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

Active substance: phenazepam

Type: Tranquilizer (anxiolytic)

Manufacturer: ELLARA (Russia) is produced and packaged by the STATE FACTORY OF MEDICAL PREPARATIONS (Russia)
Composition, form of production and packaging
Tablets are white, flat-cylindrical, with a bevel.
1 tab.
bromodihydrochlorophenylbenzodiazepine 0.5 mg
Excipients: lactose monohydrate (sugar milk) 69.5 mg, potato starch 28.1 mg, gelatin 0.9 mg, calcium stearate 1 mg.
10 pieces. - packings of cellular contour (1) - packs cardboard.
10 pieces. - packings cellular planimetric (2) - packs cardboard.
10 pieces. - packings cellular planimetric (3) - packs cardboard.
Tablets are white, flat-cylindrical, with a bevel.
1 tab.
bromodihydrochlorophenylbenzodiazepine 0.5 mg
Excipients: lactose monohydrate (sugar milk) 69.5 mg, potato starch 28.1 mg, gelatin 0.9 mg, calcium stearate 1 mg.
10 pieces. - packings of cellular contour (1) - packs cardboard.
10 pieces. - packings cellular planimetric (2) - packs cardboard.
10 pieces. - packings cellular planimetric (5) - packs cardboard.
Tablets are white, flat-cylindrical, with a bevel.
1 tab.
bromodihydrochlorophenylbenzodiazepine 1 mg
Excipients: lactose monohydrate (milk sugar) 104.05 mg, potato starch 42.1 mg, gelatin 1.35 mg, calcium stearate 1.5 mg.
10 pieces. - packings of cellular contour (1) - packs cardboard.
10 pieces. - packings cellular planimetric (2) - packs cardboard.
10 pieces. - packings cellular planimetric (3) - packs cardboard.
10 pieces. - packings cellular planimetric (5) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
PHARMACHOLOGIC EFFECT
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 effect 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 digestive tract, the time to reach Cmax bromodihydrochlorophenylbenzodiazepine in the blood from 1 to 2 hours.
Metabolized in the liver, T 1/2 is from 6 to 18 h. It is excreted mainly by the kidneys in the form of metabolites.
INDICATIONS
- neurotic, neurotic disorders, accompanied by anxiety, fear, increased irritability, emotional lability and tension, vegetative disorders, hypochondriacelo-senesthetic syndrome (including resistant to other tranquilizers);
- sleep disorders;
- in the complex therapy of alcohol withdrawal syndrome;
- as an auxiliary for the treatment of patients with temporal and myoclonic epilepsy;
- treatment of increased muscle tone, hyperkinesia and rigidity in CNS lesions.
DOSING MODE
Inside.
A single dose is usually 0.5-1 mg, with sleep disorders - 0.5 mg for 20-30 minutes before sleep.
With neurotic, neurosis-like disorders, hypochondriacelo-sensopathic syndrome, 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 4-6 mg / day, morning and daytime doses are 0.5-1 mg, at night - 2.5 mg.
If anxiety is expressed, treatment starts with a dose of 3 mg / day, rapidly increasing the dose to obtain a therapeutic effect.
In the complex treatment of alcohol withdrawal symptoms are prescribed in a dose of 2.5-6 mg per day.
As an auxiliary for the treatment of patients with temporal and myoclonic epilepsy, the dose is 2-10 mg / day.
With increased muscle tone, hyperkinesia and rigidity in the CNS lesion, the drug is prescribed 2-3 mg once or twice a day. The maximum daily dose is 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. In some cases, the duration of treatment can be increased to 2 months.
SIDE EFFECT
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 the eye), asthenia, myasthenia gravis, dysarthria, convulsions (in 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.
On the part of 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.
On the part of 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 in the first trimester), central nervous system depression, respiratory depression and sucking reflex suppression in newborns whose mothers used the drug.
Other: addiction, drug dependence; lowering blood pressure; impaired vision (diplopia), weight loss, tachycardia. With a sharp decrease in dose or discontinuation of reception - the syndrome of "cancellation" (sleep disturbance, dysphoric reactions, spasm of smooth muscles of internal organs and skeletal muscles, depersonalization, increased sweating, depression, nausea, vomiting, tremor, perception disorders, including hyperacusis , paresthesia, photophobia, tachycardia, convulsions, 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.
CONTRAINDICATIONS
- hypersensitivity to the components of the drug, as well as to other benzodiazepine derivatives;
- coma, shock, myasthenia gravis, angle-closure glaucoma (acute attack or predisposition);
- Acute alcohol poisoning (with impaired vital functions), narcotic analgesics and hypnotics;
- severe chronic obstructive pulmonary disease (possibly increased respiratory failure);
acute respiratory failure;
- severe depression (suicidal tendencies may manifest);
- age under 18 years (safety and efficacy not established);
- deficiency of lactase;
- lactose intolerance, glucose-galactose malabsorption.
With caution: hepatic and / or renal insufficiency, cerebral and spinal ataxia, drug dependence in the anamnesis, propensity to abuse of psychoactive drugs, hyperkinesia, organic brain diseases, psychosis (possible paradoxical reactions), hypoproteinemia, nocturnal apnea (established or putative) , elderly age.
PREGNANCY AND LACTATION
The use of the drug during pregnancy and during breastfeeding is contraindicated.
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution in kidney failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution in liver failure.
APPLICATION FOR CHILDREN
Contraindicated for children under 18 years.
SPECIAL INSTRUCTIONS
In 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 the drug, side effects tend to disappear.
Like other benzodiazepines, it has the ability to induce drug dependence when taken for more than 2 weeks.
The use immediately before childbirth or during childbirth can cause a respiratory depression, a decrease in muscle tone, a decrease in blood pressure, hypothermia, and a weak act of sucking in the newborn ("sluggish child" syndrome). The drug enhances the effect of alcohol, so the use of alcoholic beverages during treatment with the drug is contraindicated.
Influence on the ability to drive vehicles, work with mechanisms.
When taking the drug is prohibited to drive vehicles and engage in other activities that require increased concentration and speed of psychomotor reactions.
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 (5% dextrose solution or 0.9% sodium chloride solution) can be used at an initial dose of 0.2 mg (if necessary, up to a dose of 1 mg).
DRUG INTERACTION
Compatible with other drugs that cause depression of the central nervous system (hypnotics, anticonvulsants, neuroleptics, etc.), however, in complex application it is necessary to take into account the mutual enhancement of their action. Reduces the effectiveness of levodopa.
Inhibitors of microsomal liver enzymes increase the risk of toxic effects and reduce efficacy.
Increases the concentration of imipramine in the blood serum.
Hypotensive drugs can increase the severity of lowering blood pressure. Simultaneous use with clozapine may cause respiratory depression.
TERMS OF RELEASE FROM PHARMACY
On prescription.
TERMS AND CONDITIONS OF STORAGE
In dry, dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children. Shelf life - 3 years.
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