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Pharmachologic effect

The active substance diazepam belongs to the group of drugs of the benzodiazepine series (tranquilizer), which have anxiolytic, sedative, muscle relaxant, and anticonvulsant properties. The mechanism of action of diazepam is due to stimulation of benzodiazepine receptors, leading to an increase in the inhibitory effect of γ-aminobutyric acid (GABA), which is the main inhibitory neurotransmitter in the brain.

Indications for use

Symptomatic treatment of anxiety, restlessness and tension in mental and hereditary diseases and transient situational mental disorders. As an aid in the treatment of anxiety in organic mental disorders. Anxiety can manifest itself in the form of anxious mood, restless behavior and/or in the form of functional autonomic or motor symptoms (palpitations, sweating, insomnia, tremors, restlessness, etc.).

As an aid to relieve reflex muscle spasm at the site of injury (trauma, inflammation), for the treatment of spastic conditions in case of damage to the spine and supraspinal interneurons, to relieve spasms of cerebral origin and paraplegia, as well as athetosis and rigidity.

Alcohol withdrawal syndrome: anxiety, tension, agitation, tremor, transient reactive states.

Dosage and administration

The tablet may be divided into two equal portions to ensure proper dosing.

Adults. Inside. To achieve the maximum effect, the dosage should be selected individually. The usual daily doses given below meet the needs of most patients, however, some patients may require higher doses. In such cases, the dose should be increased carefully to avoid side effects. A single dose should not exceed 10 mg. The time of taking the drug depends on the individual characteristics of the patient. With multiple doses, a large dose is recommended to be taken in the evening.

Anxiety disorders and reduction of anxiety symptoms: 2.5-10 mg 2-4 times a day.

Spasms of skeletal muscles: 2.5-10 mg 3-4 times a day.

Alcohol withdrawal syndrome: 10 mg 3-4 times a day for the first 24 hours, then reduced to 5 mg 3-4 times a day as needed.

Elderly patients or debilitated patients. Treatment should begin at half the usual adult dose (2.5 mg once or twice daily) and, if necessary, increase gradually based on tolerability. These patients should be examined before starting treatment with the drug and undergo regular medical monitoring. A re-examination is recommended a week after the start of the drug. To prevent overdose, reduce the dose or increase the interval between taking the drug.

Children. From 5 to 7 years: 2.5 mg 3-4 times a day. From 7 years and older: 5 mg. The maximum daily dose is 10 mg.

Treatment should be as short as possible. With long-term treatment, the patient's condition should be monitored. The duration of treatment should not exceed 2-3 months. Longer treatment should be prescribed after re-evaluation of the patient's condition. It is necessary to warn the patient about the time-limited use of the drug, about how to gradually reduce the dose and about the drug withdrawal syndrome, especially when taken in high doses.

Side effects

The most common side effects are fatigue, drowsiness and muscle weakness, which are generally dose dependent. These effects occur mainly at the beginning of treatment and usually disappear with further use of diazepam.

From the nervous system: ataxia, dysarthria, slurred speech, headache, tremor, dizziness. Anterograde amnesia may occur at therapeutic doses, with the risk increasing with dose. Amnesia may be accompanied by inappropriate behavior.

Mental disorders: when taking benzodiazepines, the development of paradoxical reactions, such as anxiety, agitation, irritability, aggressiveness, delirium, anger, nightmares, hallucinations, psychoses, behavioral abnormalities and other negative behavioral manifestations, has been reported. In such cases, the drug should be discontinued. The likelihood of the described effects is higher in children and the elderly.

Confusion, emotional impoverishment, decreased attention, depression, increased or decreased libido.

Long-term ingestion (even at therapeutic doses) can lead to the development of physical dependence: discontinuation of treatment may cause withdrawal or "withdrawal" syndrome. Talk with your doctor before you buy valium online !

From the musculoskeletal system: muscle weakness. Patients treated with benzodiazepines report a greater incidence of falls and fractures. The risk increases with the simultaneous use of sedatives (including alcoholic beverages) and in the elderly.

From the digestive system: nausea, pain in the abdomen, dry mouth or increased salivation (drooling), diarrhea, constipation and other gastrointestinal disorders.

On the part of the organs of vision: blurred vision, double vision.

From the blood vessels: hypotension, circulatory disorders.

Laboratory tests: irregular pulse, very rarely - an increase in transaminases, an increase in alkaline phosphatase.

From the genitourinary system: urinary incontinence, urinary retention.

Allergic reactions: skin rash.

On the part of the organ of hearing: dizziness.

Since the cardiovascular system: heart failure, including cardiac arrest.

From the respiratory system: respiratory depression, including respiratory arrest.

From the side of the liver and biliary tract: very rarely - jaundice.

In the event of the above adverse reactions or adverse reactions not listed in these instructions for medical use of the drug you should consult a doctor.

Contraindications

Hypersensitivity, coma, shock, acute alcohol intoxication with weakening of vital functions, acute intoxication with drugs that have a depressant effect on the central nervous system (including narcotic analgesics and hypnotic drugs), myasthenia gravis, angle-closure glaucoma (acute attack or predisposition ); severe chronic obstructive pulmonary disease (danger of progression of the degree of respiratory failure), acute respiratory failure, pregnancy (especially the first trimester), lactation. Not recommended for the primary treatment of psychotic disorders. It is not used to treat depression or anxiety with depression, as such patients are at risk of suicide.

This dosage form is not intended for children under 5 years of age.

With caution: history of epilepsy or epileptic seizures (initiation of treatment with diazepam or its abrupt withdrawal may accelerate the development of seizures or status epilepticus), absence or Lennox-Gastaut syndrome (with intravenous administration contributes to tonic status epilepticus), hepatic and / or renal insufficiency, cerebral and spinal ataxias, hyperkinesias, a history of drug dependence, a tendency to abuse psychoactive drugs, organic brain diseases, hypoproteinemia, sleep apnea (respiratory arrest) (established or suspected), old age.

Overdose

Symptoms: drowsiness, confusion, paradoxical arousal, decreased reflexes, areflexia, stupor, reduced response to painful stimuli, deep sleep, dysarthria, ataxia, visual disturbance (nystagmus), tremor, bradycardia, shortness of breath or shortness of breath, apnea, severe weakness, decrease in blood pressure, collapse, depression of cardiac and respiratory activity, coma. Respiratory disturbances are more severe in patients with respiratory failure.

Treatment: gastric lavage, forced diuresis, activated charcoal. Symptomatic therapy (maintenance of breathing and blood pressure), mechanical ventilation. Flumazenil is used as a specific antagonist (in a hospital setting). Hemodialysis is ineffective. The benzodiazepine antagonist flumazenil is not indicated in patients with epilepsy treated with benzodiazepines. In such patients, the antagonistic effect of benzodiazepines can provoke the development of epileptic seizures. An overdose is rarely fatal.

Pregnancy and lactation

During pregnancy, they are used only in exceptional cases and only for "vital" indications. It has a toxic effect on the fetus and increases the risk of congenital malformations when used in the first trimester of pregnancy. Taking therapeutic doses later in pregnancy can cause depression of the central nervous system of the newborn, hypotension, respiratory failure, and hypothermia. Continuous use during pregnancy can lead to physical dependence - possible "withdrawal" syndrome in the newborn. If the drug is used during labor and childbirth, then special care should be taken, since high doses can lead to cardiac arrhythmias in the child, as well as cause hypotension, hypothermia, and respiratory depression. Diazepam and its metabolites pass into breast milk. Breast-feeding during treatment with the drug should be discontinued.

Influence on the ability to drive vehicles and other potentially dangerous mechanisms

During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions due to the development of side effects of the drug. In addition, the patient should be warned about the dangerous combination of alcohol and diazepam.

Drug interactions

With the combined use of diazepam with drugs that have a depressant effect on the central nervous system (for example, antipsychotics, anxiolytics / sedatives, antidepressants, hypnotics, anticonvulsants, narcotic analgesics, anesthetics and sedative antihistamines or alcohol), the inhibitory effect on the central nervous system, respiratory center increases and hemodynamics.

Patients taking diazepam should avoid alcohol intake.

Theophylline may inhibit the action of diazepam.

Simultaneous administration of antidiabetic agents, anticoagulants and diuretics does not affect diazepam.

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

With the simultaneous use of diazepam with opiates, the likelihood of an increase in the effect of respiratory depression should be considered.

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