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

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May 26, 2012

Pexeva

Depression »

Depression facts

A depressive disorder is a syndrome (group of symptoms) that reflects a sad, blue mood exceeding normal sadness or grief.
Depressive disorders are characterized not only by negative thoughts, moods, and behaviors but also by specific changes in bodily functions (for example, eating, sleeping, and sexual activity).
One in 10 people will have a depressive disorder in their lifetime, and in one of 10 cases, the depression is a fatal disease as a result of suicide.
Some types of depression, especially bipolar depression, run in families.
While there are many social, psychological, and environmental risk factors for developing depression, some are particularly prevalent in one gender or the other, or in particular age or ethnic groups.
There can be some differences in symptoms of depression depending on age, gender, and ethnicity.
Depression is diagnosed only clinicall...

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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.