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Manufacturers: Tarchominskie Zaklady Farmaceutyczne “Polfa” (Poland)
Active ingredients
- Chlordiazepoxide
Disease class
- Mental and behavioral disorders caused by alcohol consumption - dependence syndrome
- Panic disorder [episodic paroxysmal anxiety]
- Other neurotic disorders
- Neurasthenia
- Dystonia
- Disturbances in falling asleep and maintaining sleep [insomnia]
- Stomach ulcer
- Duodenal ulcer
- Anxiety and agitation
- Surgical practice
Clinical and pharmacological group
- Not indicated. See instructions
Pharmacological action
- Anxiolytic
- Muscle relaxant
- Hypnotic
- Anticonvulsant
Pharmacological group
- Anxiolytics
Pharmacokinetics
After oral administration, chlordiazepoxide is almost completely absorbed from the gastrointestinal tract. After intramuscular administration, absorption is slow.
Plasma protein binding is high - about 96%.
Chlordiazepoxide penetrates the BBB, is excreted in breast milk, and penetrates the placental barrier.
Metabolized to form pharmacologically active metabolites desmethyldiazepam, desmethylchlordiazepoxide, demoxepam and oxazepam.
T1/2 of chlordiazepoxide is variable and ranges from 5-30 hours, T1/2 of the main active metabolite (desmethyldiazepam) is several days. It is excreted in the urine unchanged and in the form of conjugated metabolites.
Elenium oral tablets (Eldisine)
Instructions for medical use of the drug
Description of pharmacological action
A tranquilizer from the group of benzodiazepines. It has an anxiolytic, sedative, hypnotic, anticonvulsant, and central muscle relaxant effect. The mechanism of action is associated with an increase in the inhibitory effect of GABA in the central nervous system due to increased sensitivity of GABA receptors to the mediator as a result of stimulation of benzodiazepine receptors.
Indications for use
Neuroses, sleep disorders, nervous tension, anxiety, irritability, reactive depression, withdrawal syndrome, convulsive state or its threat, NCD, menopausal syndrome, premenstrual tension syndrome, for preparation for operations.
Release form
film-coated tablets 10 mg; blister 25, box (box) 2; Composition: 1 tablet contains chlordiazepoxide 10 mg; 25 pcs in a blister, 2 blisters in a box.
Pharmacodynamics
A tranquilizer from the group of benzodiazepines. It has an anxiolytic, sedative, hypnotic, anticonvulsant, and central muscle relaxant effect. The mechanism of action is associated with an increase in the inhibitory effect of GABA in the central nervous system due to increased sensitivity of GABA receptors to the mediator as a result of stimulation of benzodiazepine receptors.
Pharmacokinetics
After oral administration, chlordiazepoxide is almost completely absorbed from the gastrointestinal tract. After intramuscular administration, absorption is slow. Plasma protein binding is high - about 96%. Chlordiazepoxide penetrates the BBB, is excreted in breast milk, and penetrates the placental barrier. Metabolized to form pharmacologically active metabolites desmethyldiazepam, desmethylchlordiazepoxide, demoxepam and oxazepam. T1/2 of chlordiazepoxide is variable and ranges from 5-30 hours, T1/2 of the main active metabolite (desmethyldiazepam) is several days. It is excreted in the urine unchanged and in the form of conjugated metabolites.
Use during pregnancy
Chlordiazepoxide should not be used during the first trimester of pregnancy unless absolutely necessary. It should be borne in mind that when using chlordiazepoxide during pregnancy, a significant change in fetal heart rate is possible. When used in obstetrics in doses recommended to facilitate childbirth, temporary muscle hypotension, hypothermia, and respiratory failure are possible in newborns, more often in premature infants. If regular use is necessary during lactation, breastfeeding should be discontinued. The use of chlordiazepoxide in neonates should be avoided.
Contraindications for use
Myasthenia gravis, acute respiratory failure, severe chronic hypercapnia, phobias, obsessive states, chronic psychoses, a history of alcohol or drug dependence (except acute withdrawal), hypersensitivity to chlordiazepoxide and other benzodiazepines.
Side effects
Drowsiness, fatigue, fatigue, memory loss, impaired concentration, dizziness, incoordination, decreased libido; rarely - nausea, diarrhea, agranulocytosis, jaundice, paradoxical reactions (psychomotor agitation, insomnia, muscle tremors), allergic skin manifestations.
Directions for use and doses
Orally, for adults, usually - in cases of anxiety - 5-10 mg 2-4 times a day, in severe cases (especially with alcoholic psychosis) - up to 40-100 mg / day in divided doses; as a sleeping pill - 10–20 mg 1 hour before bedtime; children: 4–7 years old — 5–10 mg/day, 8–14 years old — 10–20 mg/day, 15–18 years old — 20–30 mg/day in 3–4 doses.
Interactions with other drugs
Antiepileptic and antihistamine drugs, neuroleptics, narcotic analgesics and hypnotics enhance the effect; prolong - cimetidine, disulfiram, oral contraceptives.
Precautions for use
Prescribe with caution in case of insufficiency of liver and kidney function (dose reduction required); patients over 65 years of age (half the usual dose is recommended). Should not be used during work by vehicle drivers and people whose profession involves increased concentration of attention. It must be borne in mind that long-term use (for several months) can lead to addiction and drug dependence. To avoid the development of withdrawal syndrome (excitement, insomnia, loss of appetite), treatment is stopped gradually. During the course and for 3 days after its completion, you should not drink alcohol.
Special instructions for use
Use with extreme caution in patients with cardiac and chronic respiratory failure, organic changes in the brain (in such cases it is recommended to avoid parenteral administration of chlordiazepoxide), with angle-closure glaucoma and predisposition to it, with myasthenia gravis, with chronic kidney and/or liver diseases. Particular caution is required when using chlordiazepoxide, especially at the beginning of treatment, in patients who have been receiving centrally acting antihypertensive drugs, beta-blockers, anticoagulants, and cardiac glycosides for a long time. When discontinuing therapy, the dose should be reduced gradually. If chlordiazepoxide is suddenly discontinued after prolonged use, anxiety, agitation, tremor, and convulsions may occur. With prolonged use in high doses, addiction and drug dependence may develop. Chlordiazepoxide should be discontinued if paradoxical reactions develop (acute agitation, anxiety, sleep disturbances and hallucinations). Avoid intravenous administration. During the treatment period, avoid drinking alcohol. Effect on the ability to drive vehicles and operate machinery Patients taking chlordiazepoxide should refrain from engaging in potentially hazardous activities that require increased attention and rapid psychomotor reactions.
Storage conditions
In a dry place, protected from light, at room temperature no higher than 25 °C.
Best before date
48 months
ATX classification:
N Nervous system
N05 Psycholeptics
N05B Anxiolytics
N05BA Benzodiazepine derivatives
N05BA02 Chlordiazepoxide
Dosage
When taken orally by adults - 5-10 mg 2-4 times a day. For states of tension and anxiety combined with sleep disorders - 10-20 mg 1 time 1-2 hours before bedtime. In psychiatric practice, the initial dose is 50-100 mg/day, then the dose is gradually increased to 300 mg/day, the frequency of use is 3-4 times/day. For withdrawal symptoms, more than 300 mg/day can be used.
Children aged 4-7 years - 5-10 mg/day, 8-14 years old - 10-20 mg/day, 15-18 years old - 20-30 mg/day; frequency of use - 3-4 times/day.
With intramuscular administration, a single dose for adults is 50-100 mg.
Side effects
From the central nervous system and peripheral nervous system:
possible drowsiness, dizziness, muscle weakness; rarely - confusion, depression, visual impairment, diplopia, dysarthria, headache, tremor, ataxia; in isolated cases - paradoxical reactions (excitement, anxiety, sleep disturbances, hallucinations). After IV administration, hiccups are sometimes observed. With prolonged use, drug dependence and memory impairment may develop.
From the digestive system:
rarely - constipation, nausea, dry mouth, drooling; in isolated cases - increased levels of transaminases and alkaline phosphatase in the blood plasma, jaundice.
From the endocrine system:
rarely - increased or decreased libido.
From the urinary system:
rarely - urinary incontinence.
From the cardiovascular system:
with intramuscular use, a slight decrease in blood pressure is possible.
From the respiratory system:
with parenteral use in isolated cases - respiratory problems.
Allergic reactions:
rarely - skin rash.
Drug interactions
When used simultaneously with antipsychotics (neuroleptics), antidepressants, sedatives, hypnotics, anesthetics, analgesics, ethanol, the inhibitory effect on the central nervous system increases, especially when administered parenterally.
Concomitant use of antacids may delay, but not reduce, the absorption of chlordiazepoxide.
With simultaneous ingestion of hormonal contraceptives, the effectiveness of chlordiazepoxide increases. The incidence of breakthrough bleeding increases.
When used simultaneously with muscle relaxants, the effect of muscle relaxants may be enhanced; with levodopa - it is possible to suppress the antiparkinsonian effect.
When used concomitantly, theophylline in low doses distorts the sedative effect of chlordiazepoxide.
When used concomitantly, phenobarbital and phenytoin may accelerate the metabolism of chlordiazepoxide. In rare cases, chlordiazepoxide suppresses metabolism and enhances the effects of phenytoin.
Experimental studies have shown that, when used concomitantly, chlordiazepoxide may increase the toxicity of cyclophosphamide.
When used simultaneously with cimetidine, omeprazole, disulfiram, it is possible to increase the intensity and duration of action of chlordiazepoxide.
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special instructions
Use with extreme caution in patients with cardiac and chronic respiratory failure, organic changes in the brain (in such cases it is recommended to avoid parenteral administration of chlordiazepoxide), with angle-closure glaucoma and predisposition to it, with myasthenia gravis, with chronic kidney and/or liver diseases.
Particular caution is required when using chlordiazepoxide, especially at the beginning of treatment, in patients who have been receiving centrally acting antihypertensive drugs, beta-blockers, anticoagulants, and cardiac glycosides for a long time.
When discontinuing therapy, the dose should be reduced gradually. If chlordiazepoxide is suddenly discontinued after prolonged use, anxiety, agitation, tremor, and convulsions may occur.
With prolonged use in high doses, addiction and drug dependence may develop.
Chlordiazepoxide should be discontinued if paradoxical reactions develop (acute agitation, anxiety, sleep disturbances and hallucinations).
Avoid intravenous administration.
During the treatment period, avoid drinking alcohol.
Impact on the ability to drive vehicles and operate machinery
Patients taking chlordiazepoxide should refrain from engaging in potentially hazardous activities that require increased attention and rapid psychomotor reactions.
Instructions for use ELENIUM
General information regarding observed effects during treatment with benzodiazepines and other hypnotics that should be considered when prescribing chlordiazepoxide
Tolerance
Regular use of benzodiazepines or similar drugs, including chlordiazepoxide, over several weeks may reduce their effectiveness.
Drug addiction
The use of benzodiazepines or drugs with similar effects can lead to the development of mental and physical drug dependence. The risk of developing drug dependence increases with the dose and duration of treatment, and increases in patients with alcohol dependence, as well as in patients with a history of drug dependence.
If drug dependence develops, abrupt cessation of drug use may lead to withdrawal syndrome.
Characteristic manifestations of withdrawal syndrome are: headache, muscle pain, agitation and emotional tension, restlessness, confusion and disorientation, irritability, insomnia. In severe cases, you may experience:
- loss of a sense of reality of the environment, personality disturbances, increased sensitivity to touch, increased sensitivity to auditory and visual stimuli, crawling sensations and numbness of the limbs, hallucinations or seizures. There is evidence that with short-acting benzodiazepines and similar drugs, withdrawal symptoms may occur even between doses, especially if the drug is used in large doses.
Amnesia
Chlordiazepoxide, as well as benzodiazepines and similar drugs, can cause antegrade amnesia.
Paradoxical reactions
Chlordiazepoxide, as well as benzodiazepines and similar drugs, can cause paradoxical reactions, such as restlessness, agitation, irritability, aggressiveness, hostility, nightmares, hallucinations, psychosis, somnambulism, personality disorders, severe insomnia. These reactions are much more common in elderly patients or those with alcohol dependence.
If such symptoms appear, you must stop taking the drug.
Specific patient groups
In elderly patients, lower doses of chlordiazepoxide should be used, due to increased side effects in this age group, mainly disorders of orientation and coordination of movements (falls, injuries).
The use of benzodiazepines and similar drugs is not recommended in patients with severe hepatic impairment as they may precipitate the development of hepatic encephalopathy. Liver failure may lead to increased side effects of benzodiazepines.
Chlordiazepoxide should be used with caution in patients with chronic renal failure.
Chlordiazepoxide should be used with caution in patients with chronic respiratory failure, since benzodiazepines have been shown to have a depressant effect on the respiratory center.
In patients with chronic renal failure, liver disease, or chronic respiratory failure, a dose reduction may be necessary.
The use of benzodiazepines and similar drugs in patients with psychosis is not recommended.
Use for depression
Chlordiazepoxide should be used with great caution in patients with symptoms of endogenous depression. These patients may experience suicidal thoughts. Due to the possibility of intentional overdose, these patients should be treated with chlordiazepoxide in the smallest doses possible.
Benzodiazepines and similar drugs should not be used as monotherapy for depression or anxiety associated with depression. Monotherapy with these drugs may increase suicidal tendencies.
Benzodiazepines and similar drugs should be used with great caution in patients with a history of alcohol, drug and drug addiction. Such patients should be strictly monitored during treatment with chlordiazepoxide, as they are at risk of developing addiction and mental dependence.
Chlordiazepoxide should be used with caution in patients with porphyria. The use of chlordiazepoxide may increase the symptoms of this disease.
Use with caution in patients with glaucoma, especially angle-closure glaucoma.
Chlordiazepoxide should be used with caution in patients with cerebellar and spinal ataxia, as well as myasthenia.
Due to its sucrose content, Elenium should not be used in patients with rare hereditary disorders associated with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency.
Due to its lactose content, Elenium should not be used in patients with rare hereditary galactose intolerance, Lapp lactase deficiency or poor absorption of glucose-galactose.
During treatment with chlordiazepoxide and for another 3 days after its completion, you should not drink any alcoholic beverages.
Impact on the ability to drive vehicles and maintain moving mechanical devices
Chlordiazepoxide, as well as all drugs from the benzodiazepine group, can affect the reaction rate depending on the dose, route of administration and individual sensitivity. Slow reaction times, poor concentration, impaired memory, and impaired muscle function can impair the ability to drive and operate mechanical equipment. While using chlordiazepoxide, as well as for 2-3 days after stopping use, you should not drive vehicles or operate moving mechanical devices.
