Nitrazepam

Nitrazepam – strong somnolent drug from group of benzodiazepines with anxiolytic, anticonvulsant, sedative and miorelaksantny action.

Form of release and structure

Dosage form – tablets: ploskotsilindrichesky or spherical shape, color, white with a yellowish-greenish shade, with a facet (on 10 pieces in a blister strip packaging, in a pack of cardboard 1, 2 or 5 packagings; on 20 or 50 pieces in bank polymeric or from light-protective glass, in a pack of cardboard 1 bank).

Active agent: nitrazepam, its contents in 1 tablet makes 5 mg.

Additional components: polyvinylpirrolidone low-molecular medical (povidone), sugar milk (lactose), talc, примогель (sodium carboxymethylstarch), potato starch, magnesium stearate.

Indications to use

• Sleep disorders of various nature of an origin (difficulty with backfilling, frequent night and/or early morning awakenings);
• Noctambulation;
• Some forms of convulsive attacks, including Vest's syndrome (fulminant nodding salaamova of a spasm) at children of younger age;
• Organic lesions of the central nervous system (disturbance of blood circulation of a brain, effect of a craniocereberal injury);
• Neurosises;
• Maniac-depressive psychosis;
• The mental disorders which are followed by increased feeling of concern and alarm;
• Encephalopathy with epileptic manifestations;
• Abstinence syndrome at alcoholism and drug addiction;
• Schizophrenia (as a part of a combination therapy).

Contraindications

Absolute:

• Heavy depression;
• Acute respiratory insufficiency;
• Medicinal or alcohol addiction;
• Drug addiction;
• The acute drunkenness which is followed by weakening of the vital functions;
• Temporal epilepsy;
• Closed-angle glaucoma;
• Coma;
• Shock;
• Myasthenia;
• Hypercapnia;
• Serious chronic obstructive illness of lungs;
• Acute intoxications the medicines having the oppressing effect on the central nervous system;
• Disturbance of swallowing at children;
• Period of pregnancy and lactation;
• Hypersensitivity to components of drug or other benzodiazepines.

Relative:

• Respiratory insufficiency;
• Hyperkinesias;
• Cerebral and spinal ataxy;
• Liver and/or renal failure;
• Organic diseases of a brain;
• Night an apnoea (including assumed);
• Hypoproteinemia;
• Ataxy;
• Psychosis;
• Tendency to abuse of psychoactive medicines;
• Medicinal dependence in the anamnesis;
• Advanced age.

Route of administration and dosage

Nitrazepam should be accepted inside.

As sleeping pill at sleep disorders – 1 time a day in 30 minutes prior to a dream. The recommended doses:

• Children till 1 year – 1,25-2,5 mg;
• Children of 1-5 years – 2,5-5 mg;
• Children of 6-14 years – 5 mg;
• Teenagers are more senior than 14 years and adult – 5-10 mg, the most admissible daily dose – 20 mg;
• Elderly people (65 years are more senior) – 2,5-5 mg.

The recommended doses at use of Nitrazepam as anticonvulsant and anxiolytic drug:

• Adults – on 5-10 mg 2-3 times a day;
• Patients of advanced age – on 2,5-5 mg 2-3 times a day;
• Children of 6-14 years – 7,5-15 mg (daily dose) in 3 receptions;
• Children of 1-6 years – 5-10 mg (daily dose) in 3 receptions;
• Children till 1 year – 2,5-7,5 mg (daily dose) in 3 receptions.

2/3 daily doses are recommended to be accepted for the night.

When calculating a children's dose of nitrazepam it is recommended to consider body weight. For children weighing up to 30 kg appoint 0,3-1 mg/kg/days in 3 receptions.

At Vest's syndrome at children aged from 1 up to 2 years appoint 2,5-5 mg a day in 1 reception.

Chest and to children who cannot swallow a tablet entirely the corresponding amount of drug can be crushed and dissolved (to suspend) in a small amount of water.

Treatment duration usually makes 30-45 days.

All doses stated above are approximate. In each case the doctor defines an optimum dose individually depending on the indication, the general condition of the patient, an etiopathogenesis and individual portability of drug.

Side effects

• Nervous system: in an initiation of treatment (especially at people of advanced age) – decrease in concentration of attention, delay of mental and motor reactions, dizziness, feeling of fatigue, obtusion of emotions, drowsiness, slackness, an ataxy; seldom – confusion of consciousness, euphoria, a katalepsy, a headache, dystonic extrapyramidal reactions (the uncontrollable movements of a body, including an eye), a speech smazannost, a depression, an ecmnesia, a dysarthtia, muscular weakness, a tremor; in some cases – paradoxical reactions (psychomotor excitement, alarm, fear, sleeplessness, aggressive flashes, an acrimony, hallucinations, a muscular spasm, suicide bent);
• Alimentary system: hypersalivation or dryness in a mouth, decrease or increase in appetite, nausea, vomiting, a diarrhea/lock, jaundice, increase in activity of hepatic transaminases and an alkaline phosphatase, abnormal liver function;
• Urinogenital system: incontience or ischuria, increase or decrease libido, renal failure, dysmenorrhea;
• Bodies of a hemopoiesis: anemia, neutropenia, leukopenia, thrombocytopenia, agranulocytosis (unusual fatigue or weakness, pharyngalgia, hyperthermia, fever);
• Cardiovascular system: lowering of arterial pressure; seldom – tachycardia;
• Allergic reactions: an itch, rash on skin;
• Others: accustoming, medicinal dependence; seldom – decrease in body weight, bulimia, a vision disorder (diplopia), oppression of a respiratory center.

At a sharp dose decline or the termination of reception of Nitrazepam development of the withdrawal which is shown the following symptoms is possible: psychomotor initiation, alarm, fear, acrimony, depersonalization, dysphoria, tremor, sleep disorder, headache, disorders of perception (including paresthesia, hyperesthesia, hyperacusia, photophobia), depression, hallucinations, sweating strengthening, tachycardia, nausea, vomiting, spasm of unstriated muscles of internals and skeletal muscles, spasm; seldom – acute psychosis.

At newborns whose mothers during pregnancy accepted Nitrazepam, suppression of a sucking reflex, disturbance of breath and oppression of the central nervous system is possible.

Special instructions

With care it is necessary to begin treatment of patients who before purpose of nitrazepam underwent therapy by any other drug for a long time.

Under special observation during treatment there have to be patients with heavy depressions as they can use drug for implementation of suicide intentions.

Without appointment of the doctor Nitrazepam it is not necessary to accept it is long.

During therapy it is strictly forbidden to take alcohol, it is necessary to refrain from driving of the car and performance of potentially dangerous types of the works demanding the high speed of reactions and special attention.

At prolonged treatment, and also at patients with a renal and/or liver failure it is necessary to control liver enzymes and a picture of peripheral blood.

Nitrazepam has primary potential causing dependence. The risk of formation of medicinal dependence increases at the patients who were earlier abusing medicines or alcohol and also at use of drug in high doses or for a long time, even in usual therapeutic doses. For this reason the doctor appoints this means individually after careful assessment of advantage and possible risk of development of accustoming or dependence.

In order to avoid development of a withdrawal treatment cannot be stopped sharply, it is necessary to reduce a dose gradually.

Drug needs to be cancelled in case of development of paradoxical reactions, such as hallucinations, a superficial dream, the complicated backfilling, psychomotor excitement, strengthening of muscular spasms, fear, aggression, suicide thoughts.

In case of frequent use of drug during pregnancy there is a risk of development of physical dependence (withdrawal) in the newborn.

Reception of Nitrazepam just before childbirth or at the time of delivery can cause in the newborn the weak act of suction ("a syndrome of the sluggish child"), decrease in a muscle tone and arterial pressure, a hypothermia, respiratory depression.

At children of early age the raised products of a phlegm and slime in respiratory tracts therefore it is necessary to take measures for ensuring good passability of respiratory tracts are noted.

Medicinal interaction

Inductors of microsomal enzymes of a liver reduce efficiency of nitrazepam, oral estrogensoderzhashchy contraceptives and Cimetidinum – strengthen and extend.

Mutual strengthening of action is noted at the Nitrazepam combination with psychotropic and anticonvulsants, the general anesthetics, narcotic analgetics, muscle relaxants, lithium drugs, antihistaminic and sedatives, anxiolytics, barbiturates, a clonidine and ethanol.

The accepted at the same time narcotic analgetics increase euphoria and lead to increase of medicinal dependence.

Nitrazepam reduces efficiency of a levodopa, can increase toxicity of a zidovudine.

In case of simultaneous use of clozapine respiratory depression, antihypertensives – the expressed lowering of arterial pressure is possible.

Inhibitors of a microsomal oxidation extend an elimination half-life of nitrazepam and increase risk of development of its toxic effects.

Valproic acid can probably strengthen influence of nitrazepam on the children sick with epilepsy.

Probenetsid and Cimetidinum slow down nitrazepam removal owing to what there is cumulation of substance in an organism that leads to excessive manifestation of sedation.

Rifampicin strengthens nitrazepam excretion.

Terms and storage conditions

To store in the place protected from light and moisture unavailable to children, at a temperature up to 25 ºС.

Period of validity – 3 years.