Instruction for use: Diazepam Nycomed

Dosage form: Solution for intravenous and intramuscular injection; Tablets

Active substance: Diazepam*

ATX

N05BA01 Diazepam

Pharmacological groups:

Anxiolytics

Antiepileptic drugs

The nosological classification (ICD-10)

F10.3 Abstinence: Alcohol withdrawal syndrome; Abstinence syndrome; Abstinence syndrome with alcoholism; Abstinence; Alcohol abstinence; Alcohol withdrawal status; Alcohol withdrawal syndrome; Postabstinctive disorder; Post-abstinence condition; Hangover syndrome; Abstinence syndrome; Alcohol abstinence syndrome; Alcohol withdrawal syndrome; Abstinence condition

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

F20 Schizophrenia: Schizophrenic conditions; Exacerbation of schizophrenia; Schizophrenia; Chronic schizophrenia; Dementia praecox; Bleuler's disease; Psychotic discordant; Dementia early; The febrile form of schizophrenia; Chronic schizophrenic disorder; Psychosis of the schizophrenic type; Acute form of schizophrenia; Acute schizophrenic disorder; Cerebral Organic Insufficiency in Schizophrenia; Acute attack of schizophrenia; Schizophrenic psychosis; Acute schizophrenia; Sluggish schizophrenia; Sluggish schizophrenia with apathoabulic disorders; Acute stage of schizophrenia with excitation

F41 Other anxiety disorders: Anxiety status; Anxiety; Chronic alarm; Sense of anxiety; Anxious-hypothetical states; Stopping an alarm; Nonpsychotic anxiety disorders

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

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

R45.7 Condition of emotional shock and stress, unspecified: Exposure to stress factors; Exposure to extreme situations; Neuropsychic stresses; Professional stress; Psychoemotional overload and stress; Psychoemotional stress; Stressful condition; Stress; Stress loading; Stressful condition; Stressful situations; Stress of everyday life; Chronic stress; Long-term emotional stress; Psychological stress in air flights; Psychoemotional stress in stressful situations

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

1 ampoule with 2 ml solution for injection contains diazepam 10 mg, in a box 5 ampoules.

Pharmachologic effect

Mode of action - anticonvulsant, miorelaksiruyuschee, tranquilizing.

Pharmacokinetics

Completely absorbed from the digestive tract. The action develops in 15-30 minutes. Cmax in plasma is achieved 30-60 minutes after administration. T1 / 2 - 20-45 h, in newborns can reach 100 hours. Binding to plasma proteins - 96-98%. Metabolised in the liver with the formation of active metabolites, which are excreted by the kidneys.

Indication of the drug Diazepam Nycomed

Anxiety (chronic, neurotic, acute situational and stressful). Stress, sleep disorders, psychosomatic condition, schizophrenia, borderline disorders, seizures, facial spasms, abstinence, predeliry, delirium, premedication.

Contraindications

Acute poisoning with alcohol and sedatives, myasthenia gravis, sleep apnea, acute respiratory failure, severe liver failure, pregnancy (I and III trimester), breastfeeding (4 weeks after giving birth), age (up to 2 years).

Application in pregnancy and breastfeeding

Contraindicated in pregnancy (I and III trimesters). At the time of treatment should stop breastfeeding.

Side effects

Drowsiness, depression, weakness, dizziness, ataxia, itching, muscle weakness, diarrhea disorders, bradycardia, hypotension, menstrual irregularities, gynecomastia, leukopenia, agranulocytosis, aplastic anemia, allergic reactions, bronchospasm, tolerance, drug dependency.

Interaction

Neuroleptics, antihistamines, alcohol, clonidine, opioids, hypnotics, sedative effect and influence (inhibitory) on vascular tone. Cimetidine, omeprazole, anti-estrogenic agents, and oral contraceptives reduce diazepam metabolism in the body and may cause cumulation. Theophylline weakens the sedative and psychomotor effect.

Dosing and Administration

IM or IV.

Epileptic status: IV, slowly 0.15-0.25 mg / kg, with the impossibility of IV the introduction of the same dose of IM. If necessary, re-introduction after 30-60 minutes; Drip infusion (maximum dose of 3 mg / kg / day) is acceptable.

Tetanium: IV, very slowly 0.1-0.3 mg / kg with an interval of 1-4 hours or drip 3-4 mg / kg / day.

Muscular spasms of central origin: IM or slowly IV in the beginning 10-20 mg (children 2-10 mg) with continued intake of the drug inside. Muscular spasms of peripheral origin: IM 10-20 mg 1-2 times a day.

Pre-eclampsia: IV in the beginning, 10 mg slowly, if necessary, subsequently injected IV or in the form of a drop infusion (up to 100 mg / day).

Overdose

Symptoms: drowsiness, dizziness, muscle weakness, ataxia, stupor, coma with respiratory depression and collapse.

Treatment: a specific antidote - flumazenil.

Precautionary measures

If the kidneys and in elderly people are impaired, a dose reduction is necessary. In patients with impaired liver function and depression, use with caution.

Storage conditions of the drug Diazepam Nycomed

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life of the drug Diazepam Nycomed

2 years.

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