Verenigde Staten - Engels - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 250 mg - levetiracetam tablets usp are indicated for treatment of partial-onset seizures in patients 1 month of age and older. levetiracetam tablets usp are indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. levetiracetam tablets usp are indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy. levetiracetam is contraindicated in patients with a hypersensitivity to levetiracetam. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.4)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), including levetiracetam, during pregnancy. encourage women who are taking levetiracetam during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. risk summary prolonged experience with levetiracetam in pregnant women has not identified a drug-associated risk of major birth defects or miscarriage, based on published literature, which includes data from pregnancy registries and reflects experience over two decades [see human data]. in animal studies, levetiracetam produced developmental toxicity (increased embryofetal and offspring mortality, increased incidences of fetal structural abnormalities, decreased embryofetal and offspring growth, neurobehavioral alterations in offspring) at doses similar to human therapeutic doses [see animal data]. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. clinical considerations levetiracetam blood levels may decrease during pregnancy [see warnings and precautions (5.10)]. physiological changes during pregnancy may affect levetiracetam concentration. decrease in levetiracetam plasma concentrations has been observed during pregnancy. this decrease is more pronounced during the third trimester. dose adjustments may be necessary to maintain clinical response. data human data while available studies cannot definitively establish the absence of risk, data from the published literature and pregnancy registries have not established an association with levetiracetam use during pregnancy and major birth defects or miscarriage. animal data when levetiracetam (0, 400, 1200, or 3600 mg/kg/day) was administered orally to pregnant rats during the period of organogenesis, reduced fetal weights and increased incidence of fetal skeletal variations were observed at the highest dose tested. there was no evidence of maternal toxicity. the no-effect dose for adverse effects on embryofetal developmental in rats (1200 mg/kg/day) is approximately 4 times the maximum recommended human dose (mrhd) of 3000 mg on a body surface area (mg/m2 ) basis. oral administration of levetiracetam (0, 200, 600, or 1800 mg/kg/day) to pregnant rabbits during the period of organogenesis resulted in increased embryofetal mortality and incidences of fetal skeletal abnormalities at variations at the mid and high dose and decreased fetal weights and increased incidence of fetal malformations at the high dose, which  associated with maternal toxicity. the no effect dose for adverse effects on embryofetal development in rabbits (200 mg/kg/day) is approximately equivalent to the mrhd on a mg/m2 basis. oral administration of levetiracetam (0, 70, 350, or 1800 mg/kg/day) to female rats throughout pregnancy and lactation led to an increased incidence of fetal skeletal variations, reduced fetal body weight, and decreased growth in offspring at the mid and high doses and increased pup mortality and neurobehavioral alterations in offspring at the highest dose tested. there was no evidence of maternal toxicity. the no-effect dose for adverse effects on pre- and postnatal development in rats (70 mg/kg/day) is less than the mrhd on a mg/m2 basis. oral administration of levetiracetam to rats during the latter part of gestation and throughout lactation produced no adverse developmental or maternal effects at doses of up to 1800 mg/kg/day (6 times the mrhd on a mg/m2 basis). the effect of levetiracetam on labor and delivery in humans is unknown. the safety and effectiveness of levetiracetam for the treatment of partial-onset seizures in patients 1 month to 16 years of age have been established [see clinical studies (14.1)] . the dosing recommendation in these pediatric patients varies according to age group and is weight-based [see pharmacology (12.3) and clinical studies (14.1)] . the safety and effectiveness of levetiracetam as adjunctive therapy for the treatment of myoclonic seizures in adolescents 12 years of age and older with juvenile myoclonic epilepsy have been established [see clinical studies (14.2)] . the safety and effectiveness of levetiracetam as adjunctive therapy for the treatment of primary generalized tonic- clonic seizures in pediatric patients 6 years of age and older with idiopathic generalized epilepsy have been established [see clinical studies (14.3)] . safety and effectiveness for the treatment of partial-onset seizures in pediatric patients below the age of 1 month; adjunctive therapy for the treatment of myoclonic seizures in pediatric patients below the age of 12 years; and adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in pediatric patients below the age of 6 years have not been established. a 3-month, randomized, double-blind, placebo-controlled study was performed to assess the neurocognitive and behavioral effects of levetiracetam as adjunctive therapy in 98 (levetiracetam n=64, placebo n=34) pediatric patients, ages 4 to 16 years old, with partial seizures that were inadequately controlled. the target dose was 60 mg/kg/day. neurocognitive effects were measured by the leiter-r attention and memory (am) battery, which measures various aspects of a child's memory and attention. although no substantive differences were observed between the placebo and drug treated groups in the median change from baseline in this battery, the study was not adequate to assess formal statistical non-inferiority of the drug and placebo. the achenbach child behavior checklist (cbcl/6 to 18), a standardized validated tool used to assess a child's competencies and behavioral/emotional problems, was also assessed in this study. an analysis of the cbcl/6 to 18 indicated on average a worsening in levetiracetam-treated patients in aggressive behavior, one of the eight syndrome scores. [see warnings and precautions (5.1)]. juvenile animal toxicity data studies of levetiracetam in juvenile rats (dosed on postnatal days 4 through day 52) and dogs (dosed from postnatal weeks 3 through 7) at doses of up to 1800 mg/kg/day (approximately 7 and 24 times, respectively, the maximum recommended pediatric dose of 60 mg/kg/day on a mg/m2 basis) did not demonstrate adverse effects on postnatal development. there were 347 subjects in clinical studies of levetiracetam that were 65 and over. no overall differences in safety were observed between these subjects and younger subjects. there were insufficient numbers of elderly subjects in controlled trials of epilepsy to adequately assess the effectiveness of levetiracetam in these patients. levetiracetam is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see clinical pharmacology (12.3)]. clearance of levetiracetam is decreased in patients with renal impairment and is correlated with creatinine clearance [see clinical pharmacology (12.3)] . dose adjustment is recommended for patients with impaired renal function and supplemental doses should be given to patients after dialysis [see dosage and administration (2.5)] .

Verenigde Staten - Engels - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 500 mg - levetiracetam tablets usp are indicated for treatment of partial-onset seizures in patients 1 month of age and older. levetiracetam tablets usp are indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. levetiracetam tablets usp are indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy. levetiracetam is contraindicated in patients with a hypersensitivity to levetiracetam. reactions have included anaphylaxis and angioedema [see warnings and precautions ( 5.4)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), including levetiracetam, during pregnancy. encourage women who are taking levetiracetam during pregnancy to enroll in the north american antiepileptic drug (na

Verenigde Staten - Engels - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 500 mg - levetiracetam tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy. levetiracetam tablets are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. levetiracetam tablets are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. none. levetiracetam blood levels may decrease during pregnancy [see warnings and precautions (5.9) ] . pregnancy category c there are no adequate and controlled studies in pregnant women. in animal studies, levetiracetam produced evidence of developmental toxicity, including teratogenic effects, at doses similar to or greater than human therapeutic doses. levetiracetam should be used during pregnancy only if the potential benefit justifies the potential risk to the f

Verenigde Staten - Engels - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine 100 mg - nevirapine extended-release tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection in adults and pediatric patients 6 years of age or older with a body surface area (bsa) of 1.17 m2 or greater [see clinical studies (14.1, 14.2)] . limitations of use: based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine extended-release tablets are not recommended to be initiated, unless the benefit outweighs the risk, in: nevirapine extended-release tablets are contraindicated: there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to nevirapine during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. available data from the apr show no difference in the risk of overall major birth defects for nevirapine compared with the background rate for major birth defects of 2.7% in a u.s. reference population of the metropolitan atlanta congenital defects program (macdp) [see data] . the rate of miscarriage is not reported in the apr. the estimated background rate of miscarriage in clinically recognized pregnancies in the u.s. general population is 15-20%. the background risk of birth defects and miscarriage for the indicated population is unknown. methodological limitations of the apr include the use of macdp as the external comparator group. the macdp population is not disease-specific, evaluates women and infants from a limited geographic area, and does not include outcomes for births that occurred at < 20 weeks gestation. there is a risk for severe hepatic events in pregnant women exposed to nevirapine extended-release tablets [see clinical considerations] . in animal reproduction studies, no evidence of adverse developmental outcomes was observed following oral administration of nevirapine during organogenesis in the rat and rabbit, at systemic exposures (auc) to nevirapine approximately equal (rats) and 50% higher (rabbits) than the exposure in humans at the recommended 400 mg daily dose [see data] . severe hepatic events, including fatalities, have been reported in pregnant women receiving chronic nevirapine therapy as part of combination treatment of hiv-1 infection. regardless of pregnancy status, women with cd4+ cell counts greater than 250 cells/mm3 should not initiate nevirapine unless the benefit outweighs the risk. it is unclear if pregnancy augments the risk observed in non-pregnant women [see warnings and precautions (5.1)] . based on prospective reports to the apr of exposures to nevirapine during pregnancy resulting in live births (including over 1100 exposed in the first trimester and over 1500 exposed in the second/third trimester), the prevalence of birth defects in live births was 3.0% (95% ci: 2.1%, 4.1%) and 3.3% (95% ci: 2.4%, 4.3%) following first and second/third-trimester exposure, respectively, to nevirapine-containing regimens, compared with the background birth defect rate of 2.7% in a u.s. reference population of the macdp. nevirapine was administered orally to pregnant rats (at 0, 12.5, 25, and 50 mg/kg/day), and rabbits (at 0, 30, 100, and 300 mg/kg/day) through organogenesis (on gestation days 7 through 16 and 6 through 18, respectively). no adverse developmental effects were observed at doses producing systemic exposures (auc) approximately equivalent to (rats) or approximately 50% higher (rabbits) than human exposure at the recommended daily dose. in rats, decreased fetal body weights were observed at a maternally toxic dose at an exposure approximately 50% higher than the recommended daily dose. the centers for disease control and prevention recommend that hiv-1 infected mothers in the united states not breastfeed their infants to avoid risking postnatal transmission of hiv-1 infection. published data report that immediate-release nevirapine is present in human milk. there are limited data on the effects of nevirapine on the breastfed infant. there is no information on the effects of nevirapine on milk production. because of the potential for (1) hiv-1 transmission (in hiv-negative infants), (2) developing viral resistance (in hiv-positive infants), and (3) serious adverse reactions in nursing infants, mothers should not breastfeed if they are receiving nevirapine extended-release tablets. limited human data are insufficient to determine the risk of infertility in humans. based on results from animal fertility studies conducted in rats, nevirapine extended-release tablets may reduce fertility in females of reproductive potential. it is not known if these effects on fertility are reversible [see nonclinical toxicology (13.1)] . nevirapine extended-release tablets are indicated for use in combination with other antiretroviral agents for the treatment of hiv-1 infection in children 6 years of age or older with a bsa of 1.17 m2 or greater [see indications and usage (1) and dosage and administration (2.3)]. the use of nevirapine extended-release tablets for the treatment of hiv-1 infection in pediatric patients 6 to less than 18 years of age is based on pharmacokinetic, safety, and antiviral activity data from an open-label trial with nevirapine extended-release tablets. the results of this trial were supported by previous demonstration of efficacy in adult patients [see adverse reactions (6.1) , clinical pharmacology (12.3), and clinical studies (14.2)]. nevirapine extended-release tablets are not recommended for children less than 6 years of age. trial 1100.1518 did not provide sufficient pharmacokinetic data for children 3 to less than 6 years of age to support the use of nevirapine extended-release tablets in this age group. furthermore, nevirapine extended-release tablets are not recommended for children less than 3 years of age because they are not able to swallow tablets. clinical studies of nevirapine extended-release tablets did not include sufficient numbers of subjects aged 65 and older to determine whether elderly subjects respond differently from younger subjects. in general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. in subjects with renal impairment (mild, moderate or severe), there were no significant changes in the pharmacokinetics of nevirapine. nevirapine is extensively metabolized by the liver and nevirapine metabolites are extensively eliminated by the kidney. nevirapine metabolites may accumulate in patients receiving dialysis; however, the clinical significance of this accumulation is not known. no adjustment in nevirapine dosing is required in patients with crcl greater than or equal to 20 ml per min. the pharmacokinetics of nevirapine have not been evaluated in patients with crcl less than 20 ml per min. in patients undergoing chronic hemodialysis, an additional dose of immediate-release nevirapine (200 mg) following each dialysis treatment is indicated [see dosage and administration (2.5) and clinical pharmacology (12.3)]. nevirapine extended-release tablets have not been studied in patients with renal dysfunction. because increased nevirapine levels and nevirapine accumulation may be observed in patients with serious liver disease, do not administer nevirapine to patients with moderate or severe (child-pugh class b or c, respectively) hepatic impairment [see contraindications (4), warnings and precautions (5.1), and clinical pharmacology (12.3)]. nevirapine extended-release tablets have not been evaluated in subjects with hepatic impairment.

Verenigde Staten - Engels - NLM (National Library of Medicine)

nucare pharmaceuticals, inc. - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 50 mg - topiramate tablets, usp are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see clinical studies ( 14.1)] . topiramate tablets, usp are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with lennox-gastaut syndrome [see clinical studies ( 14.2)] . additional pediatric use information for patients ages 12 to 17 years is approved for janssen pharmaceuticals, inc.’s topamax (topiramate) tablets and sprinkle capsules. however, due to janssen pharmaceuticals, inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. none. pregnancy category

Verenigde Staten - Engels - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - paroxetine hydrochloride anhydrous (unii: 3i3t11ud2s) (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.

Verenigde Staten - Engels - 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).

Verenigde Staten - Engels - 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

Verenigde Staten - Engels - NLM (National Library of Medicine)

denton pharma, inc. dba northwind pharmaceuticals - 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 adeq

Verenigde Staten - Engels - NLM (National Library of Medicine)

denton pharma, inc. dba northwind pharmaceuticals - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate tablets usp are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures.                                                                                                                                   topiramate tablets are indicated as adjunctive therapy for adults and pediatric patients 2 to 16 years of age with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with lennox-gastaut syndrome. topiramate tablets are indicated for patients 12 years of age and older for the prophylaxis of migraine headache. none pregnancy category d   [see   warnings and precautions 5.7 ] topiramate  can cause fetal harm when administered to a pregnant woman. data from pregnancy registries indicate that infants exposed to topiramate in utero have an increased risk for cleft lip and/or cleft palate (oral clefts)