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Manufacturers: AWD.pharma GmbH & Co.KG
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
- 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
- Hypnotic
Pharmacological group
- Sleeping pills
Oral tablets Radedorm 5 (Radedorm 5)
Instructions for medical use of the drug
Description of pharmacological action
Interacts with benzodiazepine receptors and activates GABAergic transmission, causing inhibition of central nervous system function.
Indications for use
Sleep disturbances of various origins, lightning-fast nodding Salaam convulsions (as the equivalent of an epileptic seizure) in infants and young children (for example, with mental retardation).
Release form
tablets 5 mg; blister 10 box (box) 2;
Pharmacodynamics
A sleeping pill from the group of benzodiazepines. It has a pronounced hypnotic effect, as well as anxiolytic, sedative, anticonvulsant and central muscle relaxant effects. The mechanism of action is associated with an increase in the inhibitory effect of GABA in the central nervous system due to increased 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 administration and lasts 6-8 hours. Moderately inhibits the REM sleep phase.
Pharmacokinetics
Plasma protein binding is more than 80%. Vd - 1.9 l/kg. T1/2 averages 26 hours. It is excreted mainly in the form of metabolites.
Use during pregnancy
Contraindicated during pregnancy. Breastfeeding should be stopped during treatment.
Contraindications for use
Hypersensitivity (including to other benzodiazepines), drug or drug addiction, chronic alcoholism, acute poisoning with alcohol, sleeping pills, painkillers and psychotropic drugs (antidepressants, antipsychotics, lithium drugs), severe myasthenia gravis, acute attack of glaucoma, pregnancy, lactation.
Side effects
From the nervous system and sensory organs: daytime fatigue, loss of strength, weakness, drowsiness, dizziness, stupor, disturbance of gait and movements, slower reactions to external stimuli, decreased concentration and weakened memory, articulation disorders, double vision, nystagmus, rarely - muscle weakness, headache, confusion, dry mouth. From the gastrointestinal tract: nausea, vomiting, constipation. From the cardiovascular system and blood (hematopoiesis, hemostasis): slight decrease in blood pressure. Allergic reactions: skin itching and skin rashes. Other: development of paradoxical reactions (increased aggressiveness, feelings of fear, spasms of various muscle groups, sleep disorders), extremely rarely - bulimia.
Directions for use and doses
Inside. As a sleeping pill 30 minutes before bedtime: adults - 2.5-5 mg (1/2-1 tablet), maximum daily dose - 10 mg (2 tablets); for elderly patients, as well as debilitated patients - 2.5 mg (1/2 tablet), maximum daily dose - 5 mg (1 tablet). For the treatment of West syndrome, the daily dose for children 1–2 years old and infants is 2.5–5 mg (1/2–1 tablet). The daily dose is taken once; when prescribed to infants, the appropriate amount of the drug is crushed and dissolved (suspended) in a volume of water convenient for administration.
Interactions with other drugs
Mutual enhancement of effects is possible when combined with psychotropic, hypnotics, analgesics, muscle relaxants, ethanol and ethanol-containing drugs. Cimetidine, valproic acid and hormonal contraceptives enhance the effect.
Precautions for use
You should not suddenly stop taking the drug, because the development of withdrawal syndrome is possible. Particular care should be taken in case of impaired liver and/or kidney function, severe forms of respiratory and chronic heart failure, sleep apnea syndrome, organic changes in the brain, spinal or cerebral ataxia, as well as in elderly and debilitated patients. Should not be used during work by vehicle drivers and people whose profession involves increased concentration of attention.
Storage conditions
At temperatures below 30 °C.
Best before date
60 months
ATX classification:
N Nervous system
N05 Psycholeptics
N05C Hypnotics and sedatives
N05CD Benzodiazepine derivatives
N05CD02 Nitrazepam
Reladorm
The decision to treat insomnia should be preceded by a thorough analysis of existing disorders; it is necessary to exclude other possible causes of insomnia (somatogenic, psychogenic, bad habits).
The drug Reladorm must be used under strict medical supervision.
The use of benzodiazepines or drugs with similar effects, as well as barbiturates, can lead to the development of mental and physical drug dependence. The risk of developing drug dependence increases with the dose and duration of treatment and increases in patients with a history of dependence on other drugs, as well as in patients with alcohol dependence. The combination of a benzodiazepine and cyclobarbital increases the potential for the development of drug dependence and toxicity of the drug Reladorm.
If drug dependence develops, abrupt cessation of use of the drug Reladorm may lead to withdrawal syndrome. Characteristic manifestations of withdrawal syndrome are: headache, muscle pain, psychomotor agitation and emotional stress, motor restlessness, confusion and disorientation, increased irritability, insomnia. In severe cases, the following may appear: loss of a sense of the reality of the environment (derealization), personality disorders (depersonalization), increased sensitivity to touch (tactile hyperesthesia), increased sensitivity to auditory and visual stimuli (acoustic and light hyperesthesia), a feeling of “crawling” and numbness limbs, hallucinations or seizures.
Reladorm may cause antegrade amnesia. This condition is most often observed several hours after taking the drug, especially in a large dose. It is recommended to use the drug Reladorm an hour before bedtime and ensure conditions for continuous 7-8 hours of sleep.
The drug Reladorm can cause paradoxical reactions, such as motor restlessness, psychomotor agitation, increased irritability, aggressiveness, nightmares, hallucinations, psychosis, somnambulism, personality disorders, severe insomnia and other behavioral side effects. These reactions are much more common in elderly patients or in patients with alcohol dependence.
If such symptoms occur, you must immediately stop treatment with Reladorm.
The drug Reladorm should be used with great caution in patients with mild or moderate renal and hepatic insufficiency, as well as in patients with chronic respiratory failure; such patients should receive lower doses of the drug.
It is not recommended to use the drug Reladorm in patients with psychosis.
Reladorm should be used with great caution in patients with symptoms of endogenous depression. These patients may experience suicidal thoughts. Due to the possibility of intentional overdose, these patients should be prescribed Reladorm in smaller doses, that is, ½ tablet.
The drug should be used with caution in patients prone to suicidal behavior, because it may cause the condition to worsen.
The drug Reladorm should be used with great caution in patients with a history of alcohol, drug or drug dependence. These patients should be under strict supervision while taking the drug Reladorm, because are at risk of developing addiction and mental dependence.
Reladorm should be used with caution in patients with non-acute porphyria. The use of the drug may increase the symptoms of this disease.
During long-term therapy with Reladorm, periodic studies of the morphological composition of the peripheral liver and functional liver tests are indicated.
During treatment with Reladorm and for 3 days after its completion, you should not drink any alcoholic beverages.
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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 Radedorm 5, 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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Radedorm 5
From the nervous system: at the beginning of treatment (especially in elderly patients) - drowsiness, feeling of fatigue, dizziness, decreased ability to concentrate, ataxia, uncertainty when walking, gait disturbance, lethargy, dullness of emotions, slowing 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 spasms, confusion, 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 (especially the first trimester), 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. 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, perceptual disorders, including hyperacusia, hyperesthesia, paresthesia, photophobia, tachycardia, convulsions, hallucinations, rarely - acute psychosis).
Overdose. Symptoms: drowsiness, confusion, paradoxical arousal, decreased reflexes, dazedness, 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.
