Pexeva (Paroxetine Mesylate) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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February 10, 2012

Pexeva

Panic Attacks »

What are panic attacks?

Panic attacks may be symptoms of an anxiety disorder. These attacks are a serious health problem in the U.S. At least 20% of adult Americans, or about 60 million people, will suffer from panic attacks at some point in their lives. About 1.7% of adult Americans, or about 3 million people, will have full-blown panic disorder at some time in their lives, twice as often for women than men. The peak age at which people have their first panic attack (onset) is 15-19 years. Another fact about panic is that this symptom is strikingly different from other types of anxiety; panic attacks are so very sudden and often unexpected, appear to be unprovoked, and are often disabling.

Childhood panic disorder facts include that about 0.7% of children suffer from panic disorder or generalized anxiety disorder and that although panic is found to occur twice as often in women compared to men, boys and girls tend to experience this disorder a...

Read the Panic Attacks article »

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PEXEVA®
(paroxetine mesylate) Tablets

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. (See WARNINGS: Clinical Worsening and Suicide Risk, PATIENT INFORMATION, and PRECAUTIONS: Pediatric Use)

DRUG DESCRIPTION

PEXEVA® (paroxetine mesylate) is an orally administered psychotropic drug with a chemical structure related to paroxetine hydrochloride (Paxil®). It is the mesylate salt of a phenylpiperidine compound identified chemically as (-)-trans -4R- (4'-fluorophenyl) - 3S - [(3', 4'-methylenedioxyphenoxy) methyl] piperidine mesylate and has the empirical formula of C₁₉H₂₀FNO₃•CH₃SO₃H. The molecular weight is 425.5 (329.4 as free base). The structural formula is:

Paroxetine mesylate is an odorless, off-white powder, having a melting point range of 147° to 150°C and a solubility of more than 1 g/ml in water.

Tablets

Each oval, film-coated tablet contains paroxetine mesylate equivalent to paroxetine as follows: 10 mg (white); 20 mg (scored, dark orange); 30 mg (yellow); 40 mg (rose). Inactive ingredients consist of dibasic calcium phosphate, hydroxypropyl methylcellulose, hydroxypropylcellulose, magnesium stearate, sodium starch glycolate, titanium dioxide, ferric oxide red (C.I. 77491) (20 mg and 40 mg only) and ferric oxide yellow (C.I. 77492) (20 mg, 30 mg, and 40 mg only).

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 mesylate (Pexeva)?

Before taking paroxetine mesylate, 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...

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Last reviewed on RxList: 6/10/2011
This monograph has been modified to include the generic and brand name in many instances.