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1 tablet – 5 mg of nitrazepam.
In addition: MKTs, magnesium stearate, sodium starch glycollate, lactose anhydrous.
Radedormum is issued in the form of tablets No. 20 in packaging.
Anticonvulsant, somnolent, myorelaxation, sedative, anksiolitichesky.
Pharmacodynamics and pharmacokinetics
The medicine Radedormum 5 is a hypnagogue and belongs to group of benzodiazepines. Efficiency of drug is shown thanks to the central anticonvulsant, myorelaxation and anksiolitichesky effect of its active component – nitrazepam.
Nitrazepam, contacting a characteristic benzodiazepine complex of receptors GAMK-benzodiazepin-hlorionofornogo of a row, provokes its start, increases sensitivity to media even system, initiates activation of an ion channel and increases the braking impact of GAMK on TsNS. Effects of nitrazepam lead to lowering of cellular excitability in a cerebellum, bark and subcrustal regions of a brain (a thalamus, limbic system, a hypothalamus), and also in other departments of TsNS.
Somnolent efficiency of Radedormum is shown thanks to suppression of a cellular complex of a reticular formation in a brain trunk that leads to reduction of influence of the emotional, motor and vegetative irritating factors breaking backfilling processes. Effect of nitrazepam directionally on increase in duration and depth of a dream, and also on normal physiological regulation of mechanisms of backfilling and awakening.
The beginning of action of Radedormum is observed in 30 minutes after oral administration of a tablet and proceeds for 6-8 hours.
Nitrazepam absorption, at its internal reception, takes place quickly enough and fully. When using a dose of 5 mg plasma Cmax is observed in a period from 38 to 120 minutes and 40-68 ng/ml equal. Parallel meal brakes and reduces plasma Cmax to 30%. Communication with plasma proteins is carried out for 85-88%, bioavailability equals 54-98%.
Nitrazepam possesses a variable phase of distribution, depending on specific features, the component is from 1,7 to 3,5 hours old.
About 25-30 hours are characterized by slow hepatic elimination, with T1/2. In an invariable form kidneys remove only 1% of drug.
At regular reception, because of slow removal, there is cumulation of nitrazepam in an organism. Drug passes placental and hematoencephalic barriers and it is found in milk of the nursing mother.
Indications to use
Use of Radedormum is shown at frustration of a dream of various nature at adult patients.
- drug, medicamentous or alcohol addiction (including, observed in the anamnesis);
- hypersensitivity to nitrazepam, other benzodiazepines or the HP additional ingredients;
- heavy manifestations of chronic insufficiency of breath;
- night apnoea;
- children's age;
- cerebellar and spinal ataxy;
- insufficiency of hepatic function of difficult character;
- feeding by a breast;
- acute intoxication alcohol, anesthetics, in somnolent or psychotropic HP (lithium drugs, neuroleptics, antidepressants);
- myasthenia in a severe form;
- narrow angle glaucoma in the acute period.
Often (depending on the accepted dose):
- day fatigue;
- disturbances of movements and gait;
- disturbances of psychomotor reactions;
- concentration disturbances.
At reception of Radedormum in the evening, in the morning observed the expressed residual fatigue and the disturbances of concentration ability able to lead to inadequate behavior of the patient at the time of traffic (in particular at advanced age).
Nitrazepam is capable to reduce a muscle tone that can lead to loss of balance and demands care of use.
- muscular weakness;
- confusion of consciousness;
- itch/rash on integuments;
- dryness in an oral cavity;
- lowering of the ABP (insignificant).
- appetite strengthening.
- decrease in sexual desire at men;
- frustration of a menstrual cycle at women;
- oppression of respiratory function (most often at a stenosis of ways of breath and damages of a brain).
At the sharp termination of long daily reception of Radedormum, for 2-5 days dreadful dreams or other sleep disorders, aggravations of sensation of fear, overexcitement, emotional intensity, feelings of concern (withdrawal) can be observed. Clinical manifestations of these states can be followed by perspiration, a shiver, and also to get a form of the mental and physical reactions capable to threaten the patient's life (symptomatic psychoses, convulsive attacks).
In case of development in patients of the hallucinations and reactions which are followed by aggression, overexcitement, sensation of fear, suicide bents, muscular spasms, heavy backfilling or small duration of a dream therapy by Radedormum needs to be stopped.
Radedormum, application instruction
Dosages of Radedormum are selected strictly in an individual order, according to the general condition of the patient and weight of observed symptoms, by the principle of purpose of the smallest effective doses throughout the shortest period of their reception.
As a rule, at frustration of a dream appoint to adult patients 2,5-5 mg of drug at 24 o'clock. Radedormum should be accepted in the evening, in 30 minutes prior to an expected dream. As much as possible per day it is possible to accept 10 mg of nitrazepam.
At damages of a brain, disturbances of cardiovascular, respiratory, hepatic/renal functions, and also in advanced age, daily dosages reduce twice (it is recommended – 2,5 mg, as much as possible – 5 mg).
Pill of Radedormum is taken whole, washing down 100-200 ml of water. It is not recommended to carry out evening reception of tablets on a full stomach as it can slow down the beginning of their action and aggravate the possible morning negative phenomena.
In case of the sudden termination of reception of Radedor, the previous treatment by which it was carried out for more than 7 days is possible forming of a withdrawal in this connection refusal of therapy has to take place gradually.
It is better to limit a course of treatment 4 weeks, considering the step-by-step period of cancellation of therapy. Further reception of Radedormum is possible only after a careful repeated assessment of a clinical condition of the patient.
Overdose manifestations by nitrazepam do not pose threat for the patient's life, except for cases of its combined use with the HP suppressing TsNS (including alcohol).
The observed symptomatology of intoxication dozozavisimy is also reduced to dysfunctions of TsNS of varying severity which are shown drowsiness, a confusion/loss of consciousness, a lethargy, dystonia, visual disturbances, an ataxy, respiratory depression, suppression of cordial activity and, perhaps, a coma.
Recommend carrying out medical actions depending on observed symptoms (a gastric lavage, support of respiratory and/or cardiovascular functionality and so forth). Because of the considerable volume of distribution of nitrazepam the hemodialysis is not effective. For decrease in the sedative phenomena of the central character appoint Flumazenil.
Parallel reception of Radedormum with the other HP influencing TsNS (psychotropic, anesthetics, hypnotic drugs and so forth) can cause mutual strengthening of their effects.
Nitrazepam can increase pharmacological action of muscle relaxants.
The combined reception with Cimetidinum can lead to lengthening and strengthening of sedations of Radedormum which are generally expressed by disturbances of consciousness and fatigue.
Combined use with oral hormonal contraceptives slows down nitrazepam removal.
Because of long reception by some patients of other HP to foresee quantity and nature of possible interactions quite hard in this connection the beginning of therapy should be spent by Radedormum with care.
Terms of sale
Radedormum goes on sale as HP of the prescription list, except Internet drugstores where it is possible to buy Radedormum without recipe.
Tablets need to be kept in the dark place where temperature does not exceed 25 °C.
Period of validity
From the moment of production – 5 years.
It is necessary to remember that not all frustration of a dream demand purpose of medicamentous therapy. Often symptoms of such states are a consequence mental or somatopathies at which it is possible to apply other medical measures or to be limited to therapy of a basic disease.
Extra care of purpose of treatment using Radedormum is demanded by the painful states connected with lacks of coordination, a night apnoea and also heavy pathologies of a liver.
The weakened, elderly people, and also patients with pathologies of a brain of an organic origin, sick with insufficiency of respiratory and cardiovascular system, disturbances of hepatic/renal function possess stronger response to effect of nitrazepam. When diagnosing similar states treatment by Radedormum is carried out in reduced doses and with extra care.
Use of Radedormum throughout long time without instructions of the doctor is not recommended.
In case of emergence at patients of the unnatural reactions consisting in sensation of fear, the increased aggression, the expressed excitement, hallucinations, self-destructive moods, myotonia and also at heavy process of backfilling and an uneasy dream, therapy by nitrazepam should be stopped.
Reception of Radedormum can result in medicinal dependence. In practice of purposes of nitrazepam, at its daily use, in particular in the raised dosages for several weeks, observed signs of forming of mental and physical dependence. In this regard purpose of Radedormum is carried out only according to vital indications, at a careful assessment advantage/risk. In case of medicinal dependence, the termination of therapy leads to the withdrawal which is followed by headaches, uneasiness, a mialgiya, mental tension, irritability, confusion of consciousness. In hard cases develop: hyperacusia, depersonalization, photophobia, hallucinations, paresthesias of extremities, epileptic seizures. Proceeding from it, treatment cancellation by Radedormum needs to be carried out step by step.
The risk of forming of medicinal dependence increases at reception of the raised dosages of nitrazepam, long therapy, abuse of alcoholic beverages or narcotic drugs.
Radedormum is prohibited to appointment at children's age.
Section: For a nervous system
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