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Drug Notebook

Generic Name: paroxetine

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Pexeva, Paxil, Paroxetine Hydrochloride ER, Paxil CR, Paroxetine Hydrochloride
An SSRI Antidepressant - It is used to treat depression
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FDA Alerts

Special Alerts:

[Posted 05/02/2007] FDA notified healthcare professionals that the Agency proposed that makers of all antidepressant medications update the existing black box warning on the prescribing information for their products to include warnings about the increased risks of suicidal thinking and behavior in young adults ages 18 to 24 years old during the first one to two months of treatment. The proposed labeling changes also state that scientific data did not show this increased risk in adults older than 24 years of age and that adults 65 years of age and older taking antidepressants have a decreased risk of suicidality. The proposed updates apply to the entire category of antidepressants. Individuals currently taking prescribed antidepressant medications should not stop taking them and should notify their healthcare professional if they have concerns. Manufacturers of antidepressant medications will have 30 days to submit their revised product labeling and revised Medication Guides to FDA for review. See the FDA press release for the list of products affected by the proposed antidepressant product labeling changes. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Antidepressant, http://www.fda.gov/bbs/topics/NEWS/2007/NEW01624.html and http://www.fda.gov/cder/drug/antidepressants/default.htm.

[Posted 07/19/2006] FDA notified healthcare professionals and consumers of important information from two recent studies that should be considered when making treatment decisions in pregnant women who take antidepressants. The studies included pregnant women who were treated with selective serotonin reuptake inhibitors (SSRIs), or in a few cases, other antidepressant medications.

One study illustrated the potential risk of relapsed depression after stopping antidepressant medication during pregnancy. In this study, women who stopped their medicine were five times more likely to have a relapse of depression during their pregnancy than were women who continued to take their antidepressant medicine while pregnant.

The second study suggests there may be additional, though rare, risks of taking SSRI medications during pregnancy. This study focused on newborn babies with persistent pulmonary hypertension (PPHN), which is a serious and life-threatening lung condition that occurs soon after birth. Babies born with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream. In this study, PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of pregnancy compared to babies whose mothers did not take an antidepressant. The study was too small to compare the risk of one drug compared to another. The finding of PPHN in babies of mothers who used a SSRI antidepressant in the second half of pregnancy adds to concerns from previous reports that infants of mothers taking SSRIs late in pregnancy may experience difficulties such as irritability, difficulty feeding and in very rare cases, difficulty breathing.

Additionally, the labeling for paroxetine (Paxil) was recently changed to add information about findings in an epidemiologic study that suggests that exposure to the drug in the first trimester of pregnancy may be associated with an increased risk of cardiac birth defects.

Women who are pregnant or thinking about becoming pregnant should not stop any antidepressant medication without first consulting their physician. The FDA is seeking additional information about the possible risk of PPHN in newborn babies of mothers who took SSRI antidepressants in pregnancy. FDA has asked the sponsors of all SSRIs to change prescribing information to describe the potential risk for PPHN. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2006/safety06.htm#SSRIpreg and http://www.fda.gov/cder/drug/advisory/SSRI_PPHN200607.htm.

[Posted 07/19/2006] FDA notified healthcare professionals and consumers of new safety information regarding taking medications used to treat migraine headaches (triptans) together with certain types of antidepressant and mood disorder medications (selective serotonin reuptake inhibitors (SSRIs) and selective serotonin/norepinephrine reuptake inhibitors (SNRIs). A life-threatening condition called serotonin syndrome may occur when triptans are used together with a SSRI or a SNRI.

Serotonin syndrome occurs when the body has too much of a chemical found in the nervous system (serotonin). Each of the above medications (triptans, SSRIs, and SNRIs), cause an increase in serotonin levels. Symptoms of serotonin syndrome may include restlessness, hallucinations, loss of coordination, fast heart beat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting, and diarrhea.

Healthcare professionals prescribing a triptan, SSRI or SNRI should keep in mind that triptans are often used intermittently and either the triptan, SSRI or SNRI may be prescribed by a different physician; weigh the potential risk of serotonin syndrome with the expected benefit of using the above combination; discuss the possibility of serotonin syndrome with patients if a triptan and an SSRI or SNRI will be used together; and follow patients closely during treatment if a triptan and an SSRI or SNRI are used together.

Patients taking a triptan along with an SSRI or SNRI should talk to their doctor before stopping their medication and should immediately seek medical attention if they experience any of the above symptoms. FDA requested that all manufacturers of triptans, SSRIs and SNRIs update their prescribing information to warn of the possibility of serotonin syndrome when these medications are taken together. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2006/safety06.htm#Triptans and http://www.fda.gov/cder/drug/advisory/SSRI_SS200607.htm.

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paroxetine
(pa ROX e teen)
What is this medicine?What is the price of this medication and similar alternatives?What side effects may I notice from receiving this medicine?How should I use this medicine?What if I miss a dose?What may interact with this medicine?Who should NOT use this medication?What should I watch for while using this medicine?What should I tell my health care provider before I take this medicine?Can I stop taking the medication if I feel better?I am on so many medications; do I have to take them all?Where can I get more information?

What is this medicine?
PAROXETINE (pa ROX e teen) is used to treat depression. It may also be used to treat anxiety disorders, obsessive compulsive disorder, panic attacks, post traumatic stress, and premenstrual dysphoric disorder (PMDD).

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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What is the price of this medication and similar alternatives?

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 09/2009. For the most current and up-to-date pricing information, please visit www.drugstore.com. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

PARoxetine HCl 10MG Tablets APOTEX30/$30.99 or 90/$89.96
PARoxetine HCl 12.5MG 24-hr Tablets MYLAN30/$96.99 or 90/$261.96
PARoxetine HCl 20MG Tablets TEVA PHARMACEUTICALS USA30/$13.99 or 60/$22.98
PARoxetine HCl 25MG 24-hr Tablets MYLAN30/$99.99 or 90/$272.98
PARoxetine HCl 30MG Tablets APOTEX30/$35.99 or 90/$89.96
PARoxetine HCl 37.5MG 24-hr Tablets MYLAN30/$101.99 or 90/$279.95
PARoxetine HCl 40MG Tablets TEVA PHARMACEUTICALS USA30/$24.99 or 90/$59.95
Paxil 10MG/5ML Suspension GLAXO SMITH KLINE250/$175.25 or 750/$507.08
Paxil 10MG Tablets GLAXO SMITH KLINE30/$105 or 90/$301.6
Paxil 20MG Tablets GLAXO SMITH KLINE30/$109.18 or 90/$302.07
Paxil 30MG Tablets GLAXO SMITH KLINE30/$119.69 or 90/$325.47
Paxil 40MG Tablets GLAXO SMITH KLINE30/$121.78 or 90/$342.25
Paxil CR 12.5MG 24-hr Tablets GLAXO SMITH KLINE30/$111.29 or 90/$312.88
Paxil CR 25MG 24-hr Tablets GLAXO SMITH KLINE30/$112.34 or 90/$319.15
Paxil CR 37.5MG 24-hr Tablets GLAXO SMITH KLINE30/$121.78 or 90/$333.86
Pexeva 20MG Tablets NOVEN THERAPEUTICS30/$167.42 or 90/$463.62
Pexeva 30MG Tablets NOVEN THERAPEUTICS30/$176.57 or 90/$514.71
Pexeva 40MG Tablets NOVEN THERAPEUTICS30/$180.3 or 90/$502.24

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What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • black or bloody stools, blood in the urine or vomit
  • fast, irregular heartbeat
  • hallucination, loss of contact with reality
  • painful or prolonged erection (men)
  • seizures
  • suicidal thoughts or other mood changes
  • trouble passing urine or change in the amount of urine
  • unusual bleeding or bruising
  • unusually weak or tired
  • vomiting

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • change in appetite, weight
  • change in sex drive or performance
  • constipation or diarrhea
  • difficulty sleeping
  • drowsy
  • headache
  • increased sweating
  • muscle pain or weakness
  • tremors

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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How should I use this medicine?
Take this medicine by mouth. Follow the directions on the prescription label. Shake well before using. Use a specially marked spoon or container to measure your medicine. Ask your pharmacist if you do not have one. Household spoons are not accurate. You can take it with or without food. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

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What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

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What may interact with this medicine?
Do not take this medicine with any of the following medications:

  • certain diet drugs like dexfenfluramine, fenfluramine, phentermine
  • MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
  • medicines similar to paroxetine like fluoxetine, sertraline, citalopram
  • phenothiazines like thioridazine
  • pimozide
  • procarbazine
  • St. John's wort
  • tryptophan

This medicine may also interact with the following medications:

  • aspirin and aspirin-like drugs
  • cimetidine
  • digoxin
  • fosamprenavir
  • linezolid
  • medicines for depression, anxiety, or psychotic disturbances
  • medicines for migraine headache like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
  • medicines that treat or prevent blood clots like warfarin, enoxaparin, and dalteparin
  • NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
  • phenobarbital
  • phenytoin
  • procyclidine
  • ritonavir
  • theophylline

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

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Who should NOT use this medication?

  • Concurrent or recent (i.e., within 2 weeks) therapy with an MAO inhibitor.
  • Concurrent therapy with thioridazine. (See Drug Interactions under Warnings.)
  • Concurrent pimozide therapy. (See Interactions.)
  • Known hypersensitivity to paroxetine or any ingredient in the formulation.

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What should I watch for while using this medicine?
Visit your doctor or health care professional for regular checks on your progress. Continue to take your medicine even if you do not immediately feel better. It can take several weeks before you feel the full effect of this medicine.

Patients and their families should watch out for depression or thoughts of suicide that get worse. Also watch out for sudden or severe changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of antidepressant treatment or after a change in dose, call your health care professional.

If you have been taking this medicine regularly for some time, do not suddenly stop taking it. You must gradually reduce the dose or your symptoms may get worse. Ask your doctor or health care professional for advice.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol can increase or decrease the effects of this medicine. Avoid alcoholic drinks.

Do not treat yourself for coughs, colds or allergies without asking your doctor or health care professional for advice. Some ingredients can increase possible side effects.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water will help.

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What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:

  • bipolar disorder or a family history of bipolar disorder
  • heart disease
  • kidney or liver disease
  • receiving electroconvulsive therapy
  • seizures (convulsions)
  • suicidal thoughts or a previous suicide attempt
  • an unusual or allergic reaction to paroxetine, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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