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Active ingredients
- Oxazepam
Disease class
- Mental and behavioral disorders caused by alcohol consumption - dependence syndrome
- Phobic anxiety disorders
- Panic disorder [episodic paroxysmal anxiety]
- Other neurotic disorders
- Disturbances in falling asleep and maintaining sleep [insomnia]
- Anxiety and agitation
- State of emotional shock and stress, unspecified
Clinical and pharmacological group
- Not indicated. See instructions
Pharmacological action
- Anxiolytic
- Tranquilizing
Pharmacological group
- Anxiolytics
Chemical properties
The substance is classified as an anxiolytic of the benzodiazepine series. According to its physical properties, Oxazepam is a white or white with a yellowish tint powder that is insoluble in water, poorly soluble in ethanol , ether , chloroform , and highly soluble in dimethylformamide . Molecular weight = 286.7 grams per mole.
The molecular structure of the drug is similar to diazepam and chlordiazepoxide . The drug is less toxic, has a less pronounced muscle relaxant effect and anticonvulsant effect. Available in the form of 10 mg tablets.
Oral tablets Oxazepam (Oxazepam)
Instructions for medical use of the drug
Description of pharmacological action
Excites benzodiazepine receptors and increases the sensitivity of GABA receptors to the mediator, enhancing the inhibitory effect of GABA on the central nervous system. It has a sedative, hypnotic, muscle relaxant and anticonvulsant effect. In neurotic syndromes, obsessive fear has a stronger effect on the mental than on the autonomic component of fear.
Indications for use
Neuroses; states of anxiety, tension, fear, excitability (with chronic alcoholism); sleep disorders.
Release form
tablets 10 mg; blister 20 box (box) 1;
Pharmacodynamics
Excites benzodiazepine receptors and increases the sensitivity of GABA receptors to the mediator, enhancing the inhibitory effect of GABA on the central nervous system. It has a sedative, hypnotic, muscle relaxant and anticonvulsant effect. In neurotic syndromes, obsessive fear has a stronger effect on the mental than on the autonomic component of fear.
Use during pregnancy
Contraindicated during pregnancy. Breastfeeding should be stopped during treatment.
Contraindications for use
Hypersensitivity, myasthenia gravis, liver and kidney diseases, respiratory failure, pregnancy, breastfeeding.
Side effects
Weakness, feeling of fatigue, drowsiness, anxiety, paradoxical reactions (psychomotor agitation, etc.), headache and dizziness, ataxia, decreased blood pressure, urinary disorders, decreased libido, allergic skin reactions.
Directions for use and doses
Inside. Adults: 1–2 tablets. 2-3 times a day, for older people - 1-2 tablets. 2 times a day. Children: 1–3 tablets. per day in 2-3 doses. For inpatient treatment - up to 120 mg/day (maximum daily dose).
Interactions with other drugs
Strengthens the effect of sedatives, hypnotics, psychotropic, antiepileptic drugs, alcohol and anticholinergics. May alter the effect of indirect anticoagulants.
Precautions for use
It should be kept in mind that drug dependence may develop. Use with caution in elderly people with cardiac disorders. With long-term treatment, monitoring of liver function and the composition of cellular elements in peripheral blood is necessary. While taking it, you should not drink alcohol, drive vehicles, operate machinery or engage in activities that require increased attention.
Special instructions for use
Treatment is discontinued gradually, reducing daily doses.
Storage conditions
In a place protected from light.
Best before date
36 months
ATX classification:
N Nervous system
N05 Psycholeptics
N05B Anxiolytics
N05BA Benzodiazepine derivatives
N05BA04 Oxazepam
Pharmacodynamics and pharmacokinetics
Oxazepam acts on specific benzodiazepine receptors, which are located in the postsynaptic gamma-aminobutyric acid of the limbic system of the brain. The substance increases the sensitivity of receptors to gamma-aminobutyric acid . The balance in the cytoplasmic membrane shifts towards chloride ion channels. There is inhibition of neuronal activity due to membrane hyperpolarization. The CNS inhibitory effect of GABA .
The medicine has anxiolytic, sedative and hypnotic effects. After taking the pills, emotional stress decreases, anxiety and fear, and the feeling of restlessness disappear, and patients with insomnia can finally fall asleep. The substance relieves symptoms of alcohol withdrawal . Oxazepam also has an anticonvulsant and central muscle relaxant effect.
With the drug, compared to other benzodiazepine derivatives, there is a large difference between the effective dosage and the dose that causes unwanted side effects. During animal studies, the ability of the drug to cause the growth of benign tumors was discovered. However, in humans, no such pattern was identified during clinical trials.
After taking the tablets, they are absorbed quite slowly in the digestive tract. Oxazepam reaches its maximum concentration in the blood after 60 - 120 minutes, up to 4 hours. The substance has a high degree of binding to plasma proteins (about 98%). To achieve equilibrium concentration in the blood, several days must pass. The drug is well distributed throughout the tissues of the body, overcomes the blood-brain barrier, the placental barrier, and is excreted in breast milk.
Metabolism ( glucuronidation ) occur in the liver tissues; all metabolites formed are inactive. The half-life is from 6 to 10 hours. The medicine is excreted through the kidneys in the form of metabolites. The medicine practically does not accumulate in the body.
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** The Drug Directory is intended for informational purposes only. For more complete information, please refer to the manufacturer's instructions. Do not self-medicate; Before starting to use Oxazepam, you should consult a doctor. EUROLAB is not responsible for the consequences caused by the use of information posted on the portal. Any information on the site does not replace medical advice and cannot serve as a guarantee of the positive effect of the drug.
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Indications for use
Oxazepam is prescribed:
- for the treatment of neuroses , neuropathy , conditions accompanied by anxiety, irritability, insomnia and fear;
- for senesto-hypochondriacal disorders and obsessive states (if other anxiolytics are poorly tolerated);
- for the treatment of autonomic disorders in women during menopause ;
- with severe premenstrual syndrome;
- as part of a complex treatment of reactive depression ;
- during abstinence in alcoholics (combination with other drugs).
Side effects
During treatment with Oxazepam the following are observed:
- drowsiness , especially in the initial stages of treatment;
- dizziness , general weakness, lethargy, fatigue;
- headaches , memory loss, tremors , difficulty speaking;
- paradoxical reactions (anxiety, central nervous system excitement);
- dry mouth, indigestion , leukopenia ;
- liver failure, allergies , decreased and increased libido, fainting;
- addiction, withdrawal syndrome , drug dependence.
Rarely occur:
- euphoria , numbness, depression , fear, suicidal thoughts and behavior, hallucinations , insomnia ;
- agranulocytosis , anemia , constipation, urinary incontinence, and kidney disease;
- dysmenorrhea , decreased blood pressure , bulimia , tachycardia .
Oxazepam
From the nervous system: at the beginning of treatment (especially in elderly patients) - drowsiness, dizziness, increased fatigue, decreased ability to concentrate, ataxia, unsteady gait and poor coordination of movements, lethargy, dullness of emotions, slowed mental and motor reactions; rarely - headache, euphoria, depression, tremor, depressed mood, catalepsy, memory impairment, dystonic extrapyramidal reactions (uncontrolled movements including the eyes), asthenia, myasthenia during the day, dysarthria, confusion; extremely rarely - paradoxical reactions (aggressive outbursts, psychomotor agitation, fear, suicidal tendencies, muscle spasms, hallucinations, acute agitation, irritability, anxiety, insomnia).
From the hematopoietic organs: leukopenia, neutropenia, agranulocytosis (chills, hyperthermia, sore throat, excessive fatigue or weakness), anemia, thrombocytopenia.
From the digestive system: dry mouth or drooling, heartburn, nausea, vomiting, loss of appetite, constipation or diarrhea; liver dysfunction, increased activity of liver transaminases and alkaline phosphatase, jaundice.
From the genitourinary system: urinary incontinence, urinary retention, renal dysfunction, increased or decreased libido, dysmenorrhea.
Allergic reactions: skin rash, itching.
Effect on the fetus: teratogenicity, central nervous system depression, respiratory impairment and suppression of the sucking reflex in newborns whose mothers used the drug.
Other: addiction, drug dependence; decrease in blood pressure; rarely - depression of the respiratory center, visual impairment (diplopia), bulimia, weight loss, tachycardia, anterograde amnesia. If the dose is sharply reduced or taken is stopped - withdrawal syndrome (irritability, headache, anxiety, excitement, agitation, fear, nervousness, sleep disturbances, dysphoria, spasm of smooth muscles of internal organs and skeletal muscles, depersonalization, increased sweating, depression, nausea, vomiting, tremor, perception disorders, including hyperacusis, paresthesia, photophobia, tachycardia, convulsions, hallucinations, rarely - acute psychosis).Overdose. Symptoms: drowsiness (with a single dose exceeding 10 times the therapeutic dose, sleep occurs, from which the patient recovers on his own), confusion, paradoxical arousal, decreased reflexes, stunnedness, decreased response to painful stimuli, deep sleep, dysarthria, ataxia, visual impairment (nystagmus ), tremor, bradycardia, shortness of breath or difficulty breathing, severe weakness, decreased blood pressure, collapse, depression of cardiac and respiratory activity, coma.
Treatment: gastric lavage, forced diuresis, activated charcoal. Symptomatic therapy (maintaining breathing and blood pressure). Flumazenil is used as a specific antagonist (in a hospital setting). Hemodialysis is ineffective.
Overdose
There is an increase in adverse reactions, depression of the central nervous system, up to coma , confusion , drowsiness , lethargy , ataxia , arterial hypotension .
As therapy, it is recommended to lavage the stomach, monitor vital signs, and administration of norepinephrine , an antidote (inpatient), is indicated. Hemodialysis is ineffective.
Interaction
The effectiveness of the drug is reduced when combined with oral contraceptives.
The medicine reduces the bioavailability of zidovudine headaches develop more often .
Combination with phenytoin leads to a decrease in the concentration of Oxazepam.
The medicine cannot be combined with other drugs that depress the central nervous system, MAO inhibitors phenothiazine derivatives .
special instructions
Particular care should be taken when treating patients with arterial hypotension , elderly people, and patients who have previously suffered from drug addiction with Oxazepam.
It is not recommended to treat with the drug for a long time (4 or more weeks). If treatment is necessary over several months, intermittent therapy is used. The pills are discontinued gradually to avoid the development of withdrawal syndrome ( convulsions , tremors , vomiting, spasms and pain, sweating ).
Also, during long-term treatment, it is necessary to monitor liver function and peripheral blood picture.
The drug should not be taken by drivers or if it is necessary to perform work with increased concentration.
Precautions for the substance Oxazepam
Use with caution in cases of predisposition to arterial hypotension, especially in elderly patients (due to the possibility of cardiac dysfunction), and an increased risk of drug dependence.
Should not be administered with MAO inhibitors, phenothiazine derivatives. The likelihood of overdose symptoms increases with concomitant use of CNS depressants or alcohol. During the treatment period, alcoholic beverages are excluded.
Should not be used for a long time (due to the risk of developing drug dependence). If long-term treatment is necessary (several months), the course should be carried out using the method of intermittent therapy, stopping treatment for several days and then prescribing the same individually selected dose. Cancellation should be carried out gradually. With abrupt withdrawal of oxazepam, withdrawal syndrome may occur (tremor, convulsions, abdominal or muscle spasms, vomiting, perspiration), most often appearing after taking high doses or long-term treatment.
With long-term treatment, monitoring of liver function and peripheral blood patterns is necessary.
Should not be used by vehicle drivers and people whose profession involves increased concentration of attention.
Drugs containing (Oxazepam analogues)
Level 4 ATC code matches:
Bromazepam
Helex
Rudotel
Relium
Nozepam
Tazepam
Xanax
Elenium
Valium Roche
Alprazolam
Tofisopam
Diazepam
Grandaxin
Mezapam
Sibazon
Seduxen
Relanium
Lorazepam
Analogues: Nozepam , Oxazepam tablets , Tazepam , Vaben , Nozepam tablets 0.01 g.