Tranquesipam
Tranquezipam: 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: Trankvezipam
ATX code: N05BX
Active ingredient: bromdihydrochlorophenylbenzodiazepine (bromdihydrochlorphenylbenzodiazepine)
Manufacturer: Dalkhimpharm (Russia)
Description and photo update: 2018-21-11
Prices in pharmacies: from 126 rubles.
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Tranquesipam is a tranquilizer, anxiolytic drug.
Release form and composition
Dosage forms of Tranquezipam:
- solution for intravenous (i / v) and intramuscular (i / m) administration: weakly colored liquid (1 ml in an ampoule: in a cardboard box 10 ampoules; in blisters or plastic pallets for 5 ampoules, in a cardboard box 2 packages or pallet);
- tablets: flat-cylindrical, white, beveled (10 pcs. in blisters, in a cardboard box 5 packs; 50 pcs. in a dark glass jar or polymer jar, in a cardboard box 1 can or jar).
1 ml of Tranquezipam solution contains:
- active substance: bromodihydrochlorophenylbenzodiazepine - 1 mg;
- auxiliary components: distilled glycerin (glycerol), polysorbate (tween-80), povidone (low molecular weight medical polyvinylpyrrolidone 12 600 ± 2700), sodium hydroxide solution 0.1 M (up to pH 6-7.5), sodium metabisulfite (sodium disulfite), water for injections.
1 tablet Tranquezipam contains:
- active substance: bromodihydrochlorophenylbenzodiazepine - 0.5 mg or 1 mg;
- auxiliary components: calcium stearate, potato starch, milk sugar (lactose monohydrate), medical gelatin.
Pharmacological properties
Pharmacodynamics
Tranquesipam is a tranquilizer, a benzodiazepine drug with anxiolytic, sedative, hypnotic, anticonvulsant and central muscle relaxant action. The mechanism of its action is associated with increased inhibition of the effect of gamma-aminobutyric acid on the transmission of nerve impulses, inhibition of polysynaptic spinal reflexes, stimulation of binding sites with benzodiazepines, which are located in the allosteric center of postsynaptic receptors of gamma-aminobutyric acid. Tranquesipam helps to reduce the excitability of such subcortical structures of the brain as the limbic system, hypothalamus, thalamus.
The manifestation of anxiolytic action is a decrease in emotional stress, a weakening of feelings of fear, anxiety, anxiety.
The influence of the active substance on the reticular formation of the brainstem and nonspecific nuclei of the thalamus causes the sedative effect of Tranquesipam, which reduces the manifestations of symptoms of neurotic origin.
The hypnotic effect is associated with inhibition of the cells of the reticular formation of the brain stem, as a result of which the effect of autonomic, emotional, and motor stimuli on the mechanism of falling asleep decreases.
The anticonvulsant effect is associated with an increase in presynaptic inhibition, as a result of which only the propagation of the convulsive impulse is suppressed, while the state of excitement in the focus itself remains.
The central muscle relaxant effect of Tranquezipam becomes possible mainly due to inhibition of polysynaptic spinal reflexes and, to a lesser extent, inhibition of monosynaptic spinal reflexes. In addition, it is possible to directly inhibit motor nerves and muscle contractility.
Pharmacokinetics
After taking Tranquezipam tablets inside, the drug is rapidly absorbed from the gastrointestinal tract, which makes it possible to reach the maximum concentration in the blood plasma within 1–2 hours. The active substance is characterized by a wide distribution in the body. Metabolism of bromodihydrochlorophenylbenzodiazepine occurs in the liver.
The half-life is 6-18 hours.
It is excreted from the body in the form of metabolites, mainly through the kidneys.
Indications for use
- psychopathic, psychopathic, neurotic, neurosis-like and other states, which are accompanied by increased irritability, emotional lability, tension, feelings of anxiety, fear;
- autonomic dysfunction, sleep disorders;
- reactive psychoses, senesto-hypochondriacal disorders, including those resistant to the action of other tranquilizers;
- temporal lobe and myoclonic epilepsy;
- hyperkinesis, tic, muscle stiffness in neurological conditions.
Contraindications
- angle-closure glaucoma (including those with a predisposition to it);
- severe form of chronic obstructive pulmonary disease;
- acute respiratory failure;
- coma;
- shock;
- myasthenia gravis;
- period of pregnancy;
- breast-feeding;
- age up to 18 years;
- hypersensitivity to other benzodiazepine drugs;
- individual intolerance to the components of Tranquezipam.
In addition, additional contraindications for the use of tablets:
- acute poisoning with narcotic analgesics, hypnotics and alcohol, accompanied by a weakening of vital functions;
- syndrome of glucose-galactose malabsorption, lactose intolerance, lactase deficiency;
- severe depression.
Care should be taken when prescribing Tranquezipam to patients prone to abuse of psychoactive drugs, with hepatic and / or renal failure, cerebral and spinal ataxia, a history of drug dependence, hyperkinesis, organic brain diseases, psychosis, hypoproteinemia, established or suspected in sleep apnea old age.
Instructions for the use of Tranquezipam: method and dosage
Solution for i / v and i / m administration
The Tranquezipam solution is used by intramuscular injection or by jet or drip intravenous administration.
The usual single dose is 0.5-1 mg, which corresponds to 0.5-1 ml of solution.
Recommended dosage:
- vegetative paroxysms, psychotic states, relief of fear, anxiety, psychomotor agitation: the initial dose (i / m or i / v) is 0.5-1 ml. The frequency of procedures depends on the clinical condition of the patient, the daily dose can vary from 3 to 5 ml, and in the treatment of severe cases - up to 7–9 ml of solution;
- status epilepticus and serial epileptic seizures: initial dose (i / m or i / v) - 0.5 ml;
- neurological diseases, accompanied by increased muscle tone: i / m - 0.5 ml 1-2 times a day;
- sleep disorders: before bedtime - 0.5–1 ml.
The average daily dose of Tranquezipam is 1.5–5 ml, the maximum daily dose is 10 ml.
The use of the drug in the form of a solution is continued until a stable therapeutic effect is achieved, then it is recommended to transfer the patient to taking tablets.
The general course of therapy with Tranquezipam should not exceed 14 days, the cancellation is carried out by a gradual decrease in the daily dose of the drug. For individual patients, it is possible to extend the course of treatment up to 21–28 days, while the increased risk of drug dependence in the patient should be taken into account.
Pills
Tranquezipam tablets are taken orally.
Recommended dosage:
- neurotic, neurosis-like, psychopathic, psychopathic states: initial dose - 0.5-1 mg 2-3 times a day. With the effectiveness and good tolerance of Tranquezipam after 2-4 days of therapy, the dose can be increased to 4-6 mg. In this case, in the morning and in the afternoon, you should take 0.5-1 mg, before bedtime - 2.5 mg;
- severe agitation, a sense of fear and anxiety: the initial dose is 3 mg per day. This is followed by a rapid increase in dose until the desired therapeutic effect is achieved;
- epilepsy: 2-10 mg daily;
- neurological diseases, accompanied by increased muscle tone: 2-3 mg 1-2 times a day;
- sleep disturbance: 0.5 hours before going to bed - 0.5 mg.
The average daily dose is 1.5-5 mg, divided into 2-3 doses. Usually in the morning and in the afternoon take 0.5-1 mg, before bedtime - 2.5 mg. The maximum daily dose is 10 mg.
The duration of the course of treatment is 14 days, in some cases it can be increased to 60 days, while the increased risk of drug dependence in the patient should be taken into account.
Cancellation of Tranquezipam is carried out by gradually reducing the daily dose.
Side effects
- on the part of the nervous system: at the beginning of therapy (more often in elderly patients) - drowsiness, dizziness, fatigue, impaired concentration, slowing down motor and mental reactions, ataxia, confusion, disorientation; headache, deterioration of mood, euphoria, tremor, memory loss, impaired coordination of movements (more often at high doses), dystonic extrapyramidal reactions (uncontrolled movements of the eyes and other organs), myasthenia gravis, dysarthria, asthenia, depression, in patients with epilepsy - epileptic seizures; paradoxical reactions - a feeling of fear, anxiety, sleep disturbance, psychomotor agitation, outbursts of aggression, muscle spasm, hallucinations, suicidal tendencies;
- from the digestive system: drooling, dry mouth, nausea, vomiting, decreased appetite, heartburn, diarrhea, constipation; liver dysfunction, jaundice, increased activity of hepatic transaminases, alkaline phosphatase;
- on the part of the hematopoietic system: agranulocytosis (unusual weakness or fatigue, hyperthermia, chills, sore throat), leukopenia, neutropenia, thrombocytopenia, anemia;
- from the genitourinary system: impaired renal function, urinary incontinence, dysmenorrhea, increased or decreased libido;
- allergic reactions: itchy skin, rash;
- effect on the fetus: teratogenicity (especially in the first trimester of pregnancy), respiratory failure, depression of the central nervous system, suppression of the sucking reflex;
- local reactions: when applying the solution - pain at the injection site, redness, swelling, phlebitis;
- others: drug dependence, addiction, tachycardia, lowering blood pressure (BP), decrease in body weight, diplopia (visual impairment), tachycardia; against the background of a sharp decrease in the dose or withdrawal of Tranquezipam - the development of withdrawal syndrome [nausea, vomiting, sleep disturbance, increased sweating, dysphoria, spasm of smooth muscles of internal organs and skeletal muscles, convulsions, depersonalization, depression, tremor, perception disorders (including photophobia, hyperacusis paresthesia), psychotic reactions].
Overdose
Symptoms: with a moderate degree of overdose - increased clinical effect and manifestation of dose-dependent undesirable effects. Against the background of a significant overdose, a pronounced inhibition of the activity of the cardiac and respiratory systems, consciousness develops.
Treatment: immediate gastric lavage, taking activated charcoal, prescribing symptomatic therapy. Careful monitoring of the state of the respiratory and cardiovascular systems and other vital functions of the body. Shown in / in the introduction of flumazenil at a dose of 0.2 mg with 0.9% sodium chloride solution or 5% glucose (dextrose) solution, if necessary, the dose of flumazenil can be increased to 1 mg.
The use of hemodialysis is ineffective.
special instructions
The appointment of Tranquezipam to patients with psychosis should be done with caution because of the risk of paradoxical reactions.
In patients with renal and / or hepatic insufficiency, as well as in the case of a prolonged period of therapy, it is necessary to monitor the picture of peripheral blood and the activity of liver enzymes.
Side effects disappear after dose reduction or drug withdrawal, their frequency and nature depend on the individual tolerance and duration of the drug.
Long-term use of Tranquezipam at a dose above 4 mg per day can cause drug dependence in the patient.
The use of the drug before immediate childbirth or during delivery can cause hypothermia in the newborn, decreased muscle tone, respiratory depression, lower blood pressure, weakened sucking reflex.
During the period of treatment, the use of alcohol and ethanol-containing drugs is contraindicated.
Influence on the ability to drive vehicles and complex mechanisms
During the period of treatment with Tranquezipam, it is contraindicated to perform any work that requires precise movements and speed of psychomotor reactions, including driving vehicles and complex mechanisms.
Application during pregnancy and lactation
According to the instructions, Tranquezipam is contraindicated for use during gestation and lactation.
The drug crosses the placental barrier and has a teratogenic effect on the fetus, especially in the first trimester of pregnancy. In infants whose mothers took benzodiazepine drugs, after birth, depression of the central nervous system, respiratory failure, and a decrease in the sucking reflex are diagnosed.
Tranquesipam is excreted in breast milk, therefore, if necessary, breastfeeding should be discontinued.
Pediatric use
Since the safety and efficacy of Tranquezipam in patients under the age of 18 has not been established, the appointment of the drug in this category of patients is contraindicated.
With impaired renal function
It is recommended to use pills and solution with caution in case of renal failure.
For violations of liver function
It is recommended to use the solution and tablets with caution for liver failure.
Use in the elderly
Care should be taken when treating elderly patients.
Drug interactions
With the simultaneous use of Tranquezipam:
- hypnotics, antipsychotics, anticonvulsants and other drugs that depress the function of the central nervous system can cause a mutual enhancement of the action;
- levodopa reduces its therapeutic effect;
- inhibitors of liver microsomal enzymes increase the risk of toxic effects;
- inducers of liver microsomal enzymes reduce the therapeutic effect of Tranquezipam;
- imipramine increases its serum concentration;
- ethanol enhances its effect;
- antihypertensive drugs enhance the severity of their action;
- clozapine may increase respiratory depression.
Analogs
Tranquezipam analogues are: Adaptol, Mebikar, Fezipam, Fenorelaksan, Anvifen, Fenazepam, Fezanef, Selank, Elzepam.
Terms and conditions of storage
Keep out of the reach of children.
Store at temperature: solution - 15-25 ° C in a dark place, tablets - up to 25 ° C in a place protected from light and moisture.
Shelf life: solution - 2 years, tablets - 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Tranquezipam
The few reviews about Tranquezipam are mostly positive. More often, there are reports of doctors about the therapeutic efficacy of the drug; they note a rather low incidence of undesirable actions.
The price of Tranquesipam in pharmacies
The price of Tranquesipam is for a pack of tablets containing 10 pcs. in a dose of 1 mg, it can be from 100 rubles.
Tranquezipam: prices in online pharmacies
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Drug name Price Pharmacy |
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Tranquezipam 1 mg tablets 50 pcs. 126 RUB Buy |
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Tranquezipam 1 mg / ml solution for intravenous and intramuscular administration 1 ml 10 pcs. 169 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!
