IMPORTANT SAFETY INFORMATION
This Important Safety Information has been adapted from the Prescribing Information for BRISDELLE®.
What is the most important information I should know about paroxetine?
BOXED WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
SUICIDALITY AND ANTIDEPRESSANT DRUGS
Paroxetine and other antidepressant medicines may increase suicidal thoughts or actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. 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 sertraline is started or when the dose is changed.
- You should not drive, operate heavy machinery, or do other dangerous activities until you know how paroxetine affects you.
Who should not take paroxetine?
Do not take paroxetine if you:
- 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 14 days of stopping paroxetine unless directed to do so by your healthcare provider. Do not start paroxetine if you stopped taking an MAOI in the last 14 days unless directed to do so by your healthcare provider. People who take paroxetine close in time to an MAOI may have serious or 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
- loss of consciousness (pass out).
- Take thioridazine or pimozide. Do not take thioridazine or pimozide together with paroxetine because this can cause serious heart problems or sudden death.
- Are allergic to paroxetine.
- Are pregnant. paroxetine is not for pregnant women. Paroxetine can harm your unborn baby.
When should I call my primary provider?
Call your healthcare provider right away if you have any of the following symptoms:
- Suicidal thoughts or actions: paroxetine, and related antidepressant medicines, may increase suicidal thoughts or actions within the first few months of treatment. 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 paroxetine is started. 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 or go to the nearest emergency room if you have any of the following symptoms, 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 or other unusual changes in behavior or mood.
- Serotonin Syndrome. This condition can be life-threatening and may include: Nervousness, hallucinations, coma, or other changes in mental status; coordination problems or small movements of the muscles that you cannot control; racing heartbeat, high or low blood pressure; sweating or fever; nausea, vomiting, or diarrhea; muscle rigidity; dizziness; flushing; tremors; seizures.
- Reduced effectiveness of tamoxifen: Tamoxifen (a medicine used to treat breast cancer) may not work as well if it is taken at the same time as paroxetine. If you are taking tamoxifen, tell your healthcare provider before starting paroxetine.
- Abnormal bleeding: paroxetine may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin, or non-steroidal anti-inflammatory drugs (NSAIDs), like ibuprofen, naproxen, or aspirin.
- Visual symptoms.
- 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.
- Bone Fractures: Women who take paroxetine may have a higher risk of bone fractures.
- Manic episodes: Greatly increased energy; severe trouble sleeping; racing thoughts; reckless behavior; unusually grand ideas; excessive happiness or irritability; talking more or faster than usual.
- Seizures or convulsions.
- Restlessness: Women who take paroxetine may feel an inner restlessness, nervousness, or be unable to sit still or stand still especially when they start taking paroxetine.
If you are experiencing a medical emergency, call 911 or seek immediate medical attention.
What is the FDA-approved use of paroxetine?
Paroxetine (10 mg, 20 mg, 30 mg, 40 mg) is approved by the FDA for treatment of Major Depressive Disorder (MDD), Obsessive-Compulsive Disorder (OCD), Panic Disorder, Social Anxiety Disorder, Generalized Anxiety Order, and Posttraumatic Stress Disorder (PTSD). Paroxetine (7.5 mg) is approved by the FDA under the brand name Brisdelle® for the treatment of moderate to severe vasomotor symptoms associated with menopause, and is not approved for the treatment of any psychiatric condition.
What should I tell my Rory-affiliated provider before starting paroxetine?
Before starting paroxetine, tell your healthcare provider if you have:
- liver or kidney problems
- bipolar disorder or mania
- low sodium levels in your blood
- glaucoma (high pressure in the eye)
- have or had seizures, convulsions, or bleeding problems
- have any other medical conditions
- are breastfeeding or plan to breastfeed.
Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines such as migraine headache medication (triptans), other antidepressants and antipsychotics, vitamins, and herbal supplements. If you take paroxetine, you should not take any other medicines that contain paroxetine, including Paxil® , Paxil CR® , and Pexeva® .
Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.
What are the most common side effects of paroxetine?
The most common possible side effects of paroxetine include:
- and vomiting
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 paroxetine. Please read the Medication Guide within the full Prescribing Information, including information about the BOXED WARNING, before taking paroxetine.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.
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