Nozepamum

General characteristics. Structure:

Active ingredient: 10 mg of oxazepam.

Excipients: lactose (sugar milk); potato starch; calcium stearate; talc.

The anxiolytic means rendering sedative and somnolent, anticonvulsant and central myorelaxation action.

Pharmacological properties:

Pharmacodynamics. Anxiolytic means (tranquilizer) from group of derivatives of benzodiazepine. Has anxiolytic and sedative effect. Has anticonvulsant and central myorelaxation activity. The mechanism of action is connected with strengthening GABA ергических of processes in a brain. Influences mainly the activating mesh formation of a brain, reducing perception of impulses from sensitive receptors on limbic system and reducing emotional coloring.

Pharmacokinetics. After intake it is soaked up slowly, fully. Linkng with proteins of plasma makes 97%. Cmax is reached in 1-4 h and makes 450 ng/ml after reception of a dose of 30 mg. Gets through GEB, a placental barrier, into breast milk. It is metabolized in a liver with formation of the glucuronides which do not have pharmacological activity. T1/2 is 5-15 h. It is removed by kidneys and with a stake. Css is noted in 1-3 days of treatment. Accumulation at repeated appointment - minimum (treats benzodiazepines with short and average T1/2), removal after the treatment termination - bystry.

Indications to use:

Neurosises, frustration of a dream, psychovegetative frustration. The vegetative frustration at women connected with frustration of a menstrual cycle or a climacteric and also at the expressed premenstrual syndrome. Situational depressions (as a part of a combination therapy).

Route of administration and doses:

Establish individually, depending on indications and development of therapeutic effect. The daily dose varies from 10 to 120 mg. Duration of a course of treatment is determined individually. Therapy should be finished gradually.

Features of use:

Oxazepam has toxic effect on a fruit and increases risk of development of inborn defects at use in the I trimester of pregnancy. Reception of therapeutic doses in later durations of gestation can cause oppression of TsNS of the newborn. Constant use at pregnancy can result in physical dependence with development of a withdrawal in the newborn. Children, especially at younger age, are very sensitive to the oppressing TsNS to effect of benzodiazepines. Use just before childbirth or at the time of delivery can cause respiratory depression, decrease in a muscle tone, hypotonia, a hypothermia and a syndrome of sluggish suction of the newborn in the newborn. It is contraindicated in the period of a lactation.

Any change of a dose should be carried out under control of the doctor.

With care apply at tendency to arterial hypotension, at the increased risk of formation of medicinal dependence, at patients of advanced age, at a liver and/or renal failure, a cerebral and spinal ataxy, a hyperkinesia, tendency to abuse of psychotropic drugs, organic diseases of a brain, psychosis (paradoxical reactions are possible), of a hypoproteinemia, the night apnoea (established or assumed).

Oxazepam should not be applied it is long (within several months) in connection with a possibility of development of medicinal dependence. At long treatment control of function of a liver and a condition of peripheral blood is necessary.

Influence on ability to driving of motor transport and to control of mechanisms. During treatment it is not necessary to drive vehicles and to be engaged in other potentially dangerous types of activity requiring special attention; it is not necessary to take alcohol.

Side effects:

From TsNS and peripheral nervous system: in an initiation of treatment (especially at elderly patients) drowsiness, dizziness, fatigue, disturbance of concentration of attention, an ataxy, instability of gait and bad coordination of movements, slackness, obtusion of emotions, delay of mental and motor reactions are possible; seldom - a headache, euphoria, a depression, a tremor, depression of mood, catalepsy, memory disturbance, dystonic extrapyramidal reactions (the uncontrollable movements, including an eye), weakness, muscular weakness during the day, a dysarthtia (a speech smazannost), confusion of consciousness; extremely seldom - paradoxical reactions (aggressive flashes, psychomotor excitement, fear, suicide bent, a muscular spasm, hallucinations, acute excitement, irritability, uneasiness, sleeplessness).

From system of a hemopoiesis: leukopenia, neutropenia, agranulocytosis (fever, hyperthermia, pharyngalgia, unusual fatigue or weakness), anemia, thrombocytopenia.

From the alimentary system: dryness in a mouth or hypersalivation, heartburn, nausea, vomiting, anorexia, a lock, diarrhea, abnormal liver functions, increase in activity of hepatic transaminases and ShchF, jaundice.

From an urinary system: urine incontience, ischuria, renal failure.

From a reproductive system: increase or decrease in a libido, dysmenorrhea.

Allergic reactions: skin rash, itch.

Influence on a fruit: teratogenecity, oppression of TsNS, disturbance of breath and suppression of a sucking reflex at newborns whose mothers used drug.

Others: accustoming, medicinal dependence, decrease in the ABP; seldom - oppression of a respiratory center, a vision disorder (diplopia), bulimia, decrease in body weight, tachycardia, an ecmnesia.

At a sharp dose decline or the termination of reception a withdrawal (irritability, a headache, uneasiness, nervousness, excitement, sensation of fear, nervousness, a sleep disorder, a dysphoria, a spasm of unstriated muscles of internals and skeletal muscles, depersonalization, sweating strengthening, a depression, nausea, vomiting, a tremor, disorders of perception, including a hyperacusia, paresthesia, a photophobia, tachycardia, spasms, hallucinations, it is rare - acute psychosis).

Interaction with other medicines:

At simultaneous use with oral contraceptives efficiency of oxazepam decreases.

At simultaneous use bioavailability of a zidovudine moderately increases and the frequency of development of a headache increases.

At simultaneous use with Phenytoinum there is a risk of reduction of concentration of oxazepam in a blood plasma.

At simultaneous use with ethanol the oppressing influence on TsNS amplifies.

Contraindications:

Coma, shock, acute drunkenness with weakening of vital signs, acute intoxications the medicines having the oppressing effect on TsNS (narcotic, somnolent and psychotropic drugs), a myasthenia, closed-angle glaucoma (a bad attack or predisposition), heavy HOBL (progressing of degree of respiratory insufficiency), acute respiratory insufficiency, a heavy depression (suicide bents), pregnancy (especially the I trimester can be noted), a lactation (breastfeeding), children's age up to 6 years, hypersensitivity to oxazepam.

Overdose:

Symptoms: drowsiness (at single exceeding of a terapevticheskoydoza by 10 times there comes the dream which the patient leaves independently), confusion of consciousness, paradoxical excitement, decrease in reflexes, an oglushennost, reduced reaction to pain stimulations, a deep sleep, a dysarthtia, an ataxy, a vision disorder (nystagmus), a tremor, bradycardia, an asthma ilizatrudnenny breath, the expressed weakness, decrease in the ABP, a collapse, ugneteniyeserdechny and respiratory activity, a lump.

Treatment: gastric lavage, artificial diuresis, priyemaktivirovanny coal. Symptomatic therapy (maintenance of breath and ABP). To Vkachestva the specific antagonist is used flumazenit (in an usloviyakhstatsionar). The hemodialysis is inefficient.

Storage conditions:

The list III of the list of the drugs, psychotropic substances and their precursors which are subject to control in the Russian Federation. To store in the unavailable to children, protected from light place at a temperature not above 30 °C.

Issue conditions:

According to the recipe

Packaging:

On 50 pieces of tablets - banks of dark glass (1) - a pack cardboard.