Paroxetine (Page 16 of 17)
Long-term maintenance of efficacy was demonstrated in a 3-month relapse prevention trial. In this trial, patients with panic disorder assigned to paroxetine demonstrated a lower relapse rate compared to patients on placebo (see CLINICAL PHARMACOLOGY — Clinical Trials). Panic disorder is a chronic condition, and it is reasonable to consider continuation for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.
Social Anxiety Disorder:
Paroxetine tablets should be administered as a single daily dose with or without food, usually in the morning. The recommended and initial dosage is 20 mg/day. In clinical trials the effectiveness of paroxetine tablets was demonstrated in patients dosed in a range of 20 to 60 mg/day. While the safety of paroxetine tablets has been evaluated in patients with social anxiety disorder at doses up to 60 mg/day, available information does not suggest any additional benefit for doses above 20 mg/day (see CLINICAL PHARMACOLOGY — Clinical Trials).
There is no body of evidence available to answer the question of how long the patient treated with paroxetine tablets should remain on it. Although the efficacy of paroxetine tablets beyond 12 weeks of dosing has not been demonstrated in controlled clinical trials, social anxiety disorder is recognized as a chronic condition, and it is reasonable to consider continuation of treatment for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.
Generalized Anxiety Disorder:
Paroxetine tablets should be administered as a single daily dose with or without food, usually in the morning. In clinical trials the effectiveness of paroxetine tablets was demonstrated in patients dosed in a range of 20 to 50 mg/day. The recommended starting dosage and the established effective dosage is 20 mg/day. There is not sufficient evidence to suggest a greater benefit to doses higher than 20 mg/day. Dose changes should occur in 10 mg/day increments and at intervals of at least 1 week.
Systematic evaluation of continuing paroxetine tablets for periods of up to 24 weeks in patients with Generalized Anxiety Disorder who had responded while taking paroxetine tablets during an 8-week acute treatment phase has demonstrated a benefit of such maintenance (see CLINICAL PHARMACOLOGY — Clinical Trials). Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment.
Posttraumatic Stress Disorder:
Paroxetine tablets should be administered as a single daily dose with or without food, usually in the morning. The recommended starting dosage and the established effective dosage is 20 mg/day. In 1 clinical trial, the effectiveness of paroxetine tablets was demonstrated in patients dosed in a range of 20 to 50 mg/day. However, in a fixed dose study, there was not sufficient evidence to suggest a greater benefit for a dose of 40 mg/day compared to 20 mg/day. Dose changes, if indicated, should occur in 10 mg/day increments and at intervals of at least 1 week.
There is no body of evidence available to answer the question of how long the patient treated with paroxetine tablets should remain on it. Although the efficacy of paroxetine tablets beyond 12 weeks of dosing has not been demonstrated in controlled clinical trials, PTSD is recognized as a chronic condition, and it is reasonable to consider continuation of treatment for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.
Treatment of Pregnant Women During the Third Trimester:
Neonates exposed to paroxetine tablets and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see WARNINGS: Usage in Pregnancy). When treating pregnant women with paroxetine during the third trimester, the physician should carefully consider the potential risks and benefits of treatment.
Dosage for Elderly or Debilitated Patients, and Patients with Severe Renal or Hepatic Impairment:
The recommended initial dose is 10 mg/day for elderly patients, debilitated patients, and/or patients with severe renal or hepatic impairment. Increases may be made if indicated. Dosage should not exceed 40 mg/day.
Switching a Patient to or from a Monoamine Oxidase Inhibitor (MAOI) Intended To Treat Psychiatric Disorders:
At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with paroxetine tablets. Conversely, at least 14 days should be allowed after stopping paroxetine tablets before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS).
Use of Paroxetine Tablets With Other MAOIs Such as Linezolid or Methylene Blue:
Do not start paroxetine tablets in a patient who is being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS).
In some cases, a patient already receiving therapy with paroxetine tablets may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, paroxetine tablets should be stopped promptly, and linezolid or methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with paroxetine tablets may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS).
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with paroxetine is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS).
Discontinuation of Treatment with Paroxetine Tablets:
Symptoms associated with discontinuation of paroxetine tablets have been reported(see PRECAUTIONS: Discontinuation of Treatment With Paroxetine Tablets). Patients should be monitored for these symptoms when discontinuing treatment, regardless of the indication for which paroxetine tablets are being prescribed. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
NDC: 50436-3933-3 90 TABLET, FILM COATED in a BOTTLE
Read the Medication Guide that comes with paroxetine tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or want to learn more about.
What is the most important information I should know about paroxetine?
Paroxetine and other antidepressant medicines may cause serious side effects, including:
1. Suicidal thoughts or actions:
- Paroxetine 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 paroxetine 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.
Paroxetine 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
- eye pain
- changes in vision
- swelling or redness in or around the eye
Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.
- trouble breathing
- swelling of the face, tongue, eyes, or mouth
- rash, itchy welts (hives), or blisters, alone or with fever or joint pain
Paroxetine 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 antiinflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.
6. Seizures or convulsions
7. 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
8. Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.
9. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:
- weakness or feeling unsteady
- confusion, problems concentrating or thinking, or memory problems
Do not stop paroxetine without first talking to your healthcare provider. Stopping paroxetine 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
Paroxetine is a prescription medicine used to treat depression. It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider.
Paroxetine is also used to treat:
- Major Depressive Disorder (MDD)
- Obsessive Compulsive Disorder (OCD)
- Panic Disorder
- Social Anxiety Disorder
- Generalized Anxiety Disorder (GAD)
- Posttraumatic Stress Disorder (PTSD)
Talk to your healthcare provider if you do not think that your condition is getting better with treatment using paroxetine.
Who should not take paroxetine tablets?
Do not take paroxetine tablets if you:
- are allergic to paroxetine hydrochloride or any of the ingredients in paroxetine tablets. See the end of this Medication Guide for a complete list of ingredients in paroxetine tablets.
- 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 paroxetine tablets unless directed to do so by your physician.
- Do not start paroxetine tablets if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.
- People who take paroxetine tablets 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:
• uncontrolled muscle spasms
• stiff muscles
• rapid changes in heart rate or blood pressure
• loss of consciousness (pass out)
- take MELLARIL ®* (thioridazine). Do not take MELLARIL ®* together with paroxetine tablets because this can cause serious heart rhythm problems or sudden death.
- take the antipsychotic medicine pimozide (ORAP ®*) because this can cause serious heart problems.
What should I tell my healthcare provider before taking paroxetine tablets? Ask if you are not sure.
Before starting paroxetine tablets, tell your healthcare provider if you:
- are pregnant, may be pregnant, or plan to become pregnant. There is a possibility that paroxetine tablets may harm your unborn baby, including an increased risk of birth defects, particularly heart defects. Other risks may include a serious condition in which there is not enough oxygen in the baby’s blood. Your baby may also have certain other symptoms shortly after birth. Premature births have also been reported in some women who used paroxetine tablets during pregnancy.
- are breastfeeding. Paroxetine passes into your milk. Talk to your healthcare provider about the best way to feed your baby while taking paroxetine.
- are taking certain drugs such as:
• 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
• 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. Paroxetine and some medicines may interact with each other, may not work as well, or may cause serious side effects.
Your healthcare provider or pharmacist can tell you if it is safe to take paroxetine tablets with your other medicines. Do not start or stop any medicine while taking paroxetine tablets without talking to your healthcare provider first.
|If you take paroxetine tablets, you should not take any other medicines that contain paroxetine hydrochloride.|
How should I take paroxetine tablets?
- Take paroxetine tablets exactly as prescribed. Your healthcare provider may need to change the dose of paroxetine tablets until it is the right dose for you.
- Paroxetine tablets may be taken with or without food.
- If you miss a dose of paroxetine tablets, 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 paroxetine tablets at the same time.
- If you take too much paroxetine tablets, call your healthcare provider or poison control center right away, or get emergency treatment.
- Do not stop taking paroxetine tablets suddenly without talking to your doctor (unless you have symptoms of a severe allergic reaction). If you need to stop taking paroxetine tablets, your healthcare provider can tell you how to safely stop taking it.
What should I avoid while taking paroxetine?
Paroxetine 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 paroxetine affects you. Do not drink alcohol while using paroxetine.
What are possible side effects of paroxetine?
Paroxetine may cause serious side effects, including all of those described in the section entitled “What is the most important information I should know about paroxetine?”
Common possible side effects in people who take paroxetine include:
- feeling anxious or trouble sleeping
- sexual problems
- not feeling hungry
- dry mouth
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of paroxetine. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or 1-800-332-1088.
How should I store paroxetine tablets?
- Store paroxetine tablets at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].
- Keep paroxetine tablets away from light.
- Keep bottle of paroxetine tablets closed tightly.
Keep paroxetine tablets and all medicines out of the reach of children.
General information about paroxetine tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use paroxetine tablets for a condition for which they were not prescribed. Do not give paroxetine tablets to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about paroxetine. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about paroxetine that is written for healthcare professionals.
Address medical inquiries to, Telephone: 1-877-993-8779 or MedicalAffairs@zydususa.com.
What are the ingredients in paroxetine tablets, USP ?
Active ingredient: paroxetine hydrochloride, USP
Inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose 6 cP, lactose anhydrous, magnesium stearate, polyethylene glycol 6000, povidone, sodium starch glycolate, talc, and titanium dioxide.
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This Medication Guide has been approved by the U.S. Food and Drug Administration.
This product’s package insert may have been updated. For current package insert, please visit www.zydususa.com
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