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Manufacturers: Organics, Glaxo Wellcome Poznan (Poland), Moscow Endocrine Plant, Altai - Federal Research and Production Center
Active ingredients
- Nitrazepam
Disease class
- Dementia due to Alzheimer's disease (G30.-)
- Personality and behavioral disorders caused by disease, damage or dysfunction of the brain
- Schizophrenia
- Manic episode
- Mixed anxiety and depressive disorder
- Neurasthenia
- Sleep disorders of non-organic etiology
- Sleepwalking [somnambulism]
- Other types of generalized epilepsy and epileptic syndromes
- Epilepsy, unspecified
- Disturbances in falling asleep and maintaining sleep [insomnia]
- Encephalopathy, unspecified
- Cramp and spasm
- Surgical practice
Clinical and pharmacological group
- Not indicated. See instructions
Pharmacological action
- Anxiolytic
- Sedative
- Hypnotic
- Anticonvulsant
Pharmacological group
- Sleeping pills
Pharmacological properties of the drug Nitrazepam
A benzodiazepine derivative with a pronounced hypnotic effect. It also has anxiolytic, central muscle relaxant and anticonvulsant effects. Increases the depth and duration of sleep. Sleep usually occurs 20–40 minutes after taking nitrazepam and lasts 6–8 hours. Bioavailability when taken orally is about 78%, more than 80% of nitrazepam is bound to blood plasma proteins. The volume of distribution is 1.9 l/kg. The half-life is about 26 hours and is excreted mainly in the form of metabolites.
Publications in the media
(Mttiazepamum) INN
Synonyms. Mogadon, Radedorm. Eunoctine. Composition and release form. Nitrazepam tablets 0.005 g.
Indications. Sleep disorders, neuroses, psychopathy with a predominance of anxiety; premedication; some organic lesions of the central nervous system; relief of withdrawal symptoms; epilepsy (complex therapy); postoperative period. Pharmachologic effect. Nitrazepam is a benzodiazepine drug and has hypnotic, anxiolytic, sedative, anticonvulsant, and central muscle relaxant activity. The hypnotic and anxiolytic effect of nitrazepam is associated with its effect on the limbic system (hippocampus) and the mechanism of its action is associated with the interaction of the drug with special benzodiazepine receptors, which are part of the macromolecular barbiturate-benzodiazepine-GABA receptor complex. Sleep usually occurs 45 minutes after taking the drug and lasts 6-8 hours. Nitrazepam, unlike phenobarbital, changes the structure of sleep to a lesser extent, has a greater breadth of therapeutic action, it has less pronounced induction of microsomal liver enzymes and a lower risk of developing drug dependence. Pharmacokinetics. Nitrazepam is well absorbed from the gastrointestinal tract into the blood within 1-2 hours. Metabolized in the liver to inactive metabolites by cleavage of the nitro group. A steady-state concentration of the drug in plasma is established within 2-3 days. The drug accumulates in the body. When you stop taking nitrazepam, it is quickly eliminated from the body. Side effects. Drowsiness, feeling of lethargy, ataxia, headache, stunnedness, dizziness, skin allergic reactions. Contraindications. Severe liver and kidney dysfunction, severe depression, porphyria, severe obstructive pulmonary disease, first trimester of pregnancy, hypersensitivity to benzodiazepines. Adverse reactions when interacting with other drugs. When prescribing nitrazepam simultaneously with analgesics and other neurotropic drugs, the possibility of enhancing their effect should be taken into account, i.e. simultaneous use may enhance the CNS depressant effect of these drugs or benzodiazepines. Carbamazepine, being a stimulator of microsomal liver enzymes, accelerates the metabolism of nitrazepam, as a result of which its concentration in the blood decreases and its T1/2 decreases. Cimetidine and OK inhibit the metabolism of nitrazepam in the liver, leading to an increase in the concentration of nitrazepam in the blood serum, a delay in elimination and an increase in T1/2 of the drug. Concomitant use of nitrazepam with clozapine may lead to respiratory depression. Information for the patient. Nitrazepam is taken orally half an hour before bedtime, usually in doses of 0.005-0.01 g. Due to the inhibitory effect of nitrazepam on reaction speed and attention, it should not be prescribed to transport drivers and persons whose activities require a quick mental and physical reaction. Elderly and senile people age are more sensitive to the effects of nitrazepam. During treatment with nitrazepam, alcoholic beverages are not allowed.
Side effects of the drug Nitrazepam
Possible daytime fatigue, drowsiness, lethargy, dizziness, lethargy, ataxia, decreased reaction speed and ability to concentrate, decreased libido, anterograde amnesia, morning drowsiness after taking the drug, muscle weakness, headache, confusion, itching, skin rash, bulimia ; with long-term treatment and/or use of nitrazepam in high doses, temporary articulation disorders, gait disturbances, diplopia, nystagmus, hallucinations, paradoxical reactions (aggression, psychomotor agitation, fear, suicidal tendencies, convulsive reactions, sleep disturbances) are possible.
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Special instructions for the use of the drug Nitrazepam
Use with extreme caution in severe liver and kidney damage, cholestatic jaundice, sleep apnea syndrome, circulatory and respiratory failure, spinal and cerebral ataxia, organic brain damage, severe forms of myasthenia gravis, in weakened patients and the elderly. Possible depression of external respiratory function in patients with obstructive diseases of the respiratory system. Considering the inhibitory effect of nitrazepam and the presence of bronchial hypersecretion in infants and young children, when using nitrazepam, the airway should be ensured and, if necessary, treatment should be interrupted. During pregnancy and breastfeeding, nitrazepam is prescribed only according to strict indications, taking into account the possible risk to the fetus or child. When using nitrazepam in the third trimester of pregnancy, a newborn may experience withdrawal symptoms or floppy baby syndrome. During treatment with nitrazepam, you should refrain from driving vehicles and working with potentially dangerous mechanisms, which require increased attention and reaction speed. If nitrazepam is suddenly discontinued, withdrawal syndrome may develop, which manifests itself as insomnia in a more severe form than before the start of treatment. Abrupt withdrawal of nitrazepam in persons with drug dependence can cause symptoms of withdrawal syndrome - feelings of anxiety, tension, fear, psychomotor agitation, sweating, tremor, convulsions; in rare cases, acute psychosis may develop.
Nitrazepam oral tablets
Instructions for medical use of the drug
Description of pharmacological action
Interacts with specific benzodiazepine receptors of the GABA-benzodiazepine-chlorionophore complex, increases the sensitivity of GABA receptors to the mediator (GABA), which causes an increase in the frequency of opening channels in the cytoplasmic membrane of neurons for incoming currents of chlorine ions.
Indications for use
Sleep disorders of various origins, somnambulism, neurotic (neurosis-like) disorders, psychopathy with a predominance of anxiety and restlessness; premedication before surgical interventions and the postoperative period; as part of combination therapy in the treatment of schizophrenia, manic-depressive psychosis (manic and hypomanic phases), with certain organic lesions of the central nervous system (trauma, cerebrovascular disorders), for the relief of alcohol withdrawal syndrome; epilepsy, incl. epileptic encephalopathy (in combination with anticonvulsants), lightning-fast nodding Salaam convulsions (as the equivalent of an epileptic seizure) in infants and small children.
Release form
tablets 5 mg; blister 20, box (box) 1.2; tablets 5 mg; jar (jar) of dark glass, 20 and 50 pcs., cardboard pack 1; tablets 5 mg; packaging contour charunkova 10, cardboard pack 1,2,5; tablets 5 mg; polymer jar (jar) 20 and 50 pcs., cardboard pack 1;
Pharmacodynamics
The interaction with specific benzodiazepine receptors of the GABA-benzodiazepine-chlorine ionophore complex promotes the sensitivity of GABA receptors to the neurotransmitter (GABA), which results in an increase in the frequency of excretion in the cytoplasmic The membranes of neuron channels for the input streams of chlorine ions. As a result, the galmic influx of GABA into the central nervous system is enhanced. It changes the alertness of neurons in the subcortical areas of the brain (limbic system, thalamus, hypothalamus), cerebellum, cortex, etc. viddilah of the central nervous system. Suppresses mental and polysynaptic spinal reflexes. The variety of emotional, vegetative and motor stimuli changes, which disrupts the process of sleepiness and shortens the hour necessary for sleepiness. Changes the number of times you wake up before you go to bed, increasing the depth and difficulty of sleep. The drug effect develops 20-45 minutes after administration and lasts 6-8 years.
Pharmacokinetics
After taking it, the liquid will soak up quickly, and the bioavailability will become close to 80%. C Max is available in 2-3 years. Plasma protein binding - 87%. The correct concentration in the blood must be achieved within 2-3 days after taking the cob. Obsyag rospodil - 1.3-2.6 l/kg. T1/2 - 16-48 years. It is good to pass through histohematic barriers, including the hematoencephalic barrier, placental barrier, and breast milk. Amenable to biotransformation in the liver by updating the nitro group and further acetylation with the addition of inactive acetyl-like compounds. It is important to be excreted in the form of metabolites, about 5% - in the unchanged form. Seen after the celebration of the Swede. Accumulation is minimal when repeated doses are taken.
Use during pregnancy
Contraindicated during pregnancy (especially in the first trimester). For an hour of rejoicing, follow the instructions for breastfeeding.
Contraindications for use
Hypersensitivity (including to other benzodiazepines, scronal epilepsy, severe myasthenia, gastric insufficiency, severely impaired liver function, glaucoma; drug, narcotic or alcohol addiction ( due to the relief of alcohol withdrawal syndrome); withdrawal from tranquilizers, neuroleptics, consumables, ethyl alcohol and other drugs that depress the central nervous system, vaginity (especially in the first trimester), breastfeeding.
Side effects
On the side of the nervous system and organs one feels: headache, confusion, anterograde amnesia, confusion of fluid, bloatiness, muscle weakness, increased mental and mental reactions, impaired concentration and respect. , as soon as possible (on the next day after taking it), daytime drowsiness, disorientation (in summer patients), dysarthria, ataxia, impaired vision (diplopia, etc.), paradoxical reactions (increased aggression, anxiety, fear, hallucinations, increased suicidal thoughts in frail patients entiv, sleep disturbance). On the side of the organs of the intestinal tract: boredom, dry mouth, decreased appetite, dyspepsia, intestinal paresis (especially in children). Others: tachycardia, hyperhidrosis, dysmenorrhea, decreased libido, allergic reactions (wheezing, itching). Possible development of the following syndrome, medicinal confinement (physical and mental), urinary syndrome, rebound syndrome (division “Confinement”).
Directions for use and doses
In the middle. As a guideline: a year before bedtime, as adults - 5-10 mg; for sick people - 2.5-5 mg; Children up to 1st birthday - 1.25-2.5 mg before bedtime, from 1st birthday to 6th birthday - 2.5-5 mg before bedtime, from 6th to 14th birthday - 5 mg before bedtime. The maximum single dose in a drink for adults is 20 mg. As an anxiolytic and anti-epileptic drug: for adults - 5-10 mg 2-3 times per dose. Vishcha dobova dose is 30 mg.
Overdose
Symptoms: depression of the central nervous system at a high level of severity - hypotension, weakness, severe drowsiness, deep sleep, confusion, decreased response to pain stimuli; in most important forms - ataxia, areflexia, hypotension, depressed respiratory and cardiac function, coma. Treatment: induction of vomiting or rinsing of the mucus, administration of active vugill, monitoring of vital functions, symptomatic therapy, intravenous administration, if necessary - SHVL. As a specific antidote, the benzodiazepine receptor antagonist flumazenil is used (in the hospital).
Interactions with other drugs
It enhances (mutually) the effect of analgesics, tranquilizers, tricyclic antidepressants, narcotics, narcotics, anti-convulsants, etc. neurotropic properties, incl. ethyl alcohol, muscle relaxants. Cimetidine and estrogen-containing oral contraceptives interfere with the metabolism and T1/2 of nitrazepam; with trival sleep ingestion, the concentration of nitrazepam in the blood may increase.
Precautions for use
Mothers are aware that nitrazepam may interfere with the relaxation of parasitic ulcers, worsening the loss of mobility in children. Care should be taken to prevent elderly people from experiencing a high risk of side effects, incl. paradoxical reactions. In case of severe stagnation, there may be a guilty reaction (the effect may be a slight weakness), as well as medicinal delay. The scraping of the trace is carried out step by step, because with a sharp dose of alcohol there is a possibility of development of headache syndrome (headache and muscle pain, anxiety, fear, stress, sleep disturbance, nightmares, etc.) and rebound syndrome (intensification of outgoing symptoms c). At the hour of celebration, follow with the intake of alcoholic beverages. The work of transport drivers and people whose profession is associated with a high concentration of respect should not be stagnated during the hour.
Storage conditions
In a protected, bright place, at a temperature not exceeding 30 ° C.
Best before date
48 months
ATX classification:
A Digestive tract and metabolism
A05 Drugs for the treatment of diseases of the liver and biliary tract
A05A Preparations for the treatment of diseases of the biliary tract
A05AX Other drugs for the treatment of diseases of the biliary tract
