Expiration date: 09/2020
Active substance: Bromdihydrochlorphenylbenzodiazepine.
Structure and Composition:
Solution for intravenous and intramuscular administration. 1 ml contains:
Bromdihydrochlorphenylbenzodiazepine 1 mg
Excipients: low molecular weight polyvinyl Medical (povidone) glycerol sodium disulfite polysorbate (Tween 80), water for injections
in ampoules and 1 ml (complete with a knife ampoule), in a cardboard bundle 5 or 10 vials or in strip cellular pack of 5 ampoules in a cardboard pack 1 or 2 packs or 10 packs in a box.
Description pharmaceutical form:
Colorless or slightly yellowish liquid.
Widely distributed in the body. It is metabolized in the liver. T1 / 2 of the body - from 6 to 10-18 h, excretion of the drug is mainly through the kidneys as metabolites.
Description of the pharmacological actions:
It possesses anxiolytic, hypnotic, sedative, and anticonvulsant and central muscle relaxant effect.
It has a depressant effect on the central nervous system, is realized mainly in the thalamus, the hypothalamus and the limbic system. It increases the inhibitory effect of GABA, which is one of the major mediators of the pre- and post-synaptic inhibition of transmission of nerve impulses in the central nervous system.
The mechanism of action of the drug is determined Elzepam stimulation of benzodiazepine receptors supramolecular GABA-benzodiazepine-hlorionofor-receptor complex, leading to activation of GABA receptor, causes a decrease in the excitability of the subcortical structures of the brain, spinal reflexes polysynaptic braking.
- various neurotic, neurosis, psychotic, psychopathic and other conditions accompanied by anxiety, fear, increased irritability, tension, emotional lability
- reactive psychosis, hypochondriacally-senestopatichesky syndrome (including resistant to the action of other tranquilizers)
- autonomic dysfunction and sleep disorders (for the prevention of states of fear and emotional stress)
- as an anticonvulsant - to treat patients with temporal lobe epilepsy and myoclonic
- in neurological practice - for the treatment of hyperkinetic and tics, muscle rigidity, autonomic lability.
- hypersensitivity (including other benzodiazepines)
- angle-closure glaucoma (acute onset or predisposition)
- Severe COPD (possibly increasing respiratory failure)
- acute respiratory failure
- pregnancy (especially the I trimester)
- age of 18 years (the safety and effectiveness are not determined).
Be wary - hepatic and / or renal failure, cerebral and spinal ataxia, hyperkinesis, a tendency to abuse of psychotropic drugs, organic brain disease (possible paradoxical reactions), hypoproteinemia, old age, depression (see "Special Instructions".).
From the nervous system: at the beginning of treatment (particularly in elderly patients) - drowsiness, fatigue, dizziness, impaired concentration, ataxia, disorientation, mental retardation and motor reactions, confusion, rarely - headache, euphoria, depression, tremors, decreased memory, loss of coordination of movements (particularly at high doses), depressed mood, dystonic extrapyramidal reactions (uncontrolled movements, including eye), asthenia, myasthenia gravis, dysarthria, very rarely - paradoxical reactions (aggressive outbursts, agitation, anxiety, suicidal tendencies, muscle spasms, hallucinations, anxiety, sleep disturbance).
From the side of hematopoiesis: leukopenia, neutropenia, agranulocytosis (chills, pyrexia, sore throat, unusual tiredness or weakness), anemia, thrombocytopenia.
From the digestive system: dry mouth or salivation, heartburn, nausea, vomiting, loss of appetite, constipation or diarrhea, abnormal liver function, increased activity of hepatic transaminases and alkaline phosphatase, jaundice.
From the urogenital system: urinary incontinence, urinary retention, renal dysfunction, decreased or increased libido, dysmenorrhea.
Allergic reactions: skin rash, pruritus.
Effect on the fetus: teratogennst (especially I trimester), central nervous system depression, respiratory failure and suppression of sucking reflex in infants whose mothers used the drug.
Other: addiction, drug dependency reduction of blood pressure, rarely - blurred vision (diplopia), weight loss, tachycardia. With a sharp decrease in dose or discontinuation - withdrawal symptoms (sleep disorders, dysphoric reactions, spasm of smooth muscles of internal organs and skeletal muscles, depersonalization, increased sweating, depression, nausea, vomiting, tremors, disorders of perception, including hyperacusis, paresthesia , photophobia, tachycardia, convulsions, rarely - psychotic reactions).
Local reactions: phlebitis or venous thrombosis (redness, swelling or pain at the injection site).
Elzepam compatible with other drugs that cause depression of the central nervous system (hypnotics, anticonvulsants, antipsychotics, and others.), But the combined use is necessary to take into account the mutual reinforcement of their activities.
Reduces the effectiveness of levodopa in patients with Parkinson's disease.
It may increase the toxicity of zidovudine.
Inhibitors of microsomal oxidation increase the risk of toxic effects.
Inductors microsomal liver enzymes decrease the efficiency.
Increases concentration of imipramine in blood serum.
Antihypertensive agents may increase the severity of blood pressure lowering.
Against the background of the simultaneous appointment of clozapine may increase the respiratory depression.
Dosage and administration:
V / m, in / in (bolus or infusion).
A single dose is usually 0.5 mg -1, sleep disorders it is prescribed bedtime.
For relief of fear, anxiety, psychomotor agitation, as well as autonomic epileptic and psychotic states Elzepam used in an initial dose of 0.5 mg -1 (0.5-1 ml of 0.1% solution), the average daily dose - 3-5 mg (5.3 ml of a 0.1% solution), in severe cases - up to 9.7 mg (9.7 ml of a 0.1% solution).
When status epilepticus seizures and production preparation is administered starting at a dose of 0.5 mg.
For the treatment of alcohol withdrawal symptoms the drug is prescribed in a dose of 2.5-5 mg per day.
In practice, in neurological diseases with increased muscle tone drug administered in / m, 0.5 mg of 1 or 2 times per day.
To pre - in / in slowly injected 3-4 mg (3-4 ml of 0.1% solution).
The average daily dose of the drug is Elzepam 1.5-5 mg. The maximum daily dose - 10 mg.
After achieving sustainable therapeutic effect, it is advisable to move to the use of oral dosage forms of the drug.
In order to avoid the development of drug dependence, at course treatment duration of application Elzepam drug, like other benzodiazepines, it is 2 weeks. But in some cases, the duration of treatment can be increased to 3-4 weeks.
When you remove the drug dose is reduced gradually.
Symptoms: moderate overdose - increased therapeutic effect and side effects if a large overdose - marked depression of consciousness, cardiac and respiratory activity.
Treatment: Control of vital functions, maintaining respiratory and cardiovascular activity, symptomatic therapy. As antagonists of the drug miorelaksantnogo Elzepam prescribed strychnine nitrate (injection 1 ml 0.1% 2-3 times a day solution) or metrazole solution (1 ml injections of 10% solution 1-2 times a day). As a specific antagonist flumazenil can be used (aneksat) - / v (a 5% solution of glucose (dextrose) or 0.9% sodium chloride) in an initial dose of 0.2 mg (if necessary - to a dose of 1 mg).
Require special care when assigning Elzepam medication for severe depression since the drug can be used for the implementation of suicidal intentions. Caution should use the drug in elderly and debilitated patients. In renal / hepatic failure and prolonged treatment is necessary to monitor patterns of peripheral blood and liver enzymes.
The frequency and nature of the side effects depend on the individual sensitivity, dosage and duration of treatment. When reducing the dose or discontinuation of the drug Elzepam side effects disappear.
Like other benzodiazepines, it has the ability to cause drug dependency chronic administration in large doses (up to 4 mg / day).
In a sudden discontinuation may experience withdrawal symptoms (depression, irritability, insomnia, sweating, etc.), Particularly during chronic administration (more than 8-12 weeks).
The gestation period is only used for emergencies. It has a toxic effect on the fetus and increase the risk of birth defects when used in the I trimester of pregnancy. Therapeutic dose in the later stages of pregnancy can cause depression of the central nervous system of the newborn. The constant use during pregnancy may lead to physical dependence with the emergence of withdrawal symptoms in the newborn.
Children, especially at a younger age, are very sensitive to the CNS depressant effects of benzodiazepines.
Using just before birth or during labor may cause neonatal respiratory depression, decreased muscle tone, hypotension, hypothermia and a weak act of sucking (flaccid baby syndrome).
The drug increases the effects of alcohol, so drinking alcohol during treatment is not recommended.
Elzepam contraindicated during transport drivers and other persons performing work that requires fast reactions and precise movements.
(Away from the fire)
Elzepam 0.1% 1ml 10 vials
- Brand: Ellara
- Availability: Out of stock