Children and teenagers (under the age of 18) Paksil preparation Do not use in children and adolescents under 18 years of age. |
Treatment with antidepressants for children and adolescents suffering from major depressive disorder and other mental illnesses is associated with an increased risk of suicidal thoughts and undesirable reactions associated with suicidal attempts and suicidal thoughts, hostility (mainly aggression, deviant behavior and anger), were more often observed in children and adolescents who received paroxetine, than in patients of this age group who received a placebo. At present, there is no data on the long-term safety of paroxetine for children and adolescents, which would affect the effect of this drug on growth, maturation, cognitive and behavioral development. Clinical deterioration and suicidal risk in adults
Young patients, especially those suffering from major depressive disorder, may be at increased risk of suicidal behavior during paroxetine therapy. Analysis of the placebo-controlled studies in adults with mental illness indicates an increase in the incidence of suicidal behavior in young patients (aged 18-24 years) when taking paroxetine compared to the placebo group: 17/776 (2.19%) versus 5/542 ( 0.92%), respectively, although this difference is not considered statistically significant. In patients of older age groups (25 to 64 years and older than 65 years), there was no increase in the incidence of suicidal behavior. In adults of all age groups suffering from major depressive disorder, there was a statistically significant increase in casessuicidal paroxetine compared with the placebo group (incidence of suicide attempts: 11/3455 (0.32 vs 1/1978 (0.05%), respectively. However, most of these cases, when taking paroxetine (8 of 11), were registered in young patients aged 18 to 30 years.
The data obtained in the study of patients with major depressive disorder may indicate an increase in the incidence of suicidal behavior in young patients, which may persist in patients older than 24 years with various mental disorders.
In patients with depression, the exacerbation of symptoms of this disorder and / or the appearance of suicidal thoughts and suicidal behavior (succidality) can be observed regardless of whether they receive antidepressants. This risk persists until a pronounced remission is achieved. Improvement of the patient's condition may be absent in the first weeks of treatment or more, and therefore, the patient's condition should be monitored for the timely detection of clinical exacerbation and suicide, especially at the beginning of the course of treatment, as well as during periods of dose changes, whether they increase or decrease.Clinical experience with the use of all antidepressants shows that the risk of suicide may increase in the early stages of recovery.
Other mental disorders for which treatment is used paroxetine, too, may be associated with an increased risk of suicidal behavior. In addition, these disorders can represent are comorbid conditions associated with a major depressive disorder. Therefore, in treating patients suffering from other mental disorders, the same precautions should be followed as in the treatment of major depressive disorder. The greatest risk of suicidal thoughts or suicidal attempts is experienced by patients with a history of suicidal behavior or suicidal ideation, young patients, and patients with severe suicidal thoughts prior to treatment, and therefore all need to be given special attention during treatment. Patients (and those who care for them) need to be warned about the need to monitor their worsening (including the development of new symptoms) and / or the appearance of suicidal behavior or thoughts of self-harm during the entire coursetreatment, especially at the beginning of treatment, or during a dose change (increase and decrease). If these symptoms occur, seek medical help immediately. |
It must be remembered that the appearance of such symptoms as agitation, akathisia or mania may be associated with both the underlying disease and be a consequence of the therapy used. If symptoms of clinical impairment (including development of new symptoms) and / or suicidal thoughts and / or suicidal behavior occur, especially if they appear suddenly, the severity of the manifestations increases, or if they are not part of the preceding symptomatic complex in this patient, It is necessary to revise the regimen of therapy until the drug is withdrawn. Akathisia
Occasionally, treatment with paroxetine or another drug of the SSRI group is accompanied by the appearance of akathisia, which manifests itself sense of internal anxiety and psychomotor agitation, when the patient can not sit or stand still; At akathisia the patient usually experiences subjective discomfort. The likelihood of akathisia is highest in the first few weeks of treatment.
Serotonin syndrome, malignant neuroleptic syndrome
On the background of paroxetine treatment, in rare cases, serotonin syndrome or symptomatology similar to
malignant neuroleptic syndrome, especially if paroxetine are used in combination with other serotonergic drugs and / or antipsychotics. These syndromes can pose a potential threat to life, and therefore treatment Paroxetine should be discontinued if they occur (they are characterized by groups of symptoms such as hyperthermia, muscular stiffness, myoclonus, autonomic disorders with possible rapid changes in vital signs, changes in mental status, including confusion, irritability, extremely hard agitation, progressing to delirium and coma) and begin supporting symptomatic therapy. Paroxetine as L-tryptophan, oxytryptan) in connection with the risk of developing serotonergic syndrome.
Mania and bipolar disorder
A major depressive episode may be primary manifestation of bipolar disorder. It is generally accepted (although it is not proved controlled clinical trials) that treating such an episode with antidepressant alone can increase the likelihood accelerated development of a mixed or manic episode in patients, subject to the risk of bipolar disorder. Before starting treatment with an antidepressant, you need carry out thorough screening to assess the risk of the patient bipolar disorder; such screening should include collection a detailed psychiatric history, including data on the presence in the family of cases of suicide, bipolar disorder and depression.
Paroxetine It is not registered for the treatment of a depressive episode in the context of bipolar disorder. Like other antidepressants, paroxetine should be used with caution in patients who have a history of mania.
Diabetes
In patients with diabetes mellitus, treatment with SSRIs may affect glycemic control. You may need to adjust the dose of insulin and / or oral hypoglycemic drugs.
cautiously 2 weeks after discontinuation of treatment with irreversible MAOI or 24 hours after discontinuation of treatment with reversible MAOIs.The dose of paroxetine should be increased gradually to achievements optimal therapeutic effect.
Impaired kidney or liver function Care should be taken when treating patients with severe paroxetine degree of impaired renal function or patients with impaired hepatic function.
Epilepsy
Like other antidepressants, paroxetine should be used with caution in patients with epilepsy.
Convulsive seizures
Frequency of convulsive seizures in patients taking paroxetine, is less than 0.1%. In the event of a seizure, paroxetine should be discontinued.
Electroconvulsive therapy
There is only limited experience in the simultaneous use of paroxetine and electroconvulsive therapy.
Glaucoma
Like other SSRIs, paroxetine may cause mydriasis, and it should be used with caution in patients with closed-angle glaucoma.
Hyponatremia
When treatment paroxetine hyponatremia occurs rarely and mainly in elderly patients and is leveled after the withdrawal of paroxetine.
Bleeding Hemorrhages in the skin and mucous membranes (including gastrointestinal and gynecological bleeding) have been reported in patients on paroxetine. therefore paroxetine Caution should be used with caution in patients who simultaneously receive drugs that increase the risk of bleeding in patients with a known tendency to bleeding and patients with diseases predisposing to bleeding. Heart Disease In the treatment of patients with heart disease, the usual precautionary measures should be observed. Symptoms that may occur when discontinuing paroxetine treatment in adults According to the results of clinical trials in adults, the incidence of adverse reactions upon discontinuation of treatment in patients taking paroxetine, was 30%, while the incidence of adverse reactions in the placebo group was 20 %. The appearance of withdrawal symptoms does not mean that the drug is abused or causes dependence, as the ego takes place in the case of drugs and psychotropic substances. |
Described such withdrawal symptoms as dizziness, sensory disturbances (including paresthesia, electric shock and tinnitus), agitation or anxiety, nausea, tremor, confusion, increased sweating, headache and diarrhea, palpitations, emotional lability, irritability and visual disturbances. Usually these symptoms are mild or moderate, but in some patients they can be severe. Usually they occur in the first few days after the drug is withdrawn, but in very rare cases, patients who accidentally missed the dose were seen. As a rule, these symptoms pass spontaneously and disappear within 2 weeks, but in some patients they can last much longer (23 months or more). It is recommended to reduce the dose of paroxetine gradually, for several weeks or months before its complete cancellation, depending on the needs of the individual patient.
Symptoms that may occur when paroxetine is discontinued in children and adolescents
As a result of clinical studies in children and adolescents, the incidence of adverse reactions upon discontinuation of treatment in patients taking paroxetine, was 32%, while the incidence of adverse reactions in the placebo group was 24%.
After the withdrawal of paroxetine, the following are undesirable reactions registered at least 2% of patients and met at least 2 times more often than in the placebo group: emotional lability, including suicidal ideation, suicidal attempts, mood changes and tearfulness, as well as nervousness, dizziness, nausea and abdominal pain.
Fractures of bones.
Based on the results of epidemiological studies of the risk of bone fractures, bone fragility has been linked to some antidepressants, including SSRIs. The risk was observed during the course of treatment with antidepressants and was the maximum at the beginning of the course of therapy. The possibility of bone fractures should be considered when using paroxetine.
Tamoxifen
Some studies have shown that the effectiveness of tamoxifen, measured in the risk of recurrence of breast cancer and mortality, may decrease when combined with paroxetine as a result of irreversible inhibition of the isoenzyme CYP2D6. Risk can increase with joint application over time. When tamoxifen is used to treat or prevent breast cancer, consideration should be given to using alternative antidepressants that do not have an inhibitory effect on the isoenzyme CYP2D6 or render it to a lesser extent.