Sibazon for children instructions for use. Tranquilizer Sibazon - reviews

Sibazon is an anxiolytic drug, a tranquilizer. This remedy has a calming effect on the central nervous system, and also helps to reduce anxiety, fear, tension.

The drug has a pronounced antiarrhythmic and anticonvulsant effect, helps to reduce the excretion gastric juice, as well as a decrease muscle tone.

In this article, we will consider why doctors prescribe Sibazon, including instructions for use, analogues and prices for this drug in pharmacies. Real REVIEWS of people who have already used Sibazon can be read in the comments.

Composition and form of release

Sibazon is produced in pharmacological forms tablets for adults (0.005 g each, 20 pieces per pack), tablets for children (20 pieces of 0.001 and 0.002 g each, coated) and a solution in ampoules (0.5% diazepam, 10 ampoules of 2 ml).

The composition of 1 tablet includes:

• Active substance: diazepam - 5 mg;
• Auxiliary components: lactose monohydrate (milk sugar), potato starch, calcium stearate (calcium stearate).

Pharmacological action: tranquilizer, has an anxiolytic effect.

Indications for use

The drug is prescribed in such cases:

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

pharmachologic effect

Tranquilizer. According to the instructions, Sibazon has a calming effect on the central nervous system, reducing the feeling of fear, anxiety and tension.

Sibazon has the following effects: anxiolytic, antiarrhythmic, muscle relaxant, mild hypnotic, antispasmodic, potentiating, anticonvulsant.

Due to increased presynaptic inhibition, the spread of epileptiform activity is stopped. Against the background of taking Sibazon, blood pressure decreases, coronary vessels expand, and the threshold of sensitivity to pain increases. The drug suppresses vestibular paroxysms, reduces the secretion of gastric juice. The therapeutic response is observed after a week (with paresthesia, cardialgia, arrhythmias).

Instructions for use

Sibazon is taken orally, injected intramuscularly, intravenously, rectally.

The daily dose varies from 500 mcg to 60 mg. A single dose, frequency and duration of use are set individually.

Contraindications

Do not use the drug in the presence of the following factors:

• with myasthenia;
• intolerance to diazepam;
• with angle-closure glaucoma;
• in case of poisoning with drugs that depress the central nervous system;
• when in a coma or shock;
• with acute alcohol intoxication with a threat to the functioning of body systems;
• in the presence of serious illnesses lungs and respiratory failure.

Side effects

In accordance with reviews of Sibazon, the drug in some cases can cause the development of such adverse reactions:

• allergic reactions: itching, skin rash.
• Local reactions: local thrombosis or phlebitis at the injection site.
• Hematopoietic system: neutropenia, leukopenia, thrombocytopenia, agranulocytosis, anemia.
• Digestive tract: loss of appetite, vomiting, nausea, dry mouth, constipation, jaundice, increased levels of liver enzymes, hypersalivation.
• Genitourinary system: urinary retention or incontinence, dysmenorrhea, decreased or increased libido, impaired renal function.
• Cardiovascular system: with parenteral administration, there is a drop in the level blood pressure, tachycardia, palpitations.
• Effect on the fetus: CNS depression, teratogenicity (especially in the first trimester of pregnancy). In the case of the use of Sibazon by the mother, suppression of the sucking reflex and respiratory failure in the child may be observed.
• Nervous system: ataxia, reduced ability to concentrate, poor coordination of movements, disorientation, dullness of emotions, fatigue, dizziness, drowsiness, slowing down of the speed of motor and mental reactions, gait instability, anterograde amnesia, euphoria, catalepsy, depression of mood, tremor of the extremities, depressive mood, weakness, confusion, euphoria, myasthenia during the day, headache, paradoxical reactions, dysarthria, hyporeflexia, irritability, acute agitation, hallucinations, muscle spasm, suicidal tendencies, fear, psychomotor agitation, outbursts of aggression, insomnia, anxiety, uncontrolled body movements.
• Other side effects: drug dependence and addiction, bulimia, blurred vision, weight loss, depression of the respiratory center.

With a sharp cancellation of Sibazon, according to reviews, it can cause a “withdrawal” syndrome (excitement, nervousness, irritability, sleep disturbances, fear, depression, nausea, tremor, vomiting, hallucinations, convulsions, increased sweating, spasm of smooth muscles).

Analogues Sibazon

Structural analogues for the active substance:

• Apaurin;
• Valium Roche;
• diazepabene;
• diazepam;
• Diazepex;
• diapam;
• Relanium;
• Relium;
• Seduxen.

Attention: the use of analogues must be agreed with the attending physician.

Price

The average price of SIBAZON, tablets in pharmacies (Moscow) is 40 rubles.

Terms of sale

You can buy Sibazon in the pharmacy chain upon presentation of a prescription, medical form.

1. Yana

   I don’t like the fact that the drug hits the windpipe - breathing becomes superficial, and the panic only intensifies. The doctor prescribed tablets under the tongue for a quick effect of 10 mg, I drink 5 mg each and then this is a loading dose for me. I'm waiting for a wild panic and experimenting.

2. Lada

   This drug was prescribed to me when I was in the hospital for treatment, one tablet at night. After taking Sibazon, she fell asleep instantly, did not wake up at night, did not see dreams. Only in the morning I felt completely overwhelmed, with a headache, without any desire to wake up and without mood. I had to give up the drug after a couple of days, though the dream returned by itself, maybe from the action of this drug, but the doctors don’t explain from it or not ...

3. hope

   I took a good sleep but the doctor canceled. She said that after the application you will lose your memory.

4. LEONID

   I've been ill for a long time terrible disease meningoencephalitis. In the hospital, they injected me with sibazon at night, it was easier. I had a dream until 5 in the morning and then I was like boiled. Then later they didn’t prick me. Now I take another tranquilizer, fenozepam, you get used to it, then you need to increase the dose. this is very bad. To relax muscle tone, they attributed mydocalm to me, it helps badly. So there is almost no sense from them. Now I need to take droppers every six months. This is with Actovegin, B vitamins, nootropics, mexidol. And good nutrition with vitamins. The hospital no longer treats me, the neurologist said. my treatment is not working. I will not treat you. This is the kind of medicine we have now in Russia. So now I myself buy everything at home that I need. me over the years. who have been treated. already know. what I need. and my wife does everything for me. Even the doctor said. that you go here, you already know. what to prick you. and you need to drink. So I do it myself. Still alive. but I suffer a lot, my whole body hurts. burning. itching. weakness. This is how I live.

5. Anatoly

   For two months I was tormented by insomnia. I turned to a psychotherapist and prescribed sibazon two tablets half an hour before bedtime and one in the evening after work. I took these pills to work, I couldn’t go, the condition was bad, right now I take one pill before going to bed, I fall asleep well, but a problem appeared in the morning, I feel sluggish, I really want to sleep, severe weakness lasts from about 8 to 15 hours, then it passes, I made an appointment again, I can change the medicine

means. Application of this pharmacological agent indicated in case of a feeling of anxiety or fear, pathologically increased muscle tone, convulsions, spasms of central origin and disorders heart rate. A tranquilizer is recommended for use in stomach ulcers to reduce acidity.

active ingredient

The active ingredient in Sibazon is the well-known tranquilizer diazepam. The drug is available both in the form for oral administration and as a solution for parenteral administration. Sibazon is produced in tablets designed specifically for patients childhood. These tablets of 0.001 and 0.002 grams (in terms of the active substance) are coated to facilitate the process of taking by the child. this medicine. For adults, tablets of 0.005 grams are produced, which are packaged in contour cell shells of 20 pieces. In addition, you can purchase an injection solution (0.5%) in 2 ml ampoules (ampoules are supplied to pharmacy chains in boxes of 10 pieces). A form is also available for use per rectum.

When is the use of Sibazon indicated?

Sibazon is prescribed for a number of diseases and pathological conditions. Among them:

• chronic sleep disorders ();
• anxiety disorders different genesis;
• withdrawal syndrome on the background;
• spasms of the muscles due to damage to the central nervous system.

The drug is also indicated for a number of diseases, one of clinical manifestations which is skeletal muscle hypertonicity:

• inflammatory and degenerative joint pathologies;
• muscle inflammation;
• inflammation of the joint bag;
• (including progressive chronic polyarthritis).

In some cases, according to the instructions, Sibazon can be used for premedication, and also as one of the components for introducing the patient into a state of anesthesia.

As one of the drugs for carrying out complex therapy Sibazon tablets are prescribed for diseases such as:

• hypertonic disease;
• ulcerative lesions of the stomach and (or) duodenum;
• menstrual disorders;
• psychosomatic pathologies characteristic of the menopause period;
• gestosis (late toxicosis during pregnancy);
• eczema;
• other lesions skin accompanied by itching;
• epileptic status.

How should Sibazon be used?

Sibazon tablets are intended for oral administration. The injection solution can be administered intravenously or intramuscularly.

The optimal dose of this tranquilizer is calculated for each patient individually, depending on the nosological form, severity of the course and dynamics of the disease, as well as on the patient's individual sensitivity to the active substance.

In most cases, a single dose is from 2.5 to 10 mg, and the frequency of administration is from 2 to 4 times a day.

With increased blood pressure and the treatment of angina pectoris, as well as psychosomatic disorders during pregnancy, the optimal dosage is 2-5 mg 3 times a day.

In neurological practice, a scheme is common, according to which patients take an anxiolytic drug 5-10 mg 2-3 times a day.

For parenteral administration, the optimal solvent is saline sodium chloride or dextrose.

Contraindications for use

Sibazon, according to the instructions, should not be prescribed to patients who have:

• individual increased sensitivity to the active substance;
• state of shock;
• coma;
• acute intoxication with ethyl alcohol (with a threat to the vital functions of the body);
• acute poisoning pharmacological agents that can depress the central nervous system;
• angle-closure glaucoma;
• dysfunction respiratory system;
• severe chronic obstructive pulmonary disease.

Special Instructions for Use and Warnings

With a sharp interruption of the therapeutic course, the development of a "withdrawal syndrome" is not excluded, which is characterized by increased irritability and nervousness. With abrupt cancellation, hallucinations, spastic contractions of smooth muscles, dyspeptic disorders and increased sweating may occur.

Particular care should be taken when prescribing Sibazon if the patient has pronounced renal and (or) hepatic insufficiency, ataxia, hyperkinesis, organic brain damage, and a tendency to nocturnal respiratory arrest (apnea). A tranquilizer should not be prescribed to people who abuse pharmacological substances with psychoactive effects. Against the background of epilepsy, abrupt withdrawal of the tranquilizer can accelerate the development of status epilepticus. Care must also be taken when prescribing medicinal product persons of advanced and senile age. During the period of taking a tranquilizer, patients are forbidden to administer vehicles or work with other potentially dangerous mechanisms, since the concentration of attention under the influence of diazepam is significantly reduced.

How does Sibazon work?

Quite a powerful tranquilizer drug Sibazon is characterized by a direct effect on the central nervous system. It is able to stop the feeling of unmotivated anxiety and fear and relieves the patient of excessive tension. Diazepam helps fight convulsions, muscle hypertonicity and heart rhythm disturbances. Due to the fact that this substance is able to partially block the activity of the secretory glands of the stomach, reducing the production of gastric juice, it is often prescribed during therapy. peptic ulcer. Long-term clinical trials have shown that Sibazon has pronounced hypnotic properties.

Diazepam increases the affinity of a specific receptor for gamma-aminobutyric acid.

The drug allows you to lower blood pressure, increase individual pain threshold and expand coronary vessels.

With violations of sensitivity, as well as pain in the heart and heart rhythm disturbances therapeutic effect develops on average one week after the start of the drug.

Side effects

The active substance of this drug (diazepam) can lead to the development of a number of undesirable effects, which include:

• allergic reactions (with hypersensitivity to diazepam);
• constant sleepiness;
• fatigue;
• disorientation in space;
• ataxia;
• impaired coordination of movements;
• depressed state;
• confusion;
• tremor (trembling) of the limbs;
• recurrent headaches;
• decreased ability to concentrate and remember;
• loss of appetite (up to anorexia);
• dyspeptic disorders;
• decreased functional activity of the liver;
• kidney failure;
• increased separation of saliva;
• violation of sexual desire;
• arterial hypotension;
• cardiopalmus.

When conducting laboratory research a blood test may reveal anemia (anemia), agranulocytosis, neutropenia, and thrombocytopenia.

With parenteral administration of a solution of Sibazon, the development of phlebitis or thrombosis at the injection site is possible. To prevent this complication, it is recommended to change the needle injection point.

It is not excluded the development of drug dependence on this pharmacological agent, as well as the appearance of "wolf hunger" or a pronounced decrease in body weight.

Interaction with other drugs

Sibazon is able to potentiate the action of drugs from the group of neuroleptics.

Sibazon and alcohol

Sibazon significantly enhances the effect of ethanol on the body. During therapy with the use of this anxiolytic agent, even low-alcohol drinks should be completely abandoned, since even relatively small doses can cause confusion or loss of consciousness.

Overdose

When single and daily doses are exceeded, there may be an increase side effects. In particular, respiratory failure is not ruled out.

Sibazon during pregnancy and lactation

According to the instructions, Sibazon can be prescribed to pregnant women at the end of the last trimester in case of premature birth. An anxiolytic agent is also indicated to facilitate labor and in such a serious pathology as placental abruption. In the first trimester, diazepam is contraindicated for expectant mothers, since diazepam has a teratogenic effect, as well as its negative effect on the central nervous system of the fetus. According to the instructions, Sibazon tablets should also not be taken by women during breastfeeding, since the child may develop respiratory failure and suppression of the sucking reflex.

Sibazon in pediatric practice

For small patients, the remedy is indicated for the relief of spastic conditions, as well as for diagnosed psychosomatic disorders. Initially, the child is prescribed the minimum dose, gradually increasing it to the minimum therapeutic dose. The maximum allowable daily dose for a child older than six months should not exceed 1-2.5 mg. It can be determined at the rate of 40-200 mcg per 1 kilogram of the baby's weight. A tranquilizer in the form for oral administration is contraindicated in children under six months of age. The injection form is not administered to babies in the first month of life. According to studies by neonatologists, both in full-term and premature babies, Sibazon can cause side effects such as a decrease in overall body temperature, respiratory failure and deterioration in muscle tone.

Storage conditions and shelf life

Both tablets and solution for injection must be stored in a place that is reliably shielded from light. The humidity level should be as low as possible. Sibazon solution can be stored for up to 2 years, and a tablet form for adults - up to 3 years. The shelf life of a tranquilizer intended for children should not exceed 2 years.

| Sibazon

Analogues (generics, synonyms)

Alizeum, Diazepam, Sikotrit, Faustan, Apo-Diazepam, Diazepex, Apaurin, Bensedin, Diazepabene, Diazepam Desitin, Relanium, Valium, Diazekpex, Seduxen, Diazepam-Teva, Metapam, Novo-Dipam Diapam, Dikam, Kalmpouz, Vatran, Vival, Lembrol, Aposepam, Atilene, Eridan, Quetinil, Saromet, Serenamine, Sonason, Stesolin, Ushamir, Valitran

Recipe (international)

Rep.: Tab. Sibazoni 0.005 №30
D.S. 1 tab. 2 r / d.

Rep: Sol. Sibazonii 0.5% - 2 ml

D.t.d.N. 5 in amp.

S. According to the scheme.

Recipe (Russia)

Prescription form - 148-1 / y-88

Rp.: Sol. Diazepami 0.5% - 2 ml

S. 1 ampoule 2 times a day

Rep: Tab. Diazepami 0.005

D.t.d: No. 20 in tab.

S: 1 tab. 2 times a day inside.

Active substance

Diazepam (Diazepamum)

pharmachologic effect

A tranquilizer, a benzodiazepine derivative. It has an anxiolytic, sedative, anticonvulsant, central muscle relaxant effect. The mechanism of action is associated with an increase in the inhibitory effect of GABA in the central nervous system. The muscle relaxant effect is also due to the inhibition spinal reflexes. May cause anticholinergic effects.

Pharmacokinetics

Absorption is fast. Cmax in plasma is observed after 90 minutes. Plasma protein binding is 98%. Penetrates through the placental barrier, into the cerebrospinal fluid, excreted with breast milk. Metabolized in the liver. Excreted by the kidneys - 70%.

Mode of application

For adults:

inside. The dose is calculated individually, depending on the patient's condition, clinical picture disease, drug sensitivity.

When taken orally, the average single dose for adults is 5-15 mg. In some cases, with severe excitement, fear, anxiety, a single dose is increased to 20 mg. The daily dose is usually 15-45 mg, the maximum daily dose is 60 mg. The daily dose of the drug is divided into 2-3 doses.

As an anxiolytic - 5-10 mg 2-4 times a day.

With alcohol withdrawal syndrome - 10 mg 3-4 times a day for the first 24 hours, followed by a decrease to 5 mg 3-4 times a day.

For elderly patients and debilitated patients, the drug is administered at lower doses, which are 1/2 or 2/3 of the average.

Neurology: spastic states of central origin in degenerative neurological diseases- 5-10 mg 2-3 times a day.

Clinic of internal diseases: 5 mg 2-3 times a day, if necessary and taking into account tolerance - up to 10 mg 4 times a day.

Climacteric and menstrual disorders: 5 mg 2-3 times a day.

Anesthesiology, surgery: premedication - on the eve of surgery, in the evening - 10-20 mg.

Indications

neuroses
- boundary conditions with stress phenomena
- anxiety, anxiety, fear;
- sleep disorders
- motor excitation of various etiologies in neurology and psychiatry
- withdrawal syndrome in chronic alcoholism;
- spastic states
associated with damage to the brain or spinal cord
- myositis
- bursitis
- arthritis
- associated with skeletal muscle tension
- status epilepticus
- premedication before anesthesia
- as a component of combined anesthesia
- facilitating labor
- premature birth
- premature detachment of the placenta
- tetanus.

Contraindications

severe myasthenia gravis
- severe chronic hypercapnia
- indications in the anamnesis of alcohol or drug dependence (except for acute withdrawal)
- hypersensitivity to diazepam and other benzodiazepines.

Side effects

From the side nervous system: drowsiness, dizziness, muscle weakness; rarely - confusion, depression, visual disturbances, diplopia, dysarthria, headache, tremor, ataxia; in isolated cases - paradoxical reactions: agitation, anxiety, sleep disturbances, hallucinations. After intravenous administration, hiccups are sometimes observed. With prolonged use, the development of drug dependence, memory impairment is possible.

From the side digestive system: rarely - constipation, nausea, dry mouth, salivation; in isolated cases - an increase in the activity of transaminases and alkaline phosphatase in the blood plasma, jaundice.

From the side endocrine system: rarely - increase or decrease in libido.

From the urinary system: rarely - urinary incontinence.

From the side of cardio-vascular system: with parenteral use, a slight decrease in blood pressure is possible.

On the part of the respiratory system: in case of parenteral use in isolated cases - respiratory disorders.

Allergic reactions: rarely - skin rash.

Release form

Tablets 1 tab.

active ingredient: diazepam (sibazon) 0.005 g
excipients: lactose monohydrate (milk sugar); potato starch; calcium stearate (calcium stearate)

Release form, composition and packaging
Solution for injection 0.5% 1 ml 1 amp.
diazepam 5 mg 10 mg
2 ml - dark glass ampoules (5) - blister packs (1) - cardboard packs.
2 ml - dark glass ampoules (5) - blister packs (2) - cardboard packs.
2 ml - dark glass ampoules (5) - blister packs.
2 ml - dark glass ampoules (5) - blister packs (100) - cardboard boxes.

ATTENTION!

The information on the page you are viewing was created for informational purposes only and does not promote self-treatment in any way. The resource is intended to familiarize healthcare professionals with additional information about certain medicines, thereby increasing their level of professionalism. The use of the drug "" without fail provides for a consultation with a specialist, as well as his recommendations on the method of application and dosage of the medicine you have chosen.

Composition and form of release of the drug

20 pcs. - jars of dark glass (1) - packs of cardboard.
20 pcs. - polymer cans (1) - packs of cardboard.
20 pcs. - cellular contour packings (1) - packs of cardboard.

pharmachologic effect

A tranquilizer, a benzodiazepine derivative. It has an anxiolytic, sedative, anticonvulsant, central muscle relaxant effect. The mechanism of action is associated with an increase in the inhibitory effect of GABA in the central nervous system. The muscle relaxant effect is also due to the inhibition of spinal reflexes. May cause anticholinergic effects.

Pharmacokinetics

Absorption is fast. C max in is noted after 90 minutes. Plasma protein binding is 98%. Penetrates through the placental barrier, into the cerebrospinal fluid, excreted in breast milk. Metabolized in the liver. Excreted by the kidneys - 70%.

Indications

Neuroses, borderline states with manifestations of tension, anxiety, anxiety, fear; sleep disorders, motor excitation of various etiologies in neurology and psychiatry, withdrawal syndrome in chronic alcoholism; spastic conditions associated with damage to the brain or spinal cord, as well as myositis, bursitis, arthritis, accompanied by skeletal muscle tension; epileptic status; premedication before anesthesia; as a component of combined anesthesia; relief of labor activity, premature birth, premature detachment of the placenta, tetanus.

Contraindications

Severe myasthenia gravis, severe chronic hypercapnia. History of alcohol or drug dependence (other than acute withdrawal). Hypersensitivity to diazepam and other benzodiazepines.

Dosage

It is taken orally, administered intramuscularly, intravenously, rectally. The daily dose varies from 500 mcg to 60 mg. A single dose, frequency and duration of use are set individually.

Side effects

From the nervous system: drowsiness, dizziness, muscle weakness; rarely - confusion, depression, visual disturbances, diplopia, dysarthria, headache, tremor, ataxia; in isolated cases - paradoxical reactions: agitation, anxiety, sleep disturbances, hallucinations. After intravenous administration, hiccups are sometimes observed. With prolonged use, the development of drug dependence, memory impairment is possible.

From the digestive system: rarely - constipation, nausea, dry mouth, salivation; in isolated cases - an increase in the activity of transaminases and alkaline phosphatase in the blood plasma, jaundice.

From the endocrine system: rarely - an increase or decrease in libido.

From the urinary system: rarely - urinary incontinence.

From the side of the cardiovascular system: with parenteral use, a slight decrease in blood pressure is possible.

From the respiratory system: with parenteral use in isolated cases - respiratory disorders.

Allergic reactions: rarely - skin rash.

drug interaction

When used simultaneously with medicines that have a depressing effect on the central nervous system (including with neuroleptics, sedatives, hypnotics, opioids, anesthetics), the inhibitory effect on the central nervous system, on the respiratory center, and severe arterial hypotension increase.

With simultaneous use with tricyclic antidepressants (including with amitriptyline), it is possible to increase the inhibitory effect on the central nervous system, increase the concentration of antidepressants and increase the cholinergic effect.

In patients receiving long-term central action, beta-blockers, anticoagulants, cardiac glycosides, degree and mechanisms drug interaction unpredictable.

With simultaneous use with muscle relaxants, the effect of muscle relaxants increases, the risk of apnea increases.

With simultaneous use with oral contraceptives, it is possible to enhance the effects of diazepam. Increased risk of breakthrough bleeding.

With simultaneous use with possible increase in the concentration of bupivacaine in the blood plasma; with diclofenac - dizziness may increase; with isoniazid - a decrease in the excretion of diazepam from the body.

drugs, causing induction liver enzymes, incl. antiepileptic drugs (, phenytoin), can accelerate the excretion of diazepam.

With simultaneous use with caffeine, the sedative and, possibly, anxiolytic effect of diazepam decreases.

With simultaneous use with possible severe arterial hypotension, respiratory depression, loss of consciousness; with levodopa - suppression of antiparkinsonian action is possible; with lithium carbonate - a case of the development of a coma is described; with metoprolol - a decrease in visual acuity, a deterioration in psychomotor reactions are possible.

With simultaneous use with paracetamol, it is possible to reduce the excretion of diazepam and its metabolite (desmethyldiazepam); with risperidone - cases of the development of NMS are described.

With simultaneous use with rifampicin, the excretion of diazepam increases due to a significant increase in its metabolism under the influence of rifampicin.

Theophylline in low doses, perverts the sedative effect of diazepam.

With simultaneous use in rare cases, diazepam inhibits metabolism and enhances the effect of phenytoin. Phenobarbital and phenytoin may accelerate the metabolism of diazepam.

With the simultaneous use of fluvoxamine increases the concentration in the blood plasma and the side effects of diazepam.

With simultaneous use with cimetidine, omeprazole, disulfiram, an increase in the intensity and duration of action of diazepam is possible.

With the simultaneous intake of ethanol, ethanol-containing drugs, the inhibitory effect on the central nervous system (mainly on the respiratory center) increases, and a syndrome of pathological intoxication may also occur.

special instructions

Use with extreme caution in patients with cardiac and respiratory failure, organic changes in the brain (in such cases it is recommended to avoid parenteral administration of diazepam), with angle-closure glaucoma and a predisposition to it, with myasthenia gravis.

Special care is required when using diazepam, especially at the beginning of treatment, in patients who have long received centrally acting antihypertensive drugs, beta-blockers, anticoagulants, cardiac glycosides.

When therapy is discontinued, the dose should be reduced gradually. With the sudden cancellation of diazepam after prolonged use, anxiety, agitation, tremor, convulsions are possible.

Diazepam should be discontinued with the development of paradoxical reactions (acute agitation, anxiety, sleep disturbances and hallucinations).

After an intramuscular injection of diazepam, an increase in the activity of CPK in the blood plasma is possible (which should be taken into account when differential diagnosis myocardial infarction).

Avoid intravenous administration.

Avoid drinking alcohol during treatment.

Influence on the ability to drive vehicles and control mechanisms

Diazepam may cause a slowdown in the rate of psychomotor reactions, which should be considered in patients involved in potentially dangerous species activities.

Pregnancy and lactation

Do not use diazepam in the first trimester of pregnancy, except in cases of emergency. It should be borne in mind that when diazepam is used during pregnancy, a significant change in the fetal heart rate is possible.

When taken regularly during lactation breast-feeding should be stopped.

Application in childhood

The use of diazepam in newborns should be avoided, since they have not yet fully formed the enzyme system involved in the metabolism of diazepam.

Sibazone is an effective tranquilizer from the family of benzodiazepine derivatives. When prescribing this drug, a number of restrictions and contraindications must be taken into account. If side effects develop, dosage adjustment or drug withdrawal will be required, followed by selection of alternative therapy.

Throughout the course of treatment, it is necessary to strictly adhere to the instructions of the attending physician. When Sibazon is used simultaneously with antihypertensive drugs, an increase in their action is observed, which can lead to an excessive decrease in blood pressure.

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general information

The active substance of the drug Sibazon is diazepam.

This medication is available in the following dosage forms:

Dosage form		Auxiliary components	Release form
Tablets	In one tablet 5 mg diazepam	calcium stearate, lactose monohydrate, starch	20 tablets in a dark glass jar or in a polymer jar. 20 tablets in a blister pack. Secondary packaging - a cardboard bundle containing one jar or cell packaging
Solution for injection 0.5%	In one milliliter of a solution of 5 mg of diazepam	Specially prepared water for injection, ethanol, sodium chloride, macrogol, propylene glycol	Dark glass ampoules, 2 ml medicinal solution, in a cell pack of 5 pieces. Secondary packaging - a carton box containing 1 or 2 blister packs. For hospitals, cardboard boxes are produced containing 100 blister packs

The release of the drug Sibazon from pharmacies is carried out by prescription.

The medicinal product should be stored at a temperature not exceeding 30 degrees and not more than 5 years.



Pharmacological properties

Sibazon belongs to the group of tranquilizers (anxiolytic drugs).

The active substance, diazepam, is a member of the class of benzodiazepine derivatives.

Diazepam has the following effects on the body:

• anticonvulsant;
• sedative-hypnotic;
• central muscle relaxant;
• anxiolytic;
• antispasmodic, which is expressed in a decrease in blood pressure, expansion of the lumen of the coronary arteries.

Also active ingredient capable of:

• increase the threshold of pain sensitivity;
• suppress the activity of the parasympathetic nervous system;
• reduce the production of gastric juice at night.

A stable effect of treatment with Sibazon is noted in the interval from the 2nd to the 7th day of the start of therapy.

The mechanism of action of diazepam is based on the stimulation of benzodiazepine receptors in the central nervous system. The anxiolytic effect is due to the influence of the substance on the amygdala complex of the limbic system.

Sedation and elimination of symptoms of neurotic disorders (fear, anxiety) are provided due to the effect of diazepam on nonspecific thalamic nuclei and the reticular formation.



Pregabalin - instructions for use and analogues

Indications for use

Treatment with Sibazon is effective in the following pathologies:

• all forms of disorders accompanied by a state of anxiety;
• dysphoria (in the treatment of this disorder, Sibazon is a component of combination therapy);
• state of spasticity (with tetanus, cerebral palsy, organic lesions brain and spinal cord, athetosis);
• a condition accompanied by spasms of skeletal muscles in rheumatic spondyloarthritis, arthrosis, bursitis, myositis, progressive chronic polyarthritis, vertebral syndrome, tension headaches, angina pectoris;
• withdrawal syndrome on the background of alcoholic disease, accompanied by agitation, anxiety, tension, transient reactive state, tremor;
• psychosomatic disorders in gestosis, premenstrual syndrome, status epilepticus, peptic ulcer, arterial hypertension, eczema (in the treatment of these conditions, Sibazon is a component of complex therapy);
• drug intoxication;
• Meniere's disease;
• premedication before the proposed endoscopic examination or surgery;
• epileptic seizures;
• paranoid-hallucinatory states;
• motor excitation in psychiatric and neurological practice.

Also, the drug is indicated to facilitate labor in case of premature detachment of the placenta.



Contraindications

The conditions excluding the use of Sibazon are:

• intolerance to the active substance - diazepam;
• acute intoxication caused by other medicines;
• acute alcohol intoxication with concomitant damage to vital organs;
• angle-closure glaucoma;
• myasthenia gravis;
• severe variant of the course of chronic obstructive pulmonary disease;
• absence seizures in epilepsy;
• acute form of respiratory failure;
• period of pregnancy;
• breast-feeding.

Increased caution requires the appointment of Sibazon to the following categories of patients:

• elderly people;
• patients with a diagnosis of epilepsy, as well as those with a history of epileptic seizures;
• patients with cerebral or spinal ataxia;
• patients with insufficiency of liver function, with renal insufficiency;
• patients with organic brain diseases;
• people with nocturnal respiratory arrest syndrome;
• patients with a tendency to abuse psychotropic drugs;
• individuals with a history of drug dependence.

Side effects

Against the background of the use of Sibazon, the development of the following adverse reactions is likely:

• ataxia;
• decrease in the degree of concentration of attention;
• deterioration in coordination of movements;
• disorientation in space and time;
• weakening of emotions;
• increased fatigue;
• dizziness;
• increased drowsiness;
• slowing down the speed of psychomotor reactions;
• unsteadiness when walking;
• anterograde amnesia;
• euphoric state;
• catalepsy;
• depressed emotional background;
• tremor of the limbs;
• depressive state;
• weakness;
• confusion;
• headache;
• paradoxical reactions;
• speech disorder;
• decreased reflexes;
• irritability, psychomotor agitation;
• hallucinatory syndrome;
• muscle spasms;
• suicidal thoughts and tendencies;
• fears; anxiety;
• episodes of aggressiveness;
• sleep disturbance in the form of insomnia;
• uncontrolled body movements;
• loss of appetite;
• vomit;
• dyspeptic syndrome;
• yellowness of the skin;
• increased levels of liver enzymes in the blood;
• increased salivation;
• decrease in the content of formed elements in the peripheral blood;
• drop in blood pressure (more typical for parenteral - intramuscular or intravenous - administration of the drug);
• increased heart rate, increased heart rate;
• dysmenorrhea;
• kidney dysfunction;
• urinary retention;
• allergic reactions in the form skin rashes and itching.

Reactions such as double vision, weight loss, bulimia are also possible.

With parenteral administration of Sibazon at the injection site, venous thrombosis, phlebitis, hyperemia and infiltrate.

When using the drug during pregnancy in a newborn baby, inhibition of the sucking reflex and impaired function of the respiratory system are noted.

When Sibazon is used in neonatology, both full-term and premature babies experience dyspnea, hypothermia, and a decrease in muscle tone.

With a sharp discontinuation of the medication or a decrease in the dose, the development of a withdrawal syndrome is characteristic, characterized by a state of anxiety, irritability, depression, hyperhidrosis, depersonalization, sleep disturbances, nervousness, dysphoria, muscle spasms (mainly characteristic of smooth muscles), acute psychosis, hallucinations, convulsions, headache, photophobia, paresthesias, perception disorders.

Directions for use and dosage

The use of Sibazon is possible both inside and in the form of injections - intramuscular and intravenous.

The dosage is selected individually and depends on the reaction of the patient's body to active substance, severity of symptoms and their dynamics during treatment.

According to the instructions for use, Sibazon is dosed as follows:

Indications	Dosages
In psychiatry: for phobic disorders, dysphoria, hypochondria, hysterical reactions and neuroses	5-10 mg 2-3 times a day
To achieve anxiolytic action	2.5 to 10 mg 2-4 times a day. If necessary, the attending physician may increase the dosage to 60 mg per day
With alcohol withdrawal syndrome	On the first day - 10 mg 3-4 rubles / day. Starting from the next day, the dose of the drug is reduced by 2 times
In neurological practice: in degenerative diseases, in spastic conditions of central origin	5-10 mg of Sibazon 2-3 rubles / day
With arterial hypertension and angina pectoris	From 2 to 5 mg in a single dose 2-3 rubles / day
With vertebral syndrome	10 mg 4 times a day
In the complex therapy of myocardial infarction	Initial dosage - 10 mg intramuscularly, after which a single dose of 5-10 mg - 1-3 rubles / day
As a premedication for defibrillation	The drug is administered intravenously slowly, in separate doses of 10-30 mg
In spastic conditions of rheumatic vertebral genesis	Initial dose - 10 mg intramuscularly, then 5 mg 1-4 times a day
With menstrual or menopausal disorders, as well as psychosomatic diseases	Single dose - 2-5 mg 2-3 rubles / day
For preeclampsia	Intravenous administration of 10 to 20 mg Sibazon. In the future, oral administration of 5-10 mg 3 times a day
With premature detachment of the placenta	Continuous reception of Sibazon until the moment of full maturation of the fetus
In anesthesiology and surgical practice for premedication	10-20 mg once
In pediatrics: in spastic states of central origin and reactive psychosomatic disorders	You should start taking Sibazon with small doses, gradually increasing them.
With repeated severe epileptic seizures, as well as epileptic status in children under 5 years of age	Only parenterally. Intravenously administered 0.2-0.5 mg every 5 minutes, the maximum total dose is 5 mg
With traumatic lesions of the spinal cord, accompanied by hemiplegia or paraplegia, as well as with chorea	Sibazone is administered intramuscularly in an amount of 10-20 mg
When stimulated	Requires intravenous administration of 10-20 mg 3 times a day
For the relief of severe muscle spasm	Once intravenously at a dose of 10 mg
If the patient has atherosclerosis or weakened immunity	2 mg twice a day

Overdose

Taking an excessive amount of Sibazon is manifested by the following symptoms:

• decrease or complete absence reflexes;
• paradoxical reaction in the form of excitation;
• confused mind;
• increased drowsiness, falling into a deep sleep;
• reduced response to pain irritation;
• a state of stupor;
• slow heart rate;
• tremor of the limbs;
• violation of visual perception;
• oppression respiratory function and work of the cardiovascular system;
• the appearance of nystagmus;
• state of collapse;
• coma.

An overdose of Sibazon requires the following set of measures:

• intake of enterosorbents;
• gastric lavage;
• artificial ventilation of the lungs in case of severe respiratory depression;
• maintaining blood pressure levels.

The specific antagonist of Sibazone is Flumazenil. The use of this substance is possible strictly in a hospital setting. Flumazenil should not be administered to patients with epilepsy taking benzodiazepine derivatives, as there is a risk of provoking epileptic seizures.

Hemodialysis with an overdose of Sibazon is ineffective.

Interaction

Sibazon is able to enhance the severity of the inhibitory effect on the central nervous system of the following drugs:

• antidepressants;
• neuroleptics;
• sedatives;
• antipsychotic drugs;
• muscle relaxants;
• drugs for general anesthesia;
• narcotic analgesics.

At joint admission Sibazone with Propoxyphene, valproic acid preparations, Propranolol, Metoprolol, Ketoconazole, Isoniazid, Fluoxetine, Erythromycin, oral contraceptives, Cimetidine and other inhibitors of microsomal oxidation, an increase and an increase in the duration of action of Sibazone, as well as a lengthening of its half-life from the body.

The following features must also be taken into account:

A drug	The effect of the combination with Sibazon
Narcotic analgesics	An increase in psychological dependence and an increase in euphoria are recorded
Antacids	Against the background of taking antihypertensive drugs, there is an increase in their action in the form of an excessive decrease in blood pressure.
Clozapine	Simultaneous use can increase the blocking of respiratory function
Levodopa	In patients with Parkinson's disease, the effectiveness of an antiparkinsonian agent decreases while taking diazepam.
Omeprazole	The time of excretion of Sibazon from the body increases
Psychostimulants, analeptics, monoamine oxidase inhibitors	Sibazon's activity is decreasing
Zidovudine	The toxicity of the drug increases
Theophylline	The sedative effect of Sibazon is reduced and perverted
Rifampicin	Can enhance excretion active substance, thereby reducing its concentration

Mixing Sibazon's solution with other drugs in one syringe is unacceptable.

special instructions

Intravenous administration of Sibazon should be carried out slowly. It must be injected into a large vein at a rate of 5 mg (1 ml) per minute. Continuous intravenous infusion is unacceptable due to the risk of sedimentation.

At the time of treatment with Sibazon, an absolute rejection of the use of alcoholic beverages and drugs is necessary.

With clinically significant liver pathology, systematic monitoring of liver enzymes and the biochemical picture of peripheral blood is required.

With prolonged therapy, especially with high doses of the drug, the formation of drug dependence is characteristic. Long-term treatment is possible only in exceptional cases. Abrupt discontinuation of the drug Sibazon is unacceptable, as it leads to a withdrawal syndrome, which significantly worsens the patient's condition.

Side effects in the form of the appearance of suicidal thoughts and intentions, an increase in the degree of muscle cramps require discontinuation of the drug and the selection of alternative therapy.

During pregnancy, Sibazon can be prescribed only for health reasons. During the treatment with Sibazon during this period, there is an increased risk of the formation of congenital malformations, as well as toxic effects on the fetus.

The most sensitive to the inhibitory effect of benzodiazepines are young children, so Sibazon should be prescribed to newborns only in exceptional cases.

Given the negative effect of diazepam on coordination, during treatment with this drug, it is necessary to refrain from driving vehicles and work that requires increased concentration.