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

janssen pharmaceuticals, inc. - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 25 mg - topamax ® is indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. topamax ® is indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with lennox-gastaut syndrome in patients 2 years of age and older. topamax ® is indicated for the preventive treatment of migraine in patients 12 years of age and older. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to topamax ® during pregnancy. patients should be encouraged to enroll in the north american antiepileptic drug (naaed) pregnancy registry if they become pregnant. this registry is collecting information about the safety of antiepileptic drugs during pregnancy. to enroll, patients can call the toll-free number 1-888-233-2334. information about th

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

apotex corp - paroxetine hydrochloride (unii: x2els050d8) (paroxetine - unii:41vrh5220h) - paroxetine 10 mg - paxil is indicated in adults for the treatment of: - major depressive disorder (mdd) - obsessive compulsive disorder (ocd) - panic disorder (pd) - social anxiety disorder (sad) - generalized anxiety disorder (gad) - posttraumatic stress disorder (ptsd)   paxil is contraindicated in patients: - taking, or within 14 days of stopping, maois (including the maois linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see warnings and precautions (5.2), drug interactions (7)]. - taking thioridazine because of risk of qt prolongation [see warnings and precautions (5. 3) and drug interactions (7)] - taking pimozide because of risk of qt prolongation [see warnings and precautions (5. 3) and drug interactions (7)] - with known hypersensitivity (e.g., anaphylaxis, angioedema, stevens-johnson syndrome) to paroxetine or any of the inactive ingredients in paxil [see adverse reactions (6.1), (6.2)]. pregnancy category d [see warnings and precautions (5.4)] epidemiological studies have

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

apotex corp - paroxetine hydrochloride (unii: x2els050d8) (paroxetine - unii:41vrh5220h) - paxil is indicated in adults for the treatment of: - major depressive disorder (mdd) - obsessive compulsive disorder (ocd) - panic disorder (pd) - social anxiety disorder (sad) - generalized anxiety disorder (gad) - posttraumatic stress disorder (ptsd)   paxil is contraindicated in patients: - taking, or within 14 days of stopping, maois (including the maois linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see warnings and precautions (5.2), drug interactions (7)]. - taking thioridazine because of risk of qt prolongation [see warnings and precautions (5. 3) and drug interactions (7)] - taking pimozide because of risk of qt prolongation [see warnings and precautions (5.3), drug interactions (7)]. with known hypersensitivity (e.g., anaphylaxis, angioedema, stevens-johnson syndrome) to paroxetine or any of the inactive ingredients in paxil [see adverse reactions (6.1), (6.2)]. 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 (5.5) and clinical considerations] . epidemiological studies have shown that infants exposed to paroxetine in the first trimester of pregnancy have an increased risk of congenital malformations, particularly cardiovascular malformations. if paroxetine is used during pregnancy, or if the patient becomes pregnant while taking paroxetine, advise the patient of the potential hazard to the fetus. clinical considerations unless the benefits of paroxetine to the mother justify continuing treatment, consideration should be given to either discontinuing paroxetine therapy or switching to another antidepressant [see warnings and precautions (5.7)]. for - a study based on swedish national registry data demonstrated that infants exposed to paroxetine during pregnancy (n = 815) had an increased risk of cardiovascular malformations (2% risk in paroxetine-exposed infants) compared to the entire registry population (1% risk), for an odds ratio (or) of 1.8 (95% confidence interval 1.1 to 2.8). no increase in the risk of overall congenital malformations was seen in the paroxetine-exposed infants. the cardiac malformations in the paroxetine-exposed infants were primarily ventricular septal defects (vsds) and atrial septal defects (asds). septal defects range in severity from those that resolve spontaneously to those which require surgery. - a separate retrospective cohort study from the united states (united healthcare data) evaluated 5,956 infants of mothers dispensed antidepressants during the first trimester (n = 815 for paroxetine). this study showed a trend towards an increased risk for cardiovascular malformations for paroxetine (risk of 1.5%) compared to other antidepressants (risk of 1%), for an or of 1.5 (95% confidence interval 0.8 to 2.9). of the 12 paroxetine-exposed infants with cardiovascular malformations, 9 had vsds. this study also suggested an increased risk of overall major congenital malformations including cardiovascular defects for paroxetine (4% risk) compared to other (2% risk) antidepressants (or 1.8; 95% confidence interval 1.2 to 2.8). - two large case-control studies using separate databases, each with >9,000 birth defect cases and >4,000 controls, found that maternal use of paroxetine during the first trimester of pregnancy was associated with a 2- to 3-fold increased risk of right ventricular outflow tract obstructions. in one study the or was 2.5 (95% confidence interval, 1 to 6, 7 exposed infants) and in the other study the or was 3.3 (95% confidence interval, 1.3 to 8.8, 6 exposed infants). other studies have found varying results as to whether there was an increased risk of overall, cardiovascular, or specific congenital malformations. a meta-analysis of epidemiological data over a 16-year period (1992 to 2008) on first trimester paroxetine use in pregnancy and congenital malformations included the above-noted studies in addition to others (n = 17 studies that included overall malformations and n = 14 studies that included cardiovascular malformations; n = 20 distinct studies). while subject to limitations, this meta-analysis suggested an increased occurrence of cardiovascular malformations (prevalence odds ratio [por] 1.5; 95% confidence interval 1.2 to 1.9) and overall malformations (por 1.2; 95% confidence interval 1.1 to 1.4) with paroxetine use during the first trimester. it was not possible in this meta-analysis to determine the extent to which the observed prevalence of cardiovascular malformations might have contributed to that of overall malformations, nor was it possible to determine whether any specific types of cardiovascular malformations might have contributed to the observed prevalence of all cardiovascular malformations. unless the benefits of paroxetine to the mother justify continuing treatment, consideration should be given to either discontinuing paroxetine therapy or switching to another antidepressant [see warnings and precautions (5.7)]. for women who intend to become pregnant or are in their first trimester of pregnancy, paroxetine should only be initiated after consideration of the other available treatment options [see warnings and precautions (5.4)] . treatment of pregnant women during their third trimester: neonates exposed to ssris or serotonin and norepinephrine reuptake inhibitors (snris), including paxil, 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, tremor, jitteriness, irritability, and constant crying. these features 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)] . exposure to ssris in late pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (pphn). pphn occurs in 1 – 2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. in a retrospective case-control study of 377 women whose infants were born with pphn and 836 women whose infants were born healthy, the risk for developing pphn was approximately six-fold higher for infants exposed to ssris after the 20th week of gestation compared to infants who had not been exposed to antidepressants during pregnancy. there have also been postmarketing reports of premature births in pregnant women exposed to paroxetine or other ssris. when treating a pregnant woman with paroxetine during the third trimester, the physician should carefully consider both the potential risks and benefits of treatment. a prospective longitudinal study of 201 women with a history of major depression who were euthymic at the beginning of pregnancy. the women who discontinued antidepressant medication during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressant medication. maternal adverse reactions use of paxil in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see warnings and precautions (5.5)]. animal findings reproduction studies were performed at doses up to 50 mg/kg/day in rats and 6 mg/kg/day in rabbits administered during organogenesis. these doses are approximately 6 (rat) and less than 2 (rabbit) times the maximum recommended human dose (mrhd – 75 mg) on an mg/m2 basis. these studies have revealed no evidence of developmental effects. however, in rats, there was an increase in pup deaths during the first 4 days of lactation when dosing occurred during the last trimester of gestation and continued throughout lactation. this effect occurred at a dose of 1 mg/kg/day which is than the mrhd on an mg/m2 basis. the no‑effect dose for rat pup mortality was not determined. the cause of these deaths is not known. like many other drugs, paroxetine is secreted in human milk. because of the potential for serious adverse reactions in breastfeeding children from paxil, a decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the drug to the mother. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for paxil and any potential adverse effects on the breastfed child from paxil or from underlying maternal condition. the safety and effectiveness of paxil in pediatric patients have not been established [see box warning] . effectiveness was not demonstrated in three placebo-controlled trials in 752 paxil-treated pediatric patients with mdd.  antidepressants increase the risk of suicidal thoughts and behaviors in pediatric patients [see boxed warning, warnings and precautions (5.1)] . decreased appetite and weight loss have been observed in association with the use of ssris. in placebo-controlled clinical trials conducted with pediatric patients, the following adverse reactions were reported in at least 2% of pediatric patients treated with paxil 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. adverse reactions upon discontinuation of treatment with paxil in the pediatric clinical trials that included a taper phase regimen, which occurred in at least 2% of patients and 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 . in premarketing clinical trials with paxil, 17% of patients treated with paxil (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;, however, no overall differences in safety or effectiveness were observed between elderly and younger patients [see dosage and administration (2.4), clinical pharmacology (12.3)] . ssris including paxil, 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 (5.7)] . increased plasma concentrations of paroxetine occur in patients with renal and hepatic impairment. the initial dosage of paxil should be reduced in patients with severe renal impairment and in patients with severe hepatic impairment [see dosage and administration (2.4), clinical pharmacology (12.3)] .

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

remedyrepack inc. - paroxetine hydrochloride hemihydrate (unii: x2els050d8) (paroxetine - unii:41vrh5220h) - paxil is indicated in adults for the treatment of: - major depressive disorder (mdd) - obsessive compulsive disorder (ocd) - panic disorder (pd) - social anxiety disorder (sad) - generalized anxiety disorder (gad) - posttraumatic stress disorder (ptsd)   paxil is contraindicated in patients: - taking, or within 14 days of stopping, maois (including the maois linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see warnings and precautions ( 5.2), drug interactions (7)]. - taking thioridazine because of risk of qt prolongation [see warnings and precautions ( 5. 3) and drug interactions ( 7)] - taking pimozide because of risk of qt prolongation [see warnings and precautions (5. 3) and drug interactions ( 7)] - with known hypersensitivity (e.g., anaphylaxis, angioedema, stevens-johnson syndrome) to paroxetine or any of the inactive ingredients in paxil

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

rebel distributors corp - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 25 mg - topamax® (topiramate) tablets and topamax® (topiramate capsules) sprinkle capsules are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. 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)] . topamax® (topiramate) tablets and topamax® (topiramate capsules) sprinkle capsules 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)] . topamax® (topiramate) tablets and topamax® (topiramate capsules) sprin

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

physicians total care, inc. - paroxetine hydrochloride (unii: 3i3t11ud2s) (paroxetine - unii:41vrh5220h) - paroxetine hydrochloride 12.5 mg - paxil cr is indicated for the treatment of major depressive disorder. the efficacy of paxil cr in the treatment of a major depressive episode was established in two 12-week controlled trials of outpatients whose diagnoses corresponded to the dsm-iv category of major depressive disorder (see clinical pharmacology: clinical trials). a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least 5 of the following 9 symptoms during the same 2-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation. the antidepressant act

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

physicians total care, inc. - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 25 mg - topamax® (topiramate) tablets and topamax® (topiramate capsules) sprinkle capsules 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)] . topamax® tablets and topamax® sprinkle capsules 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)] . topamax® tablets and topamax® sprinkle capsules are indicated for adults for the prophylaxis of migraine headache [see clinical studies (14.3)] . the usefulness of topamax® in the acute treatment of migraine headache has not been studied. none. pregnanc

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

apotex corp - paroxetine hydrochloride (unii: x2els050d8) (paroxetine - unii:41vrh5220h) - paroxetine 12.5 mg - paxil cr is indicated in adults for the treatment of: - major depressive disorder (mdd) - panic disorder (pd) - social anxiety disorder (sad) - premenstrual dysphoric disorder (pmdd) paxil cr is contraindicated in patients:  - taking, or within 14 days of stopping, maois (including the maois linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see warnings and precautions (5.2), drug interactions (7)]. - taking thioridazine because of risk of qt prolongation [see warnings and precautions (5.3), drug interactions (7)] . - taking pimozide because of risk of qt prolongation [see warnings and precautions (5.3), drug interactions (7)]. - with known hypersensitivity (e.g., anaphylaxis, angioedema, stevens-johnson syndrome) to paroxetine or to any of the inactive ingredients in paxil cr [see adverse reactions (6.1, 6.2)]. 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 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-researchprograms/ 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 (5.5) and clinical considerations] . paxil cr is associated with a less than 2-fold increase in cardiovascular malformations when administered to a pregnant woman during the first trimester. while individual epidemiological studies on the association between paroxetine use and cardiovascular malformations have reported inconsistent findings, some meta-analyses of epidemiological studies have identified an increased risk of cardiovascular malformations (see data). there are risks of persistent pulmonary hypertension of the newborn (pphn) (see data) and/or poor neonatal adaptation with exposure to selective serotonin reuptake inhibitors (ssris), including paxil cr, during pregnancy. there also are risks associated with untreated depression in pregnancy (see clinical considerations). for women who intend to become pregnant or who are in their first trimester of pregnancy, paroxetine should be initiated only after consideration of the other available treatment options. no evidence of treatment related malformations was observed in animal reproduction studies, when paroxetine was administered during the period of organogenesis at doses up to 50 mg/kg/day in rats and 6 mg/kg/day in rabbits. these doses are approximately 6 (rat) and less than 2 (rabbit) times the maximum recommended human dose (mrhd – 75 mg) on an mg/m2 basis. when paroxetine was administered to female rats during the last trimester of gestation and continued through lactation, there was an increase in the number of pup deaths during the first four days of lactation. this effect occurred at a dose of 1 mg/kg/day which is less than the mrhd on an mg/m2 basis (see data). the estimated background risks of major birth defects and miscarriage for the indicated populations are 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 of 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. consider the risks of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. maternal adverse reactions use of paxil cr in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see warnings and precautions (5.5)] . fetal/neonatal adverse reactions neonates exposed to paxil cr and other ssris 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 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 (5.4)] . data human data published epidemiological studies on the association between first trimester paroxetine use and cardiovascular malformations have reported inconsistent results; however, meta-analyses of population-based cohort studies published between 1996-2017 indicate a less than 2-fold increased risk for overall cardiovascular malformations. specific cardiac malformations identified in two meta-analyses include approximately 2 to 2.5-fold increased risk for right ventricular outflow tract defects. one meta-analysis also identified an increased risk (less than 2- fold) for bulbus cordis anomalies and anomalies of cardiac septal closure, and an increased risk for atrial septal defects (pooled or 2.38, 95% ci 1.14-4.97). important limitations of the studies included in these meta-analyses include potential confounding by indication, depression severity, and potential exposure misclassification. exposure to ssris, particularly later in pregnancy, may have an increased risk for pphn. pphnoccurs in 1-2 per 1000 live births in the general population and is associated with substantialneonatal morbidity and mortality. animal data   reproduction studies were performed at doses up to 50 mg/kg/day in rats and 6 mg/kg/day in rabbits administered during organogenesis. these doses are approximately 6 (rat) and less than 2 (rabbit) times the maximum recommended human dose (mrhd – 75 mg) on an mg/m2 basis. these studies have revealed no evidence of malformations. however, in rats, there was an increase in pup deaths during the first 4 days of lactation when dosing occurred during the last trimester of gestation and continued throughout lactation. this effect occurred at a dose of 1 mg/kg/day which is less than the mrhd on an mg/m2 basis. the no‑effect dose for rat pup mortality was not determined. the cause of these deaths is not known. risk summary data from the published literature report the presence of paroxetine in human milk (see data).there are reports of agitation, irritability, poor feeding and poor weight gain in infants exposedto paroxetine through breast milk (see clinical considerations). there are no data on the effectsof paroxetine on milk production. the developmental and health benefits of breastfeeding shouldbe considered along with the mother's clinical need for paxil cr and any potential adverse effects on the breastfed infant from paxil cr or the underlying maternal condition. clinical considerations infants exposed to paxil cr should be monitored for agitation, irritability, poor feeding andpoor weight gain. data published literature suggests the presence of paroxetine in human milk with relative infant dosesranging between 0.4% to 2.2%, and a milk: plasma ratio of <1. no significant amounts weredetected in the plasma of infants after breastfeeding. infertility male based on findings from clinical studies, paroxetine may affect sperm quality which may impairfertility; it is not known if this effect is reversible [see nonclinical toxicology (13.1)]. the safety and effectiveness of paxil cr in pediatric patients have not been established [see boxed warning, warnings and precautions (5.1)].    three placebo-controlled trials in 752 pediatric patients with mdd have been conducted with immediate-release paroxetine, and effectiveness was not established in pediatric patients.   decreased appetite and weight loss have been observed in association with the use of ssris.     in placebo-controlled clinical trials conducted with pediatric patients, the following adverse reactions were reported in at least 2% of pediatric patients treated with immediate-release paroxetine hydrochloride and 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. adverse reactions upon discontinuation of treatment with immediate-release paroxetine hydrochloride in the pediatric clinical trials that included a taper phase regimen, which occurred in at least 2% of patients and 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. ssris and snris, including paxil cr, 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)].   in premarketing clinical trials with immediate‑release paroxetine hydrochloride, 17% of paroxetine treated patients (approximately 700) were 65 years or older. pharmacokinetic studies revealed a decreased clearance in the elderly, and a lower starting dose is recommended; however, no overall differences in safety or effectiveness were observed between these subjects and younger subjects [see dosage and administration (2.5) and clinical pharmacology (12.3)]. increased plasma concentrations of paroxetine occur in patients with renal and hepatic impairment. the initial dosage of paxil cr should be reduced in patients with severe renal impairment and patients with severe hepatic impairment [see dosage and administration (2.5) and clinical pharmacology (12.3)].

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

stat rx usa llc - paroxetine hydrochloride (unii: 3i3t11ud2s) (paroxetine - unii:41vrh5220h) - paroxetine hydrochloride 12.5 mg - paxil cr is indicated for the treatment of major depressive disorder. the efficacy of paxil cr in the treatment of a major depressive episode was established in two 12-week controlled trials of outpatients whose diagnoses corresponded to the dsm-iv category of major depressive disorder (see clinical pharmacology—clinical trials). a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least 5 of the following 9 symptoms during the same 2-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation. the antidep

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

rebel distributors corp - paroxetine hydrochloride (unii: 3i3t11ud2s) (paroxetine - unii:41vrh5220h) - paroxetine hydrochloride 12.5 mg - paxil cr is indicated for the treatment of major depressive disorder. the efficacy of paxil cr in the treatment of a major depressive episode was established in two 12-week controlled trials of outpatients whose diagnoses corresponded to the dsm-iv category of major depressive disorder (see clinical pharmacology—clinical trials). a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least 5 of the following 9 symptoms during the same 2-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation. the antidepressant acti