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

sandoz pty ltd - paroxetine hydrochloride, quantity: 22.2 mg - tablet, film coated - excipient ingredients: magnesium stearate; microcrystalline cellulose; mannitol; titanium dioxide; sodium starch glycollate; colloidal anhydrous silica; hypromellose; copovidone; purified talc - paroxetine sandoz is indicated for the treatment of : - major depression and for the prevention of relapse of depressive symptoms - obsessive compulsive disorder (ocd) and prevention of relapse of ocd - panic disorder and for the prevention of relapse of panic disorder - social anxiety disorder/social phobia - general anxiety disorder - post-traumatic stress disorder.

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

tya pharmaceuticals - paroxetine hydrochloride anhydrous (unii: 3i3t11ud2s) (paroxetine - unii:41vrh5220h) - paroxetine 20 mg - paroxetine is 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 ). 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. clinical pharmacology: clinical trials the effects of paroxetine in hospitalized depressed patients have not been adequately studied. the efficacy of

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

a-s medication solutions - paroxetine hydrochloride anhydrous (unii: 3i3t11ud2s) (paroxetine - unii:41vrh5220h) - paroxetine 20 mg - 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

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

bryant ranch prepack - paroxetine hydrochloride hemihydrate (unii: x2els050d8) (paroxetine - unii:41vrh5220h) - paroxetine 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) paroxetine 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)]. - t aking 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 paroxetine tablets, usp[see adverse reactions (6.1), (6.2)] . pregnancy category d [see warnings and precautions (5.4)]

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

rhodes pharmaceuticals l.p. - paroxetine hydrochloride (unii: x2els050d8) (paroxetine - unii:41vrh5220h) - paroxetine extended-release tablets, usp are indicated in adults for the treatment of: - major depressive disorder (mdd) - panic disorder (pd) - social anxiety disorder (sad) - premenstrual dysphoric disorder (pmdd) paroxetine extended-release tablets are 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 paroxetine extended-release tablets [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]. paroxetine extended-release tablets are 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 paroxetine extended-release tablets, 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 paroxetine extended-release tablets 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 paroxetine extended-release tablets 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. pphn occurs in 1-2 per 1000 live births in the general population and is associated with substantial neonatal 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 exposed to paroxetine through breast milk (see clinical considerations). there are no data on the effects of paroxetine on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for paroxetine extended-release tablets and any potential adverse effects on the breastfed infant from paroxetine extended-release tablets or the underlying maternal condition. clinical considerations infants exposed to paroxetine extended-release tablets should be monitored for agitation, irritability, poor feeding, and poor weight gain. data published literature suggests the presence of paroxetine in human milk with relative infant doses ranging between 0.4% to 2.2%, and a milk: plasma ratio of <1. no significant amounts were detected in the plasma of infants after breastfeeding. infertility male based on findings from clinical studies, paroxetine may affect sperm quality which may impair fertility; it is not known if this effect is reversible [see nonclinical toxicology (13.1)] . the safety and effectiveness of paroxetine extended-release tablets 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 paroxetine extended-release tablets, 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), clinical pharmacology (12.3)]. increased plasma concentrations of paroxetine occur in patients with renal and hepatic impairment. the initial dosage of paroxetine extended-release tablets 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)].

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

amneal pharma australia pty ltd - paroxetine hydrochloride hemihydrate -

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

remedyrepack inc. - paroxetine hydrochloride hemihydrate (unii: x2els050d8) (paroxetine - unii:41vrh5220h) - paroxetine 30 mg - major depressive disorder: paroxetine tablets, usp 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 pa

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

nucare pharmaceuticals,inc. - paroxetine hydrochloride hemihydrate (unii: x2els050d8) (paroxetine - unii:41vrh5220h) - paroxetine 30 mg - major depressive disorder: paroxetine tablets, usp 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

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

bryant ranch prepack - paroxetine hydrochloride anhydrous (unii: 3i3t11ud2s) (paroxetine - unii:41vrh5220h) - paroxetine 40 mg - 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.

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

lake erie medical dba quality care products llc - paroxetine hydrochloride hemihydrate (unii: x2els050d8) (paroxetine - unii:41vrh5220h) - paroxetine 20 mg - paroxetine tablets, usp 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 ma