Universal reference book for medicines
Product name: PHENAZEPAM (PHENAZEPAM)

Active substance: phenazepam

Type: Tranquilizer (anxiolytic)

Composition, form of production and packaging
Tablets of white color, flat-cylindrical, with a facet.
1 tab.

bromodihydrochlorophenylbenzodiazepine 0.5 mg

Excipients: lactose monohydrate - 81.5 mg, potato starch - 15 mg, croscarmellose sodium (impellosis) - 2 mg, calcium stearate - 1 mg.

10 pieces.
- packings cellular planimetric (5) - packs cardboard.
25 pcs.
- packings cellular planimetric (2) - packs cardboard.
50 pcs.
- polymer cans (1) - packs of cardboard.
Tablets of white color, flat-cylindrical, with a facet and a risk.

1 tab.

bromodihydrochlorophenylbenzodiazepine 1 mg

Excipients: lactose monohydrate - 122 mg, potato starch - 22.5 mg, croscarmellose sodium (impellose) - 3 mg, calcium stearate - 1.5 mg.

10 pieces.
- packings cellular planimetric (5) - packs cardboard.
25 pcs.
- packings cellular planimetric (2) - packs cardboard.
50 pcs.
- polymer cans (1) - packs of cardboard.
Tablets of white color, flat-cylindrical, with a facet.

1 tab.

bromodihydrochlorophenylbenzodiazepine 2.5 mg

Excipients: lactose monohydrate - 161.5 mg, potato starch - 30 mg, croscarmellose sodium (impellosis) - 4 mg, calcium stearate - 2 mg.

10 pieces.
- packings cellular planimetric (5) - packs cardboard.
25 pcs.
- packings cellular planimetric (2) - packs cardboard.
50 pcs.
- polymer cans (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2016.

PHARMACHOLOGIC EFFECT

Anxiolytic agent (tranquilizer) of benzodiazepine series.
Has anxiolytic, sedative-hypnotic, anticonvulsant and central muscle relaxant effect.
Pharmacodynamics

'Enhances the inhibitory effect of gamma-aminomatic acid (GABA) on the transmission of nerve impulses.
Stimulates benzodiazepine receptors located in the allosteric center of postsynaptic GABA receptors. ascending activating reticular formation of the brain stem and intercalary neurons of the lateral horns of the spinal cord; 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 complex of the limbic system and is manifested in a decrease, 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).

The productive symptomatology of psychotic genesis (acute delusional, hallucinatory, affective disorders) practically does not affect, rarely a decrease in affective tension, delusional disorders.

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, suppressing the spread of convulsive impulse, but the excited state of the focus is not removed.
Central miorelaksiruyuschee effect due to inhibition of the polysynaptic spinal afferent inhibitory pathways (to a lesser extent, monosynaptic). Perhaps a direct inhibition of the motor nerves and muscle functions.
PHARMACOKINETICS

After oral intake is well absorbed from the gastrointestinal tract, T max in the blood plasma - 1-2 hours.

Metabolised in the liver.
Т 1/2 - 6-10-18 ч. It is deduced basically by kidneys in the form of metabolites.
INDICATIONS

- Various neurotic, neurotic-like psychopathic, psychopathic and other conditions, accompanied by anxiety, fear, increased irritability, tension, emotional lability;

- Reactive psychosis, hypochondriacal-senesthetic syndrome (including those resistant to the action of other tranquilizers);

- autonomic dysfunction;

- sleep disorders;

- prevention of states of fear and emotional stress.

As an anticonvulsant:

- temporal and myoclonic epilepsy.

In neurological practice, phenazepam is used to treat:

- hyperkinesis and ticks;

- rigidity of muscles;

- vegetative lability.

DOSING MODE

Inside: for sleep disorders - 0.5 mg for 20-30 minutes before sleep.

For treatment of neurotic, psychopathic, neurosis-like and psychopathic-like conditions, the initial dose is 0.5-1 mg 2-3 times / day.
After 2-4 days, taking into account the effectiveness and tolerability, the dose can be increased to 4-6 mg / day.
With severe agitation, fear, anxiety, treatment starts with a dose of 3 mg / day, rapidly increasing the dose to obtain a therapeutic effect.

In the treatment of epilepsy - 2-10 mg / day.

For treatment of alcohol withdrawal - inside, 2-5 mg / day.

The average daily dose is 1.5-5 mg, it is divided into 2-3 doses, usually 0.5-1 mg in the morning and in the afternoon and up to 2.5 mg at night.
In neurological practice, for diseases with muscular hypertension , 2-3 mg 1-2 times / day are prescribed.
The maximum daily dose is 10 mg.

To avoid the development of drug dependence in course treatment, the duration of the use of phenazepam is 2 weeks (in some cases, the duration of treatment can be increased to 2 months).
With the abolition of phenazepam, the dose is reduced gradually.
SIDE EFFECT

From the central nervous system and peripheral nervous system: at the beginning of treatment (especially in elderly patients) - drowsiness, fatigue, dizziness, decreased ability to concentrate, ataxia, disorientation, unsteadiness of gait, slowing of mental and motor reactions, confusion;
rarely - headache, euphoria, depression, tremor, memory loss, movement coordination disorders (especially at high doses), mood depression, dystonic extrapyramidal reactions (uncontrolled movements, including the eye), asthenia, muscle weakness, dysarthria, epileptic seizures (in patients with epilepsy); extremely rarely - paradoxical reactions (aggressive outbreaks, psychomotor agitation, fear, suicidal tendencies, muscle spasm, hallucinations, agitation, irritability, anxiety, insomnia).
From the hemopoiesis: leukopenia, neutropenia, agranulocytosis (chills, hyperthermia, sore throat, excessive 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 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.

Allergic reactions: skin rash, itching.

Other: addiction, drug dependence;
a decrease in blood pressure; rarely - visual impairment (diplopia), weight loss, tachycardia.
With a sharp decrease in dose or discontinuation of reception - withdrawal syndrome (irritability, nervousness, sleep disturbances, dysphoria, spasm of smooth muscles of the internal organs and skeletal muscles, depersonalization, increased sweating, depression, nausea, vomiting, tremor, perception disorders, incl. hyperaemia, paresthesia, photophobia, tachycardia, convulsions, rarely - acute psychosis).

CONTRAINDICATIONS

- coma;

- shock;

- Myasthenia gravis;

- Closed-angle glaucoma (acute attack or predisposition);

- Acute alcohol poisoning (with impaired vital functions), narcotic analgesics and hypnotics;

- severe COPD (possibly increased respiratory failure);

acute respiratory failure;

- severe depression (suicidal tendencies may appear);

- Pregnancy (especially the first trimester);

- lactation period;

- children and adolescents under 18 years of age (safety and efficacy not determined);

- Hypersensitivity (including to other benzodiazepines).

Carefully

Use with caution in patients with hepatic and / or renal insufficiency, cerebral and spinal ataxia, drug dependence in history, propensity to abuse psychoactive drugs, hyperkinesia, organic brain diseases, psychosis (possible paradoxical reactions), hypoproteinemia, nocturnal apnea (established or suspected ), patients of advanced age.

PREGNANCY AND LACTATION

In pregnancy, use is only possible for life indications.
Has a toxic effect on the fetus and increases the development of congenital malformations when applied in the first trimester of pregnancy. Admission to therapeutic doses in later periods of pregnancy can cause CNS depression in a newborn. Continuous use during pregnancy can lead to physical dependence with the development of withdrawal syndrome in a newborn. Children, especially at a young age, are very sensitive to the CNS depressing action of benzodiazepines.
The use immediately before childbirth or during labor can cause a respiratory depression in the newborn, a reduction in muscle tone, hypotension, hypothermia, and a weak act of sucking ("sluggish child" syndrome).

APPLICATION FOR FUNCTIONS OF THE LIVER

Use with caution in patients with renal insufficiency.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Use with caution in patients with hepatic insufficiency.

APPLICATION FOR CHILDREN

Contraindicated use of the drug for children and adolescents under the age of 18 years (safety and efficacy not determined).

APPLICATION IN ELDERLY PATIENTS

Use with caution in elderly patients.

SPECIAL INSTRUCTIONS

In renal and / or hepatic insufficiency and long-term treatment, it is necessary to monitor the picture of peripheral blood and the activity of hepatic enzymes.

Patients who had not previously taken psychoactive drugs had a therapeutic response to the use of phenazepam in lower doses, compared with patients taking antidepressants, anxiolytics or alcoholism.

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 withdrawal syndrome (including depression, irritability, insomnia, increased sweating), especially with prolonged admission (more than 8-12 weeks). When patients develop such unusual reactions as increased aggressiveness, acute excitations, feelings of fear, thoughts of suicide, hallucinations, increased muscle cramps, difficulty falling asleep, superficial sleep, treatment should be discontinued.
In the course of treatment, patients are strictly prohibited from drinking ethanol.
The efficacy and safety of the drug in patients under the age of 18 years is not established.
Impact on the ability to drive vehicles and manage mechanisms

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

OVERDOSE

Symptoms: severe depression of consciousness, cardiac and respiratory activity, pronounced drowsiness, prolonged confusion, decreased reflexes, prolonged dysarthria, nystagmus, tremor, bradycardia, shortness of breath or shortness of breath, lowering of blood pressure, coma.

Treatment: gastric lavage, reception of activated charcoal, hemodialysis ineffective, monitoring of vital body functions, maintenance of respiratory and cardiovascular activity, symptomatic therapy.
Specific antagonist flumazenil (in hospital) (iv 0.2 mg, if necessary up to 1 mg - 5% glucose solution or 0.9% sodium chloride solution).
DRUG INTERACTION

With simultaneous use of phenazepam reduces the effectiveness of levodopa in patients with Parkinsonism.

Phenazepam may increase the toxicity of zidovudine.

There is a mutual enhancement of the effect with simultaneous use of antipsychotic, antiepileptic or hypnotic drugs, as well as central muscle relaxants, narcotic analgesics, ethanol.

Inhibitors of microsomal oxidation increase the risk of toxic effects.
Inducers of microsomal liver enzymes reduce efficacy. Increases the concentration of imipramine in the blood serum.
With simultaneous use with antihypertensive agents, it is possible to increase antihypertensive action.
Against the background of simultaneous 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

The drug should be in a dry, protected from light and out of reach of children at a temperature of no higher than 25 ° C.
Shelf life - 3 years.
Do not use after the expiration date.

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