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rdfs:label "major depressive disorder the efficacy of paroxetine extended release tablets in the treatment of a major depressive episode was established in two 12 week controlled trials of outpatients whose diagnoses corresponded to the dsm iv category of major depressive disorder see clinical pharmacology clinical trials a major depressive episode dsm iv implies a prominent and relatively persistent nearly every day for at least 2 weeks depressed mood or loss of interest or pleasure in nearly all activities representing a change from previous functioning and includes the presence of at least 5 of the following 9 symptoms during the same 2 week period depressed mood markedly diminished interest or pleasure in usual activities significant change in weight and or appetite insomnia or hypersomnia psychomotor agitation or retardation increased fatigue feelings of guilt or worthlessness slowed thinking or impaired concentration a suicide attempt or suicidal ideation the antidepressant action of paroxetine in hospitalized depressed patients has not been adequately studied paroxetine extended release tablets have not been systematically evaluated beyond 12 weeks in controlled clinical trials however the effectiveness of immediate release paroxetine hydrochloride in maintaining a response in major depressive disorder for up to 1 year has been demonstrated in a placebo controlled trial see clinical pharmacology clinical trials see dosage and administration panic disorder the efficacy of paroxetine extended release tablets was established in two 1 week trials in panic disorder patients whose diagnoses corresponded to the dsm iv category of panic disorder see clinical pharmacology clinical trials panic disorder dsm iv is characterized by recurrent unexpected panic attacks i e a discrete period of intense fear or discomfort in which 4 or more of the following symptoms develop abruptly and reach a peak within 1 minutes 1 palpitations pounding heart or accelerated heart rate 2 sweating 3 trembling or shaking 4 sensations of shortness of breath or smothering 5 feeling of choking 6 chest pain or discomfort 7 nausea or abdominal distress 8 feeling dizzy unsteady lightheaded or faint 9 derealization feelings of unreality or depersonalization being detached from oneself 1 fear of losing control 11 fear of dying 12 paresthesias numbness or tingling sensations 13 chills or hot flushes long term maintenance of efficacy with the immediate release formulation of paroxetine was demonstrated in a 3 month relapse prevention trial in this trial patients with panic disorder assigned to immediate release paroxetine demonstrated a lower relapse rate compared to patients on placebo see clinical pharmacology clinical trials see dosage and administration social anxiety disorder the efficacy of paroxetine extended release tablets as a treatment for social anxiety disorder has been established in part on the basis of extrapolation from the established effectiveness of the immediate release formulation of paroxetine in addition the efficacy of paroxetine extended release tablets was established in a 12 week trial in adult outpatients with social anxiety disorder dsm iv paroxetine extended release tablets have not been studied in children or adolescents with social phobia see clinical pharmacology clinical trials the effectiveness of paroxetine extended release tablets in long term treatment of social anxiety disorder i e for more than 12 weeks has not been systematically evaluated in adequate and well controlled trials therefore the physician who elects to prescribe paroxetine extended release tablets for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient see dosage and administration premenstrual dysphoric disorder the efficacy of paroxetine extended release tablets in the treatment of pmdd has been established in 3 placebo controlled trials see clinical pharmacology clinical trials the essential features of pmdd according to dsm iv include markedly depressed mood anxiety or tension affective lability and persistent anger or irritability other features include decreased interest in usual activities difficulty concentrating lack of energy change in appetite or sleep and feeling out of control physical symptoms associated with pmdd include breast tenderness headache joint and muscle pain bloating and weight gain these symptoms occur regularly during the luteal phase and remit within a few days following the onset of menses the disturbance markedly interferes with work or school or with usual social activities and relationships with others in making the diagnosis care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant the effectiveness of paroxetine extended release tablets in long term use that is for more than 3 menstrual cycles has not been systematically evaluated in controlled trials therefore the physician who elects to use paroxetine extended release tablets for extended periods should periodically re evaluate the long term usefulness of the drug for the individual patient see dosage and administration";
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