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Paxil CR (Paroxetine Hydrochloride Controlled Release) - Summary


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 CR 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 CR is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)



Absorption and Distribution

PAXIL CR (paroxetine hydrochloride) is an orally administered psychotropic drug with a chemical structure unrelated to other selective serotonin reuptake inhibitors or to tricyclic, tetracyclic, or other available antidepressant or antipanic agents.

PAXIL CR (paroxetine hydrochloride) is indicated for the following:

Major Depressive Disorder: PAXIL CR is indicated for the treatment of major depressive disorder.

Panic Disorder: PAXIL CR is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV.

Social Anxiety Disorder: PAXIL CR is indicated for the treatment of social anxiety disorder, also known as social phobia, as defined in DSM-IV (300.23).

Premenstrual Dysphoric Disorder: PAXIL CR is indicated for the treatment of PMDD.

See all Paxil CR indications & dosage >>


Published Studies Related to Paxil CR (Paroxetine)

The paroxetine 352 bipolar trial: A study in medical ghostwriting. [2012]
that could adversely affect patient health... CONCLUSIONS: Few industry-sponsored studies gain public scrutiny. It is important

Meta-analysis of efficacy and treatment-emergent suicidality in adults by psychiatric indication and age subgroup following initiation of paroxetine therapy: a complete set of randomized placebo-controlled trials. [2011.11]
CONCLUSIONS: Across all disorders, overall suicidality incidence was similar between paroxetine and placebo. However, a higher frequency of suicidal behavior occurred with paroxetine in MDD, which was largely explained by the higher incidence in young adults. These data support the efficacy of paroxetine therapy; however, they also highlight the need for careful monitoring of suicidality during antidepressant therapy, particularly in younger adults. (c) Copyright 2011 Physicians Postgraduate Press, Inc.

Combined Prolonged Exposure Therapy and Paroxetine for PTSD Related to the World Trade Center Attack: A Randomized Controlled Trial. [2011.09.09]
Objective: Selective serotonin reuptake inhibitors (SSRIs) are often recommended in combination with established cognitive-behavioral therapies (CBTs) for posttraumatic stress disorder (PTSD), but combined initial treatment of PTSD has not been studied under controlled conditions... Combined treatment medication and prolonged exposure therapy deserves further study in larger samples with diverse forms of PTSD and over longer follow-up periods.

Neural correlates of antidepressant-related sexual dysfunction: a placebo-controlled FMRI study on healthy males under subchronic paroxetine and bupropion. [2011.08]
Sexual dysfunction is a common side effect of selective serotonin reuptake inhibitors (SSRIs) like paroxetine in the treatment of depression, imposing a considerable risk on medication adherence and hence therapeutic success. Bupropion, a norepinephrine and dopamine reuptake inhibitor, is recommended as an alternative treatment without adverse effects concerning sexual arousal and libido...

A randomized, controlled study comparing the effects of vestipitant or vestipitant and paroxetine combination in subjects with tinnitus. [2011.07]
OBJECTIVE: Tinnitus is a common symptom that demonstrates a significant comorbidity with anxiety and depression. The novel neurokinin-1 receptor antagonist, vestipitant, has anxiolytic properties and a good safety profile. Vestipitant was investigated for potential effect against chronic tinnitus as a stand-alone treatment and in conjunction with a selective serotonin reuptake inhibitor, paroxetine... CONCLUSION: Although well-tolerated vestipitant, alone or in combination with paroxetine, was not effective in ameliorating tinnitus in this patient group.

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Clinical Trials Related to Paxil CR (Paroxetine)

Paroxetine-CR (Paxil-CR) in the Treatment of Patients With Fibromyalgia Syndrome [Completed]
Objective: Although there is a high comorbidity of depressive and/or anxiety disorders with fibromyalgia, information on the clinical implications of this comorbidity is limited. We investigated whether a history of depressive and/or anxiety disorders was associated with response to treatment in a double blind, randomized, placebo controlled trial of paroxetine controlled release (CR) in fibromyalgia.

Method: One hundred and sixteen fibromyalgia subjects were randomized to receive paroxetine CR (dose 12. 5-62. 5 mg/day) or placebo for 12 weeks. The Mini International Neuropsychiatric Interview (M. I.N. I-plus) was used to ascertain current or past diagnoses of depressive and anxiety disorders. Patients with current depressive or anxiety disorders were excluded, but those with past diagnoses were enrolled in the trial. Subjective depression and anxiety were assessed using the Beck Depression Inventory (BDI) and the Beck Anxiety Inventory (BAI); subjects were excluded if they scored greater than 23 on the BDI. Health Status was determined using the 36-Item Short Form Health Survey (SF-36), the Sheehan Disability Scale (SDS), the Perceived Stress Scale (PSS) and the Pittsburgh Sleep Quality Index (PSQI). The primary outcome was treatment response defined as ≥ 25% reduction in the Fibromyalgia Impact Questionnaire (FIQ) score. Secondary outcomes included changes in scores on the Clinical Global Impression-Severity and Improvement (CGI-S and CGI-I respectively), the Visual Analogue Scale for Pain (VAS) scores and number of tender points.

Paxil Japanese Post Marketing Paediatric Study in Depression (Double-blind, Placebo Controlled Study) [Recruiting]
This study is designed to compare the efficacy of oral paroxetine 10 to 40 mg/day (initial dose: 10 mg/day) versus placebo administered once daily (after evening meal) for 8 weeks in children and adolescents with major depressive disorder (MDD) based on the change from baseline to Week 8/end-of-study in the CDRS-R total score in a randomized, double-blind, placebo-controlled parallel-group study.

Effectiveness Study of Mirtazapine Combined With Paroxetine in Major Depressive Patients Without Early Improvement [Recruiting]
Although treatment guidelines manifest that antidepressant response usually appear with a delay of several weeks and suggest that treatment should be changed if a partial response has not occurred after 4~6 week, these beliefs are no longer held by experts, and a new concept is raised that the first 2 weeks of treatment may be a useful strategy for improving the management of depression. New evidence indicates that early treatment response can be predicted with high sensitivity after 2 weeks of treatment in patients with major depressive disorder (MDD).

Because most antidepressant treatment guidelines continue to suggest 4~6 weeks of treatment until nonresponse can be assumed, adherence is required from depressed patients. The ability to identify the early action of antidepressants allows for earlier initiation of a treatment adaptation such as alternative or adjunctive treatment. The early identification of non responders is also important because selection of an antidepressant agent is still primarily guided by trial. Early improvement not only predicted response or remission, but also that lack of improvement was associated with little chance of response if the treatment strategy remained unchanged. Once a patient demonstrates an appropriate response to an antidepressant, ongoing treatment is recommended. The criterion of a 20% score reduction has been chosen as an early indicator of improvement because it can be reliably measured in clinical trials and translates into a clinically relevant change in the severity of depressive symptoms.

Antidepressants that enhance both serotonergic and noradrenergic neurotransmission may be more effective than selective serotonin reuptake inhibitors (SSRIs) for acute-phase therapy of major depressive disorder. As a noradrenergic and specific serotonergic antidepressant, the antidepressive mechanism of mirtazapine is quite superior to SSRI and in particular has been suggested to have a faster onset of action than SSRIs in MDD patients. Mirtazapine has significant advantages in response and remission rates compared with various SSRIs in double-blind treatment. Mirtazapine combined with SSRIs or venlafaxine was also found to be one of the more effective and successful strategy for nonresponders in MDD. The investigators hypothesized that mirtazapine as adjunctive treatment to paroxetine can boost the onset time and also can improve the antidepression action of SSRIs in patients without early improvement.

The aim of this study is to provide physicians with further information regarding early improvement and mirtazapine combined with a SSRI antidepressant therapy in nonresponders, by providing a comparison of depressive symptoms outcomes associated with adjunctive mirtazapine or mono- paroxetine in MDD patients who have previously been treated with paroxetine for 2 weeks and who have not attained improvement. Paroxetine has been chosen as a comparator because it is a widely-used and relatively well-tolerated SSRI antidepressant.

Food Study of Paroxetine Hydrochloride Tablets 40 mg and Paxil® Tablets 40 mg [Completed]
The objective of this study is to investigate the bioequivalence of Mylan's paroxetine hydrochloride 40 mg tablets to GSK's Paxil® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose administered under fed conditions to healthy adult volunteers.

Fasting Study of Paroxetine Hydrochloride Tablets 40 mg and Paxil® Tablets 40 mg [Completed]
The objective of this study is to investigate the bioequivalence of Mylan's paroxetine hydrochloride 40 mg tablets to GSK's Paxil® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose administered under fasting conditions to healthy adult volunteers.

more trials >>

Reports of Suspected Paxil CR (Paroxetine) Side Effects

Foetal Exposure During Pregnancy (98)Atrial Septal Defect (43)Ventricular Septal Defect (24)Patent Ductus Arteriosus (18)Talipes (17)Cardiac Murmur (17)Maternal Exposure During Pregnancy (12)Suicidal Ideation (10)Drug Ineffective (9)Coarctation of THE Aorta (9)more >>


Based on a total of 8 ratings/reviews, Paxil CR has an overall score of 6.62. The effectiveness score is 7.75 and the side effect score is 6.50. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.

Paxil CR review by 43 year old female patient

Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Mild Side Effects
Treatment Info
Condition / reason:   anxiety
Dosage & duration:   37.5 cr (dosage frequency: daily) for the period of 10 years
Other conditions:   dizziness,nausea,some sadness
Other drugs taken:   none
Reported Results
Benefits:   completely ended panic attacks,most sweating,most blushing,much discomfort.
Side effects:   more anxiety at first for about 3 weeks. some headaches,nausea
Comments:   I started the medicine 8-10 years ago and took the medicine religously to begin with. Took about 4 weeks to really make a difference. However, did notice change after only a couple weeks. I slack off many times and after a day or two of missed pills I notice dizziness and mild headache plus some nausea. Not good to do, but it happens. After being on the medicine as many years as I have, I don't think it is as effective as others may be, but I have tried many...Prozac,Zoloft and numerous others I don't remember the name of and nothing worked as well for me as Paxil..Another note is that anxiety runs in my family and a few aunts and uncles in my family have had the same good luck with Paxil. I often wonder since we are related if it treats something in our brain the same as it seems to work for this family??? Something to think about if you know someone else in your family that suffers from depression or other mental illness.


Paxil CR review by 34 year old female patient

Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Severe Side Effects
Treatment Info
Condition / reason:   Anxiety/Panic attacks
Dosage & duration:   25 mg taken daily in the morning for the period of 1.5 yrs
Other conditions:   sinus
Other drugs taken:   Klonopin
Reported Results
Benefits:   Controls the anxiety and fear of being without breathing.
Side effects:   GAIN WEIGHT (60 pnds) fron 125 lbs to 180 lbs (5'4"). Lazyness, sugar and candy cravings, depression form gain weight, sleep a lot, no concordance, No sex, confussion, nightmares, moody, constinspation at the begginng, face breakouts, intolerance, short of breath, headeach..among others.
Comments:   Begginng dose: 25 mg for 1.5 yr.(may 08 to dec 09). Dec 09: want 2 have bbs..so I talked 2 my Doc and I start with 12.5 this week (dec 7, 09). To end the process. If I can turn back time..OMG..I used alternative treatments..no drugs..


Paxil CR review by 37 year old female patient

Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Moderate Side Effects
Treatment Info
Condition / reason:   depression
Dosage & duration:   12.5 mg taken daily for the period of one year
Other conditions:   none
Other drugs taken:   none
Reported Results
Benefits:   It reduced some of the side effects of depression such as insomnia, frequent crying and feelings of hopeless.
Side effects:   Weight gain (25 lbs.), difficulty concentrating, cravings for carbohydrates, lack of interest in sex.
Comments:   Withdrawing from the drug was done slowly, with a gradual reduction over a six week period. Treatment was accompanied by talk therapy. The withdrawal from the drug itself was difficult, as it led to the emergence of anxiety and panic attacks and a new case of mild depression.

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Page last updated: 2013-02-10

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