Teraligen Valenta
Teraligen Valenta: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Teraligen Valenta
ATX code: R06AD01
Active ingredient: alimemazine (Alimemazine)
Manufacturer: JSC "Valenta Pharm" (Russia); OJSC "Novosibkhimpharm" (Russia); FSBI "RKNPK" of the Ministry of Health of Russia (Russia)
Description and photo update: 2020-05-02
Prices in pharmacies: from 541 rubles.
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Teraligen Valenta is a neuroleptic, a drug of polysystemic action (sedative, anti-anxiety, antiallergic) for the balanced therapy of autonomic disorders.
Release form and composition
Dosage forms:
- film-coated tablets: round, biconvex; dosage 5 mg - dark pink, with a dividing line, dosage 10 mg - pink; the core of the tablets is white (25 pcs. in blisters, in a cardboard box 1, 2 or 4 packages and instructions for use of the drug);
- solution for intramuscular (i / m) administration: clear or slightly opalescent liquid from colorless to slightly colored (5 ml each in ampoules of light-protective glass with a break ring / break point or without them; in a cardboard box 10 ampoules or in blister packs 5/10 ampoules, in a cardboard box, respectively 2/1 packaging. The cardboard box also contains instructions for the use of Teraligen Valent and a knife for opening ampoules / ampoule scarifier. If ampoules have a break ring / break point, a knife or scarifier is not included in the kit included).
1 tablet contains:
- active substance: alimemazine tartrate - 5 mg or 10 mg;
- auxiliary components: lactose monohydrate, croscarmellose sodium, microcrystalline cellulose, colloidal silicon dioxide (aerosil), pregelatinized starch, magnesium stearate;
- film sheath (dosage 5/10 mg): Opadray II 85F34655 [macrogol-3350, partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), aluminum varnish based on sunset yellow dye (E110), carmine red dye (E120), aluminum varnish based on indigo carmine (E132), talc] / Opadray II 85F34750 [macrogol-3350, partially hydrolyzed polyvinyl alcohol, iron dye yellow oxide (E172), aluminum varnish based on charming red dye (E129), titanium dioxide (E171), iron dye black oxide (E172), talc].
1 ml of solution contains:
- active substance: alimemazine tartrate - 5 mg;
- auxiliary components: ascorbic acid - 1 mg; sodium sulfite - 0.5 mg; water for injection - up to 1 ml.
Pharmacological properties
Pharmacodynamics
Teraligen Valenta - due to a multimodal mechanism of influence (effect on many receptors of the central and peripheral nervous system) reduces or completely relieves autonomic somatic, as well as behavioral and / or anxiety-depressive disorders of the human psyche. Its active ingredient, alimemazine, is a phenothiazine derivative and has a mild anxiolytic, anti-anxiety and sedative effect, which is positively manifested in senestopathy, obsession or phobia, has an antiallergic effect, and helps to improve sleep. In addition, it has antiemetic and antitussive activity.
Alimemazine is used as part of the complex therapy of psychosomatic conditions in patients with neurovegetative disorders and vascular, traumatic or infectious disorders of the central nervous system (central nervous system) functions, including with the aim of normalizing and improving sleep.
The anxiolytic and sedative effect is due to the property of alimemazine, to block the adrenergic receptors of the reticular formation of the brain stem, and the antiemetic and vegetative-stabilizing effect is associated with the blockade of dopamine D2 receptors in the trigger zone of the vomiting center.
The antihistaminic activity of alimemazine allows Teraligen Valenta to be used for the treatment of allergic diseases (especially of the respiratory tract) and skin itching. The antipruritic effect is due to the effect on the first type of histamine receptors.
The effect of the drug is dose-dependent.
Compared with diprazine, alimemazine has more pronounced antihistamine and sedative activity.
Pharmacokinetics
After oral administration, infusion or intramuscular administration of Teraligen Valent, alimemazine is rapidly and completely absorbed. The onset of therapeutic action varies from 15 to 20 minutes and lasts 6-8 hours.
Plasma protein binding is 20-30% of the dose. Biotransformed in the liver.
Alimemazine undergoes renal elimination - up to 70-80% (mainly in the form of a sulfoxide metabolite).
Indications for use
Film-coated tablets
In adults and children over the age of 7 years, the use of Teraligen Valenta tablets is indicated in combination therapy as an antiallergic, sedative, anxiolytic agent and to improve falling asleep in the following conditions:
- hay fever, asthma, whooping cough - as an antiallergic agent to relieve shortness of breath, cough and asthma attacks;
- unspecified allergy (also as monotherapy);
- mood disorders (affective disorders);
- generalized anxiety disorder;
- obsessive compulsive disorder;
- disorders of adaptation and response to severe stress (including unspecified response to severe stress, acute response to stress, post-traumatic stress disorder);
- dementia (including dementia due to epilepsy) with manifestations of the affect of anxiety and psychomotor agitation;
- organic anxiety disorder (including monotherapy);
- schizophrenia, with a predominance of neurosis-like disorders;
- dissociative (conversion) disorders;
- somatoform disorders (including somatoform dysfunction of the autonomic nervous system, unspecified somatoform disorder, persistent somatoform pain disorder, somatized disorder, hypochondriacal disorder, undifferentiated somatoform disorder) - with severe anxiety or lack of sufficient effect from standard therapy;
- disorder of the autonomic (autonomic) nervous system, including unspecified disorder of the autonomic (autonomic) nervous system;
- anorexia nervosa;
- impulsive and borderline type of emotionally unstable personality disorder;
- hysterical personality disorder;
- anxious (avoidant, avoidant) personality disorder;
- persistent personality change due to the experienced catastrophe;
- hyperkinetic conduct disorder;
- family-confined conduct disorder - when standard therapy drugs are ineffective;
- unsocialized conduct disorder (including in the form of monotherapy);
- agitation, anxiety, other symptoms and signs of emotional disturbance;
- unspecified neurotic disorder, neurasthenia;
- insomnia of inorganic etiology - with the ineffectiveness of standard therapy methods;
- Emotional disorders characterized by childhood onset (phobic anxiety disorder, unspecified childhood emotional disorder, social anxiety disorder, sibling rivalry disorder, and other childhood emotional disorders.
In adults and children over the age of 3 years, Teraligen Valenta tablets are used as an antiallergic agent in the form of monotherapy or as part of a combined treatment for itching of various localization and etiology (unspecified anogenital itching, itching of the anus, itching of the vulva, itching with urticaria, dermatitis, solar urticaria and photocontact dermatitis, eczema, chickenpox, Hodgkin's disease, measles, shingles, diabetes mellitus, bites / stings of non-venomous insects or other non-venomous arthropods).
In addition, for children from 3 years of age, the use of Teraligen Valent is indicated as a sedative in drug preparation for surgical operations.
Solution for i / m administration
- symptomatic treatment: allergic conditions of various etiologies - itching, urticaria, conjunctivitis, rhinitis, angioedema;
- sedative and anxiolytic therapy: relief of symptoms of psychovegetative and neurotic disorders;
- sedative therapy: preoperative sedation, postoperative period;
- complex therapy: alcohol withdrawal syndrome.
Contraindications
Absolute contraindications for taking Teraligen Valenta tablets:
- severe liver failure;
- severe renal failure;
- angle-closure glaucoma;
- hyperplasia of the prostate;
- myasthenia gravis;
- Reye's syndrome;
- parkinsonism;
- lactose intolerance, glucose-galactose malabsorption, lactase deficiency;
- concomitant therapy with MAO (monoamine oxidase) inhibitors;
- period of pregnancy;
- breast-feeding;
- children under 3 years of age (as an antiallergic agent and a sedative during drug preparation for surgical operations);
- children's age up to 7 years (for other indications);
- hypersensitivity to the components of the drug.
Absolute contraindications for the appointment of Teraligen Valenta solution:
- deep depression of the central nervous system, coma;
- simultaneous use of MAO inhibitors (alimemazine is administered no earlier than 2 weeks after the end of treatment with MAO inhibitors);
- glaucoma;
- acute poisoning with hypnotics, narcotic analgesics, alcohol intoxication;
- OSAS (obstructive sleep apnea syndrome);
- episodic vomiting in children of unexplained genesis;
- pregnancy and breastfeeding;
- hypersensitivity to phenothiazine derivatives, including alimemazine, and / or to other components of the solution.
Caution should be exercised with both forms of Teraligen Valens for open-angle glaucoma, bladder neck obstruction, predisposition to urinary retention, bone marrow suppression, epilepsy, jaundice, arterial hypotension, alcoholism, in cases where there is a history of indications of complications with phenothiazine derivatives.
Teraligen Valenta, instructions for use: method and dosage
Film-coated tablets
Teraligen Valenta tablets are taken orally, swallowing whole (without violating the integrity of the film shell).
The doctor selects the dose and duration of treatment individually, depending on the clinical indications and goals of therapy.
Recommended daily doses:
- achievement of vegetative stabilizing effect: from 15 to 60 mg;
- achievement of anxiolytic effect: for adults - from 20 to 80 mg; for children over 7 years old - 20-40 mg;
- achieving a sedative and / or hypnotic effect (once 0.5 hours before bedtime): for adults - from 5 to 10 mg; for children from 7 years old - 2.5–5 mg;
- symptomatic treatment of allergic reactions: for adults - from 10 to 40 mg; for children from 7 years old - 5–20 mg.
The course of treatment in patients over the age of 7 years should be started with taking Teraligen Valent in the evening at a dose of 2.5–5 mg, followed by a gradual increase in the daily dose to ensure the required clinical effect. The daily maintenance dose can be divided into 3-4 doses. The duration of therapy is 60-180 days or more.
The maximum daily dose for adults is 500 mg, for persons over 60 years of age - 200 mg.
In case of behavioral disturbances in psychotic conditions in children over 7 years old, to achieve a sedative effect, the daily dose of Teraligen Valent can be increased to 60 mg.
The recommended dosage for children from three years of age for symptomatic treatment of allergic reactions: 2.5–5 mg 3-4 times a day. The duration of the course of treatment is determined by the doctor, it can be from 60 to 180 days or more.
Before surgical intervention in children aged 3–7 years for the purpose of sedation, Teraligen Valenta is used once, 1–2 hours before surgery, in a dose of 2 mg per 1 kg of the child's body weight.
Solution for i / m administration
Teraligen Valenta solution is intended for parenteral administration by intramuscular administration. The drug should be administered with caution to avoid accidental ingestion of the solution under the skin, which can lead to tissue necrosis at the injection site.
The attending physician determines the dose, frequency of administration and duration of therapy individually, depending on the nature of the pathology.
The maximum daily dose of alimemazine for parenteral administration is 200 mg.
Recommended dosage:
- allergic conditions (symptomatic therapy) - 25 mg 1 or 2 times a day;
- acute cases of hypersensitivity; psychiatric practice: for the treatment of adult patients - from 100 to 200 mg per day;
- premedication (as a sedative) - 1–2 hours before surgery 25–50 mg;
- alcohol withdrawal syndrome (as part of a combination therapy) - 50 mg 1 or 2 times a day.
Side effects
Side effects both when taking alimemazine inside and when administered intramuscularly are not significantly expressed and are extremely rare:
- from the side of the central nervous system: rapid fatigue, drowsiness, lethargy (more often occur in the first days of treatment, the cancellation of Teraligen Valent is required in rare cases); dizziness; paradoxical reaction in the form of nightmares, anxiety, agitation and irritability; extrapyramidal disorders (akathisia, hypokinesia, tremor), confusion;
- on the part of the cardiovascular system: tachycardia, lowering of blood pressure (BP);
- from the senses: paresis of accommodation (blurred vision), ringing or tinnitus;
- from the digestive system: decreased appetite, dryness of the oral mucosa, constipation, atony of the gastrointestinal tract;
- from the urinary system: urinary retention, atony of the bladder;
- from the respiratory system: dryness in the nose and throat, increased viscosity of bronchial secretions;
- others: increased sweating, inhibition of bone marrow hematopoiesis, muscle relaxation, allergic reactions, photosensitization.
Overdose
Symptoms of an overdose of alimemazine are manifested by an increase in the severity of all the side effects described above, except for allergic reactions.
In the case of diagnosing drug poisoning, it is recommended to discontinue its use and prescribe symptomatic therapy.
special instructions
When used simultaneously with other drugs, alimemazine can mask their ototoxic effects (dizziness, tinnitus).
It should be borne in mind that against the background of the use of Teraligen Valent, the body's need for riboflavin increases.
The use of alcoholic beverages and ethanol-containing drugs during the treatment period is contraindicated.
When planning allergological testing, therapy should be discontinued 72 hours before skin scarification tests for allergens are taken.
It is important to take into account that Teraligen Valenta injection solution contains sulfites that can enhance anaphylactic reactions.
Influence on the ability to drive vehicles and complex mechanisms
During the period of use of alimemazine, it is recommended to refrain from driving and working with complex mechanisms or other activities, the implementation of which requires concentration of attention and a high speed of psychomotor reactions.
Application during pregnancy and lactation
The use of Teraligen Valent during pregnancy and breastfeeding is contraindicated.
In case of conception during the treatment period, the drug should be canceled.
If necessary, the appointment of alimemazine during lactation, breastfeeding is stopped.
It should be borne in mind that during treatment, it is likely to receive a false positive result for the presence of pregnancy.
Pediatric use
The use of Teraligen Valent in children under the age of three years is contraindicated as an antiallergic agent and a sedative for drug preparation for surgical operations; under the age of seven - for all other indications.
With impaired renal function
The use of Teraligen Valent is contraindicated in case of severe renal failure.
It is recommended to prescribe the drug with caution to patients with a predisposition to urinary retention and obstruction of the bladder neck.
For violations of liver function
The use of Teraligen Valent is contraindicated in severe hepatic insufficiency.
Use in the elderly
The maximum daily dose of alimemazine for patients over the age of 60 is 200 mg.
Drug interactions
Possessing an insignificant risk of pharmacological interaction with other substances / drugs, Teraligen Valenta can be easily and practically safely combined with other drugs and therapeutic regimens.
With simultaneous use:
- MAO inhibitors: the combination of phenothiazine derivatives, including alimemazine, with MAO inhibitors increases the risk of extrapyramidal disorders and arterial hypotension;
- antihypertensive, hypnotic, anxiolytic (tranquilizers) and antipsychotic (neuroleptics) drugs, drugs for general anesthesia, narcotic analgesics, m-anticholinergics: against the background of interaction with alimemazine, the effects of these drugs are enhanced, so a correction of their doses may be required;
- tricyclic antidepressants, anticholinergics: enhance the m-anticholinergic activity of alimemazine;
- ethanol: the use of alcoholic beverages or ethanol-containing drugs can increase the depression of the central nervous system;
- phenamine derivatives, m-cholinomimetics, levodopa, dopamine, ephedrine, guanethidine: the combination with alimemazine weakens the effect of each of these drugs;
- antiepileptic drugs, barbiturates: alimemazine helps to lower the threshold of seizure activity of anticonvulsants and barbiturates, therefore, careful adjustment of their doses is required;
- beta-blockers: it should be borne in mind that concomitant therapy with beta-blockers increases the risk of a pronounced decrease in blood pressure, the development of arrhythmias;
- bromocriptine: the activity of bromocriptine is weakened;
- drugs that inhibit bone marrow hematopoiesis: increase the risk of myelosuppression;
- drugs with a hepatotoxic effect: the interaction of any of the drugs in this category with alimemazine can increase the manifestations of their hepatotoxicity.
Analogs
Teraligen Valent's analogs are Teraligen, Alimemazine tartrate, Limipranil, Solian, Aripiprazole, Ariprizol, Haloperidol, Senorm, Zeldox, Clopixol-Akufaz, Hedonin, Quetiapine, Quentiax, Quetitex, Nantaridex, Normiton, Ozapinex.
Terms and conditions of storage
Keep out of the reach of children.
Store at temperatures up to 25 ° C in a dark place.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Teraligen Valenta
Pointing to the effectiveness of the drug and a favorable safety profile, in the reviews of Teraligen Valenta, patients note that it well eliminates anxiety, helps to normalize sleep, and relieves allergic reactions of various origins and localization. In the treatment of mental disorders, it does not reduce mental capacity and physical activity. Unlike other drugs with a similar effect, it does not affect libido.
As disadvantages, the high cost of Teraligen Valent and prescription leave are most often indicated. The development of adverse reactions is rarely reported. Mention is made of drowsiness with high doses at the start of treatment, and dry skin and constipation as a result of severe dehydration.
Price for Teraligen Valenta in pharmacies
The price of Teraligen Valenta can be:
- 5 mg tablets: 25 pcs per pack. from 534 rub., per package 50 pcs. - from 748 rubles;
- solution for intramuscular administration 5 mg / ml: ampoules of 5 ml, 10 pcs per pack. - from 674 rubles.
Teraligen Valenta: prices in online pharmacies
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Drug name Price Pharmacy |
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Teraligen Valenta 5 mg film-coated tablets 25 pcs. 541 r Buy |
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Teraligen Valenta tablets p.o. 5mg 25 pcs. 601 RUB Buy |
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Teraligen Valenta 5 mg film-coated tablets 50 pcs. 710 RUB Buy |
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Teraligen Valenta tablets p.o. 5mg 50 pcs. 857 r Buy |
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Teraligen Valenta 5 mg film-coated tablets 100 pcs. 1410 RUB Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
