Instruction for use: Seduxen

Dosage form: Solution for intravenous and intramuscular administration; tablets

Active substance: Diazepam*

ATX

N05BA01 Diazepam

Pharmacological group:

Anxiolytics

The nosological classification (ICD-10)

F09 Organic or symptomatic mental disorder, unspecified: Organic CNS damage; Organic Psychology; Endogenous psychosis; Psycho-organic syndrome; Psycho-organic senile syndrome; Psycho-organic syndrome in old age; Psychotic disorder in organic diseases of the central nervous system; The psycho-organic syndrome; Vascular psychosis; The age-old pseudomelanchia; Exogenous-organic psychosis; Endogenous psychosis; Pseudomelanchia senile

F10.4 Abstinent state with delirium: Alcoholic delirium; White fever alcoholic; Delirium; Delirious condition with alcoholism and drug addiction

F10.5 Alcoholic alcohol: Alcoholic hallucinations; Psycho-organic syndrome in chronic alcoholism; Alcoholic psychosis; White fever alcoholic; Delirium; Delirium with alcoholism; Acute alcoholic psychosis; Delirious condition with alcoholism and drug addiction; Acute alcoholic psychosis with autonomic disorders

F41.9 Anxiety disorder, unspecified: Neurotic disorders with anxiety syndrome; Severe anxiety; Neuro-like symptomatology; Neuro-like disorders; Neuro-like conditions; Neuroses with anxiety symptoms; Neuroses with a sense of anxiety; Acute situational and stress anxiety; Acute attack of anxiety; Severe Anxiety; Situational Anxiety Disorder; State of anxiety; Anxious and delusional component; Alarming state; Anxiety; Anxiety Disorders; Anxiety syndrome; Sense of anxiety; Alarm conditions; Chronic neurotic anxiety; Susto; Psychopathy with a predominance of anxiety and anxiety; Anxiety disorders in neurotic and neurosis-like states; Anxious neuroses; Anxious and delusional state; Acute situational stress alarm; Depressed mood with elements of anxiety

F48 Other neurotic disorders: Neurosis; Neurological diseases; Neurotic disorders; Neurotic condition; Psychoneurosis; Anxious-Neurotic Conditions; Chronic neurotic disorders; Emotional reactive disorders

F51.0 Insomnia of inorganic etiology: Situational insomnia; Situational sleep disorders

F95 Teaki: Teak child; Children's teak; Nerve Teacks in Children; Nervous teack; Teak

G24.8.0 * Hypertonus muscular: Increased muscle tone; Increased muscle tone; Spasm of striated muscle due to organic diseases of the central nervous system; Spasticity of muscles; Painful spasms of muscles in diseases of the spine; Increased skeletal muscle tone

G47.0 Disorders of falling asleep and maintaining sleep [insomnia]: Insomnia; Insomnia, especially difficulty falling asleep; desynchronosis; Prolonged sleep disturbance; Difficulty falling asleep; Short-term and transient insomnia; Short-term and chronic sleep disorders; Short or shallow sleep; Violation of sleep; Disturbed sleep, especially in the phase of falling asleep; Infringements sleep; sleep disturbances; Neurotic sleep disturbance; Shallow superficial sleep; shallow sleep; Poor quality of sleep; Night awakening; sleep Pathology; Postsomnic violation; transient insomnia; Trouble falling asleep; Early awakening; Early morning awakening; Early awakening; sleep disorder; somnipathy; persistent insomnia; difficult to fall asleep; difficulty falling asleep; Difficulty falling asleep in children; persistent insomnia; Worsening sleep; Chronic insomnia; Frequent night and / or early morning awakening; Frequent nocturnal awakening and a sense of the depth of the non-sleep; Night waking

G80.0 Spastic Cerebral Palsy: Little's Disease; Spastic Pallas; Little disease

M62.4 Contracture of muscle: Neurological contractures with spasms; Muscular contracture

O15 Eclampsia

O20.0 Threatening abortion: Threatening abortion; Miscarriage aborting; A spastic condition with a risk of abortion; Threatening miscarriage in the first trimester of pregnancy; Threat of abortion; Threatening abortion; The threat of spontaneous miscarriage; A threatening spontaneous miscarriage

O60 Premature Birth: Premature Pregnancy; Preterm birth; Premature labor contractions; Premature labor in the prehospital stage; Immobilization of the uterus before caesarean section; Immobilization of the uterus; Acute tocolysis; Threatening premature birth; Premature discharge of water; Prevention of premature birth; The threat of premature birth

R25.2 Cramp and spasm: Muscle spasms in tetanus; Pain syndrome with smooth muscle spasms; Pain syndrome with smooth muscle spasms (renal and biliary colic, intestinal spasm, dysmenorrhea); Pain syndrome with spasms of smooth muscles of internal organs; Pain syndrome with spasms of smooth muscles of internal organs (renal and biliary colic, intestinal spasm, dysmenorrhea); Painful muscular spasm; Mimic spasms; Muscular spasticity; Muscle spasms; Muscular spasms of central origin; Muscular spasticity; Muscle spasm; Neurological contractures with spasms; Night cramps in the extremities; Nocturnal cramps in the legs; Night cramps calf muscles; Symptomatic convulsive state; Vesta Syndrome; Spasm of smooth muscles; Spasm of smooth vascular musculature; Spasm of muscles; Spasm of striated muscle due to organic diseases of the central nervous system; Skeletal muscle spasms; Spasms of smooth muscles of internal organs; Skeletal Muscle Cramps; Spastic states of striated musculature; Spasmodic pain syndrome; The spastic condition of smooth muscles; Spasticity of skeletal musculature; Muscle cramp; Convulsions; Cramps of the calf muscles; Convulsions of central origin; Convulsive condition; Convulsive Syndrome; Convulsive status in children; Tonic convulsions; Cerebral spasmodic syndrome; clasp knife phenomenon

R25.8.0 * Hyperkinesis: Hyperkinesis of the Choreic; Hyperkinesis of central origin; Hyperkinesia rheumatic; Hyperkinesis; Floating tremor

R45.1 Anxiety and agitation: Agitation; Anxiety; Explosive excitability; Internal stimulation; Excitability; Excitation; Excitation acute; Psychomotor agitation; Hyperexcitability; Motor excitement; Cessation of psychomotor agitation; Nervous excitement; Restlessness; Night trouble; Acute stage of schizophrenia with excitation; Acute mental agitation; Paroxysm of excitation; Overexcitation; Increased excitability; Increased nervous excitability; Increased emotional and cardiac excitability; Increased agitation; Mental arousal; Psychomotor agitation; Psychomotor agitation in psychoses; Psychomotor agitation of an epileptic nature; Psychomotor paroxysm; Psychomotor fit; Symptoms of excitation; Symptoms of psychomotor agitation; The state of agitation; A state of anxiety; Excitation status; A state of heightened concern; The state of psychomotor agitation; Conditions of anxiety; Excitation conditions; The state of excitement in somatic diseases; Excitation level; Feelings of anxiety; Emotional arousal

Z100 * CLASS XXII Surgical practice: Abdominal surgery; adenomectomy; Amputation; Coronary angioplasty; Angioplasty of the carotid arteries; Antiseptic skin treatment for wounds; Antiseptic Hand; Appendectomy; atherectomy; Balloon coronary angioplasty; Vaginal hysterectomy; The coronary bypass; Interventions in the vagina and cervix; Interventions on the bladder; Intervention in the mouth; Restoration and reconstructive surgery; Hand hygiene of medical personnel; Gynecologic surgery; Gynecological intervention; Gynecological surgery; Hypovolemic shock during operations; Disinfection of purulent wounds; Disinfection of wounds edges; Diagnostic intervention; Diagnostic procedures; Cervical Diathermocoagulation; Long-surgery; Replacing the fistula catheters; Infection in orthopedic surgery; Artificial heart valve; cystectomy; Short-term outpatient surgery; Short-term operation; Short surgical procedures; Krikotireotomiya; Blood loss during surgery; Bleeding during surgery and in the postoperative period; Kuldotsentez; laser photocoagulation; laser coagulation; retinal laser coagulation; Laparoscopy; Laparoscopy in Gynecology; CSF fistula; Small gynecological operations; Small surgical procedures; Mastectomy and subsequent plastic; mediastinotomy; Microsurgical operations on the ear; Mukogingivalnye operation; suturing; Minor surgery; neurosurgical operation; Immobilization of the eyeball in ophthalmic surgery; testectomy; pancreatectomy; Perikardektomiya; The period of rehabilitation after surgery; The period of convalescence after surgery; Percutaneous transluminal coronary angioplasty; Pleural thoracentesis; Pneumonia postoperative and posttraumatic; Preparation for surgical procedures; Preparation for surgery; Preparation of the surgeon's hands before surgery; Preparation of the colon for surgical procedures; Postoperative aspiration pneumonia in neurosurgical and thoracic surgery; Postoperative nausea; Postoperative bleeding; postoperative granuloma; postoperative shock; The early postoperative period; myocardial revascularization; Radiectomy; gastric Resection; bowel resection; uterine Resection; liver Resection; enterectomy; Resection of part of the stomach; Reocclusion of the operated vessel; Bonding tissues during surgical procedures; Removal of sutures; Condition after eye surgery; Condition after surgery; Condition after surgery in the nasal cavity; Condition after gastrectomy; Status after resection of the small intestine; Condition after tonsillectomy; Condition after removal of the duodenum; Condition after phlebectomy; Vascular surgery; Splenectomy; Sterilization of surgical instruments; Sterilization of surgical instruments; sternotomy; Dental surgery; Dental intervention in periodontal tissues; strumectomy; Tonsillectomy; Thoracic surgery; Thoracic surgery; total gastrectomy; Transdermal intravascular coronary angioplasty; Transurethral resection; Turbinektomiya; Removal of a tooth; cataract surgery; Removal of cysts; tonsillectomy; Removal of fibroids; Removing the mobile primary teeth; Removing polyps; Removing broken tooth; Removal of the uterus body; Removal of sutures; Fistula likvoroprovodyaschih ways; Frontoetmoidogaymorotomiya; Surgical infection; Surgical treatment of chronic limb ulcers; Surgery; The surgery in the anal area; The surgery on the colon; Surgical practice; The surgical procedure; Surgical interventions; Surgery on the gastrointestinal tract; Surgical procedures on the urinary tract; Surgical procedures on the urinary system; Surgical intervention of the genitourinary system; Surgical procedures on the heart; Surgical manipulation; surgery; Surgery on the veins; Surgical intervention; Vascular surgery; Surgical treatment of thrombosis; Surgery; cholecystectomy; Partial gastric resection; hysterectomy; Percutaneous transluminal coronary angioplasty; Percutaneous transluminal angioplasty; Coronary artery bypass; tooth Extirpation; Extirpation of milk teeth; pulpectomy; pulsative cardiopulmonary bypass; tooth Extraction; teeth Extraction; cataract extraction; Electrocoagulation; endourological intervention; episiotomy; Etmoidotomiya; Complications after tooth extraction

Composition and release form

Tablets - 1 table.

Diazepam 5 mg

Auxiliary substances: aerosil; Magnesium stearic acid; talc; corn starch; Lactose monohydrate

In contour blister packing 10 pcs; In the box 2 packs.

Solution for intravenous and intramuscular injection 2 ml

Diazepam 10 mg

Auxiliary substances: methyl parahydroxybenzoate; Propyl parahydroxybenzoate; Sodium pyrosulfite; Sodium citrate; Alcohol 95%; Glycofurol; Propylene glycol; water for injections

In ampoules of 2 ml; In the box there are 5 ampoules.

Characteristic

Tranquilizer from the group of benzodiazepine derivatives.

Pharmachologic effect

Mode of action - anticonvulsant, anxiolytic, myorelaxing, sedative.

It has a regulating effect on neurovegetative functions, reduces the night secretion of gastric juice.

Pharmacokinetics

Well absorbed. Cmax in plasma is achieved after 90 minutes. Binding to plasma proteins - 98%. Penetrates through the placenta, into the cerebrospinal fluid, is excreted in breast milk.

Metabolised in the liver. It is excreted by the kidneys (70%).

The indications for the Seduxen

Neuroses of all kinds, as well as neurotic and psycho-like conditions with an anxiety syndrome with endogenous diseases, organic brain damage (including cerebral atherosclerosis); Mental illness, accompanied by motor anxiety, agitation, sharp anxiety; Nervous tension, anxiety in psychosomatic diseases, endogenous psychosis (as an auxiliary tool); Epileptic status, severe, often repeated seizures (parenteral administration); Epilepsy (as an auxiliary, including with mental equivalents); A state of anxiety accompanying diseases of internal organs; Neurotic disorders in pediatric practice (anxiety, headache, sleep disturbance, enuresis, stubbornness reaction, tick, bad habits); Spasms, rigidity of muscles, contractures; Diseases accompanied by increased muscle tone, spasticity, or hyperkinesia; eclampsia; Tetanus and all kinds of convulsive conditions; Premedication before surgical operations; Induction of anesthesia, premature birth or the threat of premature birth due to muscle spasm (only at the end of the third trimester of pregnancy).

Contraindications

Myasthenia gravis, acute attack of glaucoma, zakratougolnaya glaucoma, pregnancy (I trimester), children's age (up to 6 months.)

Application in pregnancy and breastfeeding

Contraindicated in pregnancy. Care should be taken when prescribing during breastfeeding.

Side effects

From the side of the nervous system: at the beginning of treatment there may be increased fatigue, drowsiness (disappear spontaneously or with a decrease in the dose of the drug). Rarely - ataxia; In some cases - paradoxical reactions (agitation, anxiety, sleep disturbances).

Interaction

Potentiates the effects of tricyclic antidepressants, drugs that have an inhibitory effect on the central nervous system, muscle relaxants (caution should be exercised when combined).

Seduxen's solution is incompatible in one syringe with any other drugs.

Dosing and Administration

Inside, IV, IM.

Tablets. The dose of the drug is selected individually, while taking into account both the patient's condition and the response to treatment - only general guidelines are given below. At the beginning of therapy it is recommended to apply small doses of the drug with a gradual increase. Separate the daily dose for 2-4 admission is necessary individually. It is advisable to take 2/3 of the daily dose in the evening.

Adults, neurological disorders, psychosomatic diseases, anxiety and phobic disorders: usual single dose - 2.5-5 mg (1 / 2-1 table). The average daily intake for adults is 5-20 mg.

Single dose should not exceed 10 mg.

Symptomatic treatment of convulsive syndrome: usually 2.5-10 mg (1 / 2-2 table) 2-4 times a day.

In the complex treatment of mental disorders of organic origin: the initial dose of 20-40 mg (4-8 tablets) per day, supporting the daily - 15-20 mg (3-4 tablets).

Muscular contractures, spasticity, rigidity - 5-20 mg (1-4 tablets) per day.

In elderly and cachectic patients, as well as with a decrease in liver function, the excretion of Seduxen may be significantly prolonged. It is recommended to start treatment with a lower (approximately half) dose, which can be gradually increased, taking into account the individual tolerance of the drug.

The dose for children should always be determined individually, taking into account the age, the level of physical development, the general condition and the response to ongoing treatment. The initial dose for children is 1.25-2.5 mg / day, divided into 2-4 doses. This dose can be reduced or increased, taking into account the individual reaction to the therapy.

Children up to 6 months of use of anxiolytic drugs from the benzodiazepine group is not allowed.

Solution for IV and IM. It is forbidden to enter extravasely (except IM) and in the artery! Enter deep into the muscle with the IM application. In a vein to enter slowly: no more than 5 mg (1 ml) of a preparation within 1 min. A rapid introduction can cause apnea. Children enter very slowly: more than 3 minutes.

In connection with the presence of significant individual differences in the response to the drug, treatment should begin with the lowest effective dose, gradually increasing it until the least effective and at the same time sufficiently tolerated dose is reached.

Stimulation of psychomotor agitation proceeding with anxiety - 10-20 mg IM, in severe cases - IV, if necessary - 10 mg 3-4 times a day.

Alcohol abstinence syndrome, delirium, conditions that occur with an increase in muscle tone - no more than 10 mg 3-4 times a day, IM.

In tetanus - 10-20 mg IM or IV (including drip), every 2-8 hours, depending on the clinical picture.

With epileptic status - the initial dose is 10-30 mg IV, which can be repeated after 0.5-1 h, then after 4 hours. The maximum daily dose is 80-100 mg. After cessation of seizures, you can go to the IM introduction (10 mg every 4-6 hours, if necessary - for several days).

To remove spasm of skeletal muscles - 0.5 hours before the start of surgery - no more than 10 mg, IM.

Newborns older than 5 weeks (older than 30 days) - 0.1-0.3 mg / kg body weight IV, slowly. The maximum dose is 5 mg. If necessary, depending on the clinical picture, after 2-4 hours the injection can be repeated, however, the administration of more than 3 injections per day is only permissible in the case of tetanus and epileptic status. Except for absolute indications - epilepsy, tetanus - administration of the drug to children under 6 years is not recommended due to age-related features of distribution, metabolism and safety of use.

Children older than 5 years - 1 mg iv every 2-5 minutes to a maximum dose of 0.2 mg / kg (with convulsions - up to 0.3 mg / kg), if necessary, after 2-4 hours treatment can be repeated. With the increase in epileptic seizures and the epileptic status of the dose, the initial dose is 2-10 mg IV, then 0.5-1 hours later, after 4 hours the dose can be repeated. The introduction of more than 3 injections per day is permissible only in the case of tetanus and epileptic status.

Overdose

Symptoms: drowsiness, confusion, coma, oppression of reflexes.

Treatment: gastric lavage, artificial ventilation, measures to increase blood pressure.

Precautionary measures

Against the background of the use of Seduxen, alcohol is categorically prohibited.

Special instructions

In the case of prolonged use, it is possible to develop drug dependence.

Do not abruptly stop treatment because of the risk of withdrawal syndrome.

With rapid parenteral administration of the drug, lowering blood pressure, respiratory failure, is possible.

At the beginning of the application it is not recommended to engage in activities requiring increased attention and rapid psychomotor reactions; In the future these restrictions are determined individually.

Storage conditions of the drug Seduxen

In the dark place at a temperature of 8-15 ° C.

Keep out of the reach of children.

Shelf life of the drug Seduxen

Solution for intravenous and intramuscular injection 10 mg / 2 ml - 3 years.

Tablets 5 mg - 5 years.

Do not use after the expiry date printed on the package.