Fezanef

General characteristics. Structure:

Active ingredient: 1 mg of Phenazepamum (bromdigidrokhlorfenilbenzodiazepin).

Excipients: sugar milk (lactose), potato starch, gelatin, calcium stearate, stearic acid.

Pharmacological properties:

Pharmacodynamics. Phenazepamum is derivative benzodiazepine. Possesses the expressed anxiolytic, anticonvulsant, central myorelaxation and somnolent action.

Strengthens brake influence of GAMK in TsNS due to increase in sensitivity of GAMK-of receptors to a mediator as a result of stimulation of benzodiazepknovy receptors, reduces excitability of subcrustal structures of a brain, brakes polisinaptichesky spinal reflexes.

Pharmacokinetics. At intake drug is well soaked up from a GIT, time of achievement of the maximum concentration of Phenazepamum in blood from 1 to 2 hours. It is metabolized in a liver. Biological half-life makes from 6 to 18 hours, drug excretion, is generally carried out through kidneys.

Indications to use:

Drug is used at various neurotic, neurosis-like psychopathic, psychopatholike and other states which are followed by alarm, fear, an acrimony, tension, emotional lability. At reactive psychoses, a hypochiondrial and senestopathetic syndrome (including other tranquilizers, resistant to action), vegetative dysfunctions and frustration of a dream, for prevention of conditions of fear and emotional pressure.

As an anticonvulsant drug is used for treatment of patients with temporal and myoclonic epilepsy.

In neurologic practice Phenazepamum is applied to treatment of hyperkinesias and tics, by muscle tensions.

Route of administration and doses:

Drug is appointed inside. The single dose of Phenazepamum usually makes 0,0005 - 0,001 g (0,5 - 1 mg), and at sleep disorders of 0,00025 - 0,0005 g (0,25 - 0,5 mg) in 20 - 30 minutes prior to a dream.

For treatment of neurotic, psychopathic, neurosis-like and psychopatholike states the initial dose makes 0,0005 - 0,001 g (0,5 - 1 mg) 2-3 times a day. In 2-4 days taking into account efficiency and portability of drug the dose can be increased to 0,004 - 0,006 g a day (4-6 mg), the morning and day dose makes 0,0005 - 0,001 g, for night of 0,0025 g. At the expressed agitation, fear, alarm treatment begin with a dose 0,003 g (3 mg) a day, quickly increasing a dose before obtaining therapeutic effect.

At treatment of epilepsy the dose makes 0,002 - 0,01 g (2 - 10 mg) a day.

For treatment of alcoholic abstinence Phenazepamum appoint in a dose 0,0025 - 0,005 g (2,5 - 5 mg) a day.

In neurologic practice at diseases with the raised muscle tone drug appoint on 0,002 - 0,003 g (2 - 3 mg) one or twice a day.

The average daily dose of Phenazepamum makes 0,0015 - 0,005 g (1,5 - 5 mg), it is divided into 3 or 2 receptions, usually on 0,5 - 1,0 mg in the morning and in the afternoon and to 2,5 mg for the night. Maximum daily dose of 0,01 g (10 mg).

In order to avoid development of medicinal dependence, at course treatment duration of use of Phenazepamum, as well as other benzodiazepines, makes 2 weeks. But in some cases duration of treatment can be increased up to 2 months. At drug withdrawal the dose is reduced gradually.

Features of use:

It is necessary to use with care drug at the elderly and weakened patients. Frequency and the nature of side effect depend on individual sensitivity, a dose and duration of treatment. At reduction of doses or the termination of reception of Phenazepamum side effects disappear.

Like other benzodiazepines, has ability to cause medicinal dependence at long reception in high doses (more than 4 mg/days).

At the sudden termination of reception the syndrome of "cancellation" can be noted (depressions, irritability, sleeplessness, the increased sweating, etc.), especially at long reception (more than 8-12 weeks).

Drug strengthens effect of alcohol therefore the use of alcoholic drinks during treatment by Phenazepamum is not recommended.

Phenazepamum is contraindicated in operating time to the drivers of transport and other persons performing the work demanding bystry reactions and exact movements.

Side effects:

Disturbances of memory, concentration of attention, coordination of movements (are sometimes observed especially at high doses); drowsiness, muscular weakness, an ataxy, sometimes perhaps paradoxical excitement, dizziness, a headache, dryness in a mouth, nausea, diarrhea, disturbance of a menstrual cycle, decrease a libido, a dysuria, skin rash, an itch. At prolonged use, especially in high doses — accustoming, medicinal dependence.

Interaction with other medicines:

Phenazepamum is compatible to other drugs causing TsNS function oppression (somnolent, anticonvulsant, antipsychotic, etc.), however at complex use it is necessary to consider mutual strengthening of their action. Reduces efficiency of a levodopa at patients with parkinsonism. Can increase toxicity of a zidovudine.

Inhibitors of a microsomal oxidation increase risk of development of toxic effects. Inductors of microsomal enzymes of a liver reduce efficiency. Increases concentration of Imipraminum in blood serum.

Antihypertensives can increase expressiveness of a lowering of arterial pressure.

Contraindications:

Myasthenia, the expressed abnormal liver functions and kidneys, pregnancy and the period of breastfeeding; poisonings with tranquilizers, antipsychotic means.

Overdose:

At moderate overdose — strengthening of therapeutic action and side effects; at considerable overdose — the expressed oppression of consciousness, cordial and respiratory activity.

Treatment: control of the vital functions of an organism, maintenance of respiratory and cardiovascular activity, symptomatic therapy. As antagonists of miorelaksantny action of Phenazepamum nitrate is recommended strychnine (an injection on 1 ml of 0,1% of solution 2-3 times a day). As the specific antagonist it can be used flumazenit (анексат) — intravenously (for 5% solution of glucose (dextrose) or 0,9% sodium chloride solution) in an initial dose of 0,2 mg (if necessary to a dose of 1 mg).

Storage conditions:

Period of validity - 4 years. Not to use after the period of validity specified on packaging! List B. To store in dry, protected from light, the place, unavailable to children, at a temperature not above 25 °C.

Issue conditions:

According to the recipe

Packaging:

On 10 tablets in a blister strip packaging; 5 blister strip packagings in a pack together with the application instruction.