar (lactose), colloidal silicon dioxide, refined sugar (sucrose), wheat starch, tapioca (tapioca starch), talc, magnesium stearate.

The shell of one tablet contains:
hypromellose, macrogol 6000, titanium dioxide, pink Osprey R110 dye, talc.

Description:

Dark pink coated tablets with an embossed symbol on one side and a stripe on the other; the sides and edges are undamaged.

Pharmacotherapeutic group:

Antipsychotic drugs.

Pharmacological properties:

Pharmacodynamics: An
antipsychotic agent (neuroleptic), has an antihistamine, antispasmodic, serotonin-blocking and moderate alpha-adrenergic blocking effect, as well as antiemetic, hypnotic, sedative and antitussive effects. The antipsychotic effect is due to the blockade of the dopamine D2 receptors of the mesolimbic and mesocortical systems. The sedative effect is due to the blockade of adrenergic receptors of the reticular formation of the brain stem; antiemetic effect - blockade of D2 receptors of the trigger zone of the vomiting center; hypothermic action - blockade of dopamine receptors of the hypothalamus. The onset of the effect is after 15-20 minutes, the duration of the action is 6-8 hours.
It has a low antipsychotic activity, therefore it is ineffective in acute psychotic conditions.
Due to its good tolerance, it is used in pediatric, adolescent and gerontological practice.

Pharmacokinetics:
Rapidly and completely absorbed, the maximum plasma concentration is observed 1-2 hours after ingestion. Communication with plasma proteins - 20-30%, half-life - 3.5-4 hours. Excreted by the kidneys - 70-80% in the form of a metabolite (sulfoxide) within 48 hours. The onset of the effect is 15-20 minutes, the duration of the action is 6-8 hours.

Indications for use:

Neuroses and neurosis-like states of endogenous and organic genesis with a predominance of senestopathic, hypochondriacal, phobic and psychovegetative disorders; psychopathy with asthenic and psychoasthenic disorders; anxiety-depressive states in the framework of borderline endogenous and vascular diseases; senestopathic depression, somatized mental disorders; states of excitement and anxiety in case of somatic diseases; sleep disorders of various origins, allergic reactions (symptomatic treatment).

Contraindications:

Hypersensitivity, angle-closure glaucoma, prostatic hyperplasia, severe liver and kidney disease, parkinsonism, myasthenia gravis, Reye's syndrome, simultaneous use of MAO inhibitors, pregnancy, lactation; children up to age 7 years.

With care: xp. alcoholism, if there are indications of complications in the history of the use of drugs of the phenothiazine series; obstruction of the bladder neck, predisposition to urinary retention, epilepsy, open-angle glaucoma, jaundice, bone marrow suppression, arterial hypotension.

Method of administration and dosage:

Inside. The daily dose is divided into 3-4 doses.
Adults 5-10 mg / day (hypnotic effect); 60-80 mg / day (anxiolytic effect). In psychotic conditions - 0.2-0.4 g / day.
Children from 7 years of age are prescribed according to the following scheme (depending on age and body weight):
2.5-5 mg / day (hypnotic effect)
5-20 mg / day (as a symptomatic treatment of allergic reactions)
20-40 mg / day (anxiolytic effect)
In psychotic conditions, it is possible to increase the daily dose to 60 mg / day.

Side effect:

The drug is usually well tolerated. Side effects are extremely rare and mild.
From the nervous system: drowsiness, lethargy, fatigue, arising mainly in the first days of admission and rarely requiring discontinuation of the drug; paradoxical reaction (anxiety, agitation, 'nightmares', irritability); rarely - confusion, extrapyramidal disorders (hypokinesia, akathisia, tremor); increased frequency of sleep apnea, increased seizure activity (in children).
From the senses: blurred vision (paresis of accommodation), noise or ringing in the ears.
From the CCC: dizziness, decreased blood pressure, tachycardia.
From the digestive system: dry mouth, atony of the gastrointestinal tract, constipation, loss of appetite.
From the respiratory system: dryness in the nose, throat, increased viscosity of bronchial secretions.
From the urinary system: bladder atony, urinary retention.
Others: allergic reactions, inhibition of bone marrow hematopoiesis, increased sweating, muscle relaxation, photosensitization.

Overdose:

Strengthening of side reactions, depression of consciousness. Treatment is symptomatic.

Interaction with other medicinal products:

Enhances the effects of narcotic analgesics, hypnotics, anxiolytic (tranquilizers) and antipsychotic drugs (neuroleptics), as well as drugs for general anesthesia, m-anticholinergics and antihypertensive drugs (dose adjustment is required). Weakens the action of amphetamine derivatives, m-anticholinergics, ephedrine, guanethidine, levodopa, dopamine.
Ethanol and drugs that suppress the action of the central nervous system - depression of the central nervous system.
Antiepileptic drugs and barbiturates reduce the seizure threshold (dose adjustment is required).
Beta-blockers increase (mutually) the concentration in the plasma (a pronounced decrease in blood pressure, arrhythmias are possible).
Weakens the action of bromocriptine and increases the concentration of prolactin in the blood serum.
Tricyclic antidepressants and anticholinergic drugs enhance m-anticholinergic activity.
MAO inhibitors (simultaneous administration is not recommended) and phenothiazine derivatives increase the risk of arterial hypotension and extrapyramidal disorders.
With the simultaneous appointment of alimemazine with drugs that inhibit bone marrow hematopoiesis, the risk of myelosuppression increases.
Hepatotoxic drugs increase the manifestations of drug hepatotoxicity.

Special instructions:

With long-term treatment, it is necessary to systematically carry out a complete blood count, to assess liver function.
It can mask the ototoxic effect (tinnitus and dizziness) of co-administered drugs.
Increases the need for riboflavin.
To prevent distortion of the results of skin scarification tests for allergens, it is necessary to cancel 72 hours before allergic testing.
During treatment, false positive pregnancy results are possible.
During treatment, you should not engage in activities that require increased concentration. Alcohol should not be consumed during treatment.

Release form:

5 mg film-coated tablets. 10 or 25 tablets in a blister strip packaging.
1, 2, 5 blisters, together with instructions for use, are placed in a carton box.

Storage conditions:

Store in a dry, dark place and out of reach of children at a temperature not exceeding 25 ? C.

Shelf life:

3 years. Do not use after the expiration date printed on the package.

Terms of dispensing from pharmacies:

Strictly by prescription!