Index of drugs

Short-term treatment: panic disorder with agoraphobia or without agoraphobia, generalized anxiety disorder, anxiety disorder with secondary mood depression. The drug is indicated only in situations where the symptoms are severe, disrupt proper functioning or are very troublesome for the patient.

1 tabl contains 0.25 mg or 1 mg alprazolam (and lactose).

A benzodiazepine derivative with short to medium duration. Alprazolam exerts a stronger anxiolytic effect than other benzodiazepines, while maintaining the effect of reducing muscle tone, anticonvulsant and sedative-hypnotic. It intensifies the inhibitory action of GABA, which is the main inhibitor of neurotransmission in the brain and is a mediator of pre- and postsynaptic inhibition in all areas of o.u.n. Alprazolam has a dose-dependent inhibitory effect on all levels of o.n.n., ranging from a slight sedation, through sleep to coma. After oral administration, it is absorbed quickly and completely, reaching C_max during 1-2 h. In 70-80%, it binds to plasma proteins. Steady state is achieved after 2-3 days. Alprazolam is extensively metabolised in the liver (metabolites are little active or inactive) and excreted in the urine. T_0,5 in the elimination phase is 12-15 h. In elderly patients T_0,5 it is prolonged.

Hypersensitivity to the active substance, other benzodiazepines or to any of the excipients. Myasthenia gravis. Severe respiratory failure. Chronic obstructive pulmonary disease (COPD) with respiratory failure. Sleep apnea syndrome. Severe hepatic failure. And trimester of pregnancy. Breastfeeding period.

Particularly cautiously use in elderly and / or debilitated people (use lower doses due to the risk of ataxia or overdose); with respiratory disorders (use lower doses, due to the possibility of respiratory depression); with impaired renal or liver function; with glaucoma. Benzodiazepines are not recommended for the treatment of basic psychoses. Benzodiazepine should not be used in an anxiety-related monotherapy due to depression due to the risk of suicide attempts. Use in patients with severe depression or patients with suicidal tendencies requires special attention and the right amount of the prescribed drug. Special care should be taken in patients who have abused alcohol or medication in the past. Alprazolam may induce post-mortem amnesia (occurs most frequently within the first few hours of taking the drug, therefore, in order to reduce the risk, the patient should be able to have an uninterrupted sleep lasting 7-8 hours). During the use of the drug may occur: tolerance (decreased effectiveness of sedation during repeated use in a few weeks), physical and mental addiction (especially during long-term treatment with high doses and in patients who have abused drugs and alcohol in the past). Discontinuation symptoms and "rebound" reactions may occur in the event of a sudden cessation of use. Use of the drug should be discontinued if paradoxical reactions occur; the probability of their occurrence is higher in children and the elderly. Due to the lactose content, the drug should not be used in patients with rare hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.

Alprazolam should not be used during the first trimester of pregnancy. Alprazolam may be considered during pregnancy if the therapeutic indications and dosage are strictly adhered to. Data from cohort studies indicate that exposure to benzodiazepines in the first trimester of pregnancy does not increase the risk of serious malformations. However, some early epidemiological studies have shown an increased risk of cleft lip or palate. Treatment with high doses of benzodiazepines during II and / or III trimester of pregnancy revealed a decrease in fetal motor activity and fetal heart rate fluctuations.If there is a need for alprazolam treatment at the end of pregnancy, even in small doses, the flaccid syndrome may occur, including axial hypotension, difficulty in sucking leading to poor weight gain. These symptoms are reversible, but may last 1-3 weeks, depending on T_0,5 alprazolam. At higher doses in newborns, respiratory depression or apnea and hypothermia may develop. Some days after birth, newborns may have withdrawal symptoms that include hyperactivity, agitation, and trembling, even if the flaccid baby is not present. If alprazolam treatment is necessary at the end of pregnancy, high doses should be avoided and the newborn should be monitored to detect withdrawal symptoms and / or flaccid syndrome. Alprazolam penetrates to the milk of lactating mothers very little and because it is more slowly metabolized in newborns than in adults, newborns may accumulate, sedation and eating disorders - do not use during breastfeeding.

Very often: drowsiness, calmness, fatigue. Common: anorexia, decreased appetite, confusion, depression, anxiety, coordination disorders, memory disorders, blurred speech, weakened intellectual ability, difficult concentration, headache and dizziness, insomnia, blurred vision, gastrointestinal symptoms, constipation, nausea, difficulty urinating, irritability, weakness, nervousness. Uncommon: hyperprolactinemia, dermatitis, mood changes, hallucinations, anger, aggressive behavior, hostility, anxiety, agitation, changes in libido, insomnia, thinking disorders, nervousness, excitability, amnesia, dystonia, tremors, vomiting, jaundice, liver dysfunction, muscle weakness, urinary incontinence, urinary retention, irregular menstruation, sexual dysfunction, weight change, increased intraocular pressure. Very rare: uncontrollable defecation. Not known: vegetative symptoms, hepatitis, angioneurotic edema, peripheral edema. Side effects are more common in elderly and debilitated patients, with hepatic impairment and hypoalbuminemia. Use (even in therapeutic doses) may lead to the development of physical dependence: discontinuation of treatment may result in withdrawal syndrome or "rebound" effect. Mental addiction may occur. After discontinuation of treatment, withdrawal symptoms may occur: headache, muscle pain, severe anxiety, tension, anxiety, confusion and irritability; in severe cases: derealization, depersonalization, hyperaesthesia, tingling and burning sensation in the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures. Abuse of benzodiazepines has been reported. During the withdrawal of alprazolam, patients with post-traumatic stress were characterized by episodes of irritability, manifestation of hostility and depressive moods.

Orally. Adults.Panic disorder with agoraphobia or without agoraphobia: the starting dose is 0.5 mg 3 times a day; the dose can be gradually increased, depending on the patient's needs, by 1 mg every third day. For most patients, the effective dose range is 4-6 mg / day, given in divided doses, although in some cases 10 mg / day may be needed. Treatment usually lasts 4-10 weeks (including a period of gradual dose reduction).Generalized anxiety disorder: the starting dose is 0.25-0.5 mg 3 times a day; the dose can be increased, depending on the patient's needs, up to a maximum dose of 4 mg / day given in divided doses. Treatment usually lasts for 4 months (including a period of gradual dose reduction).Anxiety syndrome with secondary mood depression: the starting dose is 0.25-0.5 mg 3 times a day; the dose can be increased, depending on the patient's needs, up to a maximum dose of 4 mg / day given in divided doses. Treatment usually lasts for 4 months (including a period of gradual dose reduction).Special groups of patients. In patients with impaired liver or kidney function and in elderly patients, the dose should be reduced accordingly.General recommendation. Treatment should be started with the lowest effective dose. The first dose should be given before the night rest. The dose should be adjusted to the severity of the symptoms and individual response to treatment in a given patient.Long-term treatment may cause the development of drug dependence. The efficacy of alprazolam used for long-term treatment of anxiety disorders has not been demonstrated. To avoid the occurrence of withdrawal symptoms, you should not stop your treatment suddenly - it is recommended to reduce the daily dose of alprazolam by no more than 0.5 mg every third day.Way of giving. The 1 mg tablet can be divided into equal doses. Take after eating.