Reference book of medicines. Influence on driving. Features of use in children and the elderly

Instructions for medical use drug

Description of the pharmacological action

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

It 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. At neurotic syndromes obsessive fear acts more strongly on the psychic than on the vegetative component of fear.

Use during pregnancy

Contraindicated in pregnancy. Stop during treatment breast-feeding.

Contraindications for use

Hypersensitivity, myasthenia gravis, liver and kidney disease, respiratory failure, pregnancy, breastfeeding.

Side effects

Weakness, fatigue, drowsiness, restlessness, paradoxical reactions ( psychomotor agitation and etc.), headache and dizziness, ataxia, lowering blood pressure, urination disorders, weakening of libido, skin allergic reactions.

Dosage and administration

inside. Adults: 1-2 tablets. 2-3 times a day, the elderly - 1-2 tablets. 2 times a day.

Children: 1-3 tablets. per day in 2-3 doses. At inpatient treatment- up to 120 mg / day (maximum daily dose).

Interactions with other drugs

Enhances the effect of sedatives, hypnotics, psychotropic, antiepileptic drugs, alcohol and anticholinergics. May alter the effect of indirect anticoagulants.

Precautions for use

It should be borne in mind that drug dependence may develop. Use with caution in the elderly with cardiac disorders. At long-term treatment monitoring of liver function and composition is necessary cellular elements peripheral blood. During the reception, you should not drink alcohol, drive vehicles, work with mechanisms and engage in activities that require increased attention.

Special instructions for admission

Cancellation of treatment is carried out gradually, reducing daily doses.

Storage conditions

In a place protected from light.

Best before date

Belonging to ATX-classification:

** The Medication Guide is for informational purposes only. For more complete information please refer to the manufacturer's instructions. Do not self-medicate; Before you start taking Oxazepam, you should consult your doctor. EUROLAB is not responsible for the consequences caused by the use of the information posted on the portal. Any information on the site does not replace the advice of a doctor and cannot serve as a guarantee positive effect medicinal product.

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** Attention! The information provided in this drug formulary is intended to medical professionals and should not be the basis for self-medication. The description of the drug Oxazepam is provided for informational purposes and is not intended for prescribing treatment without the participation of a doctor. Patients need specialist advice!


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Take medication to normalize psycho-emotional state by doctor's prescription.

Composition and form of release

The entire group of analogues (Oxazepam, Nozepam, Vaben and Tazepam) is produced by various pharmaceutical companies in the form of tablets for oral administration, dosage active ingredient in each 10 mg.

The active ingredient in oxezepam. To enhance the effect of the drug, the composition is supplemented with excipients.

Pharmacological profile

Oxazepam acts on certain benzodiazepine receptors, which are located in the brain and control the functionality of the postsynaptic complex.

As a result of taking the medication, the sensitivity of benzodiazepine receptors to amnobutyric gamma acid increases. As a result, the balance of the cytoplasmic membrane shifts towards chloride ion channels.

All these processes lead to inhibition of neuronal activity and an increase in the action of GABA, which inhibits the activity of the central nervous system.

Oxazepam has on the body complex impact about the work of the CNS. During the course of therapy, the patient observes a sedative and anxiolytic effect. It also has an anticonvulsant and relaxing effect, eliminating overstrain and.

The main effect of the drug is aimed at weakening the conditions:

  • fear;

Tablets have hypnotic properties due to sedative effect. The muscle relaxation effect of the drug can cause a slowdown in the reaction of the psychological and muscular plan.

Indications and contraindications for the appointment

The benzodiazepine tranquilizer Oksezepam is prescribed for the following violations and disorders:

In some cases, Oxazepam is prescribed together with in complex therapy.

Due to the fact that the drug is a powerful tranquilizer and has strong impact on the body, tablets have many contraindications:

  • hypersensitivity regarding the constituent components of the drug;
  • state of shock or coma;
  • alcohol intoxication;
  • alcohol intoxication;
  • angle-closure glaucoma;
  • severe respiratory failure;
  • severe depression with suicidal tendencies;
  • period of pregnancy;
  • the age of the child is up to six years;
  • breast-feeding.

Ignoring contraindications can lead to adverse reaction and also exacerbate psychological disorders and related diseases.

Scheme of administration and dosage

The next dose of a tranquilizer is taken regardless of food intake. General scheme involves the use of ½ or 1 tablet twice a day.

At severe conditions it is possible to exceed the dose up to 5 tablets per day. AT exceptional cases a larger increase in dosage is possible.

AT preventive purposes or to eliminate insomnia, take 1 to 3 tablets once a day, an hour before going to bed.

Elderly people are prescribed the drug three times a day, 1 tablet. If the drug is well tolerated, then the dose is increased to 2 tablets twice a day. After 65 years, the drug is taken at a dosage of no more than 4 tablets per day.

The course of taking Oxazepam is set depending on the concomitant disorder. On average, the therapeutic course lasts one month.

It is impossible to stop taking the drug abruptly. If the course of therapy is completed, the dosage of the drug is gradually reduced (more on the abolition of benzodiazepine tranquilizers in the video).

The instructions describe all the violations in which the use of the drug is recommended. For exclusion backlash as a result of therapy and the effectiveness of treatment, the pill regimen is determined by the doctor according to an individual scheme, taking into account all the characteristics of the patient's body.

Cases of overdose

At mild form overdose, its symptoms can be eliminated after gastric lavage. In case of significant violations of the functionality of the body, the patient is hospitalized and an antidote or norepinephrine is administered.

Adverse reactions

If you neglect the contraindications indicated in the instructions or in case of an allergic reaction to Oxazepam, side effects occur:

  • constant sleepiness and general weakness;
  • , and loss of consciousness;
  • and violation of speech functions;
  • excessive and overexcitation;
  • leukopenia, gastric disorders, dry mouth;
  • allergic reaction, change in libido (increase or decrease);
  • violation of hepatic functions;
  • drug dependence in the form of withdrawal and withdrawal syndrome.

Much less often, the drug gives the effect of the opposite effect:

  • gain depression, panic fear, insomnia, the appearance of thoughts of suicide and;
  • kidney disease, disruption of the intestines and urinary system;
  • anemia, lowering blood pressure, tachycardia and bulimia.

In order to avoid an adverse reaction, the drug is taken only on the recommendation of a doctor and in a certain dosage. Admission with contraindications is not desirable. If necessary, it is better to replace the medication with a similar drug.

special instructions

Oxazepam-based medications should be taken with caution when treating the following categories of patients:

Tranquilizer therapy for these categories of people is possible, but patients should be under the constant supervision of a specialist who monitors their condition.

Alcohol compatibility

During treatment with Oxazepam, taking alcoholic beverages even in a small dose, it can cause side effects due to an increase in the reaction of the drug together with ethanol on the central nervous system.

Impaired kidney function

The use of the drug in kidney pathologies can be carried out with caution. During therapy, liver function and changes in blood composition should be monitored.

Interaction with other drugs

Do not take drugs together with Oxazepam:

  • sleeping pills;
  • psychotropic;
  • anticholinergics;
  • anticoagulants.

The drug enhances the action of the listed groups of medicines, which can cause an overdose or an adverse reaction.

Special populations

Oxazepam has toxic effect on the body and tends to penetrate into the blood, for this reason the medication is contraindicated during pregnancy. The drug can affect the development of the fetus, provoking pathologies and drug dependence.

From the second trimester, the medicine is prescribed only at the risk of life for the fetus itself or the woman carrying the child. When using the drug during lactation, breastfeeding is stopped.

Before the age of six, a tranquilizer is not prescribed. Up to twelve years, the medication is taken with caution and under the regular supervision of a specialist.

Practical application experience

Opinion of practitioners and patients who are or have been treated with Nozepam and similar drugs.

I used Nozepam for severe depression, which arose after the loss of work and divorce. I drank two tablets a day, as prescribed by the attending physician. At first, constant drowsiness and weakness were felt, but after a week of use, the nervous system recovered.

I stopped taking it after a month, but already on the third week I began to reduce the dosage. The tablets were not addictive.

In addition to the wide impact profile, the low cost of the product can also be noted. But because of big list side effects and serious consequences in case of an overdose, it is advisable to take the medicine only with obvious indications.

Purchase and storage

The cost of drugs based on Oxazepam differs due to pricing policy manufacturer's company. average price for one package from 80 to 250 rubles.

The drug is stored away from sunlight. Shelf life (indicated on tablet blister packs) 3 years from the date of production.

AT pharmacy chains original drug Oxazepam is only available with a doctor's prescription.

There are many tranquilizers on the pharmaceutical market. In the presence of contraindications and the manifestation of a side effect, the medicine can be replaced with another medication or dietary supplement.

Direct analogues of the original remedy are Tazepam, Vaben and Nozepam, all of which are based on oxazepam. They differ from the original medicine only in the additional composition, as well as in the manufacturer.

These drugs have the same dosage active ingredient and identical pharmacological properties, therefore, it is conditionally considered that this is the same drug, produced under different trade names.

Gross formula

C 15 H 11 ClN 2 O 2

Pharmacological group of the substance Oxazepam

Nosological classification (ICD-10)

CAS code

604-75-1

Characteristics of the substance Oxazepam

Anxiolytic of the benzodiazepine series.

White or white with a slightly yellowish tinge, odorless crystalline powder. Practically insoluble in water, slightly soluble in ethanol, chloroform, ether, soluble in dimethylformamide.

Pharmacology

pharmachologic effect - anxiolytic, hypnotic, sedative.

Interacts with specific benzodiazepine receptors located in the postsynaptic GABA A receptor complex in the limbic system of the brain, the ascending activating reticular formation of the brainstem and the intercalary neurons of the lateral horns spinal cord. Increases the sensitivity of GABA receptors to the mediator (GABA). As a result, the frequency of opening of transmembrane channels in the cytoplasmic membrane of neurons for incoming currents of chloride ions increases. There is hyperpolarization of the membrane and inhibition of neuronal activity. Thus, the inhibitory effect of GABA in the central nervous system is enhanced.

It has a calming, anxiolytic and hypnotic effect on the central nervous system. Removes emotional stress, reduces anxiety, fear, anxiety, promotes the onset of sleep. Relieves symptoms of acute alcohol withdrawal. It has a weak muscle relaxant (central) and anticonvulsant effect.

Oxazepam is characterized by a large latitude therapeutic action (big difference between an effective dose and a dose causing side effects).

In studies of tolerance and toxicity of oxazepam in different types animals (mice, rats, dogs) there was a significant difference in effective doses (anxiolytic effect) and doses that cause side effects. So, in mice oral intake oxazepam effective doses were almost 10 times lower than the doses that cause ataxia (rotabar test) and sedation (cancellation of spontaneous motor activity).

Two-year studies in rats at doses 30 times the MRDH found an increase in the incidence of benign follicular cell tumors thyroid gland, testicular adenomas (interstitial cell) and adenomas prostate. In a nine-month study in rats at doses 35-100 times the daily human dose, a dose-dependent increase in the incidence of liver adenomas was found. At the same time, there are no data confirming that the clinical use of oxazepam is associated with the occurrence of tumors.

After oral administration, it is slowly absorbed from the gastrointestinal tract. Cmax is reached in 1-4 hours. Binding to blood proteins is 97%. The equilibrium concentration in the blood is reached within a few days after the start of administration. distributed throughout the tissues. Passes through the BBB, the placental barrier, penetrates into breast milk. It undergoes glucuronidation in the liver, there are no active metabolites. T 1/2 averages 8.2 hours (5.7 - 10.9 hours). It is excreted mainly by the kidneys in the form of glucuronides. When taking repeated doses, the accumulation is minimal.

The use of the substance Oxazepam

Neuroses, psychopathy, neurosis-like and psychopathic states, accompanied by fear, anxiety, increased irritability, sleep disturbances, etc.; senesto-hypochondriac disorders and obsessions (especially with poor tolerance other anxiolytics); autonomic disorders associated with menopause in women premenstrual syndrome; reactive depression (composed of combination therapy with antidepressants), withdrawal symptoms alcohol syndrome(as part of combination therapy).

Contraindications

Hypersensitivity, psychosis, severe myasthenia gravis, acute renal and / or liver failure, pregnancy (especially I trimester), breastfeeding, age up to 6 years.

Application restrictions

Tendency to abuse psychotropic drugs.

Use during pregnancy and lactation

Contraindicated in pregnancy (especially in the first trimester). At the time of treatment should stop breastfeeding.

Side effects of oxazepam

From the nervous system and sensory organs: drowsiness (usually in the first days of treatment), lethargy, dizziness, fatigue, headache, memory impairment, muscle weakness, ataxia, tremor, slurred speech, paradoxical reactions in mental patients, incl. psychomotor agitation, anxiety.

Others: dry mouth, nausea, dyspepsia, leukopenia, abnormal liver function (including jaundice), allergic reactions, fainting, changes in libido.

Possible addiction, drug dependence, withdrawal syndrome (see "Precautions").

Interaction

Enhances the effect of drugs that depress the central nervous system, incl. hypnotics, antiepileptic drugs, neuroleptics, general anesthesia, alcohol.

Overdose

Symptoms: CNS depression varying degrees severity (from drowsiness to coma) - drowsiness, confusion, lethargy; in more severe cases(especially when taking other drugs that depress the central nervous system, or alcohol) - ataxia, lowering blood pressure, hypnotic state, coma.

Treatment: induction of vomiting, gastric lavage, symptomatic therapy, monitoring is vital important functions. With severe hypotension - the introduction of norepinephrine. The specific antidote is the benzodiazepine receptor antagonist flumazenil (introduction only in a hospital setting). Hemodialysis is ineffective.

Routes of administration

inside.

Oxazepam Substance Precautions

Use with caution if you are prone to arterial hypotension, especially in elderly patients (due to the possibility of cardiac dysfunction), increased risk formation drug addiction.

It should not be administered with MAO inhibitors, phenothiazine derivatives. The likelihood of overdose symptoms increases with simultaneous reception CNS depressants or alcohol. During the treatment period, the intake of alcoholic beverages is excluded.

Should not be used for a long time (due to the risk of developing drug dependence). If necessary long-term treatment(several months) the course should be carried out according to the method of intermittent therapy, stopping the intake for several days, followed by the appointment of the same individually selected dose. Cancellation should be carried out gradually. Abrupt withdrawal of oxazepam may result in withdrawal symptoms (tremors, convulsions, abdominal or muscle spasms, vomiting, perspiration), most often appearing after taking high doses or long-term treatment.

With prolonged treatment, it is necessary to monitor liver function and peripheral blood patterns.

Should not be used by drivers of vehicles and people whose profession is related to increased concentration attention.

special instructions

Recommended in the treatment of anxiety, tension, agitation, irritability in debilitated patients, people old age as well as patients with residual effects traumatic or infectious lesions CNS.

Oxazepam Oxazepam

Active substance

›› Oxazepam* (Oxazepam*)

Latin name

›› N05BA04 Oxazepam

Pharmacological group: Anxiolytics

Nosological classification (ICD-10)

›› F10.2 Alcohol dependence syndrome
›› F40 Phobic anxiety disorders
›› F41 Other anxiety disorders
›› F48 Other neurotic disorders
›› G47.0 Disorders of initiation and maintenance of sleep [insomnia]
›› R45.1 Restlessness and agitation
›› R45.7 State of emotional shock and stress, unspecified

Composition and form of release

1 tablet contains oxazepam 10 mg; in a blister 20 pcs., in cardboard box 1 blister.

pharmachologic effect

pharmachologic effect- anxiolytic, tranquilizing. It excites benzodiazepine receptors and increases the sensitivity of GABA receptors to the mediator, enhancing the inhibitory effect of GABA on the central nervous system.

Clinical pharmacology

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 vegetative component of fear.

Indications

neuroses; states of anxiety, tension, fear, excitability (with chronic alcoholism); sleep disorders.

Contraindications

Hypersensitivity, myasthenia gravis, liver and kidney disease, respiratory failure, pregnancy, lactation.

Use during pregnancy and lactation

Contraindicated in pregnancy. At the time of treatment should stop breastfeeding.

Side effects

Weakness, fatigue, drowsiness, anxiety, paradoxical reactions (psychomotor agitation, etc.), headache and dizziness, ataxia, lowering blood pressure, urination disorders, weakening of libido, skin allergic reactions.

Interaction

Enhances the effect of sedatives, hypnotics, psychotropic, antiepileptic drugs, alcohol and anticholinergics. May alter the effect of indirect anticoagulants.

Dosage and administration

inside. Adults: 1-2 tablets. 2-3 times a day, the elderly - 1-2 tablets. 2 times a day.
Children: 1-3 tab. per day in 2-3 doses. In hospital treatment - up to 120 mg / day (maximum daily dose).

Precautionary measures

It should be borne in mind that drug dependence may develop. Use with caution in the elderly with cardiac disorders. With prolonged treatment, monitoring of liver function and the composition of cellular elements of peripheral blood is necessary. During the reception, you should not drink alcohol, drive vehicles, work with mechanisms and engage in activities that require increased attention.

special instructions

Cancellation of treatment is carried out by gradually reducing the daily dose.

Best before date

Storage conditions

In a place protected from light.


Medicine Dictionary. 2005 .

See what "Oxazepam" is in other dictionaries:

    - ... Wikipedia

    OXAZEPAM- Oxazepanum. Synonyms: tazepam, nozepam, adumbran, praksiten, psicopaks, rondar, etc. Release form. Released in the form of tablets of 0.01 g (10 mg). Store with caution (list B). Action and application. Oxazepam by chemical structure and f... Domestic veterinary drugs

"Oxazepam (Oxazepam)" used in the treatment and/or prevention the following diseases(nosological classification - ICD-10):

Molecular formula: C15-H11-Cl-N2-O2

CAS code: 604-75-1

Description

Characteristic: Anxiolytic of the benzodiazepine series.

White or white with a slightly yellowish tinge, odorless crystalline powder. Practically insoluble in water, slightly soluble in ethanol, chloroform, ether, soluble in dimethylformamide.

pharmachologic effect

Pharmacology: Pharmacological action - anxiolytic, sedative, hypnotic. Interacts with specific benzodiazepine receptors located in the postsynaptic GABA_A receptor complex in the limbic system of the brain, the ascending activating reticular formation of the brainstem and the intercalary neurons of the lateral horns of the spinal cord. Increases the sensitivity of GABA receptors to the mediator (GABA). As a result, the frequency of opening of transmembrane channels in the cytoplasmic membrane of neurons for incoming currents of chloride ions increases. There is hyperpolarization of the membrane and inhibition of neuronal activity. Thus, the inhibitory effect of GABA in the central nervous system is enhanced.

It has a calming, anxiolytic and hypnotic effect on the central nervous system. Relieves emotional stress, reduces anxiety, fear, anxiety, promotes sleep. Relieves symptoms of acute alcohol withdrawal. It has a weak muscle relaxant (central) and anticonvulsant effect.

Oxazepam is characterized by a large breadth of therapeutic action (large difference between the effective dose and the dose that causes side effects).

In studies of tolerance and toxicity of oxazepam in different animal species (mice, rats, dogs), a significant difference was observed in effective doses (anxiolytic effect) and doses that cause side effects. So, in mice with oral administration of oxazepam, effective doses were almost 10 times lower than doses that cause ataxia (rotabar test) and sedation (cancellation of spontaneous motor activity).

In 2-year studies in rats at doses 30 times the MRDH, an increase in the incidence of benign follicular cell tumors of the thyroid gland, testicular (interstitial cell) adenomas and prostate adenomas was found. In a nine-month study in rats at doses 35-100 times the daily human dose, a dose-dependent increase in the incidence of liver adenomas was found. At the same time, there are no data confirming that the clinical use of oxazepam is associated with the occurrence of tumors.

After oral administration, it is slowly absorbed from the gastrointestinal tract. C_max achieved through 1-4 hours Binding to blood proteins - 97%. The equilibrium concentration in the blood is reached within a few days after the start of administration. distributed throughout the tissues. Passes through the BBB, the placental barrier, penetrates into breast milk. It undergoes glucuronidation in the liver, there are no active metabolites. T_1/2 averages 8.2 hours (5.7 - 10.9 hours). It is excreted mainly by the kidneys in the form of glucuronides. When taking repeated doses, the accumulation is minimal.

Indications for use

Application: Neuroses, psychopathy, neurosis-like and psychopathic states, accompanied by fear, anxiety, increased irritability, sleep disturbances, etc.; senesto-hypochondriac disorders and obsession (especially with poor tolerance to other anxiolytics); autonomic disorders in women associated with menopause, premenstrual syndrome; reactive depression (as part of combination therapy with antidepressants), alcohol withdrawal syndrome (as part of combination therapy).

Contraindications

Contraindications: Hypersensitivity, psychosis, severe myasthenia gravis, acute renal and / or liver failure, pregnancy (especially the first trimester), breast-feeding, age up to 6 years.

Restrictions on use: Tendency to abuse psychotropic drugs.

Application during pregnancy and lactation: Contraindicated in pregnancy (especially in the first trimester). At the time of treatment should stop breastfeeding.

Side effects

Side effects: From the nervous system and sensory organs: drowsiness (usually in the first days of treatment), lethargy, dizziness, increased fatigue, headache, memory impairment, muscle weakness, ataxia, tremor, slurred speech, paradoxical reactions in mentally ill patients, including . psychomotor agitation, anxiety.

Other: dry mouth, nausea, dyspepsia, leukopenia, abnormal liver function (including jaundice), allergic reactions, fainting, changes in libido.

Possible addiction, drug dependence, withdrawal syndrome (see "Precautions").

Interaction: Enhances the effect of drugs that depress the central nervous system, incl. sleeping pills anticonvulsants, alcohol, etc.

Overdose: Symptoms: CNS depression of varying severity (from drowsiness to coma) - drowsiness, confusion, lethargy; in more severe cases (especially while taking other drugs that depress the central nervous system, or alcohol) - ataxia, hypotension, hypnotic state, coma.

Treatment: induction of vomiting, gastric lavage, symptomatic therapy, monitoring of vital functions. With severe hypotension - the introduction of norepinephrine. The specific antidote is the benzodiazepine receptor antagonist flumazenil (introduction only in a hospital setting). Hemodialysis is ineffective.

Dosage and method of application

Dosage and administration: Inside (regardless of the meal). The dose and duration of the course of treatment are selected strictly individually, depending on the indications and therapeutic effect. Initial single dose for adults - 5-10 mg, with outpatient treatment average daily dose of 30-50 mg, in a hospital maximum dose- 120 mg / day. Average duration course is 2-4 weeks.

The dose for children 6-12 years of age has not been established.

Precautions: Use with caution in case of predisposition to arterial hypotension, especially in elderly patients (due to the possibility of cardiac dysfunction), an increased risk of drug dependence.

It should not be administered with MAO inhibitors, phenothiazine derivatives. The likelihood of overdose symptoms increases with the simultaneous use of CNS depressants or alcohol. During the treatment period, the intake of alcoholic beverages is excluded.

Should not be used for a long time (due to the risk of developing drug dependence). If long-term treatment (several months) is necessary, the course should be carried out according to the method of intermittent therapy, stopping the intake for several days, followed by the appointment of the same individually selected dose. Cancellation should be carried out gradually. With the abrupt withdrawal of oxazepam, a withdrawal syndrome (tremor, convulsions, abdominal or muscle cramps, vomiting, perspiration) may occur, most often after high doses or long-term treatment.

With prolonged treatment, it is necessary to monitor liver function and peripheral blood patterns.

It should not be used by drivers of vehicles and people whose profession is associated with increased concentration of attention.

Special instructions: Recommended in the treatment of anxiety, tension, agitation, irritability in debilitated patients, elderly people, as well as patients with residual effects of traumatic or infectious lesions of the central nervous system.

It should be borne in mind that anxiety or tension associated with everyday stress usually does not require treatment with anxiolytics.

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