Treatment of anxiety. Supportive treatment of anxiety associated with depression. Treatment of symptoms of sudden alcohol withdrawal. Conditions of tension and anxiety associated with the hardships of everyday life are not an indication for the use of the drug.
Composition:
1 tabl contains 10 mg of oxazepam. The preparation contains lactose.
Action:
A psychotropic drug, a benzodiazepine derivative. The areas of action of the drug are the limbic system, the hill and the hypothalamus. Biochemical research suggests that oxazepam enhances the inhibitory effect of the neurotransmitter γ-aminobutyric acid (GABA) by binding to the receptors of this acid or by antagonizing the action of a protein that inhibits the binding of GABA to the receptor. Oxazepam has anxiolytic, sedative, hypnotic and anticonvulsant activity. After oral administration, oxazepam is well absorbed from the gastrointestinal tract, reaching a maximum concentration in the blood after about 3 hours after administration. About 98% is bound to plasma proteins. It is metabolized in the liver, creating connections with glucuronic acid. Metabolites are mainly excreted in the urine (67-80%), 3% of the administered dose is excreted in the faeces. A small part of the administered dose is excreted unchanged. T0,5 is about 14 hours.
Contraindications:
Hypersensitivity to benzodiazepines or other components of the preparation. Severe respiratory failure. Myasthenia gravis. Drug and alcohol addiction except for the treatment of acute withdrawal symptoms (convulsions, anxiety in alcoholics). Children under 12 years.
Precautions:
Caution is advised in patients with respiratory failure (eg COPD and sleep apnea) as well as renal and / or hepatic failure (risk of encephalopathy). Oxazepam is not intended for the primary treatment of psychotic disorders and depression, it should not be used as monotherapy in patients with anxiety and insomnia. Caution should be used in people whose pressure reduction may cause cardiovascular and cerebrovascular disorders and in elderly patients. The preparation should be avoided in patients with alcoholism or a history of drug addiction or in patients with personality disorders (increased risk of addiction). Regular use can lead to the development of tolerance. The product contains lactose - should not be used in patients with rare hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.
Pregnancy and lactation:
The use of medicines from the group of benzodiazepines during pregnancy may cause fetal harm. Oxazepam should not be used during pregnancy. Administration of the drug in the last phase of pregnancy or during delivery may lead to withdrawal syndrome in the newborn (hypothermia, hypotension, respiratory depression, apnea, reduced mobility, problems with feeding or drinking). The drug is excreted in breast milk - it should not be used during breastfeeding.
Side effects:
Very often: sedation, exhaustion, drowsiness. Common: depression, incoherency, confusion, stupor, muscle weakness, weakness. Uncommon: nausea. Not known: thrombocytopenia, agranulocytosis, aplastic anemia, hypersensitivity reactions, anaphylactic / anaphylactoid reactions, Schwartz and Bartter syndrome (SIADH), hyponatremia, anxiety, agitation, excitability, anxiety, hostility, anger, aggressiveness, delusions, mania, nightmares, hallucinations , psychosis, behavioral disorders, lack of inhibitions, euphoria, suicidal thoughts and ideas, suicide attempts, extrapyramidal symptoms, tremors, dizziness, speech disorders, slurred speech, headaches, seizures / seizures, coma, visual disturbances (eg double vision) , blurred vision), respiratory depression, apnea, deterioration of sleep apnea, deterioration of obstructive lung disease. (the severity of these symptoms depends on the dose), constipation, jaundice, elevated bilirubin, elevated levels of transaminase and alkaline phosphatase, skin allergic changes, alopecia, lowering body temperature.Oxazepam administered in therapeutic doses may cause amnesia, and the risk of it increases with increasing doses. There is also the possibility of paradoxical reactions especially in elderly people (states of acute arousal, sleep disorders, hallucinations, psychoses, as well as euphoric states) - the occurrence of these reactions is an indication for discontinuation of oxazepam treatment. Using the drug can lead to mental and physical dependence. Sudden discontinuation of oxazepam may cause withdrawal symptoms: tremors, anxiety, problems falling asleep, confusion, dizziness, irritability, depression, anxiety, headaches, muscle tension, "rebound" phenomenon, mood disorders, loss of sense of reality, personality disorders, hypersensitivity to sound, limb numbness and tingling, hypersensitivity to light, impaired sensation and perception, involuntary movements, loss of short-term memory, impaired concentration, hyperthermia; in addition: increased sweating, nausea, vomiting, diarrhea, loss of appetite, palpitations and tachycardia, excessive response to reflexes, muscle cramps, abdominal cramps, perceptual disorders, and in rare cases, delirium, hallucinations, panic attacks, seizures and cerebral seizures.
Dosage:
Orally. Usually: adults - 10-30 mg 3-4 times a day; people over 65 years - initially 10 mg three times a day, then the dose can be increased, depending on the effectiveness and severity of side effects, to 15 mg 3-4 times a day. Treatment should last as short as possible. The total duration of therapy should not exceed 8-12 weeks, including the period of gradual withdrawal of the medicinal product. In some cases, therapy may take longer, subject to a specialist assessment of the patient's condition. In patients with impaired hepatic or renal function, the dose should be adjusted to the patient's response because lower doses may be sufficiently effective.