Sibazon

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Instructions for use:

1. Release form and composition
2. Indications for use
3. Contraindications
4. Method of application and dosage
5. Side effects
6. Special instructions
7. Drug interactions
8. Terms and conditions of storage

Sibazon - anxiolytic tranquilizer, sedative, anticonvulsant, central muscle relaxant and hypnotic action; possesses moderate sympatholytic activity, is capable of causing expansion of coronary vessels and a decrease in blood pressure, increase the threshold of pain sensitivity, suppress parasympathetic (including vestibular) and sympathoadrenal paroxysms, and reduce gastric acid secretion during sleep.

Release form and composition

Sibazon is available in the following forms:

tablets: biconvex, white or white with a slight yellowish tinge (10 pieces in a blister strip, in a cardboard box 1, 2 or 5 packages; 20 pieces each in polymer cans or glass light-protective jars, in a cardboard box 1 can);
solution for intravenous and intramuscular administration: transparent, colorless or with a yellowish-green tinge (2 ml in ampoules of neutral glass, 5 ampoules in blisters, in a cardboard box 1 or 2 packs; 2 ml in ampoules, in a cardboard box 10 ampoules).

Composition of 1 tablet:

active substance: diazepam (sibazon) - 5 mg;
auxiliary components: potato starch, calcium stearate monohydrate, povidone, lactose monohydrate.

Composition of 1 ml solution:

active substance: diazepam (sibazon) - 5 mg;
auxiliary components: sodium chloride, macrogol 400, propylene glycol, ethanol, water for injection.

Indications for use

psychomotor agitation and itchy dermatoses in dermatological practice (as a sedative);
acute anxiety-phobic and anxiety-depressive states, alcoholic psychoses with withdrawal symptoms (as an anxiolytic agent);
muscle spasms of central genesis in neurodegenerative diseases, including cervical sciatica, lumbago and spinal injuries (as an anticonvulsant and muscle relaxant);
spastic conditions associated with damage to the spinal cord or brain (tetanus, athetosis, cerebral palsy);
premedication and ataralgesia in combination with analgesics and other neurotropic agents during diagnostic procedures and preparation for surgical interventions;
clinic of internal diseases: hypertension (accompanied by increased excitability and anxiety), vasospasm, hypertensive crisis, menstrual and climacteric disorders (as part of complex treatment);
relief of convulsive conditions and epileptic seizures of various origins.

The solution, in addition, is used in obstetrics to facilitate labor, in premature birth (only at the end of the third trimester) and in the case of premature placental exfoliation.

Contraindications

Absolute:

acute intoxication with drugs that depress the central nervous system (including hypnotics and narcotic analgesics);
acute alcohol intoxication (with weakening of vital functions);
severe myasthenia gravis;
shock, coma;
acute or severe respiratory failure;
severe chronic obstructive pulmonary disease;
violation of consciousness and breathing of central genesis;
acute kidney and liver diseases;
severe liver failure;
angle-closure glaucoma (including history);
hypertrophy of the prostate;
glucose-galactose malabsorption, lactase deficiency, lactose intolerance (for tablets);
children's age up to 30 days inclusive (for solution for parenteral administration);
children under 7 years of age (for tablets);
the period of pregnancy (especially the first and third trimester);
lactation period;
hypersensitivity to any component of the drug or other benzodiazepines.

Relative (Sibazon is used with caution):

severe depression (suicide attempts are possible);
psychosis;
organic diseases of the brain;
sleep apnea (both established and suspected);
epileptic seizures or epilepsy (history);
Lennox-Gastaut syndrome or absence (when administered intravenously, it can contribute to the onset of tonic status epilepticus);
spinal and cerebral ataxias;
substance abuse;
drug dependence (in history);
hyperkinesis;
hypoproteinemia;
renal and / or hepatic impairment.

Method of administration and dosage

Pills

Sibazon in the form of tablets is taken orally.

Doses of the drug are calculated individually, taking into account the picture of the disease, the patient's condition and his sensitivity to the drug.

For adult patients, the average single dose ranges from 5 to 15 mg, in some cases, a single dose may be increased to 20 mg. The average daily dose is 15–45 mg in 2-3 doses, the maximum dose is 60 mg per day.

Average recommended doses of Sibazon for adult patients in various conditions:

degenerative neurological diseases: 5-10 mg 2 to 3 times a day;
anxiety-phobic and anxiety-depressive states: 5-10 mg 2 to 4 times a day;
alcohol withdrawal syndrome: 10 mg 3 or 4 times on the first day, then the dose is reduced to 5 mg 3 or 4 times a day;
Internal Medicine Clinic: 5 mg 2 or 3 times a day; if necessary, it is possible to increase the dose to 10 mg 4 times a day;
menstrual and climacteric disorders: 5 mg 2 or 3 times a day;
premedication: 10–20 mg in the evening, on the eve of the operation.

Children and adolescents aged 7-18 years Sibazon is prescribed in low doses, gradually increasing them to optimal, well-tolerated. The initial daily dose for children over 7 years old is 5 mg in 2-3 doses (with the largest dose taken in the evening), the maximum dose is 10 mg per day.

Solution for intravenous and intramuscular administration

Sibazon in the form of a solution is administered intravenously or intramuscularly.

Recommended doses:

neurotic and neurosis-like disorders with anxiety: 10 mg intramuscularly; in some cases, it is possible to increase the dose to 20 mg (with severe fear or severe arousal);
relief of psychomotor agitation due to fear or anxiety: 5-10 mg slowly intravenously; after 3-4 hours, you can repeat the injection at the same dose;
increased muscle tone: adult patients - 10 mg slowly intravenously or deeply intramuscularly, then intravenously drip at a rate of 5-15 mg per hour (100 mg of diazepam is diluted in 500 ml of 5% dextrose solution or 0.9% sodium chloride solution); children aged 1 month to 5 years - 1-2 mg intravenously or intramuscularly; children over 5 years old - 5-10 mg intravenously or intramuscularly; after 3-4 hours, you can repeat the injection at the same dose;
relief of convulsive states and epileptic seizures: adult patients - 10–20 mg intravenously or intramuscularly (after 3-4 hours, the administration can be repeated); children aged 1 month to 5 years - 0.2-0.5 mg slowly intravenously every 2-5 minutes until a maximum dose of 5 mg is reached; children over 5 years of age - 1 mg slowly intravenously every 2–5 minutes until a maximum dose of 10 mg is reached (after 2–4 hours, if necessary, repeated administration is possible);
withdrawal symptoms in alcoholism: 10 mg intramuscularly or intravenously every 4-6 hours on the first day, then 5 mg 3-4 times a day;
Internal Medicine Clinic: 5 mg per day intramuscularly; if necessary, you can increase the dose to 10 mg per day;
premedication: intramuscularly 1–2 hours before surgery, 10–20 mg for adults or 0.1–0.2 mg / kg for children;
complex diagnostic procedures (for short-term anesthesia): 10–20 mg for adults or 0.1–0.2 mg / kg for children;
obstetrics and gynecology: when the cervix is opened by 2-3 fingers - 10–20 mg intramuscularly; with a sharp increase in blood pressure - 10–20 mg per day intravenously, during a crisis, it is possible to increase the dose to 70 mg per day.

After the relief of the acute condition with the help of the parenteral form of Sibazon, the patient is transferred to oral administration of the drug in the form of tablets.

Impaired patients and elderly patients Sibazon administered in an initial dose of ¹ / ₂ the usual dose and then gradually increased, considering the tolerance and efficacy.

Side effects

digestive system: heartburn, nausea, decreased appetite, vomiting, hypersalivation or dry mouth, hiccups, constipation, gastralgia, jaundice, increased liver enzyme activity, liver dysfunction;
cardiovascular system: tachycardia, palpitations, lowering blood pressure;
nervous system: at the beginning of therapy (especially in elderly patients): drowsiness, increased fatigue, disorientation, slowing down of motor and mental reactions, dizziness, anterograde amnesia, depression, ataxia, dullness of emotions, impaired concentration; rarely - euphoria, catalepsy, uncontrolled body movements, muscle weakness, dysarthria, headache, decreased mood, confusion, asthenia, hyporeflexia, tremor; extremely rarely - psychomotor agitation, muscle spasm, anxiety, fear, sleep disturbances, aggressive outbursts, hallucinations, suicidal tendencies, confusion;
genitourinary system: impaired renal function, dysmenorrhea, urinary retention or incontinence, decreased or increased libido;
hematopoietic system: neutropenia, anemia, agranulocytosis, thrombocytopenia, leukopenia;
allergic reactions: itching and rash on the skin;
other reactions: drug dependence and addiction; rarely - bulimia, diplopia, weight loss, depression of the respiratory center.

When using Sibazon in obstetrics, newborns may experience the following adverse reactions: hypothermia, muscle hypotension and dyspnea.

In infants whose mothers took diazepam during pregnancy, especially in the first trimester, suppression of the sucking reflex, respiratory failure and depression of the central nervous system are possible.

With a sharp cancellation or reduction in the dose of the drug, a withdrawal syndrome occurs, manifested by the following reactions: anxiety, sleep disturbance, depersonalization, nausea, vomiting, photophobia, headache, fear, dysphoria, depression, perception disorders, convulsions, hallucinations, increased irritability, psychomotor agitation, spasm of skeletal muscles and smooth muscles of internal organs, increased sweating, tremor, paresthesia, tachycardia; rarely - psychotic disorders.

special instructions

Long-term use of Sibazon is not recommended.

Patients are strictly forbidden to consume alcohol during treatment, smoking reduces the effectiveness of diazepam.

With prolonged use of the drug, the peripheral blood picture and the activity of liver enzymes should be monitored.

During treatment, care is required when performing work associated with increased concentration.

Drug interactions

Sibazon enhances the inhibitory effect of neuroleptics, muscle relaxants, antidepressants, ethanol, narcotic analgesics, sedatives and general anesthetics.

Oral contraceptives, disulfiram, isoniazid, metoprolol, propoxyphene, cimetidine, erythromycin, fluoxetine, ketoconazole, propranolol and valproic acid - enhance the therapeutic effect of the drug; carbamazepine, rifampicin, caffeine, analeptics, monoamine oxidase inhibitors, psychostimulants - weaken.

Narcotic analgesics, when used simultaneously with diazepam, increase euphoria, which leads to an increase in mental dependence.

When taken together with antihypertensive drugs, an increase in the severity of a decrease in blood pressure is possible; with clozapine - the risk of respiratory depression increases; with levodopa - its effectiveness decreases in the treatment of patients with parkinsonism; with omeprazole - the elimination time of diazepam is lengthened; with low-polarity cardiac glycosides - the development of glycosidic intoxication is possible; with zidovudine - the toxicity of zidovudine may increase; with theophylline - a decrease or perversion of the sedative effect is possible.

Premedication with Sibazone allows you to reduce the dose of fentanyl required for induction of general anesthesia, as well as reduce the time required to turn off consciousness using induction doses.

Terms and conditions of storage

Store in a dark place, out of the reach of children, at a temperature not exceeding 30 ° C - tablets; 5–20 ° C - solution.

Shelf life: tablets - 5 years; solution - 3 years.

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!