Mogadon ( Nitrazepam )

Active substances: Nitrazepam

Auxiliary substances: Milk sugar (lactose), potato starch, low molecular weight polyvinylpyrrolidone (povidone), talc, magnesium stearate, primogen (sodium carboxymethyl starch) – sufficient amount to obtain a tablet weighing 100 mg.

Description: Tablets of white color with a yellowish-greenish tinge, spherical or plane-cylindrical shape with a bevel.

Pharmacotherapeutic group: hypnotics

Pharmacological properties of Mogadon ( Nitrazepam )

The drug belongs to the list of potent agents according to the protocol of the meeting of the DAC.

The hypnotics from the group of benzodiazepines exert a depressing effect on the nervous system (CNS), which is realized mainly in the thalamus, hypothalamus and limbic system. Enhances the inhibitory effect of gamma-aminobutyric acid (GABA), which is one of the main mediators of pre- and postsynaptic inhibition of impulse transmission in the central nervous system.

The drug also has anxiolytic, sedative, muscle relaxant, and anti-vascular effects. Sleeping effect occurs 20-40 minutes after taking the drug and lasts 6-8 hours. Under the influence of the drug, the depth and duration of sleep increases. Sleep and awakening proceed physiologically.

The drug passes well through the blood-brain barrier, the placenta, penetrates into breast milk, which must be taken into account when prescribing the drug to pregnant and lactating women.

Pharmacokinetics

Absorption from the gastrointestinal tract is fast and complete. Bioavailability – from 54% to 98% (depending on the dosage form). When taken concomitantly with food, the absorption slows down and the maximum plasma concentration decreases by approximately 30%. At a single oral intake of 10 mg of nitrazepam, the average value of the maximum concentration is 0. 08-0.1 μg / ml and is reached after 1-4 hours. The connection with plasma proteins is about 85-90%. The phase of distribution of the active substance in the body varies very much and ranges from 1. 7 to 3.5 hours. The volume of distribution increases with the age of patients and is 1. 3-2. 6 l / kg. Well penetrates through the histohematological barriers, including the BBB and the placental barrier, is found in the mother’s milk.

Metabolized in the liver by reducing the nitro group and subsequent acetylation with the formation of inactive acetyl derivatives. The half-life is 16-48 hours (depending on the age and body weight of patients) from the cerebrospinal fluid – 68 hours. The main metabolites are 7-amino-nitrazepam, 7-acetaminomethyl-nitrazepam, 2-amino-5-nitrobenzophenone and hydroxy-2- amino-5-nitrobenzophenone, are excreted by the kidneys (65-71%) and with caloric masses (14-20%). About 1-5% is excreted unchanged by the kidneys.

Accumulation with a reappointment is minimal (refers to benzodiazepines with a short or medium half-life), withdrawal after cessation of treatment is rapid.

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Indications for use

sleep disturbance of various genesis (difficulty falling asleep, frequent nocturnal and / or early morning awakenings);

some forms of convulsive seizures (especially in children), including Vest syndrome.

Contraindications

increased sensitivity to benzodiazepines;

coma, shock;

closed angle glaucoma (acute attack or predisposition);

acute alcohol intoxication with impaired vital functions;

acute intoxication with drugs that have an inhibitory effect on the central nervous system;

addiction;

severe depression (suicidal tendencies may occur);

myasthenia gravis;

drug or alcohol dependence;

pregnancy, breast-feeding;

acute respiratory failure;

hypercapnia;

impaired swallowing in children;

temporal epilepsy;

severe chronic obstructive pulmonary disease (risk of progression of the degree of respiratory failure)

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Dosing and Administration

Inside. As a sleeping pill for 30 minutes before bedtime:

– adults 2.5-5 mg nitrazepam, the maximum daily dose – 10 mg;

– elderly patients, as well as the weakened patient – 2.5 mg, the maximum daily dose – 5 mg.

For treatment of the Vest syndrome, the daily dose for children 1-2 years and infants is 2. 5-5 mg. The daily dose is taken once, when administered to infants, the corresponding amount of the preparation is ground and dissolved (suspended) in a convenient volume for receiving water.

Side effect

From the nervous system: at the beginning of treatment (especially in elderly patients) – drowsiness, fatigue, dizziness, decreased concentration, ataxia, lethargy, dullness of emotions, slowing of mental and motor reactions; rarely – head pain, ecstasy, sadness, tremble, catalepsy, anterograde amnesia, confusion, dystonic extrapyramidal reactions (uncontrolled body movements, including the eyes), muscle weakness, dysarthria, blurred speech; extremely rarely, paradoxical reactions (aggressive outbreaks, fear, suicidal tendencies, muscle spasm, hallucinations, psychomotor agitation, increased irritability, anxiety, insomnia).

From the hematopoiesis: leukopenia, neutropenia, agranulocytosis (chills, hyperthermia, sore throat, unusual fatigue or weakness), anemia, thrombocytopenia.  Allergic reactions: skin rash, itching. Influence on the fetus: Oppression of the central nervous system, respiratory failure and suppression of the sucking reflex in newborns whose mothers used the drug during pregnancy.

Overdose

Symptoms: drowsiness, oppression of consciousness of varying severity (up to coma), paradoxical stimulation, decreased reflexes, reduced reaction to painful stimulation, deep sleep, dysarthria, ataxia, visual impairment (nystagmus), tremor, bradycardia, dyspnea or shortness of breath, expressed weakness, lowering of arterial pressure, collapse, depression of cardiac and respiratory activity. Treatment: gastric lavage, forced diuresis, activated charcoal. Symptomatic therapy (maintenance of breathing and blood pressure). Flumazenil is used as a specific antagonist (in hospital settings). Hemodialysis is ineffective.

Interaction

Reduces the effectiveness of levodopa in patients with Parkinsonism.

Mutual reinforcement of action when combined with psychotropic drugs, lithium preparations, narcotic analgesics, general anesthetics, alcohol, muscle relaxants, antihistamine and sedative drugs, clonidine, barbiturates and anxiolytics (tranquilizers).

The effect is enhanced and prolonged by cimetidine, oral estrogen-containing contraceptives (delay in excretion and lengthening of the half-life period).

Inhibitors of microsomal oxidation prolong the half-life, increase the risk of development of toxic effects of the drug.

Inductors of microsomal liver enzymes reduce the effectiveness of nitrazepam.

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

Hypotensive drugs can increase the severity of lowering blood pressure.

Against the background of simultaneous administration of clozapine, an increase in respiratory depression is possible.

May increase the toxicity of zidovudine.

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

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special instructions

It is necessary to observe special care when prescribing Mogadon nitrazepam in severe depression, since the drug can be used to implement suicidal intentions.

During the treatment period it is necessary to refrain from driving motor vehicles and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

In the process of treatment, patients are strictly prohibited from drinking alcohol.

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

If, prior to initiation of treatment with nitrazepam, the patient has been treated for a long time with other medicines, the treatment begins with caution.

The risk of forming drug dependence increases with the use of large doses, a considerable duration of treatment, in patients who previously abused alcohol or drugs.

Nitrazepam Mogadon has a primary potential that causes dependence.

Even with daily intake of it for several weeks, there is a danger of developing physical and mental dependence. This effect develops not only with the abuse of nitrazepam, especially high doses, but also when applied at usual therapeutic doses. Therefore, the treatment is continued only for life reasons after careful weighing of the benefits of therapy with the risk of developing addiction and dependence on the drug.

Cancellation of the drug should be carried out gradually to avoid the syndrome of “withdrawal”.

When patients develop such unusual reactions as aggressiveness, psychomotor agitation, fear, suicidal thoughts, hallucinations, increased muscle cramps, difficulty falling asleep, superficial sleep, treatment with Mogadon nitrazepam should be discontinued.

If, despite the fact that the drug is contraindicated during pregnancy, it is often used – it is possible to develop physical dependence (withdrawal syndrome) in a newborn.

Use immediately before childbirth or during childbirth can cause a newborn to depress respiration, reduce muscle tone, lower blood pressure, hypothermia and a weak act of sucking (“sluggish child syndrome”).

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

Form of issue

For 10 tablets in a planar cell package. For 1, 2 or 5 contour mesh packages together with instructions for medical use in a cardboard bundle. For 20 or 50 tablets in a jar of light-protective glass or polymer. On 1 bank together with the instruction on application in a cardboard pack.

Storage conditions

List No. 1 of the strong BACC substances. In a dry place, protected from light, out of reach of children.

Shelf life

3 years. Do not use after the expiration date indicated on the package.