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

Active substance: phenazepam

Type: Tranquilizer (anxiolytic)

Manufacturer: DALHIMFARM (Russia)
Composition, form of production and packaging
The solution for intravenous and /
or injection is colorless or slightly colored.

1 ml

phenazepam (bromodihydrochlorophenylbenzodiazepine) 1 mg

Excipients: polyvinylpyrrolidone low molecular weight medical, glycerol distilled, sodium pyrosulfite, tween-80, sodium hydroxide solution 0.1 M, water d / u.

1 ml - ampoules glass (5) - packings cellular planimetric (2) - packs cardboard.

1 ml - glass ampoules (10) - cardboard boxes.

INSTRUCTION FOR THE SPECIALIST.

The product description was approved by the manufacturer for the 2009 print edition.

PHARMACHOLOGIC EFFECT

Anxiolytic (tranquilizer), benzodiazepine derivative.
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 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 phenazepam is determined by the stimulation of the benzodiazepine receptors of the supramolecular GABA-benzodiazepine-chloronophore-receptor complex leading to the activation of GABA receptors, which in turn causes a decrease in the excitability of the subcortical structures of the brain and the inhibition of polysynaptic spinal reflexes.

PHARMACOKINETICS

Distribution and Metabolism

Widely distributed in the body.

Metabolised in the liver.

Excretion

T 1/2 is from 6 to 10-18 hours. Removal of the drug, mainly 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;

- Hypochondriatic-senesthetic syndrome (including resistant to the action of other tranquilizers);

- autonomic dysfunction;

- sleep disorders;

- prevention of states of fear and emotional stress;

- temporal and myoclonic epilepsy;

- hyperkinesis and tics;

- rigidity of muscles;

- vegetative lability.

DOSING MODE

The drug should be injected in / m or intravenously (drip or drip).
A single dose of phenazepam usually is 0.5-1 mg, the average daily dose is 1.5-5 mg, the maximum daily dose is 10 mg.
For the relief of fear, anxiety, psychomotor agitation , as well as in autonomic paroxysms and psychotic states, the drug is prescribed in the initial dose of 0.5-1 mg (0.5-1 ml 0.1% solution), the average daily dose is 3-5 mg (3-5 ml 0.1 % solution), in severe cases, the dose can be increased to 7-9 mg.

With epilepsy, the drug is given in / m or IV, starting at a dose of 0.5 mg.

With alcohol withdrawal Phenazepam is administered 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, the drug is administered iv slowly in a dose of 3-4 mg (3-4 ml 0.1% solution).

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 in course treatment, the duration of the use of phenazepam is 2 weeks.
In some cases, the duration of treatment can be increased to 3-4 weeks. If you cancel npenapata, 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, impaired concentration, ataxia, disorientation, slowing of mental and motor reactions, confusion;
rarely - headache, euphoria, depression, tremor, memory loss, movement coordination disorders (especially when used in high doses), mood reduction, dystonic extrapyramidal reactions, asthenia, myasthenia gravis, dysarthria;very rarely - paradoxical reactions (aggressive outbreaks, psychomotor agitation, stpax, suicidal tendencies, muscle spasm, hallucinations, anxiety, sleep disturbance).
On the part of the hematopoiesis system: leukopenia, neutropenia, agranulocytosis, 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.

From the urinary system: urinary incontinence, urinary retention, impaired renal function.

On the part of the reproductive system: decreased or increased libido, dysmenorrhea;
influence on fetus - teratogenicity (especially I trimester), CNS depression, respiratory failure, suppression of sucking reflex in newborns whose mothers used the drug during pregnancy.
Allergic reactions: skin rash, itching.

Other: addiction, drug dependence, lowering blood pressure;
rarely - visual impairment (diplopia), weight loss, tachycardia; with a sharp reduction in dose or discontinuation of use - withdrawal syndrome.
Local reactions: phlebitis or venous thrombosis (hyperemia, swelling, or pain at the injection site).

CONTRAINDICATIONS

- coma;

- shock;

- Myasthenia gravis;

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

- severe COPD (possibly increased respiratory failure);

acute respiratory failure;

- Pregnancy (especially the first trimester);

- the period of breastfeeding;

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

- Hypersensitivity to benzodiazepines.

With caution should be used in patients with hepatic and / or renal insufficiency, cerebral and spinal ataxia, hyperkinesia, propensity to abuse of psychotropic drugs, organic brain diseases (paradoxical reactions are possible), hypoproteinemia, depression in elderly patients.

PREGNANCY AND LACTATION

In pregnancy, phenazepam is used only for life indications.
The drug has a toxic effect on the fetus and increases the risk of developing congenital malformations when used in the first trimester of pregnancy. The use of therapeutic doses in later periods of pregnancy can cause depression of the newborn's central nervous system.Continuous use of Phenazepam in pregnancy can cause withdrawal syndrome in a newborn.
The use of the drug immediately before childbirth or during childbirth can cause a respiratory depression in the newborn, a reduction in muscle tone, hypotension, hypothermia, a weakening of the sucking act ("sluggish child" syndrome).

APPLICATION FOR FUNCTIONS OF THE LIVER

Caution should be used in patients with renal insufficiency


APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution should be used in patients with liver failure


APPLICATION FOR CHILDREN

Contraindicated: children and adolescents under 18 years of age (safety and efficacy not determined).
Children, especially young children, are very sensitive to the CNS depressing action of benzodiazepines.
APPLICATION IN ELDERLY PATIENTS

With caution should be used in elderly patients.

SPECIAL INSTRUCTIONS

It is necessary to observe special care in the appointment of Phenazepam in 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 picture of peripheral blood and the parameters of liver enzymes is necessary.

The frequency and nature of side effects depend on individual sensitivity, dose and duration of treatment.
With reduced doses or discontinuation of the use of phenazepam, side effects disappear.
Like other benzodiazepines, Phenazepam has the ability to induce drug dependence in long-term admission in large doses (> 4 mg / day).

If the drug is suddenly discontinued, withdrawal can occur, especially if the drug is used for more than 8-12 weeks.

Phenazepam increases the effect of alcohol, so the use of alcoholic beverages during drug treatment is not recommended.

Use in Pediatrics

Children, especially young children, are very sensitive to the CNS depressing action of benzodiazepines.

Impact on the ability to drive vehicles and manage mechanisms

Phenazepam is contraindicated during work by drivers of transport and other persons performing work requiring quick and accurate reactions.

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 myorelaxing action of Phenazepam, strychnine nitrate is recommended (injections of 1 ml of 0.1% solution 2-3 times / day). As a specific antagonist, flumazenil (anexat) can be used: iv 0.2 mg (if necessary, the dose can be increased to 1 mg) in a 5% solution of glucose (dextrose) or 0.9% sodium chloride solution.
DRUG INTERACTION

With the simultaneous use of phenazepam with other drugs that cause depression of the central nervous system (including hypnotics, anticonvulsant, neuroleptic), one should take into account the mutual enhancement of their action.

With the simultaneous use of phenazepam with levodopa in patients with parkinsonism, the effectiveness of the latter is reduced.

With the simultaneous use of phenazepam with zidovudine may increase the toxicity of the latter.

With the simultaneous use of phenazepam with inhibitors of microsomal oxidation, the risk of toxic effects of phenazepam is increased.

With the simultaneous use of phenazepam with inducers of microsomal liver enzymes, the effectiveness of the use of phenazepam decreases.

With the simultaneous use of phenazepam with imipramine, the concentration of the latter in the blood serum increases.

With the simultaneous use of Phenazepam with antihypertensive drugs may increase the severity of antihypertensive action.

With the simultaneous use of phenazepam with 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 out of the reach of children, protected from light.
Shelf life - 2 years.
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