Phenorelaxan - Instructions For Use, Reviews, Price, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Fenorelaxan

Fenorelaxan: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. In case of impaired liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Phenorelaxan

ATX code: N05BX

Active ingredient: bromdihydrochlorophenylbenzodiazepine (bromdihydrochlorphenylbenzodiazepinum)

Manufacturer: Moskhimfarmpreparaty them. ON. Semashko (Russia)

Description and photo update: 2018-21-11

Phenorelaxan is an anxiolytic drug (tranquilizer).

Release form and composition

Dosage form of Phenorelaxan:

• tablets: flat-cylindrical, white, with a chamfer (10 tablets in a blister, 5 blisters in a cardboard box);
• solution for intramuscular (i / m) and intravenous (i / v) administration: colorless or slightly colored transparent liquid (1 ml of solution in ampoules, 5 ampoules in a blister, in a cardboard box 2 blisters; or 10 ampoules in a cardboard box).

Composition of 1 tablet 0.5 / 1 mg:

• active substance: bromodihydrochlorophenylbenzodiazepine (in terms of 100% anhydrous substance) - 0.5 / 1 mg;
• auxiliary components: lactose monohydrate, potato starch, gelatin, calcium stearate, stearic acid.

Composition of 1 ml solution:

• active substance: bromodihydrochlorophenylbenzodiazepine - 1 mg;
• auxiliary components: povidone, glycerin, sodium disulfite, tween-80, sodium hydroxide 1 M solution, water for injection.

Pharmacological properties

Pharmacodynamics

Phenorelaxan is an anxiolytic of the benzodiazepine series. In addition to anxiolytic, it has anticonvulsant, sedative, hypnotic, and also central muscle relaxant effects. Enhances the effect of gamma-aminobutyric acid (GABA) on the transmission of nerve impulses. Thanks to Phenorelaxan, the excitability of the subcortical structures of the brain decreases. It also has an inhibitory effect on polysynaptic spinal reflexes.

The anxiolytic effect is explained by the effect of the substance on the amygdala complex of the limbic system. It manifests itself in a weakening of anxiety, a decrease in emotional stress, anxiety and fear.

The sedative effect of Phenorelaxan is due to the effect on the reticular formation of the brain stem, as well as on the nonspecific nuclei of the thalamus. Thanks to it, symptoms of neurotic origin, for example, anxiety and fear, are reduced.

The drug has practically no effect on the productive symptoms of psychotic genesis.

The hypnotic effect is due to the inhibition of the cells of the reticular formation of the brain stem. The drug reduces the effects of emotional, autonomic and motor stimuli that prevent normal sleep.

The anticonvulsant effect is associated with increased presynaptic inhibition. Phenorelaxan suppresses the spread of the convulsive impulse, but does not relieve the excitation of the focus.

The central muscle relaxant effect is realized by inhibition of polysynaptic spinal afferent inhibitory pathways, as well as monosynaptic (to a lesser extent). In addition, Phenorelaxan can have a direct inhibitory effect on motor nerves and muscle function.

Pharmacokinetics

When taken orally, phenorelaxan is well absorbed from the gastrointestinal tract and is widely distributed in the body. The time to reach the maximum concentration of the drug is 1–2 hours. Metabolized in the liver. The half-life is 6-18 hours. It is excreted mainly by the kidneys in the form of metabolites.

Indications for use

According to the instructions, Phenorelaxan is recommended for the treatment of neurosis-like, neurotic, psychopathic and psychopathic, as well as other conditions (anxiety, irritability, nervous tension, emotional lability); autonomic dysfunctions; reactive psychoses; senesto-hypochondriacal disorders, including those resistant to the effects of other anxiolytic drugs; sleep disorders.

Phenorelaxan is also used: to prevent states of emotional stress and fear; as an anticonvulsant in temporal and myoclonic epilepsy; in neurological practice with hyperkinesis, tics, muscle stiffness and autonomic lability.

Contraindications

Absolute contraindications:

• angle-closure glaucoma (incl. predisposition);
• coma;
• shock;
• severe depression;
• acute poisoning with narcotic analgesics, alcohol or sleeping pills (with weakening of vital functions);
• acute respiratory failure;
• severe obstructive pulmonary disease;
• pregnancy (especially the first trimester), lactation;
• age up to 18 years (due to the lack of data on safety and effectiveness);
• hypersensitivity to any component of Phenorelaxan, as well as to other benzodiazepines.

Relative contraindications:

• organic diseases of the brain;
• a tendency to abuse psychoactive drugs;
• a history of drug dependence;
• hyperkinesis;
• sleep apnea (including anticipated);
• cerebral and spinal ataxias;
• psychosis (risk of paradoxical reactions);
• renal and hepatic impairment;
• hypoproteinemia;
• elderly age.

Instructions for the use of Phenorelaxan: method and dosage

Pills

Phenorelaxan tablets are taken orally. The average daily dose is 1.5-5 mg / day, divided into 2-3 doses, usually 0.5-1 mg in the morning and afternoon and up to 2.5 mg at night.

Recommended dosage:

• sleep disorders: 0.25-0.5 mg 20-30 minutes before bedtime;
• neurotic, psychopathic, neurosis-like and psychopathic conditions: initial dose - 0.5-1 mg 2-3 times a day, after 2-4 days the dose is increased to 4-6 mg / day;
• severe agitation, anxiety, fear: the initial dose is 3 mg / day, then it is rapidly increased until the desired effect is obtained;
• epilepsy: 2-10 mg / day;
• alcohol withdrawal: 2–5 mg / day;
• neurological diseases accompanied by muscle hypertonia: 2-3 mg 1-2 times a day.

The maximum dose of Phenorelaxan is 10 mg / day. The recommended duration of treatment is 2 weeks, if necessary, it can be increased to 8-9 weeks.

When discontinuing therapy, the dose of the drug is reduced gradually.

Solution for intramuscular and intravenous administration

A solution of Phenorelaxan is injected intramuscularly or intravenously in a stream or drip. The average daily dose is 1.5–5 mg. The maximum dose is 10 mg / day.

Recommended dosage:

• fear, anxiety, psychomotor agitation, vegetative paroxysms, psychotic states: the initial dose is 0.5-1 mg, then it may be increased to 3-5 mg / day, in severe conditions - 7-9 mg / day;
• epilepsy: initial dose - 0.5 mg;
• alcohol withdrawal: 2.5–5 mg / day;
• neurological diseases accompanied by muscle hypertonia: 0.5 mg 1-2 times a day;
• preoperative preparation: 3-4 ml IV slowly.

After a stable therapeutic effect has been achieved, it is recommended to switch to the tablet form of Phenorelaxan. The duration of treatment is usually up to 2 weeks, but if necessary, it can be increased to 3-4 weeks.

When discontinuing therapy, the dose of the drug is reduced gradually.

Side effects

Pills

Possible memory impairment, coordination of movements, concentration of attention, drowsiness, ataxia, muscle weakness, paradoxical reactions (outbursts of aggression, fear, psychomotor agitation, muscle spasm, suicidal tendencies, hallucinations, sleep disturbances, anxiety), headache, dizziness, dryness during mouth, menstrual irregularities, nausea, diarrhea, decreased libido, dysuria, skin rash. With prolonged use in high doses, there is a risk of addiction and drug dependence.

Solution for intramuscular and intravenous administration

• nervous system: drowsiness (at the beginning of therapy, especially in elderly patients), fatigue, dizziness, impaired concentration, disorientation, ataxia, slowing down of motor and mental reactions, confusion, headache, depression, euphoria, tremor, memory loss, mood deterioration, impaired coordination of movements, dystonic extrapyramidal reactions, myasthenia gravis, asthenia, dysarthria, paradoxical reactions;
• hematopoietic organs: neutropenia, leukopenia, agranulocytosis, anemia, thrombocytopenia;
• digestive system: drooling, dry mouth, heartburn, nausea, vomiting, constipation, diarrhea, decreased appetite;
• liver: impaired liver function, jaundice, increased activity of hepatic transaminases and alkaline phosphatase;
• genitourinary system: urinary retention or incontinence, impaired renal function, decreased or increased libido, dysmenorrhea;
• allergic reactions: skin rash, itching;
• other: addiction, drug dependence, lowering blood pressure (BP), visual impairment (diplopia), weight loss, tachycardia, withdrawal syndrome (with abrupt cessation of therapy);
• local reactions: phlebitis, venous thrombosis.

Overdose

Symptoms of an overdose of Phenorelaxan: prolonged confusion, severe drowsiness, decreased reflexes, prolonged dysarthria, tremor, nystagmus, shortness of breath, shortness of breath, bradycardia, decreased blood pressure, coma.

Recommended treatment: gastric lavage, intake of activated charcoal, symptomatic therapy aimed at maintaining blood pressure and respiration, administration of flumazenil (in a hospital setting). Hemodialysis is ineffective.

The antagonist of the muscle relaxant action of Phenorelaxan is strychnine nitrate (1 ml of 0.1% solution 2-3 times a day).

special instructions

During therapy, you should refrain from drinking alcohol.

Patients who have never taken antidepressants, anxiolytics or alcoholics usually need a lower dose of the drug.

The use of Phenorelaxan should be discontinued in the event of aggression, an acute state of excitement, fear, thoughts of suicide, hallucinations, increased muscle cramps, difficulty falling asleep, superficial sleep.

Influence on the ability to drive vehicles and complex mechanisms

During the period of application of Phenorelaxan, caution should be exercised while driving vehicles and other complex mechanisms that require the speed of psychomotor reactions.

Application during pregnancy and lactation

Phenorelaxan has a toxic effect on the fetus, increasing the risk of birth defects, especially when taken in the first trimester. During pregnancy, it can be used only for health reasons.

If necessary, taking the drug during lactation, breastfeeding should be discontinued.

Pediatric use

The use of Phenorelaxan in pediatric practice is contraindicated, due to the lack of reliable data on safety and efficacy for the treatment of children and adolescents under the age of 18.

With impaired renal function

With prolonged use of Phenorelaxan in patients with renal insufficiency, it is necessary to control the picture of peripheral blood.

If liver function is impaired

With prolonged use of the drug in patients with hepatic insufficiency, control of liver enzymes is necessary.

Use in the elderly

Elderly patients are prescribed Fenorelaxan with caution.

Drug interactions

• levodopa (with parkinsonism): its effectiveness decreases;
• antipsychotics, antiepileptic and hypnotics, central muscle relaxants, narcotic analgesics, ethanol: there is a mutual enhancement of the effect;
• zidovudine: its toxicity increases;
• inhibitors of microsomal oxidation: the risk of toxic effects increases;
• inducers of liver microsomal enzymes: reduce the effectiveness of Phenorelaxan;
• imipramine: its concentration in the blood serum increases;
• antihypertensive drugs: risk of lowering blood pressure;
• clozapine: increases the likelihood of increased respiratory depression.

Analogs

Phenorelaxan analogs are Tranquezipam, Phenazepam, Fensitat, Elzepam, etc.

Terms and conditions of storage

Store in a dry place, away from light, at a temperature of 2 to 25 ° C (for tablets) and 15 to 25 ° C (for solution). Keep out of the reach of children.

Shelf life: tablets - 3 years; solution - 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Phenorelaxan

Reviews of Phenorelaxan on the network are few, mainly indicate the lower effectiveness of the drug in comparison with other analogues.

Price for Phenorelaxan in pharmacies

Estimated price for Phenorelaxan, 1 mg tablets, 50 pcs. - 72 rubles; ampoules 1mg / ml, 10 pcs. - 80 p.

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!