Australia - English - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 61393 - multi-purpose electrical stimulation system programmer - the medtronic model a510 clinician application is preloaded on a non-medical cots handset (e.g. samsung smartphone). it is used together with the model tm90 communicator by the clinician to program stimulation settings for the medtronic interstim neurostimulators for snm therapy. the medtronic model a510 clinician application (app)is intended for use with the hh90 handset and tm90 communicator to program, adjust, and troubleshoot the medtronic models 3023 and 3058 interstim? neurostimulators for sacral neuromodulation therapy. the clinician uses the clinician app to program settings for the patient.

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - paroxetine hydrochloride hemihydrate (unii: x2els050d8) (paroxetine - unii:41vrh5220h) - major depressive disorder: paroxetine tablets are indicated for the treatment of major depressive disorder. the efficacy of paroxetine tablets in the treatment of a major depressive episode was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the dsm-iii category of major depressive disorder (see clinical pharmacology: clinical trials ). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the effects of paroxetine tablets in hospitalized depressed patients have not been adequately studied. the efficacy of paroxetine tablets in maintaining a response in major depressive disorder for up to 1 year was demonstrated in a placebo-controlled trial (see clinical pharmacology: clinical trials ). nevertheless, the physician who elects to use paroxetine tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. obsessive compulsive disorder: paroxetine tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (ocd) as defined in the dsm-iv. the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. the efficacy of paroxetine tablets was established in two 12-week trials with obsessive compulsive outpatients whose diagnoses corresponded most closely to the dsm-iiir category of obsessive compulsive disorder (see clinical pharmacology: clinical trials ). obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. long-term maintenance of efficacy was demonstrated in a 6-month relapse prevention trial. in this trial, patients assigned to paroxetine showed a lower relapse rate compared to patients on placebo (see clinical pharmacology: clinical trials). nevertheless, the physician who elects to use paroxetine tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see dosage and administration). panic disorder: paroxetine tablets are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in dsm-iv. panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. the efficacy of paroxetine tablets was established in three 10- to 12-week trials in panic disorder patients whose diagnoses corresponded to the dsm-iiir 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 10 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); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. long-term maintenance of efficacy was demonstrated in a 3-month relapse prevention trial. in this trial, patients with panic disorder assigned to paroxetine demonstrated a lower relapse rate compared to patients on placebo (see clinical pharmacology: clinical trials). nevertheless, the physician who prescribes paroxetine tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see dosage and administration). social anxiety disorder: paroxetine tablets are indicated for the treatment of social anxiety disorder, also known as social phobia, as defined in dsm-iv (300.23). social anxiety disorder is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. the feared situations are avoided or endured with intense anxiety or distress. the avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is marked distress about having the phobias. lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment. the efficacy of paroxetine tablets was established in three 12-week trials in adult patients with social anxiety disorder (dsm-iv). paroxetine tablets have not been studied in children or adolescents with social phobia (see clinical pharmacology: clinical trials). the effectiveness of paroxetine 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 tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see dosage and administration). generalized anxiety disorder: paroxetine tablets are indicated for the treatment of generalized anxiety disorder (gad), as defined in dsm-iv. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the efficacy of paroxetine tablets in the treatment of gad was established in two 8-week placebo-controlled trials in adults with gad. paroxetine tablets have not been studied in children or adolescents with generalized anxiety disorder (see clinical pharmacology: clinical trials ). generalized anxiety disorder (dsm-iv) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. it must be associated with at least 3 of the following 6 symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, sleep disturbance. the efficacy of paroxetine tablets in maintaining a response in patients with generalized anxiety disorder, who responded during an 8-week acute treatment phase while taking paroxetine tablets and were then observed for relapse during a period of up to 24 weeks, was demonstrated in a placebo-controlled trial (see clinical pharmacology: clinical trials). nevertheless, the physician who elects to use paroxetine tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see dosage and administration ). posttraumatic stress disorder: paroxetine tablets are indicated for the treatment of posttraumatic stress disorder (ptsd). the efficacy of paroxetine tablets in the treatment of ptsd was established in two 12-week placebo-controlled trials in adults with ptsd (dsm-iv) (see clinical pharmacology: clinical trials ). ptsd, as defined by dsm-iv, requires exposure to a traumatic event that involved actual or threatened death or serious injury, or threat to the physical integrity of self or others, and a response that involves intense fear, helplessness, or horror. symptoms that occur as a result of exposure to the traumatic event include reexperiencing of the event in the form of intrusive thoughts, flashbacks, or dreams, and intense psychological distress and physiological reactivity on exposure to cues to the event; avoidance of situations reminiscent of the traumatic event, inability to recall details of the event, and/or numbing of general responsiveness manifested as diminished interest in significant activities, estrangement from others, restricted range of affect, or sense of foreshortened future; and symptoms of autonomic arousal including hypervigilance, exaggerated startle response, sleep disturbance, impaired concentration, and irritability or outbursts of anger. a ptsd diagnosis requires that the symptoms are present for at least a month and that they cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. the efficacy of paroxetine tablets in longer-term treatment of ptsd, i.e., for more than 12 weeks, has not been systematically evaluated in placebo-controlled trials. therefore, the physician who elects to prescribe paroxetine tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see dosage and administration ). the use of maois intended to treat psychiatric disorders with paroxetine tablets or within 14 days of stopping treatment with paroxetine tablets is contraindicated because of an increased risk of serotonin syndrome. the use of paroxetine tablets within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated (see warnings and dosage and administration ). starting paroxetine tablets in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see warnings and dosage and administration ). concomitant use with thioridazine is contraindicated (see warnings and precautions ). concomitant use in patients taking pimozide is contraindicated (see precautions ). paroxetine tablets are contraindicated in patients with a hypersensitivity to paroxetine or any of the inactive ingredients in paroxetine tablets. alcohol: although paroxetine tablets do not increase the impairment of mental and motor skills caused by alcohol, patients should be advised to avoid alcohol while taking paroxetine tablets. pediatric use: safety and effectiveness in the pediatric population have not been established (see box warning and warnings: clinical worsening and suicide risk ). three placebo-controlled trials in 752 pediatric patients with mdd have been conducted with paroxetine tablets, and the data were not sufficient to support a claim for use in pediatric patients. anyone considering the use of paroxetine tablets in a child or adolescent must balance the potential risks with the clinical need. decreased appetite and weight loss have been observed in association with the use of ssris. consequently, regular monitoring of weight and growth should be performed in children and adolescents treated with an ssri such as paroxetine tablets. in placebo-controlled clinical trials conducted with pediatric patients, the following adverse events were reported in at least 2% of pediatric patients treated with paroxetine tablets and occurred at a rate at least twice that for pediatric patients receiving placebo: emotional lability (including self-harm, suicidal thoughts, attempted suicide, crying, and mood fluctuations), hostility, decreased appetite, tremor, sweating, hyperkinesia, and agitation. events reported upon discontinuation of treatment with paroxetine tablets in the pediatric clinical trials that included a taper phase regimen, which occurred in at least 2% of patients who received paroxetine tablets and which occurred at a rate at least twice that of placebo, were: emotional lability (including suicidal ideation, suicide attempt, mood changes, and tearfulness), nervousness, dizziness, nausea, and abdominal pain (see dosage and administration: discontinuation of treatment with paroxetine tablets ). geriatric use: ssris and snris, including paroxetine tablets, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event (see precautions: hyponatremia ). in worldwide premarketing clinical trials with paroxetine tablets, 17% of patients treated with paroxetine tablets (approximately 700) were 65 years of age or older. pharmacokinetic studies revealed a decreased clearance in the elderly, and a lower starting dose is recommended; there were, however, no overall differences in the adverse event profile between elderly and younger patients, and effectiveness was similar in younger and older patients (see clinical pharmacology and dosage and administration ). controlled substance class: paroxetine hydrochloride is not a controlled substance. physical and psychologic dependence: paroxetine tablets have not been systematically studied in animals or humans for its potential for abuse, tolerance or physical dependence. while the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a cns-active drug will be misused, diverted, and/or abused once marketed. consequently, patients should be evaluated carefully for history of drug abuse, and such patients should be observed closely for signs of misuse or abuse of paroxetine tablets (e.g., development of tolerance, incrementations of dose, drug-seeking behavior).

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - paroxetine hydrochloride hemihydrate (unii: x2els050d8) (paroxetine - unii:41vrh5220h) - major depressive disorder: paroxetine tablets are indicated for the treatment of major depressive disorder. the efficacy of paroxetine tablets in the treatment of a major depressive episode was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the dsm-iii category of major depressive disorder (see clinical pharmacology: clinical trials ). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the effects of paroxetine tablets in hospitalized depressed patients have not been adequately studied. the efficacy of paroxetine tablets in maintaining a response in major depressive disorder for up to 1 year was demonstrated in a placebo-controlled trial (see clinical pharmacology: clinical trials ). nevertheless, the physician who elects to use paroxetine tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. obsessive compulsive disorder: paroxetine tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (ocd) as defined in the dsm-iv. the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. the efficacy of paroxetine tablets was established in two 12-week trials with obsessive compulsive outpatients whose diagnoses corresponded most closely to the dsm-iiir category of obsessive compulsive disorder (see clinical pharmacology: clinical trials ). obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. long-term maintenance of efficacy was demonstrated in a 6-month relapse prevention trial. in this trial, patients assigned to paroxetine showed a lower relapse rate compared to patients on placebo (see clinical pharmacology: clinical trials). nevertheless, the physician who elects to use paroxetine tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see dosage and administration). panic disorder: paroxetine tablets are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in dsm-iv. panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. the efficacy of paroxetine tablets was established in three 10- to 12-week trials in panic disorder patients whose diagnoses corresponded to the dsm-iiir 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 10 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); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. long-term maintenance of efficacy was demonstrated in a 3-month relapse prevention trial. in this trial, patients with panic disorder assigned to paroxetine demonstrated a lower relapse rate compared to patients on placebo (see clinical pharmacology: clinical trials). nevertheless, the physician who prescribes paroxetine tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see dosage and administration). social anxiety disorder: paroxetine tablets are indicated for the treatment of social anxiety disorder, also known as social phobia, as defined in dsm-iv (300.23). social anxiety disorder is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. the feared situations are avoided or endured with intense anxiety or distress. the avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is marked distress about having the phobias. lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment. the efficacy of paroxetine tablets was established in three 12-week trials in adult patients with social anxiety disorder (dsm-iv). paroxetine tablets have not been studied in children or adolescents with social phobia (see clinical pharmacology: clinical trials). the effectiveness of paroxetine 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 tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see dosage and administration). generalized anxiety disorder: paroxetine tablets are indicated for the treatment of generalized anxiety disorder (gad), as defined in dsm-iv. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the efficacy of paroxetine tablets in the treatment of gad was established in two 8-week placebo-controlled trials in adults with gad. paroxetine tablets have not been studied in children or adolescents with generalized anxiety disorder (see clinical pharmacology: clinical trials ). generalized anxiety disorder (dsm-iv) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. it must be associated with at least 3 of the following 6 symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, sleep disturbance. the efficacy of paroxetine tablets in maintaining a response in patients with generalized anxiety disorder, who responded during an 8-week acute treatment phase while taking paroxetine tablets and were then observed for relapse during a period of up to 24 weeks, was demonstrated in a placebo-controlled trial (see clinical pharmacology: clinical trials). nevertheless, the physician who elects to use paroxetine tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see dosage and administration ). posttraumatic stress disorder: paroxetine tablets are indicated for the treatment of posttraumatic stress disorder (ptsd). the efficacy of paroxetine tablets in the treatment of ptsd was established in two 12-week placebo-controlled trials in adults with ptsd (dsm-iv) (see clinical pharmacology: clinical trials ). ptsd, as defined by dsm-iv, requires exposure to a traumatic event that involved actual or threatened death or serious injury, or threat to the physical integrity of self or others, and a response that involves intense fear, helplessness, or horror. symptoms that occur as a result of exposure to the traumatic event include reexperiencing of the event in the form of intrusive thoughts, flashbacks, or dreams, and intense psychological distress and physiological reactivity on exposure to cues to the event; avoidance of situations reminiscent of the traumatic event, inability to recall details of the event, and/or numbing of general responsiveness manifested as diminished interest in significant activities, estrangement from others, restricted range of affect, or sense of foreshortened future; and symptoms of autonomic arousal including hypervigilance, exaggerated startle response, sleep disturbance, impaired concentration, and irritability or outbursts of anger. a ptsd diagnosis requires that the symptoms are present for at least a month and that they cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. the efficacy of paroxetine tablets in longer-term treatment of ptsd, i.e., for more than 12 weeks, has not been systematically evaluated in placebo-controlled trials. therefore, the physician who elects to prescribe paroxetine tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see dosage and administration ). the use of maois intended to treat psychiatric disorders with paroxetine tablets or within 14 days of stopping treatment with paroxetine tablets is contraindicated because of an increased risk of serotonin syndrome. the use of paroxetine tablets within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated (see warnings and dosage and administration ). starting paroxetine tablets in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see warnings and dosage and administration ). concomitant use with thioridazine is contraindicated (see warnings and precautions ). concomitant use in patients taking pimozide is contraindicated (see precautions ). paroxetine tablets are contraindicated in patients with a hypersensitivity to paroxetine or any of the inactive ingredients in paroxetine tablets. alcohol: although paroxetine tablets do not increase the impairment of mental and motor skills caused by alcohol, patients should be advised to avoid alcohol while taking paroxetine tablets. pediatric use: safety and effectiveness in the pediatric population have not been established (see box warning and warnings: clinical worsening and suicide risk ). three placebo-controlled trials in 752 pediatric patients with mdd have been conducted with paroxetine tablets, and the data were not sufficient to support a claim for use in pediatric patients. anyone considering the use of paroxetine tablets in a child or adolescent must balance the potential risks with the clinical need. decreased appetite and weight loss have been observed in association with the use of ssris. consequently, regular monitoring of weight and growth should be performed in children and adolescents treated with an ssri such as paroxetine tablets. in placebo-controlled clinical trials conducted with pediatric patients, the following adverse events were reported in at least 2% of pediatric patients treated with paroxetine tablets and occurred at a rate at least twice that for pediatric patients receiving placebo: emotional lability (including self-harm, suicidal thoughts, attempted suicide, crying, and mood fluctuations), hostility, decreased appetite, tremor, sweating, hyperkinesia, and agitation. events reported upon discontinuation of treatment with paroxetine tablets in the pediatric clinical trials that included a taper phase regimen, which occurred in at least 2% of patients who received paroxetine tablets and which occurred at a rate at least twice that of placebo, were: emotional lability (including suicidal ideation, suicide attempt, mood changes, and tearfulness), nervousness, dizziness, nausea, and abdominal pain (see dosage and administration: discontinuation of treatment with paroxetine tablets ). geriatric use: ssris and snris, including paroxetine tablets, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event (see precautions: hyponatremia ). in worldwide premarketing clinical trials with paroxetine tablets, 17% of patients treated with paroxetine tablets (approximately 700) were 65 years of age or older. pharmacokinetic studies revealed a decreased clearance in the elderly, and a lower starting dose is recommended; there were, however, no overall differences in the adverse event profile between elderly and younger patients, and effectiveness was similar in younger and older patients (see clinical pharmacology and dosage and administration ). controlled substance class: paroxetine hydrochloride is not a controlled substance. physical and psychologic dependence: paroxetine tablets have not been systematically studied in animals or humans for its potential for abuse, tolerance or physical dependence. while the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a cns-active drug will be misused, diverted, and/or abused once marketed. consequently, patients should be evaluated carefully for history of drug abuse, and such patients should be observed closely for signs of misuse or abuse of paroxetine tablets (e.g., development of tolerance, incrementations of dose, drug-seeking behavior).

United States - English - NLM (National Library of Medicine)

mckesson corporation dba rx pak - paroxetine hydrochloride hemihydrate (unii: x2els050d8) (paroxetine - unii:41vrh5220h) - paroxetine tablets, usp are indicated for the treatment of major depressive disorder. the efficacy of paroxetine tablets, usp in the treatment of a major depressive episode was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the dsm-iii category of major depressive disorder (see clinical pharmacology —clinical trials ). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the effects of paroxetine tablets, usp in hospitalized depressed patients have not been adequately studie

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - paroxetine hydrochloride hemihydrate (unii: x2els050d8) (paroxetine - unii:41vrh5220h) - major depressive disorder: paroxetine tablets are indicated for the treatment of major depressive disorder. the efficacy of paroxetine tablets in the treatment of a major depressive episode was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the dsm-iii category of major depressive disorder (see clinical pharmacology: clinical trials ). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the effects of paroxetine tablets in hospitalized depressed patients have not been adequately studied. the efficacy of paroxetine tablets in maintaining a response in major depressive disorder for up to 1 year was demonstrated in a placebo-controlled trial (see clinical pharmacology: clinical trials ). nevertheless, the physician who elects to use paroxetine tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. obsessive compulsive disorder: paroxetine tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (ocd) as defined in the dsm-iv. the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. the efficacy of paroxetine tablets was established in two 12-week trials with obsessive compulsive outpatients whose diagnoses corresponded most closely to the dsm-iiir category of obsessive compulsive disorder (see clinical pharmacology: clinical trials ). obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. long-term maintenance of efficacy was demonstrated in a 6-month relapse prevention trial. in this trial, patients assigned to paroxetine showed a lower relapse rate compared to patients on placebo (see clinical pharmacology: clinical trials). nevertheless, the physician who elects to use paroxetine tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see dosage and administration). panic disorder: paroxetine tablets are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in dsm-iv. panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. the efficacy of paroxetine tablets was established in three 10- to 12-week trials in panic disorder patients whose diagnoses corresponded to the dsm-iiir 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 10 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); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. long-term maintenance of efficacy was demonstrated in a 3-month relapse prevention trial. in this trial, patients with panic disorder assigned to paroxetine demonstrated a lower relapse rate compared to patients on placebo (see clinical pharmacology: clinical trials). nevertheless, the physician who prescribes paroxetine tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see dosage and administration). social anxiety disorder: paroxetine tablets are indicated for the treatment of social anxiety disorder, also known as social phobia, as defined in dsm-iv (300.23). social anxiety disorder is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. the feared situations are avoided or endured with intense anxiety or distress. the avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is marked distress about having the phobias. lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment. the efficacy of paroxetine tablets was established in three 12-week trials in adult patients with social anxiety disorder (dsm-iv). paroxetine tablets have not been studied in children or adolescents with social phobia (see clinical pharmacology: clinical trials). the effectiveness of paroxetine 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 tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see dosage and administration). generalized anxiety disorder: paroxetine tablets are indicated for the treatment of generalized anxiety disorder (gad), as defined in dsm-iv. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the efficacy of paroxetine tablets in the treatment of gad was established in two 8-week placebo-controlled trials in adults with gad. paroxetine tablets have not been studied in children or adolescents with generalized anxiety disorder (see clinical pharmacology: clinical trials ). generalized anxiety disorder (dsm-iv) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. it must be associated with at least 3 of the following 6 symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, sleep disturbance. the efficacy of paroxetine tablets in maintaining a response in patients with generalized anxiety disorder, who responded during an 8-week acute treatment phase while taking paroxetine tablets and were then observed for relapse during a period of up to 24 weeks, was demonstrated in a placebo-controlled trial (see clinical pharmacology: clinical trials). nevertheless, the physician who elects to use paroxetine tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see dosage and administration ). posttraumatic stress disorder: paroxetine tablets are indicated for the treatment of posttraumatic stress disorder (ptsd). the efficacy of paroxetine tablets in the treatment of ptsd was established in two 12-week placebo-controlled trials in adults with ptsd (dsm-iv) (see clinical pharmacology: clinical trials ). ptsd, as defined by dsm-iv, requires exposure to a traumatic event that involved actual or threatened death or serious injury, or threat to the physical integrity of self or others, and a response that involves intense fear, helplessness, or horror. symptoms that occur as a result of exposure to the traumatic event include reexperiencing of the event in the form of intrusive thoughts, flashbacks, or dreams, and intense psychological distress and physiological reactivity on exposure to cues to the event; avoidance of situations reminiscent of the traumatic event, inability to recall details of the event, and/or numbing of general responsiveness manifested as diminished interest in significant activities, estrangement from others, restricted range of affect, or sense of foreshortened future; and symptoms of autonomic arousal including hypervigilance, exaggerated startle response, sleep disturbance, impaired concentration, and irritability or outbursts of anger. a ptsd diagnosis requires that the symptoms are present for at least a month and that they cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. the efficacy of paroxetine tablets in longer-term treatment of ptsd, i.e., for more than 12 weeks, has not been systematically evaluated in placebo-controlled trials. therefore, the physician who elects to prescribe paroxetine tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see dosage and administration ). the use of maois intended to treat psychiatric disorders with paroxetine tablets or within 14 days of stopping treatment with paroxetine tablets is contraindicated because of an increased risk of serotonin syndrome. the use of paroxetine tablets within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated (see warnings and dosage and administration ). starting paroxetine tablets in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see warnings and dosage and administration ). concomitant use with thioridazine is contraindicated (see warnings and precautions ). concomitant use in patients taking pimozide is contraindicated (see precautions ). paroxetine tablets are contraindicated in patients with a hypersensitivity to paroxetine or any of the inactive ingredients in paroxetine tablets. alcohol: although paroxetine tablets do not increase the impairment of mental and motor skills caused by alcohol, patients should be advised to avoid alcohol while taking paroxetine tablets. pediatric use: safety and effectiveness in the pediatric population have not been established (see box warning and warnings: clinical worsening and suicide risk ). three placebo-controlled trials in 752 pediatric patients with mdd have been conducted with paroxetine tablets, and the data were not sufficient to support a claim for use in pediatric patients. anyone considering the use of paroxetine tablets in a child or adolescent must balance the potential risks with the clinical need. decreased appetite and weight loss have been observed in association with the use of ssris. consequently, regular monitoring of weight and growth should be performed in children and adolescents treated with an ssri such as paroxetine tablets. in placebo-controlled clinical trials conducted with pediatric patients, the following adverse events were reported in at least 2% of pediatric patients treated with paroxetine tablets and occurred at a rate at least twice that for pediatric patients receiving placebo: emotional lability (including self-harm, suicidal thoughts, attempted suicide, crying, and mood fluctuations), hostility, decreased appetite, tremor, sweating, hyperkinesia, and agitation. events reported upon discontinuation of treatment with paroxetine tablets in the pediatric clinical trials that included a taper phase regimen, which occurred in at least 2% of patients who received paroxetine tablets and which occurred at a rate at least twice that of placebo, were: emotional lability (including suicidal ideation, suicide attempt, mood changes, and tearfulness), nervousness, dizziness, nausea, and abdominal pain (see dosage and administration: discontinuation of treatment with paroxetine tablets ). geriatric use: ssris and snris, including paroxetine tablets, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event (see precautions: hyponatremia ). in worldwide premarketing clinical trials with paroxetine tablets, 17% of patients treated with paroxetine tablets (approximately 700) were 65 years of age or older. pharmacokinetic studies revealed a decreased clearance in the elderly, and a lower starting dose is recommended; there were, however, no overall differences in the adverse event profile between elderly and younger patients, and effectiveness was similar in younger and older patients (see clinical pharmacology and dosage and administration ). controlled substance class: paroxetine hydrochloride is not a controlled substance. physical and psychologic dependence: paroxetine tablets have not been systematically studied in animals or humans for its potential for abuse, tolerance or physical dependence. while the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a cns-active drug will be misused, diverted, and/or abused once marketed. consequently, patients should be evaluated carefully for history of drug abuse, and such patients should be observed closely for signs of misuse or abuse of paroxetine tablets (e.g., development of tolerance, incrementations of dose, drug-seeking behavior).

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - paroxetine hydrochloride hemihydrate (unii: x2els050d8) (paroxetine - unii:41vrh5220h) - major depressive disorder: paroxetine tablets are indicated for the treatment of major depressive disorder. the efficacy of paroxetine tablets in the treatment of a major depressive episode was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the dsm-iii category of major depressive disorder (see clinical pharmacology: clinical trials ). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the effects of paroxetine tablets in hospitalized depressed patients have not been adequately studied. the efficacy of paroxetine tablets in maintaining a response in major depressive disorder for up to 1 year was demonstrated in a placebo-controlled trial (see clinical pharmacology: clinical trials ). nevertheless, the physician who elects to use paroxetine tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. obsessive compulsive disorder: paroxetine tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (ocd) as defined in the dsm-iv. the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. the efficacy of paroxetine tablets was established in two 12-week trials with obsessive compulsive outpatients whose diagnoses corresponded most closely to the dsm-iiir category of obsessive compulsive disorder (see clinical pharmacology: clinical trials ). obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. long-term maintenance of efficacy was demonstrated in a 6-month relapse prevention trial. in this trial, patients assigned to paroxetine showed a lower relapse rate compared to patients on placebo (see clinical pharmacology: clinical trials). nevertheless, the physician who elects to use paroxetine tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see dosage and administration). panic disorder: paroxetine tablets are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in dsm-iv. panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. the efficacy of paroxetine tablets was established in three 10- to 12-week trials in panic disorder patients whose diagnoses corresponded to the dsm-iiir 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 10 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); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. long-term maintenance of efficacy was demonstrated in a 3-month relapse prevention trial. in this trial, patients with panic disorder assigned to paroxetine demonstrated a lower relapse rate compared to patients on placebo (see clinical pharmacology: clinical trials). nevertheless, the physician who prescribes paroxetine tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see dosage and administration). social anxiety disorder: paroxetine tablets are indicated for the treatment of social anxiety disorder, also known as social phobia, as defined in dsm-iv (300.23). social anxiety disorder is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. the feared situations are avoided or endured with intense anxiety or distress. the avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is marked distress about having the phobias. lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment. the efficacy of paroxetine tablets was established in three 12-week trials in adult patients with social anxiety disorder (dsm-iv). paroxetine tablets have not been studied in children or adolescents with social phobia (see clinical pharmacology: clinical trials). the effectiveness of paroxetine 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 tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see dosage and administration). generalized anxiety disorder: paroxetine tablets are indicated for the treatment of generalized anxiety disorder (gad), as defined in dsm-iv. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the efficacy of paroxetine tablets in the treatment of gad was established in two 8-week placebo-controlled trials in adults with gad. paroxetine tablets have not been studied in children or adolescents with generalized anxiety disorder (see clinical pharmacology: clinical trials ). generalized anxiety disorder (dsm-iv) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. it must be associated with at least 3 of the following 6 symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, sleep disturbance. the efficacy of paroxetine tablets in maintaining a response in patients with generalized anxiety disorder, who responded during an 8-week acute treatment phase while taking paroxetine tablets and were then observed for relapse during a period of up to 24 weeks, was demonstrated in a placebo-controlled trial (see clinical pharmacology: clinical trials). nevertheless, the physician who elects to use paroxetine tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see dosage and administration ). posttraumatic stress disorder: paroxetine tablets are indicated for the treatment of posttraumatic stress disorder (ptsd). the efficacy of paroxetine tablets in the treatment of ptsd was established in two 12-week placebo-controlled trials in adults with ptsd (dsm-iv) (see clinical pharmacology: clinical trials ). ptsd, as defined by dsm-iv, requires exposure to a traumatic event that involved actual or threatened death or serious injury, or threat to the physical integrity of self or others, and a response that involves intense fear, helplessness, or horror. symptoms that occur as a result of exposure to the traumatic event include reexperiencing of the event in the form of intrusive thoughts, flashbacks, or dreams, and intense psychological distress and physiological reactivity on exposure to cues to the event; avoidance of situations reminiscent of the traumatic event, inability to recall details of the event, and/or numbing of general responsiveness manifested as diminished interest in significant activities, estrangement from others, restricted range of affect, or sense of foreshortened future; and symptoms of autonomic arousal including hypervigilance, exaggerated startle response, sleep disturbance, impaired concentration, and irritability or outbursts of anger. a ptsd diagnosis requires that the symptoms are present for at least a month and that they cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. the efficacy of paroxetine tablets in longer-term treatment of ptsd, i.e., for more than 12 weeks, has not been systematically evaluated in placebo-controlled trials. therefore, the physician who elects to prescribe paroxetine tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see dosage and administration ). the use of maois intended to treat psychiatric disorders with paroxetine tablets or within 14 days of stopping treatment with paroxetine tablets is contraindicated because of an increased risk of serotonin syndrome. the use of paroxetine tablets within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated (see warnings and dosage and administration ). starting paroxetine tablets in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see warnings and dosage and administration ). concomitant use with thioridazine is contraindicated (see warnings and precautions ). concomitant use in patients taking pimozide is contraindicated (see precautions ). paroxetine tablets are contraindicated in patients with a hypersensitivity to paroxetine or any of the inactive ingredients in paroxetine tablets. alcohol: although paroxetine tablets do not increase the impairment of mental and motor skills caused by alcohol, patients should be advised to avoid alcohol while taking paroxetine tablets. pediatric use: safety and effectiveness in the pediatric population have not been established (see box warning and warnings: clinical worsening and suicide risk ). three placebo-controlled trials in 752 pediatric patients with mdd have been conducted with paroxetine tablets, and the data were not sufficient to support a claim for use in pediatric patients. anyone considering the use of paroxetine tablets in a child or adolescent must balance the potential risks with the clinical need. decreased appetite and weight loss have been observed in association with the use of ssris. consequently, regular monitoring of weight and growth should be performed in children and adolescents treated with an ssri such as paroxetine tablets. in placebo-controlled clinical trials conducted with pediatric patients, the following adverse events were reported in at least 2% of pediatric patients treated with paroxetine tablets and occurred at a rate at least twice that for pediatric patients receiving placebo: emotional lability (including self-harm, suicidal thoughts, attempted suicide, crying, and mood fluctuations), hostility, decreased appetite, tremor, sweating, hyperkinesia, and agitation. events reported upon discontinuation of treatment with paroxetine tablets in the pediatric clinical trials that included a taper phase regimen, which occurred in at least 2% of patients who received paroxetine tablets and which occurred at a rate at least twice that of placebo, were: emotional lability (including suicidal ideation, suicide attempt, mood changes, and tearfulness), nervousness, dizziness, nausea, and abdominal pain (see dosage and administration: discontinuation of treatment with paroxetine tablets ). geriatric use: ssris and snris, including paroxetine tablets, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event (see precautions: hyponatremia ). in worldwide premarketing clinical trials with paroxetine tablets, 17% of patients treated with paroxetine tablets (approximately 700) were 65 years of age or older. pharmacokinetic studies revealed a decreased clearance in the elderly, and a lower starting dose is recommended; there were, however, no overall differences in the adverse event profile between elderly and younger patients, and effectiveness was similar in younger and older patients (see clinical pharmacology and dosage and administration ). controlled substance class: paroxetine hydrochloride is not a controlled substance. physical and psychologic dependence: paroxetine tablets have not been systematically studied in animals or humans for its potential for abuse, tolerance or physical dependence. while the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a cns-active drug will be misused, diverted, and/or abused once marketed. consequently, patients should be evaluated carefully for history of drug abuse, and such patients should be observed closely for signs of misuse or abuse of paroxetine tablets (e.g., development of tolerance, incrementations of dose, drug-seeking behavior).

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - paroxetine hydrochloride hemihydrate (unii: x2els050d8) (paroxetine - unii:41vrh5220h) - major depressive disorder: paroxetine tablets are indicated for the treatment of major depressive disorder. the efficacy of paroxetine tablets in the treatment of a major depressive episode was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the dsm-iii category of major depressive disorder (see clinical pharmacology: clinical trials ). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the effects of paroxetine tablets in hospitalized depressed patients have not been adequately studied. the efficacy of paroxetine tablets in maintaining a response in major depressive disorder for up to 1 year was demonstrated in a placebo-controlled trial (see clinical pharmacology: clinical trials ). nevertheless, the physician who elects to use paroxetine tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. obsessive compulsive disorder: paroxetine tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (ocd) as defined in the dsm-iv. the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. the efficacy of paroxetine tablets was established in two 12-week trials with obsessive compulsive outpatients whose diagnoses corresponded most closely to the dsm-iiir category of obsessive compulsive disorder (see clinical pharmacology: clinical trials ). obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. long-term maintenance of efficacy was demonstrated in a 6-month relapse prevention trial. in this trial, patients assigned to paroxetine showed a lower relapse rate compared to patients on placebo (see clinical pharmacology: clinical trials). nevertheless, the physician who elects to use paroxetine tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see dosage and administration). panic disorder: paroxetine tablets are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in dsm-iv. panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. the efficacy of paroxetine tablets was established in three 10- to 12-week trials in panic disorder patients whose diagnoses corresponded to the dsm-iiir 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 10 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); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. long-term maintenance of efficacy was demonstrated in a 3-month relapse prevention trial. in this trial, patients with panic disorder assigned to paroxetine demonstrated a lower relapse rate compared to patients on placebo (see clinical pharmacology: clinical trials). nevertheless, the physician who prescribes paroxetine tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see dosage and administration). social anxiety disorder: paroxetine tablets are indicated for the treatment of social anxiety disorder, also known as social phobia, as defined in dsm-iv (300.23). social anxiety disorder is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. the feared situations are avoided or endured with intense anxiety or distress. the avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is marked distress about having the phobias. lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment. the efficacy of paroxetine tablets was established in three 12-week trials in adult patients with social anxiety disorder (dsm-iv). paroxetine tablets have not been studied in children or adolescents with social phobia (see clinical pharmacology: clinical trials). the effectiveness of paroxetine 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 tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see dosage and administration). generalized anxiety disorder: paroxetine tablets are indicated for the treatment of generalized anxiety disorder (gad), as defined in dsm-iv. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the efficacy of paroxetine tablets in the treatment of gad was established in two 8-week placebo-controlled trials in adults with gad. paroxetine tablets have not been studied in children or adolescents with generalized anxiety disorder (see clinical pharmacology: clinical trials ). generalized anxiety disorder (dsm-iv) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. it must be associated with at least 3 of the following 6 symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, sleep disturbance. the efficacy of paroxetine tablets in maintaining a response in patients with generalized anxiety disorder, who responded during an 8-week acute treatment phase while taking paroxetine tablets and were then observed for relapse during a period of up to 24 weeks, was demonstrated in a placebo-controlled trial (see clinical pharmacology: clinical trials). nevertheless, the physician who elects to use paroxetine tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see dosage and administration ). posttraumatic stress disorder: paroxetine tablets are indicated for the treatment of posttraumatic stress disorder (ptsd). the efficacy of paroxetine tablets in the treatment of ptsd was established in two 12-week placebo-controlled trials in adults with ptsd (dsm-iv) (see clinical pharmacology: clinical trials ). ptsd, as defined by dsm-iv, requires exposure to a traumatic event that involved actual or threatened death or serious injury, or threat to the physical integrity of self or others, and a response that involves intense fear, helplessness, or horror. symptoms that occur as a result of exposure to the traumatic event include reexperiencing of the event in the form of intrusive thoughts, flashbacks, or dreams, and intense psychological distress and physiological reactivity on exposure to cues to the event; avoidance of situations reminiscent of the traumatic event, inability to recall details of the event, and/or numbing of general responsiveness manifested as diminished interest in significant activities, estrangement from others, restricted range of affect, or sense of foreshortened future; and symptoms of autonomic arousal including hypervigilance, exaggerated startle response, sleep disturbance, impaired concentration, and irritability or outbursts of anger. a ptsd diagnosis requires that the symptoms are present for at least a month and that they cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. the efficacy of paroxetine tablets in longer-term treatment of ptsd, i.e., for more than 12 weeks, has not been systematically evaluated in placebo-controlled trials. therefore, the physician who elects to prescribe paroxetine tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see dosage and administration ). the use of maois intended to treat psychiatric disorders with paroxetine tablets or within 14 days of stopping treatment with paroxetine tablets is contraindicated because of an increased risk of serotonin syndrome. the use of paroxetine tablets within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated (see warnings and dosage and administration ). starting paroxetine tablets in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see warnings and dosage and administration ). concomitant use with thioridazine is contraindicated (see warnings and precautions ). concomitant use in patients taking pimozide is contraindicated (see precautions ). paroxetine tablets are contraindicated in patients with a hypersensitivity to paroxetine or any of the inactive ingredients in paroxetine tablets. alcohol: although paroxetine tablets do not increase the impairment of mental and motor skills caused by alcohol, patients should be advised to avoid alcohol while taking paroxetine tablets. pediatric use: safety and effectiveness in the pediatric population have not been established (see box warning and warnings: clinical worsening and suicide risk ). three placebo-controlled trials in 752 pediatric patients with mdd have been conducted with paroxetine tablets, and the data were not sufficient to support a claim for use in pediatric patients. anyone considering the use of paroxetine tablets in a child or adolescent must balance the potential risks with the clinical need. decreased appetite and weight loss have been observed in association with the use of ssris. consequently, regular monitoring of weight and growth should be performed in children and adolescents treated with an ssri such as paroxetine tablets. in placebo-controlled clinical trials conducted with pediatric patients, the following adverse events were reported in at least 2% of pediatric patients treated with paroxetine tablets and occurred at a rate at least twice that for pediatric patients receiving placebo: emotional lability (including self-harm, suicidal thoughts, attempted suicide, crying, and mood fluctuations), hostility, decreased appetite, tremor, sweating, hyperkinesia, and agitation. events reported upon discontinuation of treatment with paroxetine tablets in the pediatric clinical trials that included a taper phase regimen, which occurred in at least 2% of patients who received paroxetine tablets and which occurred at a rate at least twice that of placebo, were: emotional lability (including suicidal ideation, suicide attempt, mood changes, and tearfulness), nervousness, dizziness, nausea, and abdominal pain (see dosage and administration: discontinuation of treatment with paroxetine tablets ). geriatric use: ssris and snris, including paroxetine tablets, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event (see precautions: hyponatremia ). in worldwide premarketing clinical trials with paroxetine tablets, 17% of patients treated with paroxetine tablets (approximately 700) were 65 years of age or older. pharmacokinetic studies revealed a decreased clearance in the elderly, and a lower starting dose is recommended; there were, however, no overall differences in the adverse event profile between elderly and younger patients, and effectiveness was similar in younger and older patients (see clinical pharmacology and dosage and administration ). controlled substance class: paroxetine hydrochloride is not a controlled substance. physical and psychologic dependence: paroxetine tablets have not been systematically studied in animals or humans for its potential for abuse, tolerance or physical dependence. while the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a cns-active drug will be misused, diverted, and/or abused once marketed. consequently, patients should be evaluated carefully for history of drug abuse, and such patients should be observed closely for signs of misuse or abuse of paroxetine tablets (e.g., development of tolerance, incrementations of dose, drug-seeking behavior).

European Union - English - EMA (European Medicines Agency)

teva pharma b.v. - rivastigmine - dementia; alzheimer disease; parkinson disease - anticholinesterases - symptomatic treatment of mild to moderately severe alzheimer's dementia.symptomatic treatment of mild to moderately severe dementia in patients with idiopathic parkinson's disease.

United States - English - NLM (National Library of Medicine)

mckesson corporation dba sky packaging - clonazepam (unii: 5pe9fde8gb) (clonazepam - unii:5pe9fde8gb) - clonazepam 0.5 mg - seizure disorders clonazepam tablets, usp are useful alone or as an adjunct in the treatment of the lennox-gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. in patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam may be useful. some loss of effect may occur during the course of clonazepam treatment (see precautions, loss of effect ). panic disorder clonazepam tablets, usp are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in dsm-v. panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. the efficacy of clonazepam was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the dsm-iiir category of

Australia - English - Department of Health (Therapeutic Goods Administration)

topcon healthcare solutions australia pty ltd - 65856 - ophthalmic remote-clinician examination software - topcon rdx is a software solution intended to be used to manage customer/patient workflow, to support remote eyecare services (ocular telehealth) and to facilitate comprehensive or substantial part of an eye examination remotely.