Short-term treatment of severe insomnia characterized by difficulty in falling asleep and frequent nocturnal awakenings, significantly worsening the patient's quality of life and exposing the patient to severe stress when sedation during the day is possible.
Composition:
1 tabl contains 5 mg of nitrazepam. The preparation contains lactose.
Action:
A benzodiazepine derivative with hypnotic, sedative, anticonvulsant and decreasing muscle tone. Nitrazepam is an agonist of the γ-aminobutyric acid receptor complex (GABA-A). It works indirectly, enhancing the affinity of GABA to GABA-A receptors. GABA stimulates the GABA-A receptor-associated chloride ionophore, enhancing the penetration of chlorine ions in the interior of neurons, which leads to hyperpolarization of the cell. This is one of the basic ways of inhibiting neuronal activity. The inhibition of pulse transmission in the temporal lobe is responsible for the amnestic and anticonvulsive effects in the spinal cord and the cerebellum for the myorelaxant effect, and in the reticular formation of the brain stem for the hypnotic effect. After oral administration, they are absorbed in about 95% (however, there are large differences in the absorption of the drug), reaching Cmaxafter 2-3 h. About 87% bound to plasma proteins. It passes into the cerebrospinal fluid, through the placental barrier (reaching in the blood of the fetus, a concentration similar or even higher than in the mother's blood) and into breast milk. It is metabolized in the liver. Metabolites are mainly excreted in the urine, 20% of the administered dose is excreted in the faeces. About 5% of the dose is excreted unchanged. T0,5 is 16-48 hours; It may increase in the case of liver failure.
Contraindications:
Hypersensitivity to nitrazepam, benzodiazepines or other components of the preparation. acute respiratory failure, respiratory depression. Sleep apnea syndrome. Severe hepatic failure. Myasthenia gravis. Do not use in patients with phobia or obsessions, with chronic psychosis. Do not use in children.
Precautions:
In the treatment of depression with accompanying insomnia or anxiety associated with depression with accompanying insomnia, do not use nitrazepam alone. Particularly cautiously used in patients with chronic bronchoconstricting conditions, with renal and / or hepatic failure, with respiratory failure, with personality disorders. The use of nitrazepam, especially at high doses and for a long time, may lead to mental and physical dependence, especially in patients with a history of alcohol or drug addiction or in patients with personality disorders - these patients should be regularly monitored and discontinued as appropriate. they are at risk of withdrawal syndrome after using therapeutic doses for a short time. Patients may also experience paradoxical reactions (especially in elderly patients) and ambulatory amnesia (to reduce the risk of follow-up obstruction, an uninterrupted 7-8-hour sleep should be provided after taking the medicine). Nitrazepam has a myorelaxive effect - there is a risk of the patient falling after getting out of bed, especially the elderly. Due to the lactose content, the preparation should not be used in patients with rare hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.
Pregnancy and lactation:
Avoid using the drug during pregnancy, especially in the first and third trimester (there is a risk of damage to the fetus). Regular administration of benzodiazepines to pregnant women can cause physical dependence and withdrawal symptoms in the newborn. Benzodiazepines used during the last trimester of pregnancy cause newborns to inhibit the function of o.u.n.n., limpness, difficulty in sucking, hypothermia, breathing disorders. The drug passes into breast milk - you should not breastfeed while taking nitrazepam.
Side effects:
Rarely: abnormal blood composition, inhibition of emotions, headache, postmortem disruption, diplopia, visual disturbances, skin rashes.In addition, there was an unknown frequency: confusion, changes in libido, exacerbation of pre-existing depression, drowsiness, dizziness, confusion, discomfort of movement, post-myocardial forgetfulness (detail, at higher doses), accompanying oblivion of a subsequent behavioral disorder, dizziness of origin vomiting, hypotension, gastrointestinal upset, jaundice, muscle weakness, urinary retention, fatigue. During the use of benzodiazepines, unusual psychological reactions were observed: paradoxical outbursts of aggression, agitation, confusion, anxiety, delusions, anger, nightmares, hallucinations, psychoses, behavioral disorders and depression with suicidal tendencies. Prolonged use of benzodiazepines can lead to mental and physical dependence. In the event of a sudden discontinuation of the drug, withdrawal symptoms may occur (depression, headache, insomnia irritability, nervous hyperactivity, anxiety, extreme anxiety, tension, convolution, mood changes, sweating, diarrhea). In more severe cases, there may be: loss of sense of reality, personality disorder, hypersensitivity to sound and / or light, touch, noise; numbness and tingling of the limbs, hallucinations, epileptic seizures, confusion, psychotic symptoms, seizures.
Dosage:
Orally. Use the lowest effective dose. Treatment should not last longer than 4 weeks Adults: 5 mg before bedtime, if necessary, increase the dose to 10 mg. Individuals> 65 years: initially 2.5 mg before bedtime, if necessary, increase the dose to 5 mg. In patients with impaired liver or kidney function, do not exceed half of the dose used in patients with normal function of these organs.
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