Pexeva

Pexeva is a prescription medication used to treat depression, panic disorder, obsessive-compulsive disorder, and Generalized anxiety disorder (GAD). Pexeva belongs to a group of drugs called selective serotonin-reuptake inhibitors (SSRIs). It works by increasing the amount of serotonin in the brain, a natural substance that helps maintain mental balance and elevate mood.

This medication comes in tablet form. It is usually taken once daily, with or without food.

Common side effects of Pexeva include headache, fatigue, nausea, sleepiness, and weakness.

Pexeva can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. Do not drive or operate heavy machinery until you know how Pexeva affects you.

Pexeva is a prescription medicine used to treat:

• Major depressive disorder (MDD)
• Obsessive compulsive disorder (OCD)
• Panic disorder
• Generalized anxiety disorder (GAD)

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Noven Therapeutics, Llc

• Synthon Pharmaceuticals, Inc.

Common side effects include:

• nausea
• headache
• sleepiness
• weakness
• dizziness
• feeling anxious or trouble sleeping
• sexual problems
• sweating
• shaking
• not feeling hungry
• dry mouth
• constipation
• infection
• yawning

Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Pexeva. For more information, ask your healthcare provider or pharmacist. Pexeva and other antidepressant medicines may cause serious side effects, see "Drug Precautions".

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Emsam, Eldepryl, Zelapar) and tranylcypromine (Parnate)
• Mellaril (thioridazine)
• Orap (pimozide)
• triptans used to treat migraine headache
• other antidepressants (SSRIs, SNRIs, tricyclics, or lithium) or antipsychotics
• drugs that affect serotonin, such as lithium, tramadol, tryptophan, St. John’s wort
• certain drugs used to treat irregular heart beats
• certain drugs used to treat schizophrenia
• certain drugs used to treat HIV infection
• certain drugs that affect the blood, such as warfarin, aspirin, and ibuprofen
• certain drugs used to treat epilepsy
• atomoxetine
• cimetidine
• fentanyl
• metoprolol
• certain medicines used to treat seizures (like phenobarbital and phenytoin)
• procyclidine
• tamoxifen

Ask your healthcare provider if you are not sure if you are taking any of these medications.

Pexeva and other antidepressant medicines may cause serious side effects, including:

1. Suicidal thoughts or actions:

• Pexeva and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.
• Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
• Watch for these changes and call your healthcare provider right away if you notice:
  • New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
  • Pay particular attention to such changes when Pexeva is started or when the dose is changed.

Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:

• attempts to commit suicide
• acting on dangerous impulses
• acting aggressive or violent
• thoughts about suicide or dying
• new or worse depression
• new or worse anxiety or panic attacks
• feeling agitated, restless, angry, or irritable
• trouble sleeping
• an increase in activity or talking more than what is normal for you
• other unusual changes in behavior or mood

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Pexeva may be associated with these serious side effects:

2. Serotonin Syndrome or Neuroleptic Malignant Syndrome-like reactions. This condition can be life-threatening and may include:

• agitation, hallucinations, coma, or other changes in mental status
• coordination problems or muscle twitching (overactive reflexes)
• racing heartbeat, high or low blood pressure
• sweating or fever
• nausea, vomiting, or diarrhea
• muscle rigidity

3. Abnormal bleeding: Pexeva and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin, Jantoven), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.

4. Seizures or convulsions

5. Bone Fractures. Women who take Pexeva may have a higher risk of bone fractures. Contact your healthcare provider if you have pain in a bone.

6. Manic episodes/Hypomania:

• greatly increased energy
• severe trouble sleeping
• racing thoughts
• reckless behavior
• unusually grand ideas
• excessive happiness or irritability
• talking more or faster than usual

7. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:

• headache
• weakness or feeling unsteady
• confusion, problems concentrating or thinking, or memory problems

8. Angle-Closure Glaucoma. Tell your doctor if you notice a change in your vision.

9. Reduced effectiveness of tamoxifen. Tamoxifen (a medicine used to treat breast cancer) may not work as well if it is taken while you take Pexeva. If you are taking tamoxifen, tell your healthcare provider before starting Pexeva.

10. Akathisia which is characterized by an inner sense of restlessness and psychomotor agitation such as an inability to sit or stand still. This is most likely to occur within the first few weeks of treatment. Tell your doctor if you notice a sense of restlessness and an inability to sit or stand still.

11. Severe allergic reactions:

• trouble breathing
• swelling of the face, tongue, eyes or mouth
• rash, itchy welts (hives) or blisters, alone or with fever or joint pain

12. Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.

Do not stop Pexeva without first talking to your healthcare provider. Stopping Pexeva too quickly may cause serious symptoms including:

• anxiety, irritability, high or low mood, feeling restless, or changes in sleep habits
• headache, sweating, nausea, dizziness
• electric shock-like sensations, shaking, confusion

Do not take Pexeva if you:

• are allergic to Pexeva or any of the ingredients in Pexeva. 
• take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
• Do not take an MAOI within 2 weeks of stopping Pexeva unless directed to do so by your physician.
• Do not start Pexeva if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.
• People who take Pexeva close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:
  • high fever
  • uncontrolled muscle spasms
  • stiff muscles
  • rapid changes in heart rate or blood pressure
  • confusion
  • loss of consciousness (pass out)
• take Mellaril (thioridazine). Do not take Mellaril together with Pexeva because this can cause serious heart rhythm problems or sudden death.
• take the antipsychotic medicine pimozide (Orap) because this can cause serious heart problems.

Pexeva can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how Pexeva affects you. Do not drink alcohol while using Pexeva.

f you take Pexeva, you should not take any other medicines that contain paroxetine including Brisdelle, Paxil, and Paxil CR.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Pexeva there are no specific foods that you must exclude from your diet when receiving Pexeva.

Before starting Pexeva, tell your healthcare provider if you:

• are pregnant or breastfeeding
• have liver problems
• have kidney problems
• have heart problems
• have or had seizures or convulsions
• have bipolar disorder or mania
• have low sodium levels in your blood
• have a history of a stroke
• have high blood pressure
• have or had bleeding problems
• have glaucoma (high pressure in the eye)

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. 

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Pexeva falls into category X. It has been shown that women taking Pexeva during pregnancy may have babies with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. These medicines should never be used by pregnant women.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Pexeva has been detected in human breast milk. Because of the possibility for side effects in nursing infants from Pexeva, a choice should be made whether to stop nursing or to stop using Pexeva. You should discuss the importance of Pexeva to your health before any decision to stop or continue using Pexeva.

• Pexeva comes in tablet form to take by mouth.
• It is usually taken once daily in the morning or evening, with or without food. You may want to take Pexeva with food to prevent stomach upset. Take Pexeva at around the same time every day.
• Follow the directions on your prescription label carefully.
• Take Pexeva exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
• If you miss a dose of Pexeva, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Pexeva at the same time.

Pexeva controls your condition but does not cure it. It may take several weeks or longer before you feel the full benefit of Pexeva. Continue to take Pexeva even if you feel well. Do not stop taking Pexeva without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking Pexeva, you may experience withdrawal symptoms such as depression; mood changes; frenzied or abnormally excited mood; irritability; anxiety; confusion; dizziness; headache; tiredness; numbness or tingling in the arms, legs, hands, or feet; unusual dreams; difficulty falling asleep or staying asleep; nausea; or sweating. Tell your doctor if you experience any of these symptoms when your dose of Pexeva is decreased.

Take Pexeva exactly as prescribed. Follow the directions on your prescription label carefully. Your healthcare provider will determine the best dose for you based on the medical condition being treated, as well as your age, other medical conditions you have, and other medications you are taking.

The recommended starting dose is usually 20 mg daily. For treatment of panic disorder, the starting dose is usually 10 mg. The dose may be increased gradually.

The maximum recommended dose is 50 or 60 mg daily, depending on the condition being treated. Elderly patients and patients with severe liver or kidney disease should not receive more than 40 mg daily.

If you take too much Pexeva, call your healthcare provider or poison control center right away or get emergency treatment.

• Store Pexeva tablets at room temperature between 59º and 86ºF (15º and 30ºC).
• Keep Pexeva away from light.
• Keep bottle of Pexeva closed tightly.
• Keep Pexeva tablets dry.
• Keep Pexeva and all medicines out of the reach of children.

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.