סינגפור - אנגלית - HSA (Health Sciences Authority)

a. menarini singapore pte. ltd. - dapoxetine eqv to dapoxetine hydrochloride 33.60mg - tablet, film coated - 30mg - dapoxetine eqv to dapoxetine hydrochloride 33.60mg 30mg

סינגפור - אנגלית - HSA (Health Sciences Authority)

a. menarini singapore pte. ltd. - dapoxetine eqv to dapoxetine hydrochloride 67.20mg - tablet, film coated - 60mg - dapoxetine eqv to dapoxetine hydrochloride 67.20mg 60mg

ארצות הברית - אנגלית - NLM (National Library of Medicine)

edgemont pharmaceuticals, llc - fluoxetine hydrochloride (unii: i9w7n6b1kj) (fluoxetine - unii:01k63sup8d) - fluoxetine 60 mg - fluoxetine is indicated for the treatment of: the use of maois intended to treat psychiatric disorders with fluoxetine or within 5 weeks of stopping treatment with fluoxetine is contraindicated because of an increased risk of serotonin syndrome. the use of fluoxetine within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2.6) and warnings and precautions (5.2)] . starting fluoxetine 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 dosage and administration ( 2.7 ) and warnings and precautions (5.2 )] . the use of fluoxetine is contraindicated with the following: pimozide and thioridazine prolong the qt interval. fluoxetine can increase the levels of pimozide and thioridazine through inhibition of cyp2d6. fluoxetine can also prolong the qt interval. pregnancy category c —fluoxetine should be used during pregnancy

ארצות הברית - אנגלית - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - paroxetine hydrochloride anhydrous (unii: 3i3t11ud2s) (paroxetine - unii:41vrh5220h) - paroxetine tablets are indicated for the treatment of major depressive disorder. the efficacy of paroxetine 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 in hospitalized depressed patients have not been adequately studied. the efficacy of paroxetine 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 for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. 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 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 for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see dosage and administration ). 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 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 for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see dosage and administration ). 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 was established in three 12-week trials in adult patients with social anxiety disorder (dsm-iv). paroxetine has not been studied in children or adolescents with social phobia (see clinical pharmacology, clinical trials ). the effectiveness of paroxetine 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 for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see dosage and administration ). 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 in the treatment of gad was established in two 8-week placebo-controlled trials in adults with gad. paroxetine has 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 in maintaining a response in patients with generalized anxiety disorder, who responded during an 8-week acute treatment phase while taking paroxetine 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 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 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. paroxetine is not a controlled substance. paroxetine has 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 (e.g., development of tolerance, incrementations of dose, drug-seeking behavior).

ארצות הברית - אנגלית - 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).

ארצות הברית - אנגלית - 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).

ארצות הברית - אנגלית - NLM (National Library of Medicine)

remedyrepack inc. - fluoxetine hydrochloride (unii: i9w7n6b1kj) (fluoxetine - unii:01k63sup8d) - fluoxetine capsules are indicated for the treatment of: - acute and maintenance treatment of major depressive disorder [see clinical studies ( 14.1)] . - acute and maintenance treatment of obsessions and compulsions in patients with obsessive compulsive disorder (ocd) [see clinical studies ( 14.2)]. - acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe bulimia nervosa [see clinical studies ( 14.3)] . - acute treatment of panic disorder, with or without agoraphobia [see clinical studies ( 14.4)]. fluoxetine capsules and olanzapine in combination are indicated for the treatment of: - acute treatment of depressive episodes associated with bipolar i disorder. - treatment resistant depression (major depressive disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with bipolar i disorder or the treatment of treatment resistant depression. when using fluoxetine capsules and olanzapine in combination, also refer to the clinical studies section of the package insert for symbyax ® . when using fluoxetine and olanzapine in combination, also refer to the contraindications section of the package insert for symbyax ® . the use of maois intended to treat psychiatric disorders with fluoxetine or within 5 weeks of stopping treatment with fluoxetine is contraindicated because of an increased risk of serotonin syndrome. the use of fluoxetine within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2.9) and warnings and precautions ( 5.2)] . starting fluoxetine 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 dosage and administration ( 2.10) and warnings and precautions ( 5.2)] . the use of fluoxetine is contraindicated with the following: - pimozide [see warnings and precautions ( 5.11) and drug interactions ( 7.7, 7.8)] - thioridazine [see warnings and precautions ( 5.11) and drug interactions ( 7.7, 7.8)] pimozide and thioridazine prolong the qt interval. fluoxetine can increase the levels of pimozide and thioridazine through inhibition of cyp2d6. fluoxetine can also prolong the qt interval. when using fluoxetine and olanzapine in combination, also refer to the use in specific populations section of the package insert for symbyax ® . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.   risk summary based on data from published observational studies, exposure to ssris, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see warnings and precautions ( 5.7) and clinical considerations] . available data from published epidemiologic studies and postmarketing reports over several decades have not established an increased risk of major birth defects or miscarriage. some studies have reported an increased incidence of cardiovascular malformations; however, these studies results do not establish a causal relationship (see data) . there are risks associated with untreated depression in pregnancy and risks of persistent pulmonary hypertension of the newborn (pphn) (see data) and poor neonatal adaptation with exposure to selective serotonin reuptake inhibitors (ssris), including fluoxetine, during pregnancy (see clinical considerations). in rats and rabbits treated with fluoxetine during the period of organogenesis, there was no evidence of developmental effects at doses up to 1.6 and 3.9 times, respectively, the maximum recommended human dose (mrhd) of 60 mg/day given to adolescents on a mg/m 2 basis. however, in other reproductive studies in rats, an increase in stillborn pups, a decrease in pup weight, and an increase in pup deaths early after birth occurred at doses that are 1.5 times (during gestation) and 0.97 time (during gestation and lactation) the mrhd given to adolescents on a mg/m 2 basis. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the us general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants. this finding is from a prospective, longitudinal study that followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. maternal adverse reactions use of fluoxetine in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see warnings and precautions ( 5.7)] . fetal/neonatal adverse reactions  neonates exposed to fluoxetine and other ssri or snris late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. such complications can arise immediately upon delivery. reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremors, jitteriness, irritability, and constant crying. these findings are consistent with either a direct toxic effect of ssris and snris or possibly a drug discontinuation syndrome. it should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see warnings and precautions ( 5.2)] . data human data  — it has been shown that ssris (including fluoxetine) can cross the placenta. published epidemiological studies of pregnant women exposed to fluoxetine have not established an increased risk of major birth defects, miscarriage, and other adverse developmental outcomes. several publications reported an increased incidence of cardiovascular malformations in children with in utero exposure to fluoxetine. however, these studies results do not establish a causal relationship. methodologic limitations of these observational studies include possible exposure and outcome misclassification, lack of adequate controls, adjustment for confounders and confirmatory studies. however, these studies cannot definitely establish or exclude any drug-associated risk during pregnancy. exposure to ssris, particularly later in pregnancy, may have an increased risk for pphn. pphn occurs in 1 to 2 per 1000 live births in the general population and is associated with substantial neonatal morbidity and mortality. animal data — in embryofetal development studies in rats and rabbits, there was no evidence of malformations or developmental variations following administration of fluoxetine at doses up to 12.5 and 15 mg/kg/day, respectively (1.6 and 3.9 times, respectively, the mrhd of 60 mg given to adolescents on a mg/m 2 basis) throughout organogenesis. however, in rat reproduction studies, an increase in stillborn pups, a decrease in pup weight, and an increase in pup deaths during the first 7 days postpartum occurred following maternal exposure to 12 mg/kg/day (1.5 times the mrhd given to adolescents on a mg/m 2 basis) during gestation or 7.5 mg/kg/day (0.97 time the mrhd given to adolescents on a mg/m 2 basis) during gestation and lactation. there was no evidence of developmental neurotoxicity in the surviving offspring of rats treated with 12 mg/kg/day during gestation. the no-effect dose for rat pup mortality was 5 mg/kg/day (0.65 time the mrhd given to adolescents on a mg/m 2 basis). risk summary data from published literature report the presence of fluoxetine and norfluoxetine in human milk (see data). there are reports of agitation, irritability, poor feeding, and poor weight gain in infants exposed to fluoxetine through breast milk (see clinical considerations). there are no data on the effect of fluoxetine or its metabolites on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for fluoxetine and any potential adverse effects on the breastfed child from fluoxetine or the underlying maternal condition. clinical considerations infants exposed to fluoxetine should be monitored for agitation, irritability, poor feeding, and poor weight gain. data a study of 19 nursing mothers on fluoxetine with daily doses of 10-60 mg showed that fluoxetine was detectable in 30% of nursing infant sera (range: 1 to 84 ng/ml) whereas norfluoxetine was found in 85% (range: <1 to 265 ng/ml). use of fluoxetine in children — the efficacy of fluoxetine for the treatment of major depressive disorder was demonstrated in two 8- to 9-week placebo-controlled clinical trials with 315 pediatric outpatients ages 8 to ≤18 [see clinical studies ( 14.1)] . the efficacy of fluoxetine for the treatment of ocd was demonstrated in one 13-week placebo-controlled clinical trial with 103 pediatric outpatients ages 7 to <18 [see clinical studies ( 14.2)] . the safety and effectiveness in pediatric patients <8 years of age in major depressive disorder and <7 years of age in ocd have not been established. fluoxetine pharmacokinetics were evaluated in 21 pediatric patients (ages 6 to ≤18) with major depressive disorder or ocd [see clinical pharmacology ( 12.3)] . the acute adverse reaction profiles observed in the 3 studies (n=418 randomized; 228 fluoxetine-treated, 190 placebo-treated) were generally similar to that observed in adult studies with fluoxetine. the longer-term adverse reaction profile observed in the 19-week major depressive disorder study (n=219 randomized; 109 fluoxetine-treated, 110 placebo-treated) was also similar to that observed in adult trials with fluoxetine [see adverse reactions ( 6.1)] . manic reaction, including mania and hypomania, was reported in 6 (1 mania, 5 hypomania) out of 228 (2.6%) fluoxetine-treated patients and in 0 out of 190 (0%) placebo-treated patients. mania/hypomania led to the discontinuation of 4 (1.8%) fluoxetine-treated patients from the acute phases of the 3 studies combined. consequently, regular monitoring for the occurrence of mania/hypomania is recommended. as with other ssris, decreased weight gain has been observed in association with the use of fluoxetine in children and adolescent patients. after 19 weeks of treatment in a clinical trial, pediatric subjects treated with fluoxetine gained an average of 1.1 cm less in height and 1.1 kg less in weight than subjects treated with placebo. in addition, fluoxetine treatment was associated with a decrease in alkaline phosphatase levels. the safety of fluoxetine treatment for pediatric patients has not been systematically assessed for chronic treatment longer than several months in duration. in particular, there are no studies that directly evaluate the longer-term effects of fluoxetine on the growth, development and maturation of children and adolescent patients. therefore, height and weight should be monitored periodically in pediatric patients receiving fluoxetine [see warnings and precautions ( 5.6)] . fluoxetine is approved for use in pediatric patients with mdd and ocd [see box warning and warnings and precautions ( 5.1)] . anyone considering the use of fluoxetine in a child or adolescent must balance the potential risks with the clinical need. animal data - significant toxicity on muscle tissue, neurobehavior, reproductive organs, and bone development has been observed following exposure of juvenile rats to fluoxetine from weaning through maturity. oral administration of fluoxetine to rats from weaning postnatal day 21 through adulthood day 90 at 3, 10, or 30 mg/kg/day was associated with testicular degeneration and necrosis, epididymal vacuolation and hypospermia (at 30 mg/kg/day corresponding to plasma exposures [auc] approximately 5 to 10 times the average auc in pediatric patients at the mrhd of 20 mg/day), increased serum levels of creatine kinase (at auc as low as 1 to 2 times the average auc in pediatric patients at the mrhd of 20 mg/day), skeletal muscle degeneration and necrosis, decreased femur length/growth and body weight gain (at auc 5 to 10 times the average auc in pediatric patients at the mrhd of 20 mg/day). the high dose of 30 mg/kg/day exceeded a maximum tolerated dose. when animals were evaluated after a drug-free period (up to 11 weeks after cessation of dosing), fluoxetine was associated with neurobehavioral abnormalities (decreased reactivity at auc as low as approximately 0.1 to 0.2 times the average auc in pediatric patients at the mrhd and learning deficit at the high dose), and reproductive functional impairment (decreased mating at all doses and impaired fertility at the high dose). in addition, the testicular and epididymal microscopic lesions and decreased sperm concentrations found in high dose group were also observed, indicating that the drug effects on reproductive organs are irreversible. the reversibility of fluoxetine-induced muscle damage was not assessed. these fluoxetine toxicities in juvenile rats have not been observed in adult animals. plasma exposures (auc) to fluoxetine in juvenile rats receiving 3, 10, or 30 mg/kg/day doses in this study are approximately 0.1 to 0.2, 1 to 2, and 5 to 10 times, respectively, the average exposure in pediatric patients receiving the mrhd of 20 mg/day. rat exposures to the major metabolite, norfluoxetine, are approximately 0.3 to 0.8, 1 to 8, and 3 to 20 times, respectively, the pediatric exposure at the mrhd. a specific effect on bone development was reported in juvenile mice administered fluoxetine by the intraperitoneal route to 4 week old mice for 4 weeks at doses 0.5 and 2 times the oral mrhd of 20 mg/day on mg/m 2 basis. there was a decrease in bone mineralization and density at both doses, but the overall growth (body weight gain or femur length) was not affected. use of fluoxetine in combination with olanzapine in children and adolescents: safety and efficacy of fluoxetine and olanzapine in combination in patients 10 to 17 years of age have been established for the acute treatment of depressive episodes associated with bipolar i disorder. safety and effectiveness of fluoxetine and olanzapine in combination in patients less than 10 years of age have not been established. us fluoxetine clinical trials included 687 patients ≥65 years of age and 93 patients ≥75 years of age. the efficacy in geriatric patients has been established [see clinical studies ( 14.1)] . for pharmacokinetic information in geriatric patients, [see clinical pharmacology ( 12.4)] . no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. snris and ssris, including fluoxetine, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see warnings and precautions ( 5.9)] . clinical studies of olanzapine and fluoxetine in combination did not include sufficient numbers of patients ≥65 years of age to determine whether they respond differently from younger patients. in subjects with cirrhosis of the liver, the clearances of fluoxetine and its active metabolite, norfluoxetine, were decreased, thus increasing the elimination half-lives of these substances. a lower or less frequent dose of fluoxetine should be used in patients with cirrhosis. caution is advised when using fluoxetine in patients with diseases or conditions that could affect its metabolism [see dosage and administration ( 2.7) and clinical pharmacology ( 12.4)] . fluoxetine has not been systematically studied, in animals or humans, for its potential for abuse, tolerance, or physical dependence. while the premarketing clinical experience with fluoxetine did not reveal any tendency for a withdrawal syndrome or 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, healthcare providers should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of fluoxetine (e.g., development of tolerance, incrementation of dose, drug-seeking behavior).

ארצות הברית - אנגלית - 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).

ארצות הברית - אנגלית - 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).

ארצות הברית - אנגלית - 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).