Terialzhen - instructions for use, dose, side effects, contraindications

Active substanceAlimemazineAlimemazine

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Terialgen®

pills inwards

VALENTA PHARM, PAO Russia

Terialgen®

solution w / m d / infusion

VALENTA PHARM, PAO Russia

Terialgen® Valenta

pills inwards

VALENTA PHARM, PAO Russia

Dosage form: & nbspfilm coated tablets

Composition:

active substance: alimamazine tartrate 5.0 mg,

auxiliary substances: lactose - 90.0 mg, silicon dioxide colloid - 0.5 mg, refined sugar (sucrose) - 14.0 mg, wheat starch - 42.0 mg, tapioca (tapioca starch) 2.0 mg, talcum powder 2.0 mg, magnesium stearate 1.5 mg,

shell: hypromellose - 4.0 mg, macrogol 6000 - 0.4 mg, titanium dioxide - 0.1 mg, dye Osprey R110 pink - 0.3 mg, talc -1.0 mg.

Description:The tablets covered with a cover of dark pink color with the squeezed out symbol on one party and a strip on another; sides and edges without damage.

Pharmacotherapeutic group:Antipsychotic agent (antipsychotic)

ATX: & nbsp

R.06.A.D. Phenothiazine derivatives

R.06.A.D.01 Alimemazine

Pharmacodynamics:

Antipsychotic agent (antipsychotic), has antihistamine, spasmolytic, serotonin blocking and moderate alpha-adrenoblocking action, as well as antiemetic, hypnotic, sedative and antitussive effect. The antipsychotic effect is due to the blockade of dopamine D2-receptionmesolimbic and mesocortical systems. Sedative action is due to blockade of adrenoreceptors of the reticular formation of the brainstem; antiemetic action - blockade of B2 receptors in the trigger zone of the vomiting center; hypothermic action - blockade of dopamine receptors of the hypothalamus. The beginning of the effect - after 15-20 minutes, the duration of the action - 6-8 hours.

Has a low antipsychotic activity, therefore, in acute psychotic conditions is ineffective.

Due to its good tolerability, it is used in children's, adolescent and gerontological practice.

Pharmacokinetics:

Quickly and completely absorbed, the maximum concentration in the plasma is observed 1-2 hours after ingestion. The connection with plasma proteins is 20-30%, the half-life is 3.5-4 hours. It is excreted by the kidneys - 70-80% in the form of a metabolite (sulfoxide) for 48 hours. The beginning of the effect - after 15-20 minutes, the duration of the action - 6-8 hours.

Indications:

Neuroses and neurosis-like conditions of endogenous and organic genesis with predominance of the senestopathic, hypochondriacal, phobic and psycho vegetative disorders; psychopathy with asthenic and psychoasthenicdisorders; anxiety-depressive states in the framework of borderline endogenous and vascular diseases; shestostaticheskie depression, somatized mental disorders; state of anxiety and anxiety in somatic diseases; sleep disorders of various genesis, allergic reactions (symptomatic treatment).

Contraindications:

Hypersensitivity, zakratougolnaya glaucoma, prostatic hyperplasia, severe liver and kidney disease, Parkinsonism, myasthenia gravis, Reye syndrome, concurrent use of MAO inhibitors, pregnancy, lactation; children under 7 years.

Carefully:

Carefully: hr. alcoholism, if in anamnesis there are indications of complications with the use of preparations phenothiazine series; obstruction of the neck of the bladder, predisposition to urinary retention, epilepsy, open-angle glaucoma, jaundice, suppression of bone marrow function, arterial hypotension.

Dosing and Administration:

Inside. The daily dose is divided into 3-4 doses.

Adults 5-10 mg / day (hypnotic effect); 60-80 mg / day (anxiolytic effect). At psychotic conditions - 0,2-0,4 g / day.

Children from 7 years old appoint 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 states, an increase in the daily dose to 60 mg / day is possible.

Side effects:

The drug is usually well tolerated. Side effects are extremely rare and are not very pronounced.

From the side of the nervous system: drowsiness, lethargy, fast fatigue, arising mainly in the first days of admission and rarely requiring withdrawal of the drug; a paradoxical reaction (anxiety, agitation, "nightmarish" dreams, irritability); rarely - confusion, extrapyramidal disorders (hypokinesia, akathisia, tremor); more frequent sleep apnea, increased convulsive activity (in children).

From the sense organs: blurred vision (paresis of accommodation), noise or ringing in the ears. From the CCC: dizziness, lowering blood pressure, tachycardia.

From the digestive system: dry mouth, atony of the gastrointestinal tract, constipation, decreased appetite.

On the part of the respiratory system: dryness in the nose, pharynx, increase in the viscosity of bronchial secretions.

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

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

Overdose:

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

Interaction:

Strengthens the effects of narcotic analgesics, hypnotics, anxiolytics (tranquilizers) and antipsychotic drugs (neuroleptics), as well as drugs for general anesthesia, m-holinoblokatorov and hypotensive drugs (requires dose adjustment).

Weaken the action of derivatives of amphetamine, m-cholinostimulants, ephedrine, guanetidine, levodopa, dopamine.

Ethanol and drugs, suppressing the effect of the central nervous system - CNS depression.

Antiepileptic drugs and barbiturates reduce the threshold of convulsive activity (correction of doses is required).

Beta-adrenoblokatory increase (mutually) the concentration in the plasma (there may be a marked decrease in blood pressure, arrhythmia).

Weaken the effect of bromocriptine and increase the concentration of prolactin in the serum.Tricyclic antidepressants and anticholinergic drugs increase m-cholinoblocking activity

MAO inhibitors (concurrent use is not recommended) and phenothiazine derivatives increase the risk of arterial hypotension and extrapyramidal disorders.

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

Hepatotoxic drugs increase the manifestation of hepatotoxicity of the drug.

Special instructions:

With prolonged treatment, it is necessary to systematically carry out a general blood test, evaluate liver function.

Can mask the ototoxic effect (tinnitus and dizziness) of shared drugs. Increases the need for riboflavin.

To prevent distortion of skin scarification test results for allergens, it is necessary to cancel 72 hours prior to allergological testing.

During treatment, false-positive pregnancy test results are possible.

During the treatment should not drink alcohol.

Effect on the ability to drive transp. cf. and fur:

Against the background of treatment should not engage in activities that require increased concentration.

Form release / dosage:Tablets of 5 mg film-coated.

Packaging:For 10 or 25 tablets in a contour mesh package. For 1,2, 5 contour squares, together with instructions for use, are placed in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

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

Terms of leave from pharmacies:On prescription

Registration number:LSR-003204/07

Date of registration:15.10.2007

The owner of the registration certificate:VALENTA PHARM, PAO VALENTA PHARM, PAO Russia

Manufacturer: & nbsp

VALENTA PHARMACEUTICS, JSC Russia

Information update date: & nbsp19.08.2015

Illustrated instructions

Instructions

Terialgen® (Teraligen®)