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

Auxiliary substances: lactose monohydrate (sugar milk) - 0.0695 g or 0.10405 g, potato starch - 0.0285 g or 0.0427 g, calcium stearate - 0.001 g or 0.00127 g, gelatin medical - 0.0005 g or 0.00098 g (tablet weight 0.1 g or 0.15 g).

Description:

Tablets are white, flat-cylindrical with a bevel.

Pharmacotherapeutic group:Anxiolytic agent (tranquilizer).

ATX: & nbsp

N.05.B.X Other anxiolytics

Pharmacodynamics:

Anxiolytic agent (tranquilizer) of benzodiazepine series.Has anxiolytic, sedative-hypnotic, anticonvulsant and central muscle relaxant effect. Increases the inhibitory effect of gamma-aminobutyric acid on the transmission of nerve impulses. Stimulates binding sites with benzodiazepines located in the allosteric center of the postsynaptic gamma-aminobutyric acid receptors; reduces the excitability of subcortical structures of the brain (limbic system, thalamus, hypothalamus), inhibits polysynaptic spinal reflexes. Anxiolytic action is due to the influence on the amygdala of the limbic system and is manifested in a decrease in emotional tension, easing anxiety, fear, anxiety. The sedative effect is due to the influence on the reticular formation of the brainstem and the nonspecific nuclei of the thalamus and is manifested by a decrease in the symptomatology of neurotic origin (anxiety, fear). Sleeping effect is associated with depression of the cells of the reticular formation of the brain stem. Reduces the impact of emotional, vegetative and motor stimuli, which break the mechanism of falling asleep.Anticonvulsant action is realized by strengthening presynaptic inhibition, the drug suppresses the spread of convulsive impulse, but does not relieve the excited state of the focus. Central miorelaksiruyuschee effect due to inhibition of the polysynaptic spinal afferent inhibitory pathways (less monosynaptic). Perhaps direct inhibition of motor nerves and muscle contractility.

Pharmacokinetics:

when ingested, the drug is well absorbed from the gastrointestinal tract, the time to reach the maximum concentration of bromodihydrochlorophenylbenzodiazepine in the blood for 1 to 2 hours. It is metabolized in the liver, the elimination half-life of the organism is from 6 to 18 hours. It is excreted mainly by the kidneys in the type of metabolites.

Indications:

The drug is used for various neurotic, neurotic-like psychopathic, psychopathic and other conditions, accompanied by anxiety, fear, increased irritability, tension, emotional lability. In reactive psychoses, senesto-hypochondriacal disorders (including those resistant to the action of other tranquilizers), autonomic dysfunction and sleep disorders.

As an anticonvulsant drug is used to treat patients with temporal and myoclonic epilepsy.

In neurological practice, the drug is used to treat hyperkinesis and tics, muscle rigidity.

Contraindications:

Hypersensitivity (including to other benzodiazepines), coma, shock, myasthenia gravis, occlusive glaucoma (acute attack or predisposition), acute alcohol poisoning (with impaired vital functions), narcotic analgesics and hypnotic drugs, severe chronic obstructive disease lungs (possibly increased respiratory failure), acute respiratory failure, severe depression (suicidal tendencies may manifest); pregnancy, lactation, age under 18 years (safety and efficacy not determined), lactase deficiency, lactose intolerance, glucosogalactose malabsorption.

Carefully:

Hepatic and / or renal insufficiency, cerebral and spinal ataxia, drug dependence in history, propensity to abuse psychoactive drugs, hyperkinesis, organic brain diseases,psychosis (paradoxical reactions are possible), hypoproteinemia, nocturnal apnea (established or presumed), elderly age.

Dosing and Administration:

The drug is prescribed inside.

A single dose is usually 0.0005 - 0.001 g (0.5-1 mg), with sleep disorders - 0.0005 g (0.5 mg) for 20-30 minutes before sleep.

For treatment of neurotic, psychopathic, neurosis-like and psychopathic-like conditions, the initial dose is 0.0005 - 0.001 g (0.5-1 mg) 2-3 times a day. After 2-4 days, taking into account the effectiveness and tolerability of the drug, the dose can be increased to 0.004-0.006 g per day (4-6 mg), the morning and daily dose is 0.0005 - 0.001 g, at night 0.0025 g. agitation, fear, anxiety treatment begin with a dose of 0.003 g (3 mg) per day, rapidly increasing the dose to obtain a therapeutic effect.

In the treatment of epilepsy, the dose is 0.002-0.01 g (2-10 mg) per day.

In neurological practice for diseases with increased muscle tone, the drug is prescribed 0.002-0.003 g (2-3 mg) once or twice a day.

The average daily dose is 0.0015-0.005 g (1.5-5 mg), it is divided into 3 or 2 doses, usually 0.5-1.0 mg in the morning and in the afternoon and 2.5 mg at night. The maximum daily dose of 0.01 g (10 mg).

To avoid the development of drug dependence, with course treatment, the duration of the drug, as well as other benzodiazepines, is 2 weeks.But in some cases, the duration of treatment can be increased to 2 months.

With the withdrawal of the drug, the dose is reduced gradually.

Side effects:

From the nervous system: at the beginning of treatment (especially in elderly patients) - drowsiness, fatigue, dizziness, impaired concentration, ataxia, disorientation, slowing of mental and motor reactions, confusion; headache, euphoria, depression, tremor, memory loss, movement coordination disorders (especially at high doses), mood reduction, dystonic extrapyramidal reactions (uncontrolled movements, including the eye), asthenia, myasthenia gravis, dysarthria, epileptic seizures (in patients with epilepsy); paradoxical reactions (outbreaks of aggression, psychomotor agitation, fear, suicidal tendencies, muscle spasm, hallucinations, anxiety, sleep disturbance).

On the part of the organs of hematopoiesis: leukopenia, neutropenia, agranulocytosis (chills, hyperthermia, sore throat, unusual fatigue or weakness), anemia, thrombocytopenia.

From the digestive system: dry mouth or drooling, heartburn, nausea, vomiting, decreased appetite,constipation or diarrhea; violations of liver function, increased activity of "liver" transaminases and alkaline phosphatase, jaundice.

From the genitourinary system: urinary incontinence, urinary retention, impaired renal function, decreased or increased libido, dysmenorrhea.

Allergic reactions: skin rash, itching.

Influence on the fetus: teratogenicity (especially I trimester), central nervous system depression, respiratory failure and suppression of sucking reflex in newborns whose mothers used the drug.

Other: addiction, drug dependence; lowering blood pressure; rarely - visual impairment (diplopia), weight loss, tachycardia. With a sharp decrease in dose or discontinuation of reception - the syndrome of "withdrawal" (sleep disturbance, dysphoric reactions, spasm of smooth muscles of internal organs and skeletal muscles, depersonalization, increased sweating, depression, nausea, vomiting, tremor, perception disorders, including hyperacuscus , paresthesia, photophobia, tachycardia, convulsions, rarely - psychotic reactions).

The frequency and nature of side effects depend on the individual sensitivity, dose and duration of treatment.With reduced doses or discontinuation of reception side effects disappear.

Overdose:

With a moderate overdose - increased therapeutic effect and dose-dependent side effects; with a significant overdose - marked depression of consciousness, cardiac and respiratory activity.

Treatment: gastric lavage, reception of activated charcoal, control For vital functions of the body, maintenance of respiratory and cardiovascular activity, symptomatic therapy. Hemodialysis is ineffective. As a specific antagonist, flumazenil - intravenously (at 5 % glucose solution (dextrose) or 0.9% sodium chloride solution) at an initial dose of 0.2 mg (if necessary, up to a dose of 1 mg).

Interaction:

Tranquesipam ® is compatible with other drugs that cause depression of central nervous system function (hypnotics, anticonvulsants, neuroleptics, etc.), however, in case of complex application it is necessary to take into account the mutual enhancement of their action. Reduces the effectiveness of levodopa in patients with Parkinsonism. Inhibitors of microsomal liver enzymes increase the risk of toxic effects and decrease efficacy. Increases the concentration of imipramine in the serum.

Hypotensive drugs can increase the severity of lowering blood pressure.

Against the background of simultaneous application of clozapine, an increase in respiratory depression is possible.

Special instructions:With renal / hepatic insufficiency and long-term treatment, control over the picture of peripheral blood and "hepatic" enzymes is necessary.

The frequency and nature of side effects depend on the individual sensitivity, dose and duration of treatment. With reduced doses or discontinuation of Tranquesipam, side effects disappear. Like other benzodiazepines, it has the ability to induce drug dependence in long-term admission in large doses (more than 4 mg / day).

Use immediately before childbirth or during childbirth can cause a newborn to depress respiration, reduce muscle tone, lower blood pressure, hypothermia and a weak act of sucking ("sluggish child" syndrome).

The drug strengthens the effect of alcohol, so the use of alcoholic beverages during treatment with Trunkwezipam® is contraindicated. The drug is contraindicated during work by drivers of transport and other persons performing work,requiring rapidity of psychomotor reactions and precise movements. .

Effect on the ability to drive transp. cf. and fur:The drug is contraindicated during the work of the drivers of transport and other persons performing work that requires the speed of psychomotor reactions and precise movements.

Form release / dosage:

Tablets 0.5 mg and 1 mg.

Packaging:10 tablets per contour cell pack. For 50 tablets in a jar of polymer or in a can of orange glass. Each jar or 5 contour mesh packages together with the instruction for use is placed in a pack of cardboard.

Storage conditions:

Store in a dry, 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:P N003747 / 02

Date of registration:28.09.2009

The owner of the registration certificate:DALHIMFARM, OJSC DALHIMFARM, OJSC Russia

Manufacturer: & nbsp

DALHIMFARM, OJSC Russia

Representation: & nbspDALHIMFARM, OJSCDALHIMFARM, OJSC

Information update date: & nbsp09.12.2015

Illustrated instructions

Instructions

Tranquesipam® (Trankvezipam)