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

Excipients: povidone (low molecular weight polyvinylpyrrolidone 12600 ± 2700) 9.0 mg, glycerol (distilled glycerin) 100.0 mg, sodium disulfite (sodium metabisulphite) 2.0 mg, polysorbate (tween 80) 50.0 mg, solution of sodium hydroxide 0.1 M - to pH 6.0 - 7.5, water for injection - up to 1 ml.

Description:

Lightly colored liquid.

Pharmacotherapeutic group:Anxiolytic agent (tranquilizer).

ATX: & nbsp

N.05.B.X Other anxiolytics

Pharmacodynamics:

Has a pronounced anxiolytic, hypnotic, sedative, as well as anticonvulsant and central muscle relaxant action. Has a depressing effect on the central nervous system (CNS), which is realized mainly in the thalamus, hypothalamus and limbic system. Enhances the inhibitory effect of gamma-aminobutyric acid (GABA), which is one of the main mediators of pre- and postsynaptic inhibition of nerve impulse transmission in the central nervous system. The mechanism of action of bromodihydrochlorophenylbenzodiazepine is determined by the stimulation of the benzodiazepine receptors of the supramolecular GABA-benzodiazepine-chloro-formof the prescription complex, which leads to the activity of the GABA receptor, which causes a decrease in the excitability of the subcortical structures of the brain, inhibition of the polysynaptic spinal reflexes.

Pharmacokinetics:

Widely distributed in the body. Metabolised in the liver. Half-life from the body from 6 to 10-18 hours, the excretion of the drug is mainly carried out through the kidneys in the form of metabolites.

Indications:PThe drug is used for various neurotic, neurotic, psychopathic, psychopathic and other conditions, accompanied by anxiety, fear, increased irritability, tension, emotional lability. In reactive psychoses, hypochondriacelo-sensopathic syndrome (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, zakratougolnaya glaucoma (acute attack or predisposition), severe chronic obstructive pulmonary disease (possibly increased respiratory failure), acute respiratory failure, pregnancy, the period of breastfeeding, age under 18 years (safety and efficacy not determined).

Carefully:

hepatic and / or renal insufficiency, cerebral and spinal ataxia, drug dependence in the anamnesis,propensity to abuse of psychoactive drugs, hyperkinesis, organic brain diseases, psychosis (possible paradoxical reactions), hypoproteinemia, nocturnal apnea (established or presumed), advanced age.

Dosing and Administration:

The drug is administered intramuscularly or intravenously (either jet or drip).

A single dose is usually 0.0005-0.001 g (0.5-1 mg), with sleep disorders 0.0005-0.001 g (0.5-1 mg) before going to bed.

For the relief of fear, anxiety, psychomotor agitation, as well as in vegetative paroxysms and psychotic states, the drug is administered intramuscularly or intravenously, the initial dose is 0.0005-0.001 g (0.5-1 ml of 0.1% solution), the average daily dose of 0.003- 0.005 g (3-5 ml 0.1% solution), in heavy cases to 0.007-0.009 g.

With epileptic status and serial epileptic seizures, the drug is administered intramuscularly or intravenously at a dose of 0.0005 g (0.5 mg).

In neurological practice for diseases with increased muscle tone, the drug is prescribed intramuscularly at 0.0005 g (0.5 mg) once or twice a day.

The average daily dose of Trunkwezipa® is 0.0015-0.005 g (1.5-5 mg). The maximum daily dose of 0.01 g (10 mg).

After achieving a sustainable therapeutic effect, it is advisable to switch to oral dosage forms of the drug.

To avoid the development of drug dependence, with course treatment, the duration of the use of Trankwezipam®, like other benzodiazepines, is 2 weeks. But in some cases, the duration of treatment can be increased to 3-4 weeks. 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 (uncontrollable movements, including eyes), asthenia, myasthenia gravis, dysarthria, epileptic seizures patients with epilepsy); paradoxical reactions (outbreaks of aggression, psychomotor agitation, fear, suicidal tendencies, muscle spasm, hallucinations, anxiety, sleep disturbance).

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

From the digestive system: dry mouth or salivation, 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, 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 of blood pressure (BP); impaired vision (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,h. Hyperacusia, paresthesia, photophobia; tachycardia, convulsions, psychotic reactions).

Local reactions: phlebitis or venous thrombosis (redness, swelling, or pain at the injection site).

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 of vital body functions. 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 the central nervous system (hypnotics, anticonvulsants, neuroleptics, etc.), but with 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. Inducers of microsomal liver enzymes reduce 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 enhances the effect of alcohol.Therefore, the use of alcoholic beverages during treatment with Tranquesipam® is contraindicated. Tranquesipam® is contraindicated during work by drivers of transport and other persons performing work requiring speed psychomoreactions and precise motion.

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

Tranquesypam is contraindicated during work by drivers of transport and other persons performing work, requiring the speed of psychomotor reactions and precise movements.

Form release / dosage:

Solution for intravenous and intramuscular injection 1 mg / ml.

Packaging:

1 ml per ampoule of neutral glass, 10 ampoules together with a vial for opening ampoules or a scarifier ampoule and instructions for use in a cardboard box.

5 ampoules per contour cell pack. 2 contoured cell packs together with instructions for use and a knife for opening ampoules or a scarifier ampullum in a pack of cardboard. When using ampoules with incisions, rings and break points, a scarifier ampoule or a knife for opening ampoules is not inserted.

Storage conditions:

In the dark place at a temperature of 15 to 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:P N003747 / 01

Date of registration:30.09.2009

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)