Nitrazepam - instructions for use, analogues, use, indications, contraindications, action, side effects, dosage, composition. Dictionary of medicines Nitrazepam analogues synonyms

Compound

1 tablet of the drug contains the active substance: nitrazepam - 5 mg, excipients: milk sugar (lactose), potato starch, magnesium stearate (magnesium stearate), talc.

Description

Tablets white or white with a yellowish-greenish tint, flat-cylindrical with a chamfer. The surface of the tablet should be smooth and uniform, with solid edges.

pharmachologic effect

Nitrazepam is a sedative of the benzodiazepine group. The action begins 30-60 minutes after ingestion and lasts from 6 to 8 hours.

Pharmacokinetics

Suction:

The drug is well absorbed from the gastrointestinal tract, the maximum level of nitrazepam in the blood is reached within 2 hours after administration. Two hours after ingestion, the concentration of nitrazepam in the cerebrospinal fluid is about 8%, and after 36 hours about 16% of the plasma concentration. Thus, the concentration in the cerebrospinal fluid corresponds to the fraction of the active substance in the plasma that is not bound to the protein. Stationary level is reached within 5 days.

Distribution:

The volume of distribution in young people is 2 l / kg, in elderly patients the volume of distribution is higher, and the average elimination half-life increases to 40 hours.

Metabolism:

Nitrazepam undergoes biotransformation with the formation of a number of metabolites, none of which has significant clinical activity.

Derivation:

Approximately 5% of the drug is excreted unchanged in the urine, together with less than 10% of each of the 7-amino and 7-dioxane metabolites during the first 48 hours. The elimination half-life averages 24 hours.

Pharmacokinetic / pharmacodynamic ratios:

A clear relationship between blood levels of nitrazepam and its clinical effects has not been demonstrated.

Indications for use

Short-term treatment of severe insomnia resulting in incapacitation or subjecting the individual to unacceptable stress when daytime sedation is acceptable.

The underlying cause of insomnia must be clarified before a decision is made to use benzodiazepines to relieve symptoms.

Contraindications

Hypersensitivity to benzodiazepines, nitrazepam or to any excipient that is part of the dosage form.

Allergic reactions to benzodiazepines, including rash, angioedema, and hypertension, have been reported in rare cases in susceptible patients.

The use of the drug is also contraindicated in patients with acute pulmonary insufficiency; respiratory depression; phobic or obsessive states; chronic psychoses; myasthenia gravis; sleep apnea syndrome; severe liver failure; in children.

Pregnancy and lactation

There are no data on the safety of the drug both during pregnancy in women and in animal tests. Do not use the drug during pregnancy, especially in the first and last trimesters, the use is possible only in exceptional cases, if there are good reasons.

If the drug is prescribed to a woman of childbearing age, she should be warned to contact her doctor about discontinuing the product if she is planning a pregnancy or suspects pregnancy.

Benzodiazepines in the last trimester of pregnancy or during labor have been reported to cause abnormal fetal heart rate and hypotension; poor suckling, hypothermia and mild respiratory depression in neonates.

Babies born to mothers who took benzodiazepines chronically in the later stages of pregnancy may develop physical dependence and may develop withdrawal symptoms in the postpartum period.

Lactation:

Since benzodiazepines pass into breast milk, the use of nitrazepam by breastfeeding mothers should be avoided.

Dosage and administration

Nitrazepam tablets are used for oral administration.

Dosage:

adults

5 mg at bedtime. This dose may be increased to 10 mg if necessary.

Elderly or debilitated patients: The elderly or patients with impaired renal or hepatic function are particularly susceptible to the adverse effects of nitrazepam. Doses should not exceed half of the commonly recommended doses.

If organic brain changes are present, the dosage of nitrazepam should not exceed 5 mg.

Other populations

For patients with chronic pulmonary insufficiency and patients with chronic renal or hepatic disease, dosage reduction may be required.

Nitrazepam tablets are contraindicated in children.

Dosage must be adjusted on an individual basis. If possible, treatment should be carried out at regular intervals.

Treatment should be as short as possible and started with the lowest recommended doses. The maximum dose must not be exceeded. Usually the duration of treatment varies from a few days to two weeks with a maximum of four weeks; including narrowing the process. Patients who have taken benzodiazepines for a long time may require a longer period during which doses are reduced. The help of specialists may be appropriate. The long-term efficacy and safety of benzodiazepines has not been well studied.

In some cases, it may be necessary to increase the period of maximum treatment; if so, it should not proceed without a reassessment of the patient's status. Long-term chronic use is not recommended. It is necessary to inform the patient about the start of treatment, its limited duration, and explain exactly how the dosage will be reduced. In addition, it is important that the patient is aware of the possibility of side effects, thus reducing the occurrence of such symptoms if they occur when the drug is interrupted. Nitrazepam therapy should not be stopped abruptly, but the dose should be reduced. The drug should be taken at bedtime.

In addition, for long-acting benzodiazepines, it should be noted that the patient should be constantly observed at the beginning of treatment in order to reduce, if necessary, the dose or frequency of administration to prevent overdose due to drug accumulation.

Overdose

An overdose of nitrazepam presents several regulatory problems and may not be life threatening unless combined with other CNS depressants (including alcohol). In the management of overdose with any drug, it should be taken into account that several agents may be taken.

Symptoms:

An overdose of benzodiazepines usually presents with a degree of central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, confusion, dysarthria, and lethargy; in more severe cases, symptoms may include ataxia, hypotension, respiratory depression, rarely to anyone, and very rarely death.

In case of benzodiazepine overdose, induce vomiting (within one hour) if the patient is conscious or gastric lavage with a tube if the patient is unconscious. If there is no benefit in gastric emptying, activated charcoal should be taken to reduce absorption.

During treatment in the intensive care unit, special attention should be paid to respiratory and cardiovascular functions. The value of dialysis has not been determined. Flumazenil is a specific intravenous antidote for emergency use. Patients requiring such intervention should be carefully monitored in the hospital. The benzodiazepine antagonist flumazenil is not indicated in patients with epilepsy treated with benzodiazepines. Antagonism of the effect of a benzodiazepine in such patients may cause convulsions.

In case of agitation, barbiturates should not be used.

Application features

Influence on the ability to drive vehicles, mechanisms:

Patients should be informed that, like all drugs of this type, nitrazepam may change the behavior of patients when performing professional tasks. Sedation, amnesia, impaired concentration, and decreased muscle function may affect the ability to drive or use machines. Insufficient sleep duration increases the likelihood of impaired attention. Patients should be informed that alcohol may increase the deterioration of the condition, and therefore its consumption should be avoided during treatment.

Precautionary measures

Patients with chronic respiratory failure and with chronic kidney or liver disease may need to reduce the dosage. Benzodiazepines are contraindicated in patients with severe hepatic impairment.

Nitrazepam should not be used solely to treat depression or anxiety associated with depression, as suicidal tendencies may occur. Benzodiazepines should be used with extreme caution in patients with a history of alcohol or drug abuse. Benzodiazepines are not recommended for the primary treatment of mental illness.

In cases of loss or bereavement, psychological restructuring can be inhibited by benzodiazepines.

The use of benzodiazepines can lead to the development of physical and psychological dependence. The risk of dependence is increased when high doses are used, especially over a long period of time. This is especially true in alcoholism or drug addiction, or in patients with overt personality disorders. Regular monitoring of such patients is essential; routine repeated prescriptions should be avoided and treatment should be tapered off gradually. Symptoms such as depression, headaches, muscle weakness, nervousness, excessive anxiety, tension, restlessness, confusion, mood swings, insomnia, irritability, sweating, and diarrhea have been reported to result from abrupt discontinuation of treatment in patients receiving even the usual therapeutic doses of for short periods of time.

When switching from long-acting benzodiazepines to short-acting benzodiazepines, withdrawal symptoms may develop.

In severe cases, the following symptoms may occur: derealization, depersonalization, hyperacusis, numbness and tingling in the extremities, increased sensitivity to light, sensation of noise and physical contact, hallucinations or epileptic seizures. In rare cases, the abolition of subsequent excessive doses can lead to anxiety, psychotic manifestations and convulsions. There is evidence of abuse of benzodiazepines.

Some loss of effectiveness of the hypnotic effects of short-acting benzodiazepines may develop after repeated use over several weeks.

Inadequate psychological response associated with the use of benzodiazepines has been reported. Rare behavioral effects have included paradoxical, aggressive outbursts, agitation, confusion, restlessness, psychomotor agitation, irritability, delusions, temper tantrums, nightmares, hallucinations, psychoses, maladaptive behavior, and manifestations of depression with suicidal tendencies. Therefore, caution should be exercised when prescribing benzodiazepines to patients with personality disorders. If any of these reactions occur, the drug should be discontinued. These reactions can be quite serious and are more common in older people.

Storage conditions

In a place protected from light at a temperature not exceeding 30 ° C.

Keep out of the reach of children.

Shelf life

5 years. Do not use after the expiry date stated on the package.

Clinical and pharmacological group

02.023 (Sleeping drug)

pharmachologic effect

A hypnotic drug from the benzodiazepine group. It has a pronounced hypnotic effect, as well as an anxiolytic, sedative, anticonvulsant and central muscle relaxant effect. The mechanism of action is associated with an increase in the inhibitory effect of GABA in the CNS due to an increase in the sensitivity of GABA receptors to the mediator as a result of stimulation of benzodiazepine receptors. Increases the depth and duration of sleep. Sleep usually occurs 20-40 minutes after ingestion and lasts 6-8 hours. Moderately inhibits the phase of "rapid" sleep.

Pharmacokinetics

Plasma protein binding - more than 80%. Vd - 1.9 l / kg. T1 / 2 averages 26 hours. It is excreted mainly as metabolites.

Dosage

The daily dose for adults varies from 2.5 mg to 25 mg; the frequency of application is set individually. The daily dose for children is 0.6-1 mg.

drug interaction

With simultaneous use with drugs that have a depressing effect on the central nervous system, with ethanol, ethanol-containing drugs, an increase in the inhibitory effect on the central nervous system occurs.

With simultaneous use with anticonvulsants, mutual enhancement of toxic effects is possible.

With simultaneous use with nitrazepam, the effect of antihypertensive drugs is potentiated.

With simultaneous use with estrogen-containing oral contraceptives, the concentration of nitrazepam in the blood plasma increases.

With simultaneous use, probenecid can disrupt the glucuronide binding of nitrazepam, which leads to an increase in its plasma concentration, and due to the enhancement of the therapeutic effect, an excessive sedative effect may develop.

With simultaneous use with rifampicin, the excretion of nitrazepam from the body increases.

With simultaneous use with cimetidine, the concentration of nitrazepam in the blood plasma increases, which may be accompanied by an increase in the sedative effect. It is possible to slow down the hepatic metabolism of nitrazepam. This can lead to a prolongation of T1 / 2 of nitrazepam, and with prolonged use - an increase in its concentration in blood plasma.

Use during pregnancy and lactation

Adequate and strictly controlled safety studies of the use of nitrazepam during pregnancy and lactation have not been conducted. Application is not recommended, especially in the I and III trimesters of pregnancy.

If necessary, use during lactation, breastfeeding should be discontinued.

Side effects

From the side of the central nervous system and peripheral nervous system: a feeling of fatigue, impaired concentration, slowing down of psychomotor reactions, muscle weakness; rarely - headaches, ataxia, confusion, amnesia, depression, visual impairment; in predisposed patients, aggravation of suicidal thoughts, hallucinations is possible.

From the side of the cardiovascular system: rarely - arterial hypotension.

From the digestive system: rarely - dry mouth, nausea, diarrhea.

From the respiratory system: in patients with obstructive pulmonary diseases, respiratory depression is possible.

From the reproductive system: changes in libido.

Allergic reactions: rarely - skin rash, itching.

Indications

Sleep disorders of various origins, somnambulism, premedication before surgery, encephalopathy accompanied by epileptic (myoclonic) seizures.

Contraindications

Acute respiratory failure, drug or alcohol dependence, myasthenia gravis, temporal lobe epilepsy, angle-closure glaucoma, acute intoxication with drugs that have a depressant effect on the central nervous system or alcohol, hypersensitivity to benzodiazepines.

special instructions

It should be used with caution in severe respiratory failure, obstructive pulmonary disease, ataxia, sleep apnea, severe liver dysfunction.

With prolonged use, the development of drug dependence is possible.

Avoid drinking alcohol during treatment.

Influence on the ability to drive vehicles and control mechanisms

During the period of treatment, it is necessary to refrain from engaging in potentially hazardous activities that require increased attention and rapid psychomotor reactions.

Preparations containing NITRAZEPAM (NITRAZEPAM)

. NITRAZEPAM (NITRAZEPAM) tab. 5 mg: 20 pcs.
. RADEDORM® 5 (RADEDORM 5) tab. 5 mg: 20 pcs.
. NITROSAN (NITROSUN) tab. 10 mg: 100 pcs.
. NITROSAN (NITROSUN) tab. 5 mg: 100 pcs.
. EUNOCTIN (EUNOCTIN) tab. 10 mg: 10 pcs.
. NITRAZEPAM (NITRAZEPAM) tab. 5 mg: 20 pcs.

Nitrazepam is a drug from the group of hypnotic benzodiazepine pharmaceuticals.

Composition and form of release

The drug is produced in tablets, their shape is spherical or flat-cylindrical, the color is white with a green or yellow-green tint, there is a chamfer on the surface. The drug is supplied in a cellular packaging for the pharmaceutical market or in a tinted glass polymer jar. The active compound is nitrazepam.

Auxiliary components of Nitrazepam: low molecular weight polyvinylpyrrolidone, milk sugar, talc, primogel is present, potato starch, magnesium stearate is added. Sleeping pills for sale by prescription.

pharmachologic effect

The hypnotic Nitrazepam belongs to the group of benzodiazepines. It has a muscle relaxant, anxiolytic (anti-anxiety) effect, and also has an anticonvulsant effect.

The drug enhances the inhibitory effect of GABA on the transmission of nerve impulses, in addition, it has a stimulating effect on benzodiazepine receptors, reduces the excitability of subcortical structures (thalamus, limbic system, hypothalamus), and also inhibits spinal reflexes.

The main mechanism of the hypnotic effect is the inhibition of the reticular formation located in the brain stem. Medicinal pharmaceutical preparation reduces the impact of motor, emotional, vegetative stimuli that disrupt the process of falling asleep.

Under the influence of the pharmaceutical preparation, the duration of sleep increases, as well as its depth. The anxiolytic effect is justified by the influence of nitrazepam on the limbic system and is manifested in a decrease in fear, emotional stress, in addition, anxiety and anxiety are weakened.

The sedative effect of Nitrazepam is due to the effect on the reticular formation and on the nuclei of the thalamus, which is manifested by a decrease in neurotic symptoms, in particular anxiety and fear.

The drug Nitrazepam causes an anticonvulsant effect due to the activation of presynaptic inhibition. The action of the drug begins after the use of the tablets in thirty minutes and lasts up to eight hours. Absorption of the drug from the gastrointestinal tract is complete. Bioavailability - up to 98%. Communication with proteins - 90%. Metabolized in hepatocytes. The elimination half-life lasts from 16 to 68 hours. Excreted by the kidneys, as well as with the stool.

Indications for use

The drug Nitrazepam is indicated for use in sleep disorders of various origins, in addition, the drug is effective in encephalopathy accompanied by myoclonic seizures, in West syndrome, neuroses, psychopathy, as well as endogenous psychoses, chronic alcoholism, organic lesions of the central nervous system and as a so-called premedication.

Contraindications for use

I will list the situations in which the use of the pharmaceutical drug Nitrazepam is contraindicated:

Hypersensitivity to the components of the drug;
Coma or shock;
Alcohol intoxication in acute form;
Acute intoxication with drugs that depress the central nervous system;
lactation period;
myasthenia;
Respiratory failure is acute;
Severe depression, as suicidal tendencies are not excluded;
Pregnancy;
Drug addiction, alcoholism;
Angle-closure glaucoma;
Epilepsy.

With caution, Nitrazepam is prescribed for liver, respiratory or renal failure, in old age, hyperkinesis, a history of drug dependence, organic brain pathology, hypoproteinemia, psychosis, sleep apnea.

Application and dosage

The drug Nitrazepam is used orally as a hypnotic pharmaceutical an hour before bedtime at an average dosage of 5-10 mg, the maximum single dosage is 20 milligrams. As an anti-anxiety and antiepileptic agent, the highest daily dose is 30 mg.

Side effect

The use of Nitrazepam causes the following side effects: drowsiness, a feeling of fatigue, dizziness is possible, a decrease in concentration of attention, ataxia is noted, there may be uncertainty when walking, lethargy, in addition, dulling of emotions, as well as slowing down mental reactions and motor.

Among other negative reactions, one can note: the presence of a headache, euphoria, depression are characteristic, tremor is observed, depression of mood is fixed, catalepsy is possible, in addition, amnesia, confusion, weakness, extrapyramidal reactions are not excluded, in addition, laboratory changes in the form of leukopenia, anemia, neutropenia, and agranulocytosis.

Other side effects: salivation, allergic reactions, heartburn, nausea, drug dependence, vomiting, loss of appetite, urinary incontinence, constipation or diarrhea, dysmenorrhea, liver dysfunction, increased liver enzymes, urinary retention, libido changes, decreased blood pressure, depersonalization, depression respiratory center, bulimia, double vision, weight loss, tachycardia.

drug overdose

Symptoms of an overdose of Nitrazepam: drowsiness, decreased reflexes, confusion, deep sleep, paradoxical arousal, stupor, ataxia, reduced response to pain, blurred vision, lethargy, tremor, bradycardia, coma, shortness of breath, decreased blood pressure. The patient is washed out the stomach and symptomatic treatment is prescribed.

special instructions

In the course of treatment with Nitrazepam, the patient is prohibited from drinking alcohol. It is not recommended to use the medication for a long time. The drug can provoke drug dependence when taken daily for several weeks, even when used in therapeutic doses.

Analogues

Eunoctin, Mogadon, Nitrazadone, Radedorm 5, Nitram, Berlidorm 10, Nitrosan, Berlidorm 5, Neozepam.

Conclusion

Nitrazepam is recommended to be taken only as prescribed by a specialist.

International name

Nitrazepam (Nitrazepam)

Group affiliation

sleeping pill

Dosage form

Pills

pharmachologic effect

A hypnotic drug of the benzodiazepine group. It also has a central muscle relaxant, anxiolytic and anticonvulsant effect.

Enhances the inhibitory effect of GABA (a mediator of pre- and postsynaptic inhibition in all parts of the central nervous system) on the transmission of nerve impulses. Stimulates benzodiazepine receptors located in the allosteric center of postsynaptic GABA receptors of the ascending activating reticular formation of the brain stem and intercalary neurons of the lateral horns of the spinal cord; reduces the excitability of the subcortical structures of the brain (limbic system, thalamus, hypothalamus), inhibits polysynaptic spinal reflexes.

The main mechanism of hypnotic action is to inhibit the cells of the reticular formation of the brain stem. Reduces the impact of emotional, vegetative and motor stimuli that disrupt the mechanism of falling asleep.

Under the influence of the drug increases the depth and duration of sleep. Sleep and awakening proceed physiologically.

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

The sedative effect is due to the effect on the reticular formation of the brain stem and nonspecific nuclei of the thalamus and is manifested by a decrease in the symptoms of neurotic origin (anxiety, fear).

Anticonvulsant action is realized by enhancing presynaptic inhibition. The spread of epileptogenic activity is suppressed, but the excited state of the focus is not removed.

The central muscle relaxant effect is due to the inhibition of polysynaptic spinal afferent inhibitory pathways (to a lesser extent, monosynaptic ones). Direct inhibition of motor nerves and muscle function is also possible.

The action begins 30 minutes after ingestion and lasts 6-8 hours.

Indications

Sleep disorders of various origins (difficulty falling asleep, frequent nocturnal and / or early morning awakenings); encephalopathies accompanied by epileptic myoclonic seizures (as part of combination therapy), epilepsy in children aged 4 months to 1-2 years - West's syndrome (infantile spasm or lightning nodding Salaam convulsions); neurosis, psychopathy, chronic alcoholism, endogenous psychoses, organic lesions of the central nervous system (as part of complex therapy); premedication.

Contraindications

Hypersensitivity, coma, shock, acute alcohol intoxication with weakening of vital functions, acute intoxication of drugs that have a depressing effect on the central nervous system (including narcotic analgesics and sleeping pills); drug addiction, alcoholism; myasthenia gravis; angle-closure glaucoma (acute attack or predisposition); temporal lobe epilepsy, severe COPD (progression of the degree of respiratory failure), acute respiratory failure, hypercapnia, severe depression (suicidal tendencies may be noted), swallowing disorders in children, pregnancy (especially the first trimester), lactation period. With caution. Liver and / or kidney failure, respiratory failure, cerebral and spinal ataxias, hyperkinesias, a history of drug dependence, a tendency to abuse psychoactive drugs, organic brain diseases, psychosis (paradoxical reactions are possible), hypoproteinemia, sleep apnea (established or suspected), elderly age.

Side effects

From the nervous system: at the beginning of treatment (especially in elderly patients) - drowsiness, fatigue, dizziness, decreased ability to concentrate, ataxia, uncertainty when walking, gait disturbance, lethargy, dullness of emotions, slowing down of mental and motor reactions; rarely - headache, euphoria, depression, tremor, depressed mood, catalepsy, anterograde amnesia, confusion, dystonic extrapyramidal reactions (uncontrolled body movements, including the eyes), weakness, myasthenia gravis, dysarthria; extremely rarely - paradoxical reactions (aggressive outbursts, fear, suicidal tendencies, muscle spasm, confusion, hallucinations, acute agitation, irritability, anxiety, insomnia).

On the part of the hematopoietic organs: leukopenia, neutropenia, agranulocytosis (chills, hyperthermia, sore throat, excessive fatigue or weakness), anemia, thrombocytopenia.

From the digestive system: dry mouth or salivation, heartburn, nausea, vomiting, loss of appetite, constipation or diarrhea; abnormal liver function, increased activity of "liver" transaminases and alkaline phosphatase, jaundice.

From the genitourinary system: urinary incontinence, urinary retention, impaired renal function, increased or decreased libido, dysmenorrhea.

Allergic reactions: skin rash, itching.

Effect on the fetus: teratogenicity (especially the first trimester), CNS depression, respiratory failure and suppression of the sucking reflex in newborns whose mothers used the drug.

Others: addiction, drug dependence; decrease in blood pressure; rarely - depression of the respiratory center, visual impairment (diplopia), bulimia, weight loss, tachycardia. With a sharp decrease in the dose or discontinuation of the intake, the "withdrawal" syndrome (irritability, headache, anxiety, excitement, agitation, fear, nervousness, sleep disturbances, dysphoria, spasm of the smooth muscles of the internal organs and skeletal muscles, depersonalization, increased sweating, depression, nausea, vomiting, tremor, perception disorders, including hyperacusis, hyperesthesia, paresthesia, photophobia, tachycardia, convulsions, hallucinations, rarely acute psychosis).

Application and dosage

inside. As a sleeping pill for 1/2 hour before bedtime: adults - 5-10 mg, elderly patients - 2.5-5 mg; children under 1 year - 1.25-2.5 mg at bedtime; from 1 to 6 years - 2.5-5 mg at bedtime; from 6 to 14 years - 5 mg at bedtime. The maximum single dose as a hypnotic for adults is 20 mg.

As an anxiolytic and antiepileptic drug: adults - 2-3 times a day, 5-10 mg. The highest daily dose is 30 mg.

The daily dose for infants is 2.5-7.5 mg, in early childhood - 5-10 mg, at school age - 7.5-15 mg in 2-3 doses or for children weighing up to 30 kg - 0.3-1 mg / kg / day in 3 doses; while most of the dose is taken in the evening before bedtime.

special instructions

In the process of treatment, patients are strictly prohibited from using ethanol.

Without special instructions should not be used for a long time.

With renal / liver failure and long-term treatment, monitoring of the picture of peripheral blood and "liver" enzymes is necessary.

The risk of developing drug dependence increases with the use of large doses, a significant duration of treatment, in patients who have previously abused ethanol or drugs. Nitrazepam has primary addictive potential. Even with its daily intake for several weeks, there is a danger of developing physical and mental dependence. This feeling develops not only when nitrazepam is abused, especially at high doses, but also when it is used in the usual therapeutic doses. Therefore, treatment continues to be carried out only for "vital" indications after carefully weighing the benefits of therapy with the risk of developing addiction to drugs and dependence on it.

In the case of drug dependence, abrupt withdrawal is accompanied by a "withdrawal" syndrome (headache, myalgia, anxiety, tension, confusion, irritability; in severe cases, derealization, depersonalization, hyperacusis, photophobia, paresthesia in the extremities; hallucinations and epileptic seizures). Cancellation of the drug should be carried out gradually.

If patients experience unusual reactions such as increased aggressiveness, acute states of arousal, fear, suicidal thoughts, hallucinations, increased muscle cramps, difficulty falling asleep, superficial sleep, treatment with nitrazepam should be discontinued.

During pregnancy, they are used only in exceptional cases and only for "vital" indications.

When administered in the first trimester, the risk of congenital malformations increases. Chronic use during pregnancy may lead to physical dependence with the development of "withdrawal" syndrome in the newborn.

Use immediately before or during labor may cause respiratory depression, reduced muscle tone, hypotension, hypothermia, and poor suckling (sluggish baby syndrome) in the newborn.

In young children, there is an increased production of mucus and sputum in the respiratory tract, so measures should be taken to ensure good airway patency (given the inhibitory effect of the drug).

During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions.

Interaction

Reduces the effectiveness of levodopa in patients with parkinsonism.

Mutual enhancement of action when combined with psychoactive drugs, Li + drugs, narcotic analgesics, general anesthetics, ethanol, muscle relaxants, antihistamine and sedative drugs, clonidine, barbiturates and anxiolytic drugs (tranquilizers).

The effect is enhanced and prolonged by cimetidine, oral estrogen-containing contraceptives (excretion delay and prolongation of T1 / 2).

Inhibitors of microsomal oxidation prolong T1 / 2, increase the risk of developing toxic effects of the drug.

Inducers of microsomal liver enzymes reduce the effectiveness of nitrazepam.

Narcotic analgesics increase euphoria, leading to an increase in drug dependence.

Antihypertensive drugs may increase the severity of lowering blood pressure.

Against the background of the simultaneous appointment of clozapine, it is possible to increase respiratory depression.

May increase zidovudine toxicity.

Valproic acid probably enhances the effect of nitrazepam in children with epilepsy.

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Do you use Nitrazepam as an analogue or vice versa?

Berlidorm 5 (Berlidorm 5), Berlidorm 10 (Berlidorm 10), Neozepam (Neozepam), Nitram (Nitram), Nitrosan (Nitrosan), Radedorm (Radedorm), Eunoctin (Eunoctin).

Composition and form of release

Nitrazepam. Tablets (5 mg, 10 mg).

pharmachologic effect

Nitrazepam is a hypnotic drug from the benzodiazepine group. It has a pronounced hypnotic effect, as well as an anxiolytic, sedative, anticonvulsant and central muscle relaxant effect.

The mechanism of action of nitrazepam is associated with an increase in the inhibitory effect of GABA in the CNS due to an increase in the sensitivity of GABA receptors to the mediator as a result of stimulation of benzodiazepine receptors. Increases the depth and duration of sleep. Sleep usually occurs 20-40 minutes after ingestion and lasts 6-8 hours. Moderately inhibits the REM sleep phase.

Indications

Various genesis, somnambulism, premedication before surgical operations, some forms of convulsive seizures (especially in children).

Application

For sleep disorders, 5-10 mg are prescribed 30 minutes before bedtime. In other cases, the daily dose varies from 2.5 mg to 25 mg, the frequency of use is 2-3 r / day; the largest dose should be taken at night. Children are prescribed at a dose of 0.6-1 mg / day.

Care should be taken to prescribe the drug in severe respiratory failure, ataxia, sleep apnea, abnormal liver function, pregnancy.

During treatment with the drug should not drink alcohol; should refrain from engaging in potentially hazardous activities that require increased attention and rapid mental and motor reactions.

Side effect

In the morning, you may feel tired, impaired concentration, slowing down mental and motor reactions. Rarely - muscle weakness, headaches, dry mouth, nausea, diarrhea, decreased blood pressure, respiratory depression, ataxia, confusion, increased appetite, decreased libido, amnesia, skin AR. In predisposed patients, suicidal thoughts may worsen, hallucinations may occur.

Contraindications

Drug or alcohol addiction; myasthenia gravis; angle-closure glaucoma; acute intoxication with drugs that have a depressing effect on the central nervous system, or alcohol. Hypersensitivity to benzodiazepines.

Interaction with other drugs

With the combined use of nitrazepam with other drugs that depress the central nervous system (barbiturates, some antidepressants, antipsychotics, tranquilizers, opioid analgesics, antihistamines and sedatives, clonidine), as well as with ethanol, their mutual inhibitory effect on the central nervous system may increase. Nitrazepam enhances the effect of muscle relaxants.