Paxil CR (Paroxetine Hydrochloride Controlled Release) - Summary

PAXIL CR SUMMARY

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.

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NEWS HIGHLIGHTS

Published Studies Related to Paxil CR (Paroxetine)

History of depressive and/or anxiety disorders as a predictor of treatment response: a post hoc analysis of a 12-week, randomized, double-blind, placebo-controlled trial of paroxetine controlled release in patients with fibromyalgia. [2009.08.31]
BACKGROUND: Despite of a high comorbidity of depressive and/or anxiety disorders with fibromyalgia, information on the clinical implications of this comorbidity is limited but antidepressants are commonly prescribed to treat fibromyalgia in clinical practice. We investigated whether a history of depressive and/or anxiety disorders was associated with response to paroxetine controlled release (CR) in the treatment of fibromyalgia... CONCLUSION: A significant proportion of patients with fibromyalgia had a history of anxiety and or depressive disorders. However response to treatment of fibromyalgia symptoms with paroxetine CR was not associated with a history of depressive and/or anxiety disorders. Our findings need to be confirmed in more adequately-powered and well-designed subsequent studies.

Investigating the efficacy of paroxetine in developmental stuttering. [2009.07]
OBJECTIVES: Paroxetine has been reported to be useful for management of stuttering symptoms, but only a few reports have examined its effects. We have investigated the efficacy of paroxetine in a randomized, placebo-controlled study... CONCLUSION: Paroxetine may be useful in qualitative management of stuttering symptoms and may act on the stuttering brain by diminution of intracortical inhibition, as revealed by the shortening of the CSP after paroxetine administration.

The effects of paroxetine on the pharmacokinetics of paliperidone extended-release tablets. [2009.07]
INTRODUCTION: Co-morbid medical and psychiatric conditions are common in individuals with schizophrenia. As such, selecting antipsychotic medications with a low potential for drug-drug interactions (DDIs) is crucial, as many are extensively metabolized by hepatic cytochrome P450 (CYP) isozymes... DISCUSSION: Results suggest that no clinically relevant pharmacokinetic interaction occurs when paroxetine and paliperidone ER are co-administered and, therefore, initiation or discontinuation of concomitant treatment with CYP2D6-inhibiting drugs does not appear to warrant an adjustment in paliperidone ER dosage.

Mirtazapine and paroxetine in major depression: a comparison of monotherapy versus their combination from treatment initiation. [2009.07]
This double-blind study compared initial combination therapy against monotherapy using two antidepressant drugs with complementary mechanisms of action on the serotonin (5-HT) and norepinephrine (NE) systems. Sixty one adult patients with a DSM-IV diagnosis of unipolar depression were randomized to receive mirtazapine (30 mg/day), paroxetine (20 mg/day), or the combination of both drugs for 6 weeks...

A comparison of low-dose risperidone to paroxetine in the treatment of panic attacks: a randomized, single-blind study. [2009.05.26]
BACKGROUND: Because a large proportion of patients with panic attacks receiving approved pharmacotherapy do not respond or respond poorly to medication, it is important to identify additional therapeutic strategies for the management of panic symptoms. This article describes a randomized, rater-blind study comparing low-dose risperidone to standard-of-care paroxetine for the treatment of panic attacks... CONCLUSION: We can identify no difference in the efficacy of paroxetine and low-dose risperidone in the treatment of panic attacks. Low-dose risperidone appears to be tolerated equally well as paroxetine. Low-dose risperidone may be an effective treatment for anxiety disorders in which panic attacks are a significant component. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT100457106.

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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.

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.

Fasting Study of Paroxetine Hydrochloride Controlled-Release Tablets 25 mg to Paxil CRâ„¢ Tablets 25 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's paroxetine hydrochloride controlled-release 25 mg tablets to GSK's Paxil CRâ„¢ 25 mg tablets following a single, oral 25 mg (1 x 25 mg) dose administered under fasting conditions.

Food Study of Paroxetine Hydrochloride Controlled-Release Tablets 25 mg to Paxil CRâ„¢ Tablets 25 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's paroxetine hydrochloride controlled-release 25 mg tablets to GSK's Paxil CRâ„¢ 25 mg tablets following a single, oral 25 mg (1 x 25 mg) dose administered under fed conditions.

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PATIENT REVIEWS / RATINGS / COMMENTS

Paxil CR review by 43 year old female patient
		Rating
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 27 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		depression, anxiety, OCD
Dosage & duration:		37.5 mg taken 1 time per day for the period of 3years plus
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		reduced depression, anxiety and obsessions. Prevented inter dose withdrawl I had with regular Paxil
Side effects:		NO side effects when taking, but HORRIBLE withdrawl side effects if I accidentally miss a couple of does in a week, or try to wean off.
Comments:		N/A

Paxil CR review by 37 year old female patient
		Rating
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.