Medically reviewed on October 1, Antidepressants increased the risk compared to placebo of suicidal thinking and behavior suicidality in children, adolescents, and young adults in short-term studies of major depressive disorder MDD and other psychiatric disorders.
Anyone considering the use of Paxil or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older.
Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide, paxil and glaucoma. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber.
Paxil is not approved for use in pediatric patients. Paxil paroxetine hydrochloride is an orally administered psychotropic drug. The molecular weight paxil and glaucoma The structural formula of paroxetine hydrochloride is:.
Inactive ingredients consist of dibasic calcium phosphate dihydrate, hypromellose, paxil and glaucoma, magnesium stearate, polyethylene paxil and glaucoma, polysorbate 80, sodium starch glycolate, titanium dioxide, and 1 or more of the following: Studies at clinically relevant doses in humans have paxil and glaucoma that paroxetine blocks the uptake of serotonin into human platelets. In vitro studies in animals also suggest that paroxetine is a potent and highly selective inhibitor of neuronal serotonin reuptake and has only very weak effects on norepinephrine and dopamine neuronal reuptake.
Paroxetine hydrochloride is completely absorbed after oral dosing of a solution of the hydrochloride salt. Paroxetine is extensively metabolized and the metabolites are considered to be inactive. Nonlinearity in pharmacokinetics is observed with increasing doses.
Paroxetine paxil and glaucoma is mediated in part by CYP2D6, paxil and glaucoma, and the metabolites are primarily excreted in paxil and glaucoma urine and to some extent in the feces.
Pharmacokinetic behavior of paroxetine has not been evaluated in subjects who are deficient in CYP2D6 poor metabolizers. The excess accumulation is a consequence of the fact that 1 of the enzymes that metabolizes paroxetine is readily saturable. The effects of food on the bioavailability of paroxetine were studied in subjects administered a single dose with and without food.
Paroxetine does not alter the in vitro protein binding of phenytoin or warfarin. Paroxetine is extensively metabolized after oral administration. The principal metabolites are polar and conjugated products of oxidation and methylation, which are readily cleared. Conjugates with glucuronic acid and sulfate predominate, and major metabolites have been isolated and identified, paxil and glaucoma. The metabolism of paroxetine paxil and glaucoma accomplished in part by CYP2D6.
Saturation of this enzyme opticlick for lantus and apidra clinical doses appears to account for the nonlinearity of paroxetine kinetics with increasing dose and increasing duration of treatment, paxil and glaucoma. Increased plasma concentrations of paroxetine occur in subjects with renal and hepatic impairment, paxil and glaucoma. In vitro drug interaction studies reveal that paroxetine inhibits CYP2D6.
In these studies, paxil and glaucoma, Paxil was shown to be significantly more effective than placebo in treating major depressive disorder by paxil and glaucoma least 2 of the following measures: Effectiveness was similar for male and female patients. Subgroup analyses did not indicate that there were any differences in treatment outcomes as a function of age or paxil and glaucoma. Patients randomized to paroxetine were significantly less likely to relapse than comparably treated patients who were randomized to placebo.
In these studies, Paxil was shown to be significantly more effective than placebo in treating panic disorder by at least 2 out of 3 measures of panic attack frequency and on the Clinical Global Impression Severity of Illness score. In these studies, the effectiveness of Paxil compared to placebo was evaluated on the basis of 1 the proportion of responders, as defined by a Clinical Global Impression CGI Improvement score of 1 very much improved or 2 much improvedand 2 change from baseline in the Liebowitz Social Anxiety Scale LSAS.
Subgroup analyses generally did not indicate differences in treatment outcomes as a function of age, race, or gender. Subgroup analyses did not indicate differences in treatment outcomes as a function of race or gender. There were insufficient elderly patients to conduct subgroup analyses on the basis of age.
The 2 primary outcomes for each trial were i change from baseline to endpoint on the CAPS-2 total score 17 itemsand ii proportion of responders on the CGI-I, paxil and glaucoma, where responders were defined as patients having a score of 1 very much improved or 2 much improved. Paxil was demonstrated to be significantly superior to placebo on change from baseline for the CAPS-2 total score and on proportion of responders on the CGI-I.
Subgroup analyses did not indicate differences in treatment outcomes as a function of gender. There were an insufficient number of patients who were 65 years paxil and glaucoma older or were non-Caucasian to conduct subgroup analyses on the basis of age or race, respectively.
Change in appetite, paxil and glaucoma, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, paxil and glaucoma, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.
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 paxil and glaucoma, which may approach the intensity of a panic attack, paxil and glaucoma. The feared situations are avoided or endured with intense anxiety or distress.
Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment. The effectiveness of Paxil in long-term treatment of social anxiety disorder, i. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
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, paxil and glaucoma, sleep disturbance.
PTSD, as defined by Lesson plans and ancient india, 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.
Paxil and glaucoma 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 use of MAOIs intended to treat psychiatric disorders with Paxil or within 14 days of stopping treatment with Paxil is contraindicated because of an increased risk of serotonin syndrome. Paxil is contraindicated in patients with a hypersensitivity to paroxetine or any of the inactive ingredients in Paxil. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.
There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs SSRIs and others showed that these drugs increase the risk of suicidal thinking and behavior suicidality in children, adolescents, and young adults ages with major depressive disorder MDD and other psychiatric disorders.
Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of short-term trials median duration of 2 months of 11 antidepressant drugs in over 77, patients, paxil and glaucoma.
There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences drug vs placebohowever, paxil and glaucoma, were relatively stable within age strata and across indications, paxil and glaucoma.
These risk differences drug-placebo difference in the number of cases of suicidality per 1, patients treated are provided in Table 1. No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.
It is unknown whether the suicidality risk extends to longer-term use, i. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression.
All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.
The following symptoms, anxiety, agitation, panic attacks, paxil and glaucoma, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia psychomotor lamictal and cocaine interactionhypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, paxil and glaucoma, both psychiatric and paxil and glaucoma. Discontinuation of Treatment With Paxil, for a description of the risks of discontinuation of Paxil.
Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well paxil and glaucoma the emergence of suicidality, and to report such symptoms immediately to healthcare providers.
Such monitoring should include daily observation by families and caregivers. Prescriptions for Paxil should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose. A major depressive episode may be the initial presentation of bipolar disorder.
Whether any of paxil and glaucoma symptoms described above represent such a conversion is unknown, paxil and glaucoma. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.
It should be noted that Paxil is not approved for use in treating bipolar depression. The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including Paxil, alone but particularly with concomitant use of other paxil and glaucoma drugs including triptans, tricyclic antidepressants, imuran and lupus, lithium, tramadol, tryptophan, buspirone, amphetamines, and St.
Serotonin syndrome symptoms may include mental status changes e. Patients should be monitored for the emergence of serotonin syndrome. Paxil should also not be started in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue. No reports involved the administration of methylene blue prilosec and protonix other routes such as oral tablets or local tissue injection or at lower doses.
There may be circumstances when it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking Paxil. If concomitant use of Paxil with certain other serotonergic drugs, i. Treatment with Paxil and any concomitant serotonergic agents should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated. Thioridazine administration alone produces prolongation of the QTc interval, which is associated with serious ventricular arrhythmias, such as torsade de pointes — type arrhythmias, and paxil and glaucoma death, paxil and glaucoma.
This effect appears to be dose related. An in vivo study suggests that drugs which inhibit CYP2D6, such as paroxetine, will elevate plasma levels of thioridazine. Epidemiological studies have shown that infants exposed to paroxetine paxel zoloft and prozac the first trimester of pregnancy have an increased risk of congenital malformations, particularly cardiovascular malformations.
Paxil and glaucoma findings from these studies are summarized below:. Other studies have found varying results as to whether there was an increased risk of overall, cardiovascular, or specific congenital malformations. While subject to limitations, this meta-analysis suggested an increased occurrence of cardiovascular malformations prevalence odds ratio [POR] 1. 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.
If a patient becomes pregnant while men and women hair loss transplant paroxetine, she should be advised of the potential harm to the fetus, paxil and glaucoma. 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 PRECAUTIONS: Discontinuation of Treatment With Paxil, paxil and glaucoma.
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. These studies have revealed no evidence of teratogenic effects, paxil and glaucoma.