Seduxen
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
Seduxen is a tranquilizer (benzodiazepine derivative) that has a muscle relaxant, sedative, anxiolytic, anticonvulsant effect.
Release form and composition
Dosage forms:
- tablets: white or white with a cream shade, flat-cylindrical shape, engraved on both sides: on one side - SEDUXEN, on the other - 5 mg, with bevel, practically odorless (10 pcs. in a blister strip, 2 packs in a box);
- solution for intravenous (i / v) and intramuscular (i / m) administration: clear liquid from colorless to light green (2 ml each in dark glass ampoules, 5 ampoules in a plastic case, 1 case in a cardboard box).
1 tablet contains:
- active substance: diazepam - 5 mg;
- auxiliary components: lactose monohydrate, corn starch, aerosil (colloidal silicon dioxide), magnesium stearate, talc.
1 ml of solution contains:
- active substance: diazepam - 5 mg;
- auxiliary components: ethanol 95%, sodium citrate, glycofurol, nipagin (methyl parahydroxybenzoate), sodium metabisulfite, propylene glycol, nipazole (propyl parahydroxybenzoate), water for injection.
Indications for use
- neuroses, including psycho- and neurosis-like states with anxiety syndrome in cerebral atherosclerosis and other organic brain lesions, endogenous diseases;
- mental pathologies, proceeding with agitation, motor restlessness, sharp anxiety;
- auxiliary therapy for endogenous psychosis, nervous tension, anxiety accompanying psychosomatic diseases;
- epilepsy, mental equivalents (as an adjuvant);
- a state of anxiety arising from diseases of the internal organs;
- pathologies that cause increased muscle tone, hyperkinesis or spasticity;
- muscle stiffness, spasms, contractures;
- tetanus, all kinds of convulsive conditions;
- eclampsia;
- premedication during surgical operations;
- neurotic conditions in pediatric practice (sleep disturbance, anxiety, enuresis, headache, stubbornness reaction, bad habits, tic);
- premature birth or their threat in case of muscle spasm (only at the end of the third trimester of pregnancy), induction anesthesia.
In addition, the solution is prescribed for status epilepticus, severe (often recurring) seizures.
Contraindications
- coma;
- shock;
- angle-closure glaucoma;
- sleep apnea syndrome;
- severe myasthenia gravis;
- state of alcoholic intoxication (suppression of important vital functions);
- an indication of a history of alcohol, drug addiction (except for delirium, alcohol withdrawal syndrome);
- a state of acute intoxication against the background of the use of hypnotics, narcotic or psychotropic drugs with a depressing effect on the central nervous system (CNS);
- acute respiratory failure;
- severe chronic obstructive pulmonary disease (risk of worsening respiratory failure);
- the period of pregnancy and breastfeeding;
- hypersensitivity to benzodiazepine derivatives.
It is strictly forbidden to use tablets in the first trimester, solution - I and III trimesters of pregnancy.
Age contraindications:
- tablets: age up to 6 years;
- solution: infants up to 30 days of age.
It is recommended to prescribe Seduxen with caution in case of renal and / or hepatic insufficiency, absence (Lennox-Gastaut syndrome), epilepsy, spinal and cerebral ataxia, organic pathologies of the brain (risk of paradoxical reactions), hyperkinesis, depression, hypoproteinemia, patients with a tendency to abuse psychotropic drugs for patients in old age.
Method of administration and dosage
Pills
The tablets are taken orally.
The doctor prescribes the dose individually, based on clinical indications, taking into account the patient's condition and his response to therapy. Treatment begins with low doses with a gradual increase.
The daily dose is divided into 2-4 doses individually, while it is considered appropriate to take 2/3 of the daily dose in the evening.
Recommended dosage for adults:
- psychosomatic diseases, neurological and anxiety-phobic disorders: the average single dose is 2.5–5 mg (but not more than 10 mg), 5–20 mg per day;
- symptomatic therapy of convulsive syndrome: usually 2.5-10 mg 2-4 times a day;
- mental disorders of organic origin (as part of complex therapy): the initial dose is 20–40 mg per day, the maintenance dose is 15–20 mg per day;
- muscle contractures, rigidity, spasticity: 5–20 mg per day.
Elderly patients, with cachexia, decreased liver function, treatment should be started with 1/2 of the recommended dose, since the elimination of Seduxen can be significantly lengthened. Then, taking into account individual tolerance, the dose can be gradually increased.
For children over 6 years of age, the dose should be determined taking into account the child's age and level of physical development.
The initial dose should be 1.25–2.5 mg per day, after evaluating the patient's response to therapy, the dose is reduced or increased.
Solution for i / v and i / m administration
The solution is injected slowly intravenously (the rate should not exceed the introduction of 1 ml (5 mg) per minute in adults and within three minutes in children) or deeply intramuscularly.
Do not inject into arteries and allow the drug to enter the tissue surrounding the vein!
Treatment should be started with the lowest effective dose, gradually increasing to the lowest effective and at the same time sufficiently tolerated dose.
Recommended dosage for adults:
- relief of psychomotor agitation proceeding with anxiety: 10–20 mg i / m, in severe cases i / v, if necessary - 10 mg 3-4 times a day;
- alcohol withdrawal syndrome, delirium, conditions with increased muscle tone: i / m no more than 10 mg 3-4 times a day;
- status epilepticus: IV, initial dose - 10-30 mg every 0.5-1 hour, then - after 4 hours. The daily dose should not exceed 80-100 mg. The intramuscular injection is switched after the patient has cessation of convulsions - 10 mg every 4-6 hours. Treatment can continue for several days;
- tetanus: intramuscular, intravenous or intravenous drip - 10–20 mg every 2–8 hours, the interval between procedures depends on the patient's clinical condition;
- removal of skeletal muscle spasm: i / m - no more than 10 mg 0.5 hours before the start of the operation.
In addition to absolute indications - epilepsy or tetanus, Seduxen should not be used in children under 5 years of age, since there are age-related characteristics of the distribution and metabolism of the drug.
Recommended dosage for children:
- children from 30 days of age: IV - at the rate of 0.1-0.3 mg per 1 kg of body weight, but not more than 5 mg. If necessary, after 2–4 hours the procedure can be repeated;
- children over 5 years of age: IV - 1 mg every 2-5 minutes until a maximum dose of 0.2 mg (with convulsions - up to 0.3 mg) is reached per 1 kg of the child's weight. If necessary, the treatment can be repeated after 2–4 hours.
With an increase in epileptic seizures and status epilepticus, the initial dose for intravenous administration increases to 2–10 mg, the second injection is given after 0.5–1 hour, the third - after 4 hours at the same dose.
The introduction of the drug in children more than 3 times a day is permissible only with tetanus and status epilepticus.
Side effects
- cardiovascular system: tachycardia, palpitations, lowering blood pressure (BP);
- nervous system: at the beginning of treatment (especially in elderly patients) - increased fatigue, drowsiness, impaired concentration, dizziness, retardation of mental and motor reactions, disorientation, anterograde amnesia, ataxia; rarely - decreased mood, headache, confusion, euphoria, catalepsy, dysarthria, tremor, dystonic extrapyramidal reactions, muscle weakness, asthenia, hyporeflexia; extremely rarely - paradoxical reactions (fear, sleep disturbances, aggressive outbursts, suicidal tendencies, psychomotor agitation, confusion, hallucinations, muscle spasm, anxiety);
- digestive system: heartburn, nausea, vomiting, dry mouth, hiccups, decreased appetite, hypersalivation, constipation, gastralgia, jaundice, liver functional disorder, increased activity of liver enzymes and alkaline phosphatase;
- hematopoietic system: neutropenia, leukopenia, agranulocytosis (chills, sore throat, hyperthermia, fatigue, weakness), thrombocytopenia, anemia;
- allergic reactions: itchy skin, rash;
- genitourinary system: urinary retention or incontinence, impaired renal function, dysmenorrhea, impaired libido;
- others: drug dependence, addiction; rarely - diplopia, depression of the respiratory center, bulimia, weight loss; possibly - the development of a withdrawal syndrome against the background of a sharp decrease in the dose or withdrawal of the drug (headache, increased irritability, anxiety, psychomotor agitation, fear, sleep disorders, spasm of smooth muscles of internal organs and skeletal muscles, dysphoria, depersonalization, depression, convulsions, increased sweating, nausea, vomiting, perception disorders, hyperacusis, photophobia, paresthesia, tremor, tachycardia, hallucinations; rarely - psychotic disorders);
- use in newborns: hypothermia, muscle hypotension, dyspnea;
- effect on the fetus (when used during pregnancy): teratogenicity (especially the first trimester), respiratory failure, inhibition of the central nervous system, suppression of the sucking reflex in newborns.
In addition, the use of Seduxen in the form of a solution can cause undesirable effects:
- nervous system: at the beginning of treatment - lethargy, impaired coordination of movements, unsteadiness of gait, dullness of emotions; rarely, depression;
- local reactions: phlebitis or venous thrombosis at the injection site.
special instructions
Do not violate the recommended dosage regimen or use Seduxen for a long time.
Patients with severe forms of depression should be prescribed the drug with extreme caution, since the action of diazepam can be used in the implementation of suicidal intentions.
It is not recommended to use drip injection, since sediment may form and the chemical composition of the drug in the infusion system is disturbed.
The risk of developing drug dependence increases in patients taking high doses of the drug, with a prolonged course of treatment, or a history of alcohol or drug dependence.
Abrupt withdrawal of therapy is contraindicated, this can cause a withdrawal syndrome.
The drug should be discontinued if increased aggressiveness, anxiety, psychomotor agitation, feelings of fear, thoughts of suicide, superficial sleep, hallucinations, sleep disturbances, increased muscle cramps occur in the patient's behavior or condition.
In patients with a history of epileptic seizures and epilepsy at the beginning of diazepam use or with its abrupt withdrawal, the development of seizures or status epilepticus may accelerate.
The appointment of diazepam to pregnant women, patients with impaired renal and / or liver function should be made only after a careful assessment of the balance of benefits and risks of therapy.
The use of any alcoholic beverages is strictly prohibited.
Long-term therapy and treatment of patients with renal or hepatic insufficiency should be accompanied by regular monitoring of the activity of liver enzymes and laboratory parameters of peripheral blood.
When used in pediatrics, it should be borne in mind that children are very sensitive to the effect of benzodiazepines, which depress the central nervous system.
In newborns, while using Seduxen solution, toxic syndrome may develop. Its symptoms include: metabolic acidosis, difficulty breathing, depression of the central nervous system, renal failure, decreased blood pressure, epileptic seizures, intracranial hemorrhage.
During the period of treatment, patients are contraindicated to drive vehicles and mechanisms.
Drug interactions
With the simultaneous use of Seduxen:
- valproic acid, propranolol, ketoconazole, isoniazid, metoprolol, oral contraceptives, cimetidine, erythromycin, fluoxetine, estrogen-containing drugs, disulfiram - can slow down the metabolism of diazepam and cause an increase in its concentration in blood plasma;
- monoamine oxidase inhibitors, corazole, strychnine - counteract the effects of the drug;
- antihypertensive drugs - enhance the severity of their action;
- benzodiazepine derivatives, antidepressants, hypnotics, sedatives, other tranquilizers, narcotic analgesics, antipsychotics, muscle relaxants, general anesthetics, ethanol - lead to a sharp increase in the inhibitory effect on the central nervous system;
- cardiac glycosides - can cause the development of digitalis intoxication against the background of an increase in its level of concentration in the blood serum;
- antacids - slow down the absorption of diazepam from the gastrointestinal tract;
- clozapine - may increase respiratory depression;
- inducers of liver microsomal enzymes - reduce the therapeutic effect of the drug;
- rifampicin - speeds up metabolism and reduces the concentration of diazepam in blood plasma;
- omeprazole - slows down the process of elimination of diazepam;
- levodopa - reduces antiparkinsonian activity;
- psychostimulants - reduce the effect of the drug;
- theophylline (in low doses) - can reduce the sedative effect of diazepam;
- zidovudine - may increase toxicity.
When using Seduxen for premedication, it is necessary to reduce the usual dose of fentanyl for induction of general anesthesia and take into account that general anesthesia will come faster.
Terms and conditions of storage
Keep out of the reach of children.
Store at temperature: tablets - 15-30 ° C, solution - 8-15 ° C, protected from light.
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!
