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, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia psychomotor restlessness , hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric.

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 as 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.

Screening Patients for Bipolar Disorder: A major depressive episode may be the initial presentation of bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown. 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 serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, 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 by 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.

Potential Interaction With Thioridazine: Thioridazine administration alone produces prolongation of the QTc interval, which is associated with serious ventricular arrhythmias, such as torsade de pointes—type arrhythmias, and sudden death.

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 in the first trimester of pregnancy have an increased risk of congenital malformations, particularly cardiovascular malformations.

The findings from these studies are summarized below: 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.

This study showed a trend towards an increased risk for cardiovascular malformations for paroxetine risk of 1. Of the 12 paroxetine-exposed infants with cardiovascular malformations, 9 had VSDs. In one study the odds ratio was 2.

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 taking paroxetine, she should be advised of the potential harm to the fetus. Discontinuation of Treatment With Paxil. 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. The cause of these deaths is not known. Neonates exposed to Paxil and other SSRIs or serotonin and norepinephrine reuptake inhibitors SNRIs , late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying.

PPHN occurs in 1 — 2 per 1, live births in the general population and is associated with substantial neonatal morbidity and mortality. Other studies do not show a significant statistical association. Physicians should also note the results of a prospective longitudinal study of pregnant women with a history of major depression, who were either on antidepressants or had received antidepressants less than 12 weeks prior to their last menstrual period, and were in remission.

Women who discontinued antidepressant medication during pregnancy showed a significant increase in relapse of their major depression compared to those women who remained on antidepressant medication throughout pregnancy. When treating a pregnant woman with Paxil, the physician should carefully consider both the potential risks of taking an SSRI, along with the established benefits of treating depression with an antidepressant.

During premarketing testing, hypomania or mania occurred in approximately 1. In a subset of patients classified as bipolar, the rate of manic episodes was 2. As with all drugs effective in the treatment of major depressive disorder, Paxil should be used cautiously in patients with a history of mania. During premarketing testing, seizures occurred in 0. Paxil should be used cautiously in patients with a history of seizures. It should be discontinued in any patient who develops seizures.

Discontinuation of Treatment With Paxil: Abnormal dreams, paresthesia, and dizziness. In the majority of patients, these events were mild to moderate and were self-limiting and did not require medical intervention. There is no body of evidence available to answer the question of how long the patient treated with PAXIL should remain on it. It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy.

Systematic evaluation of the efficacy of PAXIL has shown that efficacy is maintained for periods of up to 1 year with doses that averaged about 30 mg. OCD is a chronic condition, and it is reasonable to consider continuation for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.

Panic disorder is a chronic condition, and it is reasonable to consider continuation for a responding patient. Although the efficacy of PAXIL beyond 12 weeks of dosing has not been demonstrated in controlled clinical trials, social anxiety disorder is recognized as a chronic condition, and it is reasonable to consider continuation of treatment for a responding patient. Paroxetine may lessen premenstrual symptoms such as irritability, increased appetite, and depression.

How to use Paxil CR Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking paroxetine and each time you get a refill.

If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually once daily in the morning. Taking this medication with food may decrease nausea. If this medication makes you sleepy during the day, talk to your doctor about taking it in the evening.

Do not crush or chew this medication. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing. The dosage is based on your medical condition, response to treatment, age, and other medications you may be taking.

Maintenance Therapy There is no body of evidence available to answer the question of how long the patient treated with paroxetine tablets should remain on it. It should be noted that Paxil is not approved for use in treating bipolar depression. The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivityakathisia psychomotor restlessnesshypomaniaand maniahave been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Vitamins help paxil withdrawal clinical findings have included respiratory distress, paxil to 50mg, cyanosis, apnea, 50mg, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. As with other serotonin reuptake inhibitors, an interaction between paroxetine and tryptophan may occur when they are coadministered. When treating a pregnant woman with Paxil, the physician should carefully consider both the potential risks of taking paxil SSRI, along with the established benefits of 50mg depression paxil an antidepressant. Other notable signs and symptoms observed with overdoses involving paroxetine alone or with other substances include mydriasisconvulsions including status epilepticusventricular dysrhythmias including torsade de pointeshypertensionaggressive reactions, syncopehypotensionstupor, bradycardiadystoniarhabdomyolysissymptoms of hepatic dysfunction including hepatic failure, hepatic necrosisjaundicehepatitisand hepatic steatosisserotonin syndrome, manic reactions, myoclonusacute renal failure, and urinary retention. Such monitoring should include daily observation by families and caregivers. Bone Fracture Epidemiological studies on bone fracture risk following exposure to some antidepressants, including SSRIs, have reported an association between antidepressant treatment and fractures. Steady-state drug exposure based on AUC was about 8 times greater than would have been predicted from single-dose data in these subjects.

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