Universal reference book for medicines
Name of the preparation: ELZEPAM ® (ELZEPAM)

Active substance: phenazepam

Type: Tranquilizer (anxiolytic)

Manufacturer: МЦ ЭЛЛАРА (Russia)
Composition, form of production and packaging
The solution for intravenous and / or injection is colorless or slightly yellowish.
1 ml
bromodihydrochlorophenylbenzodiazepine 1 mg
Excipients: polyvinylpyrrolidone low molecular weight medical (povidone), glycerol, sodium disulphite, polysorbate 80 (Tween 80), sodium hydroxide 0.1M, water d / u.
1 ml - ampoules (5) - packings of cellular contour (1) - packs cardboard.
1 ml - ampoules (5) - packings the cellular contour (2) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Tranquilizer (anxiolytic). It is a derivative of benzodiazepine.
Has a pronounced anxiolytic, hypnotic, sedative, as well as anticonvulsant and central muscle relaxant action. Has a depressing effect on the central nervous system, which is realized mainly at thalamus, hypothalamus and limbic system. Enhances the inhibitory effect of 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 Elzepam is determined by the stimulation of the benzodiazepine receptors of the supramolecular GABA-benzodiazepine-chloronophore compounding complex, leading to the activation of the GABA receptor, which causes a decrease in the excitability of the subcortical structures of the brain, inhibition of polysynaptic spinal reflexes.
PHARMACOKINETICS
Widely distributed in the body. Metabolised in the liver.
T 1/2 from the body from 6 to 10-18 hours. Removal of the drug is mainly carried out with urine in the form of metabolites.
INDICATIONS
- neurotic, neurotic, psychopathic, psychopathic and other conditions, accompanied by anxiety, fear, increased irritability, tension, emotional lability;
- Reactive psychoses;
- hypochondriacal-senesthetic syndrome (including resistant to the action of other tranquilizers);
- autonomic dysfunction;
- sleep disorders;
- for the prevention of states of fear and emotional stress;
- temporal and myoclonic epilepsy (as an anticonvulsant);
- in neurological practice - for the treatment of hyperkinesis and tics, rigidity of muscles, vegetative lability.
DOSING MODE
Elzepam ® is given either in / m or in / in (jet or drip).
A single dose is usually 0.5-1 mg. For sleep disorders, the drug is prescribed in a dose of 0.5-1 mg 1 time / day before bedtime.
For the relief of anxiety, anxiety, psychomotor agitation , as well as in autonomic paroxysms and psychotic conditions, Elzepam ® is used in / m or IV, an initial dose of 0.5-1 mg (0.5-1 ml 0.1% solution), an average daily dose of 3-5 mg (3-5 ml 0.1% solution), in severe cases - up to 7-9 mg.
With epileptic status and serial epileptic seizures, the drug is administered in / m or IV, starting at a dose of 0.5 mg.
For the treatment of alcohol withdrawal, the drug is given in / m or IV in a dose of 2.5-5 mg / day.
In neurological practice with diseases with increased muscle tone, the drug is given in / m 0.5 mg 1 or 2 times / day.
For preoperative preparation - iv injection of 3-4 mg (3-4 ml of 0.1% solution) is slowly introduced.
The average daily dose of Elzepam is 1.5-5 mg. The maximum daily dose is 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 Elzepam, 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 EFFECT
From the side of the central 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; rarely - 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; extremely rarely - paradoxical reactions (aggressive outbreaks, 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.
On the part of the digestive system: dry mouth or salivation, heartburn, nausea, vomiting, decreased appetite, constipation or diarrhea; impaired liver function, increased activity of hepatic transaminases and alkaline phosphatase, jaundice.
On the part of the genitourinary system: urinary incontinence, urinary retention, impaired renal function, decreased or increased libido, dysmenorrhea.
From the cardiovascular system: a decrease in blood pressure; rarely - tachycardia.
Allergic reactions: skin rash, itching.
Other: addiction, drug dependence; rarely - impaired vision (diplopia), weight loss. With a sharp decrease in dose or discontinuation of reception - the syndrome of "withdrawal" (sleep disturbance, dysphoric reactions, spasm of smooth muscles of the internal organs and skeletal muscles, depersonalization, increased sweating, depression, nausea, vomiting, tremor, perception disorder, including hyperacusis , paresthesia, photophobia, tachycardia, seizures, rarely - psychotic reactions).
Local reactions: phlebitis or venous thrombosis (redness, swelling or pain at the injection site).
CONTRAINDICATIONS
- coma;
- shock;
- Myasthenia gravis;
- Closed-angle glaucoma (acute attack or predisposition);
- severe chronic obstructive pulmonary disease (possibly increased respiratory failure);
acute respiratory failure;
- Pregnancy (especially the first trimester);
- the period of lactation (breastfeeding);
- age under 18 years (safety and efficacy not determined);
- Hypersensitivity to the components of the drug (including other benzodiazepines).
With caution should prescribe the drug for hepatic and / or renal insufficiency, cerebral and spinal ataxia, hyperkinesia, propensity to abuse of psychotropic drugs, organic brain diseases (possible paradoxical reactions), hypoproteinemia, depression, and elderly patients.
PREGNANCY AND LACTATION
The drug is contraindicated for use in the first trimester of pregnancy and lactation. The use of the drug in the II and III trimesters of pregnancy is possible only for life indications.
It is known that Elzepam ® has a toxic effect on the fetus and increases the risk of developing congenital malformations when used in the first trimester of pregnancy. Admission to therapeutic doses at a later time of pregnancy can cause depression of the newborn's central nervous system. Continuous use during pregnancy can lead to physical dependence with the development of the syndrome of "cancellation" in a newborn.
Children, especially at a young age, are very sensitive to the CNS depressing action of benzodiazepines. Use immediately before childbirth or during childbirth can cause a respiratory depression in the newborn, a decrease in muscle tone, hypotension, hypothermia, and a weak sucking act ("sluggish child" syndrome).
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution should prescribe the drug for kidney failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution should prescribe the drug for liver failure.
APPLICATION FOR CHILDREN
Contraindicated: age under 18 years (safety and efficacy not determined).
APPLICATION IN ELDERLY PATIENTS
With caution should prescribe the drug to elderly patients

SPECIAL INSTRUCTIONS
Special care should be taken when prescribing Elzepam ® for severe depression, because the drug can be used to implement suicidal intentions.
It is necessary to use the drug with caution in elderly and weakened patients.
With renal / hepatic insufficiency and long-term treatment, control over the pattern of peripheral blood and the activity of 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 Elsepam ®, 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).
With a sudden discontinuation of reception may be a syndrome of "withdrawal" (depression, irritability, insomnia, increased sweating, etc.), especially with long-term admission (more than 8-12 weeks).
The drug enhances the effect of alcohol, so the use of alcohol during treatment with Elzepam is not recommended.
Impact on the ability to drive vehicles and manage mechanisms
The use of Elzepam is contraindicated in time for drivers of transport and other persons performing work that requires quick reactions and precise movements.
OVERDOSE
Symptoms: with a moderate overdose - increased therapeutic effect and side effects; with a significant overdose - marked depression of consciousness, cardiac and respiratory activity.
Treatment: control of vital body functions, maintenance of respiratory and cardiovascular activity, symptomatic therapy. As antagonists of the muscle relaxant action of Elzepam, strychnine nitrate is recommended (parenterally, 1 ml 0.1% solution 2-3 times / day) or a solution of corazol (parenterally 1 ml 10% solution 1-2 times / day). As a specific antagonist, flumazenil (anexat) -w / in (5% glucose solution (dextrose) or 0.9% sodium chloride solution) can be used in the initial dose of 0.2 mg (if necessary, up to a dose of 1 mg).
DRUG INTERACTION
Elzepam ® is compatible with other drugs that cause depression of the central nervous system (including hypnotics, anticonvulsants, antipsychotics), however, in case of complex application it is necessary to take into account the mutual enhancement of their function.
Elzepam ® reduces the effectiveness of levodopa in patients with Parkinsonism.
Elzepam ® may increase the toxicity of zidovudine.
Inhibitors of microsomal oxidation increase the risk of developing toxic effects of Elzepam.
The inductors of microsomal liver enzymes reduce the effectiveness of Elsepam, while with Elsepam, they increase the concentration of imipramine in the blood serum.
Hypotensive drugs with simultaneous use with Elzepam may increase the severity of blood pressure lowering.
Against the background of simultaneous with Elzepam administration of clozapine, an increase in respiratory depression is possible.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. The drug should be stored in a dry, protected from light and out of reach of children at a temperature of no higher than 20 ° C. Shelf life - 2 years.
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