Paxil (Paroxetine Hydrochloride) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 26, 2012

Paxil

Antidepressants: Get the Facts »

What does the new study say about the ineffectiveness of antidepressants?

In findings published in the February issue of the journal PloS Medicine, researchers conclude that when taken as a whole, the data show that only a small group of the most severely depressed patients benefit from taking one of the antidepressants.

For less severely depressed patients, the antidepressants were found to work no better than placebos, leading the researchers to conclude that most patients who take antidepressants probably shouldn't be on them.

Does this study contradict numerous positive studies on antidepressants?

Yes, it does. In a statement, American Psychiatric Association President-elect Nada Stotland, MD, maintains that studies like this one, which compare a single drug to placebo, do not accurately reflect the way doctors prescribe antidepressants today.

Stotland says many people who are depressed do n...

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PAXIL®
(paroxetine hydrochloride) Tablets and Oral Suspension

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 PAXIL (paroxetine hydrochloride) 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. PAXIL (paroxetine hydrochloride) is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PATIENT INFORMATION, and PRECAUTIONS; Pediatric Use.)

DRUG DESCRIPTION

PAXIL (paroxetine hydrochloride) is an orally administered psychotropic drug. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C₁₉H₂₀FNO₃•HCl•1/2H₂O.. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is:

PAXIL®
(paroxetine hydrochloride) Structural Formula Illustration

Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120° to 138°C and a solubility of 5.4 mg/mL in water.

Tablets: Each film-coated tablet contains paroxetine hydrochloride equivalent to paroxetine as follows: 10 mg-yellow (scored); 20 mg-pink (scored); 30 mg-blue, 40 mg-green. Inactive ingredients consist of dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, polyethylene glycols, polysorbate 80, sodium starch glycolate, titanium dioxide, and 1 or more of the following: D&C Red No. 30 aluminum lake, D&C Yellow No. 10 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Yellow No. 6 aluminum lake.

Suspension for Oral Administration: Each 5 mL of orange-colored, orange-flavored liquid contains paroxetine hydrochloride equivalent to paroxetine, 10 mg. Inactive ingredients consist of polacrilin potassium, microcrystalline cellulose, propylene glycol, glycerin, sorbitol, methylparaben, propylparaben, sodium citrate dihydrate, citric acid anhydrous, sodium saccharin, flavorings, FD&C Yellow No. 6 aluminum lake, and simethicone emulsion, USP.

What are the possible side effects of paroxetine (Paxil, Paxil CR, Pexeva)?

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Contact your doctor promptly if you have any of the following side effects, especially if they are new symptoms or if they get worse: mood changes, anxiety, panic attacks, trouble sleeping, irritability, agitation, aggressiveness, severe restlessness, mania (mental and/or physical hyperactivity), thoughts of suicide or hurting yourself.

Call your...

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What are the precautions when taking paroxetine hydrochloride (Paxil)?

Before taking paroxetine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal or family history of bipolar/manic-depressive disorder, personal or family history of suicide attempts, liver problems, kidney problems, low sodium in the blood, severe loss of body water (dehydration), seizures, stomach/intestinal ulcers, glaucoma (narrow-angle type).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can...

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Last reviewed on RxList: 12/6/2010
This monograph has been modified to include the generic and brand name in many instances.