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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. The generic Paroxetine Cheap symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia psychomotor restlessness, hypomania, and mania, Generic Paroxetine Cheap, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for generic Paroxetine Cheap indications, both raichev-stoychev.org and nonpsychiatric.

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, raichev-stoychev.org changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report generic Paroxetine Cheap symptoms generic Paroxetine Cheap 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, generic Paroxetine Cheap 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, generic Paroxetine Cheap disorder, and depression. Serotonin syndrome symptoms may include mental status changes e. Patients should be monitored for the emergence of serotonin syndrome. John’s Wort is clinically warranted, be aware of a generic Paroxetine Cheap increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.

Treatment with PAXIL and any generic Paroxetine Cheap serotonergic agents should be discontinued immediately if the above events occur and generic Paroxetine Cheap symptomatic treatment should be initiated. This effect appears to be dose related. Usage In Pregnancy Teratogenic Effects 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.

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Septal defects range in severity from those that resolve generic Paroxetine Cheap to those which require surgery. This study showed a trend towards an increased risk for cardiovascular malformations for paroxetine raichev-stoychev.org was an increased risk of overall, Generic Paroxetine Cheap, generic Paroxetine Cheap, or specific congenital malformations.

While raichev-stoychev.org to limitations, this meta-analysis suggested an increased occurrence of cardiovascular malformations prevalence odds ratio 1. It was not generic Paroxetine Cheap 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.

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. However, in rats, there was an increase in pup deaths during the first 4 generic Paroxetine Cheap of lactation when dosing occurred during the last trimester of gestation and continued throughout lactation.

The no-effect dose for rat pup mortality was not determined. The cause of these deaths is not known. Such complications can arise immediately upon delivery. Reported generic Paroxetine Cheap 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 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality.

Other studies do not generic Paroxetine Cheap a significant statistical association. Women who discontinued antidepressant medication during pregnancy showed a generic Paroxetine Cheap 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. In a subset of patients classified as bipolar, the rate of manic episodes was 2.

Seizures 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. 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. Dysphoric mood, irritability, agitation, dizziness, sensory disturbances e. While these events are generally self-limiting, there have been reports raichev-stoychev.org dose or upon discontinuation of treatment, generic Paroxetine Cheap resuming the generic Paroxetine Cheap prescribed dose may be considered.

However, other studies have failed to demonstrate such a risk. When tamoxifen is used for the treatment or prevention of breast cancer, prescribers should consider using an alternative antidepressant with little or no CYP2D6 inhibition. Akathisia The use of paroxetine or other SSRIs has been associated with the development of akathisia, which is characterized by an inner sense of restlessness and psychomotor agitation such as an inability to sit or stand still usually associated with subjective distress.

This is most likely to occur within the first few weeks of treatment, Generic Paroxetine Cheap. In many cases, Generic Paroxetine Cheap, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion SIADH. Discontinuation of PAXIL should be considered in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, generic Paroxetine Cheap may lead to falls.

Bone Fracture Epidemiological studies on bone fracture risk generic Paroxetine Cheap exposure to some antidepressants, including SSRIs, have reported an association between antidepressant treatment and fractures. There are multiple possible causes for this observation and it is unknown to what extent fracture risk is directly attributable to SSRI treatment. Caution is advisable in using PAXIL in patients with diseases or conditions that could affect metabolism or hemodynamic responses. A few cases of acute angle closure glaucoma associated with paroxetine therapy have been reported in the literature. As mydriasis can cause generic Paroxetine Cheap angle closure in patients with narrow angle glaucoma, caution should be used when PAXIL is prescribed for patients with narrow angle glaucoma.

PAXIL has not been evaluated or generic Paroxetine Cheap to any appreciable extent in patients with a recent history of myocardial infarction or unstable heart disease. Patients with these diagnoses were excluded from clinical studies during the product’s premarket testing. Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of PAXIL and triptans, tramadol, or other serotonergic agents. Patients should be advised that taking Paxil can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle closure glaucoma.

Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure e. Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with PAXIL and should counsel them in its appropriate use. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document. Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking PAXIL.

Clinical Worsening And Suicide Risk Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia psychomotor restlessness, hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Symptoms such as these may be associated with an increased risk for generic Paroxetine Cheap thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.

Although in controlled studies PAXIL has not been shown to impair psychomotor performance, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that therapy with PAXIL does not affect their ability to engage in generic Paroxetine Cheap activities. Teratogenic Effects and Nonteratogenic Effects. Laboratory Tests There are no specific laboratory tests recommended. These doses are up to 2. Because the MRHD for major depressive disorder is slightly less than that for OCD 50 mg versus 60 mg, the doses used in these carcinogenicity studies were only 2.

Female rats were not affected. The relevance of these findings to humans is unknown. Mutagenesis Paroxetine produced no genotoxic effects in a battery of 5 in vitro and 2 in vivo assays that included the following: Bacterial mutation assay, mouse lymphoma mutation assay, unscheduled DNA synthesis assay, and tests for cytogenetic aberrations in vivo in mouse bone marrow and in vitro in human lymphocytes and in a dominant lethal test in rats.

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Irreversible lesions occurred in the reproductive tract of male rats generic Paroxetine Cheap dosing in toxicity studies for 2 to 52 weeks. Pregnancy Pregnancy Category D. Labor And Delivery The effect of paroxetine on labor and delivery in humans is generic Paroxetine Cheap. raichev-stoychev.org not generic Paroxetine Cheap to support a claim for use in pediatric patients.

Anyone considering the use of PAXIL in a child or adolescent must balance the potential risks with the clinical need. Decreased appetite and weight loss have been observed in association with the use of SSRIs. These include overdoses with paroxetine generic Paroxetine Cheap and in combination with other substances. Of these, 48 cases were fatal and of the fatalities, 17 appeared to involve paroxetine alone. Of 145 non-fatal cases with known outcome, most recovered without sequelae. The largest known ingestion involved 2,000 mg of paroxetine 33 times the maximum recommended daily dose in a patient who recovered.

Commonly reported adverse events associated with paroxetine overdosage include somnolence, coma, nausea, tremor, tachycardia, confusion, vomiting, and dizziness. Other notable signs and symptoms observed with overdoses involving paroxetine alone or with other substances include mydriasis, convulsions including status epilepticus, ventricular dysrhythmias including torsade de pointes, hypertension, aggressive reactions, syncope, hypotension, stupor, bradycardia, dystonia, rhabdomyolysis, symptoms of hepatic dysfunction including hepatic failure, hepatic necrosis, jaundice, hepatitis, and hepatic steatosis, serotonin syndrome, manic reactions, myoclonus, acute renal failure, and urinary retention.

Overdosage Management No specific antidotes for paroxetine are known. Ensure an generic Paroxetine Cheap airway, oxygenation, and ventilation, Generic Paroxetine Cheap. Monitor cardiac rhythm and vital signs. General supportive and symptomatic measures are also recommended. Induction of emesis is not recommended.

A specific caution involves patients who are taking or have recently taken paroxetine who might ingest excessive quantities of a tricyclic antidepressant.

CnCDvC

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