Composition, form of production and packaging
Tablets are white, flat-cylindrical, with a bevel.
1 tab.
bromodihydrochlorophenylbenzodiazepine 1 mg
Excipients: lactose monohydrate (sugar milk) 104 mg, potato starch 42.8 mg, gelatin 750 Ојg, calcium stearate 750 Ојg, stearic acid 700 Ојg.
10 pieces. - packings cellular planimetric (5) - packs cardboard.
Tablets are white, flat-cylindrical, with a bevel.
1 tab.
bromodihydrochlorophenylbenzodiazepine 500 Ојg
Excipients: lactose monohydrate (sugar milk) 69.5 mg, potato starch 28.5 mg, gelatin 500 Ојg, calcium stearate 500 Ојg, stearic acid 500 Ојg.
10 pieces. - packings cellular planimetric (5) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
The product description was approved by the manufacturer for the 2009 print edition.
PHARMACHOLOGIC EFFECT
Bromodihydrochlorophenylbenzodiazepine is a benzodiazepine derivative.
Has a pronounced anxiolytic, anticonvulsant, central muscle relaxant and hypnotic action. Enhances the inhibitory effect of GABA in the central nervous system by increasing the sensitivity of GABA receptors to the mediator as a result of stimulation of benzodiazepine receptors, reduces the excitability of the subcortical structures of the brain, inhibits polysynaptic spinal reflexes.
PHARMACOKINETICS
When ingested, the drug is well absorbed from the digestive tract, the time to reach Cmax bromodihydrochlorophenylbenzodiazepine in the blood from 1 to 2 hours. It is metabolized in the liver, T 1/2 from the body is from 6 to 18 hours, the excretion of the drug is mainly through the kidneys.
INDICATIONS
The drug is used for various neurotic, neurotic-like psychopathic, psychopathic and other conditions, accompanied by anxiety, fear, increased irritability, tension, emotional lability.
The drug is used in reactive psychoses, hypochondriacelo-sensopathic syndrome (including those resistant to the action of other tranquilizers), vegetative dysfunctions and sleep disorders, for the prevention of states of fear and emotional stress.
As an anticonvulsant drug is used to treat patients with temporal and myoclonic epilepsy.
In neurological practice, Fenorelaxan is used to treat hyperkinesis and tics, muscle stiffness, vegetative lability.
DOSING MODE
The drug is prescribed inside. A single dose of phenorelaxane is usually 0.5-1 mg, and for sleep disorders - 0.25-0.5 mg for 20-30 minutes before bedtime.
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 of the drug, the dose can be increased to 4-6 g / day, the morning and daily dose is 0.5-1 mg, at night - 2.5 mg.
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, the dose is 2-10 mg / day.
To treat alcohol withdrawal, Phenorelaxan is prescribed in a dose of 2.5-5 mg / day.
In neurological practice with diseases with increased muscle tone, the drug is prescribed for 2-3 mg 1 or 2 times / day.
The average daily dose of phenorelaxane is 1.5-5 mg, it is divided into 3 or 2 doses, usually 0.5-1 mg in the morning and in the afternoon and up to 2.5 mg at night.The maximum daily dose is 10 mg.
To avoid the development of drug dependence, with course treatment, the duration of Phenorelaxan, as well as other benzodiazepines, is 2 weeks. But 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 EFFECT
The frequency and nature of side effects depend on the individual sensitivity, dose and duration of treatment. With reduced doses or discontinuation of Phenorelaxan, side effects disappear.
APPLICATION IN ELDERLY PATIENTS
It is necessary to use the drug with caution in elderly patients.
SPECIAL INSTRUCTIONS
It is necessary to use the drug with caution in elderly and weakened patients.
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 can be a withdrawal syndrome (depression, irritability, insomnia, increased sweating), especially with prolonged admission (more than 8-12 weeks).
The drug enhances the effect of alcohol, so the use of alcohol during treatment with Fenorelaxan is not recommended.
Impact on the ability to drive vehicles and manage mechanisms
Phenorelaxane is contraindicated during the work of transport drivers and others who perform work that requires rapid reactions and precise movements.
OVERDOSE
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 muscle relaxant action of Phenorelaxan, strychnine nitrate is recommended (injections of 1 ml of 0.1% solution 2-3 times / day). As a specific antagonist, flumazenil (anexat) -w / in (5% glucose / dextrose solution / or 0.9% sodium chloride solution) can be used at an initial dose of 0.2 mg (if necessary, up to a dose of 1 mg).
DRUG INTERACTION
Phenorelaxane is compatible with other drugs that cause depression of the central nervous system (hypnotics, anti-seizure, neuroleptic), however, in case of complex application it is necessary to take into account the mutual enhancement of their function.
Reduces the effectiveness of levodopa in patients with Parkinsonism.
May increase the toxicity of zidovudine.
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 blood pressure lowering.
