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IMPORTANT SAFETY INFORMATION

Concomitant use of PEXEVA in patients taking monoamine oxidase inhibitors (MAOIs) (or within 14 days of use of MAOIs), thioridazine, or pimozide is contraindicated and can become life threatening. PEXEVA is also contraindicated in patients with a hypersensitivity to paroxetine or any of the inactive ingredients in PEXEVA tablets.

Clinical Worsening and Suicide Risk: 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.

Families and caregivers of patients being treated with PEXEVA 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. The prescriber or healthcare professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents.

PEXEVA is not approved for use in bipolar depression. Prior to initiating treatment with an antidepressant, patients should be adequately screened to determine the risk of them having bipolar disorder, since PEXEVA may activate mania or hypomania.

In patients receiving SSRIs in combination with a monoamine oxidase inhibitor (MAOI), there have been reports of serious, sometimes fatal, reactions including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma. Some cases presented with features resembling a potentially life-threatening Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS). Paroxetine should not be used in combination with a MAOI, or within 14 days of discontinuing treatment with a MAOI.

Potentially life-threatening Serotonin Syndrome or Neuroleptic Malignant Syndrome-like reactions have been reported with SNRIs and SSRIs alone, including PEXEVA, but particularly with concomitant use of serotonergic drugs, including triptans, with drugs that impair the metabolism of serotonin (including MAOIs), or with antipsychotics or other dopamine antagonists. If concomitant use with a triptan is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Concomitant use of PEXEVA with serotonin precursors (such as tryptophan) is not recommended.

Thioridazine with PEXEVA is contraindicated because elevated blood levels of thioridazine can prolong QTc interval and contribute to arrhythmias and sudden death.

Infants exposed to paroxetine in the first trimester of pregnancy have an increased risk of congenital malformations, particularly cardiovascular malformations; ventricular septal defects (VSDs), atrial septal defects (ASDs), and right ventricular outflow tract obstructions.

Neonates exposed to PEXEVA late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying have been known to occur. Infants exposed to SSRIs in late pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN).

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.

Patients should be monitored for symptoms when discontinuing PEXEVA. Dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g. paresthesias such as electric shock sensations and tinnitus), anxiety, confusion, headache, lethargy, emotional lability, insomnia, and hypomania have been seen to occur. A gradual reduction in the dose, rather than abrupt cessation, is recommended whenever possible.

Tamoxifen: Some studies have shown that the efficacy of tamoxifen, as measured by the risk of breast cancer relapse/mortality may be reduced when co-prescribed with paroxetine as a result of paroxetine’s irreversible inhibition of CYP2D6. However other studies have failed to show such a risk. When Tamoxifen is used for the treatment or prevention of breast cancer, alternative antidepressants with little or no CYP2D6 inhibition should be considered.

Akathisia, hyponatremia, abnormal bleeding have been known to occur. Discontinuation of PEXEVA should be considered in patients with symptomatic hyponatremia. Patients should be cautioned about the concomitant use of PEXEVA and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation since combined use of psychotropic drugs that interfere with serotonin reuptake and these agents has been associated with an increased risk of bleeding.

Mydriasis can occur and can cause acute angle closure in patients with narrow angle glaucoma, so caution should be used when paroxetine is prescribed for patients with narrow angle glaucoma.

As with all antidepressants, PEXEVA should be used cautiously in patients with a history or family history of mania or hypomania, or with a history of seizure disorder.

The most common side effects (incidence of 5% or greater and incidence for paroxetine at least twice that of placebo) that have been reported with PEXEVA include nausea, dry mouth, constipation, decreased appetite, infection drowsiness, tremor, sweating, muscle weakness, trouble sleeping, abnormal ejaculation, impotence, and other male genital disorders and female genital disorders.