PEXEVA®

Frequently Asked Questions

What is PEXEVA?
In people with depression, PEXEVA can help resolve symptoms like sadness, low energy, sleep difficulty, irritability, and despair. PEXEVA is indicated for depression, obsessive-compulsive disorder, and panic disorder. PEXEVA contains paroxetine, which has been prescribed for millions of people.

How does PEXEVA work?
PEXEVA is a type of medicine known as a selective serotonin reuptake inhibitor, or SSRI for short. Serotonin is a chemical that occurs naturally in the brain. It affects mood and behavior. PEXEVA balances the activity of serotonin in the brain so you can return to feeling more like yourself.

What if I am pregnant or am thinking about becoming pregnant?
PEXEVA is not recommended for use in women who are pregnant or who plan to become pregnant. These women are warned that use of paroxetine during the first 3 months of pregnancy has been shown to increase the risk of severe health problems in the unborn baby.

Some of these health problems affect the baby's heart. Women who are pregnant or who plan to become pregnant should discuss other treatment choices with their doctor. Women who are breastfeeding should also talk to their doctor before taking PEXEVA.

What if I miss a dose?
If you remember that you missed a dose within a few hours of your usual time, go ahead and take PEXEVA. Then return to your usual dosing time the next day. However, if you miss a dose by many hours, skip the one you missed, then take your next dose at your usual time. You should not take more than 1 dose every 24 hours. Do not stop taking your medication without talking to your doctor first.

How long do I take PEXEVA?
Keep taking PEXEVA for as long as your doctor recommends.Taking your medicine every day is the best way to treat your symptoms and keep them from coming back. Your doctor will work with you to find out how long you should keep taking PEXEVA. Do not stop taking PEXEVA without talking to your doctor. Stopping Pexeva suddenly can cause other symptoms. That's why you should never stop your medication without speaking with your doctor first, even if you start feeling better.

When can I expect to feel better?
You may see an improvement in your mood within two weeks of starting PEXEVA. However, it may take up to 8 weeks to feel the full benefits of your medicine. Stay in close touch with your doctor during this time and be sure to continue taking PEXEVA the way your doctor advises.

What dosage should I take?
Your doctor will determine what dosage of PEXEVA is right for you, based on your individual needs. You take PEXEVA once a day, with or without food. You may take PEXEVA at any time of day, as long as you take it at approximately the same time every day.

However, your doctor may prefer that you take PEXEVA at a specific time of day—for example at breakfast or at night before you go to sleep.

What side effects may occur with PEXEVA?
With PEXEVA, side effects are usually mild to moderate. They may become less noticeable or go away completely over time. The most common side effects that have been reported with PEXEVA include nausea, dry mouth, constipation, decreased appetite, drowsiness, muscle weakness, trouble sleeping, abnormal ejaculation, impotence and other male genital disorders, and female genital disorders.

Can I take PEXEVA with other medicines?
PEXEVA should not be used with monoamine oxidase inhibitors (MAOIs) or thioridazine. Be sure to tell your doctor if you think you are taking one of these medications. As with other antidepressants, there are medicines that need to be taken with caution while taking PEXEVA. Be sure to talk with your doctor about any medicines you are taking, including over-the-counter drugs.

Can I drink alcohol while on PEXEVA?
You should avoid drinking alcohol while on PEXEVA.

Be sure to tell your doctor how you are feeling.
If you have any questions about PEXEVA, call your doctor. Be sure to let your doctor know if you notice any unusual changes while taking PEXEVA. And never stop your medicine or change your dose before speaking with your doctor.

Important Safety Information

Suicidality and Antidepressant Drugs
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 PEXEVA® (paroxetine mesylate) 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. 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. PEXEVA® (paroxetine mesylate) is not approved for use in pediatric patients. (See Warnings: Clinical Worsening and Suicide Risk, Precautions: Information for Patients, and Precautions: Pediatric Use)

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.

Concomitant use of PEXEVA® (paroxetine mesylate) in patients taking monoamine oxidase inhibitors (MAOIs), thioridazine, or pimozide is contraindicated. If concomitant use of paroxetine with a 5-hydroxytryptamine receptor agonist (triptan) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. PEXEVA® (paroxetine mesylate) tablets are contraindicated in patients with a hypersensitivity to paroxetine or any of the inactive ingredients in PEXEVA® (paroxetine mesylate) tablets.

The most common side effects 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.

Please see Important Safety Information, including Black Boxed WARNING.

Please see accompanying full Prescribing Information including WARNINGS-Clinical Worsening and Suicide Risk; Usage in Pregnancy: Teratogenic and Nonteratogenic Effects.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.


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