Fenorelaxan - instructions for use, dose, side effects, contraindications

Excipients: lactose monohydrate (milk sugar) - 69.5 mg; 104 mg; potato starch - 28.5 mg; 42.8 mg; gelatin - 0.5 mg; 0.75 mg; calcium stearate - 0.5 mg; 0.75 mg; stearic acid - 0.5 mg; 0.7 mg.

Description:

Tablets of white color of flat-cylindrical form with a facet.

Pharmacotherapeutic group:Anxiolytic agent (tranquilizer).

ATX: & nbsp

N.05.B.X Other anxiolytics

Pharmacodynamics:

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

Increases the inhibitory effect of gamma-aminobutyric acid (GABA) on the transmission of nerve impulses. Stimulates benzodiazepine receptors located in the allosteric center of postsynaptic GABA receptors of the ascending activating reticular formation of the brainstem 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 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 symptoms 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). It is possible and direct inhibition of motor nerves and muscle functions

Pharmacokinetics:

After ingestion, it is well absorbed from the gastrointestinal tract, TSam - 1-2 hours.

Metabolised in the liver. Т1 / 2 - 6-10-18 ч. It is deduced basically by kidneys in the form of metabolites.

Indications:

Neurotic, neurotic, psychopathic and psychopathic and other conditions (irritability, anxiety, nervous tension, emotional lability), reactive psychoses and senesto-hypochondriacal disorders (including those resistant to the action of other anxiolytic drugs (tranquilizers), vegetative dysfunctions and sleep disorders, the prevention of states of fear and emotional stress.

As an anticonvulsant - temporal and myoclonic epilepsy.

In neurological practice - hyperkinesis, tics, rigidity of muscles, vegetative lability.

Contraindications:

Hypersensitivity (including to other benzodiazepines), coma, shock, myasthenia gravis, closed-and-dull glaucoma (acute attack or predisposition), acute alcohol poisoning (with impaired vital functions), narcotic analgesics and hypnotic drugs severe chronic obstructive pulmonary disease (possible strengthening of the respiratory insufficiency), acute respiratory failure, severe depression (suicidal tendencies may manifest); pregnancy (especially I trimester), lactation period, age under 18 years (safety and efficacy not determined).

Carefully:

Hepatic and / or renal failure, cerebral and spinal ataxia, drug dependence in history, addiction to psychoactive drugs, hyperkinesis, organic brain diseases, psychosis (possible paradoxical reactions), hypoproteinemia, nocturnal apnea (established or suspected),elderly age.

Pregnancy and lactation:During pregnancy apply only for "vital" indications. 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 central nervous system of the newborn. Continuous use during pregnancy can lead to physical dependence with the development of the "cancellation" syndrome in a newborn.

Children, especially at a young age, are very sensitive to the depressing central nervous system by the action of benzodiazepines.

The use directly 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).

Dosing and Administration:

Inside: for sleep disorders - 0.25-0.5 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 a 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 the treatment of alcohol withdrawal, the drug is prescribed by mouth at 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, in diseases with muscle hypertension, 2-3 mg once or twice a 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 phenoreloxane, like other benzodiazepines, is 2 weeks (in some cases, the duration of treatment can be increased to 2 months).

With the withdrawal of the drug, the dose is reduced gradually.

Side effects:

Sometimes there is a memory impairment, concentration of attention, coordination of movements (especially at high doses); drowsiness, muscle weakness, ataxia, sometimes possible paradoxical arousal, dizziness, headache, dry mouth, nausea, diarrhea, menstrual irregularity, decreased libido, dysuria, skin rash, itching.

With prolonged use, especially in high doses - addiction, drug dependence.

Overdose:

Symptoms: severe 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. Symptomatic therapy (maintenance of breathing and arterial pressure), administration of flumazenil (in hospital settings). Hemodialysis is ineffective.

Interaction:

Reduces the effectiveness of levodopa in patients with Parkinsonism.

May increase the toxicity of zidovudine.

There is a mutual enhancement of the effect with simultaneous appointment antipsychotic (neuroleptic), 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 serum.

Hypotensive drugs can increase the severity of lowering blood pressure.

Against the background of simultaneous administration of clozapine, an increase in respiratory depression is possible.

Special instructions:

In the process 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.

With renal / hepatic insufficiency and long-term treatment, control over the picture of peripheral blood and "hepatic" enzymes is necessary.

Patients who did not take previously psychoactive drugs "respond" to the drug at lower doses, compared with patients taking antidepressants, anxiolytics or alcoholics. 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).

When patients develop such unusual reactions as increased aggressiveness, acute excitations,feelings of fear, thoughts of suicide, hallucinations, increased muscle cramps, difficult falling asleep, superficial sleep, treatment should be discontinued.

Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and engaging in other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Tablets of 0.5 mg and 1 mg.

Packaging:10 tablets per contour cell packaging made of polyvinylchloride film and aluminum foil. 5 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

Storage conditions:

In a dry, dark place at a temperature of 2 to 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:P N003285 / 01

Date of registration:28.05.2009

The owner of the registration certificate:MOSHIMFARM PREPARATES them. N.А.Semashko, OJSC MOSHIMFARM PREPARATES them. N.А.Semashko, OJSC Russia

Manufacturer: & nbsp

MOSHIMFARM PREPARATES them. NA Semashko OJSC Russia

Representation: & nbspMOSHIMFARM PREPARATES them. NA Semashko OJSC MOSHIMFARM PREPARATES them. NA Semashko OJSC Russia

Information update date: & nbsp10.12.2015

Illustrated instructions

Instructions

Phenorelaxan® (Phenorelaxan)