Composition, form of production and packaging
Tablets 1 tab.
diazepam 5 mg
[PRING] corn starch, silicon dioxide colloid (aerosil), lactose monohydrate, talc, magnesium stearate.
10 pieces. - packings cellular planimetric (2) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2010.
PHARMACHOLOGIC EFFECT
Anxiolytic agent from the benzodiazepine group. The action of diazepam is due to the increase in GABA-ergic inhibitory effect, primarily in subcortical structures.The drug also has antiepileptic and central muscle relaxant action, without causing extrapyramidal disorders.
PHARMACOKINETICS
Absorption of diazepam in the gastrointestinal tract occurs rapidly, binding to plasma proteins is high. The main metabolites are: N-desmethyldiazepam, oxazepam.The concentration of diazepam in the plasma is reduced in two phases: after the first rapid phase of the distribution, which lasts for 1 hour, a separation phase occurs that lasts for 24-48 hours; metabolites of diazepam can be excreted by the kidneys, a certain role is played by enterohepatic circulation. Half-life time can repeatedly increase in newborns, elderly patients, as well as in diseases of the kidneys and liver.
INDICATIONS
Use strictly according to the doctor's prescription to avoid complications!
- therapy of anxiety (neurosis, psychopathy), as well as treatment of tension, fear, autonomic symptoms (sweating, tremor, palpitations, etc.) that have occurred as a result of psychotrauma;
- comprehensive treatment of mental disorders of organic origin;
- as a symptomatic tool for the treatment of conditions, combined with an increase in muscle tone.
DOSING MODE
The dose of the drug is selected individually, while taking into account both the patient's condition and the response to treatment; only general instructions are given below. At the beginning of therapy it is recommended to apply small doses of the drug with a gradual increase.
Divide the daily dose by 2-4 admission (individually). It is advisable to take 2/3 of the daily dose in the evening.
Adults
Neurological disorders, psychosomatic diseases, anxiety-phobic disorders : the usual single dose is 2.5-5 mg (1 / 2-1 tab.). The average daily intake for adults is 5-20 mg.
A single dose of Seduxen should not exceed 10 mg!
Symptomatic treatment of convulsive syndrome: usually 2.5-10 mg (1 / 2-2 tab.) 2-4 times / day is used.
In the complex treatment of mental disorders of organic origin : the initial dose is 20-40 mg / day (4-8 tab.), Supporting a daily dose of 15-20 mg / day (3-4 tab.).
Muscular contractures, spasticity, rigidity : 5-20 mg / day (1-4 tablets).
In elderly and kakhetical patients, as well as with a decrease in liver function, the excretion of Seduxen may be significantly prolonged. It is recommended to begin treatment with a lower (approximately half) dose, which can be gradually increased, taking into account the individual tolerance of the drug.
Children should always be determined individually, taking into account age, level of physical development, general condition and response to ongoing treatment. The initial dose is 1.25-2.5 mg / day, divided into 4 doses. This dose can be reduced or increased, taking into account the individual reaction to the therapy.
For children under 6 months of age, the use of anxiolytic drugs from the benzodiazepine group is contraindicated.
SIDE EFFECT
The most common side effects are fatigue, drowsiness, muscle weakness. In most cases, they pass independently for several days (or can be eliminated by reducing the applied dose of the drug).
The following side effects were rarely noted: ataxia, psychotic reactions, dizziness, headaches, depression, visual impairment, skin rash, autonomic disorders, constipation, dysarthria, arterial hypotension, urinary incontinence, bladder atony, nausea, dry mouth or hypersalivation, exanthema, tremor, changes in libido, bradycardia, adaptation disorder.
Very rare: an increase in the level of hepatic transaminases and alkaline phosphatase in the blood serum, jaundice.
Paradoxical reaction to the drug can manifest itself in the form of increased muscle tone. In such cases, the drug should be discontinued.
Dependence on the drug
With long-term use, especially in large doses and with a predisposition, drug dependence can be formed on Seduxen.
Abstinence syndrome in less severe cases manifests itself in the form of tremors, anxiety, sleep disturbances, anxiety, headaches and reduced concentration. There may be increased sweating, muscle cramps, spasticity abdominal pain, sensitivity disorders, delirium (rarely) and convulsions of central origin.
To reduce the risk of dependence on the drug Seduxen should be used as soon as possible and after a careful reading of the indications.
To avoid the development of withdrawal symptoms at the end of treatment, it is advisable to gradually reduce the dose of the drug.
CONTRAINDICATIONS
- Myasthenia gravis;
- the closed-angle form of glaucoma and acute attack of glaucoma (however, in the open-angle form of glaucoma, its use is allowed if patients receive adequate therapy);
- severe chronic hypercapnia;
- I trimester of pregnancy;
- the period of breastfeeding;
- Children's age up to 6 months;
- Hypersensitivity to the components of the drug, as well as to other benzodiazepine derivatives.
Relative contraindications (special care is required when prescribing the drug):
- sleep apnea syndrome;
- cardiopulmonary insufficiency;
- II and III trimesters of pregnancy.
PREGNANCY AND LACTATION
In the first trimester of pregnancy, according to individual studies, benzodiazepines increase the risk of fetal development abnormalities, so in this period, the use of the drug is strictly prohibited. In later pregnancy, the use of Seduxen may lead to depression of the central nervous system and respiratory center in the fetus, therefore Seduxen's appointment is possible only if the expected benefit for the mother exceeds the potential risk to the fetus.
During the period of breastfeeding , the use of Seduxen is not recommended, since the drug penetrates into breast milk.
APPLICATION FOR FUNCTIONS OF THE LIVER
In patients with impaired renal function, the elimination half-life can multiply repeatedly.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
In patients with impaired liver function, elimination half-life can repeatedly increase.
APPLICATION FOR CHILDREN
Contraindicated in children under 6 months.
Children should always be determined individually, taking into account age, level of physical development, general condition and response to ongoing treatment.
APPLICATION IN ELDERLY PATIENTS
In elderly patients, elimination half-lives can increase many-fold.
SPECIAL INSTRUCTIONS
With respiratory failure, sleep apnea syndrome, coma, a careful evaluation of the readings is required in connection with the possibility of respiratory depression.
Selection of the dose of the drug requires special care in patients with reduced renal and hepatic function, in the presence of chronic pulmonary insufficiency, in elderly and cachectic patients, in severe general condition, and in children, incl. in newborns.
In cases of severe depression, as well as with suspicion of latent depression, the patient must be treated under special control in connection with an increased risk of suicide.
Children under 6 months of age are not eligible for anxiolytic drugs from the benzodiazepine group.
In the first trimester of pregnancy, according to individual studies, benzodiazepines increase the risk of fetal abnormalities, therefore, in this period, the use of the drug is strictly prohibited. In later pregnancy, the use of Seduxen may lead to depression of the central nervous system and respiratory center in the fetus, therefore Seduxen's appointment is possible only if the expected benefit for the mother exceeds the potential risk to the fetus.
During the period of breastfeeding , the use of Seduxen is not recommended, since the drug penetrates into breast milk.
Influence on driving vehicles and controlling mechanisms : in the initial phase of Seduxen application within 12-24 hours after taking the drug, driving and vomiting associated with an increased risk of injury are prohibited. In the future, the degree of restriction requires an individual approach.
It should be borne in mind that the release of the drug can significantly lengthen, especially in the elderly and in patients with kidney and liver diseases.
Drinking alcoholic beverages during treatment with Seduxen is strictly forbidden!
OVERDOSE
Symptoms: There may be depression, muscle weakness, drowsiness, psychotic disorders, coma, in rare cases - paradoxical arousal.
Excessive overdose can cause someone, oppression of reflexes and oppression of the function of the heart and respiratory systems, apnea.
In case of early appearance of symptoms of drug overdosage, gastric lavage should be performed.
It is necessary to monitor the parameters of respiration, circulation and kidney function.
A general symptomatic and supportive treatment should be provided, including ensuring airway patency, intravenous fluid replacement, and, if necessary, artificial respiration and the use of drugs that increase vascular tone. Flumazenil can be used as a specific antagonist of benzodiazepine receptors. In case of an overdose of Seduxen, the use of hemodialysis is ineffective.
DRUG INTERACTION
Drugs that depress the central nervous system can increase the effect of Seduxen (anesthetics, barbiturates, phenothiazines, analgesics, MAO inhibitors and other antidepressants, alcohol).
Drugs that induce induction of liver enzymes, incl. antiepileptic drugs (eg, carbamazepine, phenytoin), can accelerate the elimination of Seduxen.
With prolonged use of cimetidine or omeprazole, the clearance of Seduxen may decrease.
The effect of joint application with peripheral muscle relaxants is unpredictable, the risk of apnea increases.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
Storage conditions:
List of potent and toxic substances.
Store at a temperature of 15-30 В° C out of the reach of children!
Shelf life:
5 years.
Do not use the product after the expiry date printed on the package.
