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Dossier: | Ctd |
Transport Package: | Free |
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Generic Name | Paroxetine Hydrochloride Tablets 10mg |
Strength | 10mg |
Packing | 10tabs/blister,3blisters/box |
Origin | China |
This product is a white oval, double-sided raised film coated sheet.
Indications are for the treatment of various types of depression, including depression with anxiety and reactive depression. Common depressive symptoms: fatigue, sleep disturbances, lack of interest and pleasure in daily activities, loss of appetite. To treat obsessive-compulsive neurosis. Common obsessive-compulsive symptoms: Feeling repeated and persistent thoughts, impulses, or imaginings that can cause significant anxiety, leading to repetitive behaviors or mental activities. Treatment of panic disorder with or without agoraphobia. Common panic attack symptoms: palpitations, sweating, shortness of breath, chest pain, nausea, tingling, and near-death. Treatment of social phobia/social anxiety disorder. Common symptoms of social anxiety: palpitations, sweating, shortness of breath, etc. Often manifested as secondary to a significant or persistent fear of one or more social situations or performance situations, leading to avoidance. After satisfactory treatment, continued use of this product can prevent the recurrence of depression, panic disorder and obsessive-compulsive disorder.
Matters needing attention:
warn
Clinical deterioration and risk of suicide:
Adults or children with major depressive disorder (MDD) regardless of whether they are taking antidepressants. Are likely to experience worsening depressive symptoms and/or suicidal ideation and behavior (suicidal tendencies). This risk persists throughout the illness. Until the disease is in significant remission. Suicide is a known risk for depression and certain other mental illnesses, which are themselves the strongest predictors of suicide. It has long been thought that early treatment with antidepressants can induce deterioration and suicidal tendencies in some patients. Short-term antidepressants (SSRls class and others). A comprehensive analysis of placebo-controlled clinical trial data shows that in children. In adolescents and young adults (18-24 years), these drugs increase suicidal ideation and suicidal behavior (suicidality) in patients with major depression and other psychiatric disorders. Short-term clinical trials of antidepressants. Compared to placebo. There was no increase in suicide risk in adults over 24 years of age, but there was a decrease in suicide risk in adults over 65 years of age.
In children and adolescents with major depressive disorder, obsessive-compulsive disorder, or other psychiatric disorders. Comprehensive analysis of placebo-controlled clinical trials. That includes nine antidepressants. 24 short-term clinical trials in 4400 patients. In adults with major depression or other psychiatric disorders, a meta-analysis of placebo-controlled clinical trials included 11 antidepressants. 295 short-term clinical trials (median duration 2 months) in more than 77,000 patients. The risk of suicide varied between drugs, but almost all of the drugs tested showed an increased risk of suicide in younger patients; The absolute risk of suicide varies among different indications, with the highest incidence of major depressive disorder. Differences in risk (between drug and placebo) were relatively stable across age stratification and across indications, and these differences are shown in Table 1 (drug-placebo difference in number of suicides per 1,000 treated patients).