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PEXEVA
Overview
What is PEXEVA?
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 (-)-
-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine mesylate and has the empirical formula of C
H
FNO
•CH
SO
H. 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.
What does PEXEVA look like?
What are the available doses of PEXEVA?
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What should I talk to my health care provider before I take PEXEVA?
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How should I use PEXEVA?
PEXEVA® (paroxetine mesylate) is indicated for the treatment of MDD.
The efficacy of paroxetine in the treatment of a major depressive episode was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the DSM-III category of MDD (see
). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.
The effects of paroxetine in hospitalized depressed patients have not been adequately studied.
The efficacy of paroxetine in maintaining a response in MDD for up to 1 year was demonstrated in a placebo-controlled trial (see
). Nevertheless, the physician who elects to use PEXEVA® (paroxetine mesylate) for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
What interacts with PEXEVA?
The use of MAOIs intended to treat psychiatric disorders with PEXEVA® or within 14 days of stopping treatment with PEXEVA® is contraindicated because of an increased risk of serotonin syndrome. The use of PEXEVA® within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see and ).
Starting PEXEVA® in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see and ).
Concomitant use in patients taking thioridazine is contraindicated (see and ).
Concomitant use in patients taking pimozide is contraindicated (see ).
PEXEVA® (paroxetine mesylate) tablets are contraindicated in patients with a hypersensitivity to paroxetine or any of the inactive ingredients in PEXEVA® (paroxetine mesylate) tablets.
What are the warnings of PEXEVA?
Clinical Worsening and Suicide Risk
Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behaviour (suicidality) in children, adolescents, and young adults (ages 18-24) with major depressive disorder (MDD) and other psychiatric disorders. 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 with antidepressants compared to placebo in adults aged 65 and older.
The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in
.
No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.
It is unknown whether the suicidality risk extends to longer-term use, ie, beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression.
All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.
The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.
Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.
If the decision has been made to discontinue treatment, medication should be tapered, as rapidly as is feasible, but with recognition that abrupt discontinuation can be associated with certain symptoms (see
and
), for a description of the risks of discontinuation of PEXEVA® (paroxetine mesylate)).
Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to healthcare providers. Such monitoring should include daily observation by families and caregivers.
| Age Range | Drug-Placebo Difference in Number of Cases of Suicidality per 1000 Patients Treated |
| Increases Compared to Placebo | |
| <18 | 14 additional cases |
| 18-24 | 5 additional cases |
| Decreases Compared to Placebo | |
| 25-64 | 1 fewer case |
| ≥65 | 6 fewer cases |
Screening Patients for Bipolar Disorder:
Serotonin Syndrome:
Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome.
The concomitant use of PEXEVA® with MAOIs intended to treat psychiatric disorders is contraindicated. PEXEVA® should also not be started in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue. All reports with methylene blue that provided information on the route of administration involved intravenous administration in the dose range of 1 mg/kg to 8 mg/kg. No reports involved the administration of methylene blue by other routes (such as oral tablets or local tissue injection) or at lower doses. There may be circumstances when it is necessary to initiate treatment with a MAOI such as linezolid or intravenous methylene blue in a patient taking PEXEVA®. PEXEVA® should be discontinued before initiating treatment with the MAOI (see and ).
If concomitant use of PEXEVA® with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan, amphetamines, and St. John's Wort is clinically warranted, be aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.
Treatment with PEXEVA® and any concomitant serotonergic agents should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated.
Angle-Closure Glaucoma
The pupillary dilation that occurs following use of many antidepressant drugs including Pexeva may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.
Potential Interaction with Thioridazine
Thioridazine administration alone produces prolongation of the QTc interval, which is associated with serious ventricular arrhythmias, such as torsade de pointes-type arrhythmias, and sudden death. This effect appears to be dose-related.
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Usage in Pregnancy
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Infants exposed to SSRIs in pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). PPHN occurs in 1 – 2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. Several recent epidemiologic studies suggest a positive statistical association between SSRI use (including PEXEVA®) in pregnancy and PPHN. Other studies do not show a significant statistical association.
Physicians should also note the results of a prospective longitudinal study of 201 pregnant women with a history of major depression, who were either on antidepressants or had received antidepressants less than 12 weeks prior to their last menstrual period, and were in remission. Women who discontinued antidepressant medication during pregnancy showed a significant increase in relapse of their major depression compared to those women who remained on antidepressant medication throughout pregnancy.
When treating a pregnant woman with PEXEVA®, the physician should carefully consider both the potential risks of taking an SSRI, along with the established benefits of treating depression with an antidepressant. This decision can only be made on a case by case basis (see and ).
What are the precautions of PEXEVA?
General
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With this regimen in those studies, the following adverse events were reported at an incidence of 2% or greater for paroxetine at an incidence at least twice that reported for placebo: abnormal dreams, paresthesia, and dizziness. In the majority of patients, these events were mild to moderate and were self-limiting and did not require medical intervention.
During marketing of paroxetine and other SSRIs and SNRIs (serotonin and norepinephrine reuptake inhibitors), there have been spontaneous reports of adverse events occurring upon the discontinuation of these drugs (particularly when abrupt), including the following: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (eg, paresthesias such as electric shock sensations and tinnitus), anxiety, confusion, headache, lethargy, emotional lability, insomnia, and hypomania. While these events are generally self-limiting, there have been reports of serious discontinuation symptoms.
Patients should be monitored for these symptoms when discontinuing treatment with paroxetine. A gradual reduction in the dose, rather than abrupt cessation, is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate (see
).
See also
for adverse events reported upon discontinuation of treatment with paroxetine in pediatric patients.
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Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls. Signs and symptoms associated with more severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death.
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Patients should be cautioned about the risk of bleeding associated with the concomitant use of PEXEVA® (paroxetine mesylate) and NSAIDs, aspirin, or other drugs that affect coagulation.
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Paroxetine has not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable heart disease. Patients with these diagnoses were excluded from clinical studies during the product's premarket testing. Evaluation of electrocardiograms of 682 patients who received paroxetine in double-blind, placebo-controlled trials, however, did not indicate that paroxetine is associated with the development of significant ECG abnormalities. Similarly, paroxetine does not cause any clinically important changes in heart rate or blood pressure.
Increased plasma concentrations of paroxetine occur in patients with severe renal impairment (creatinine clearance <30 ml/min) or severe hepatic impairment. A lower starting dose should be used in such patients (see
).
Information for Patients
PEXEVA® (paroxetine mesylate) should not be chewed or crushed, and should be swallowed whole.
Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of paroxetine and triptans, tramadol, or other serotonergic agents.
Patients should be advised that taking Pexeva can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible.
Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with PEXEVA® (paroxetine mesylate) and should counsel them in its appropriate use. A patient
about “Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions” is available for PEXEVA® (paroxetine mesylate). The prescriber or health professional should instruct patients, their families, and their caregivers to read the
and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the
and to obtain answers to any questions they may have. The complete text of the
is reprinted at the end of this document.
Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking PEXEVA® (paroxetine mesylate).
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Laboratory Tests
There are no specific laboratory tests recommended.
Paxil® (paroxetine hydrochloride)
Paroxetine, the active ingredient in PEXEVA® (paroxetine mesylate), is also the active ingredient of Paxil®. Thus, these two agents should not be coadministered.
Drug Interactions
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Concomitant use of paroxetine with other drugs metabolized by cytochrome CYP2D6 has not been formally studied but may require lower doses than usually prescribed for either paroxetine or the other drug.
Therefore, coadministration of PEXEVA® (paroxetine mesylate) with other drugs that are metabolized by this isozyme, including certain drugs effective in the treatment of MDD (eg, nortriptyline, amitriptyline, imipramine, desipramine, and fluoxetine), phenothiazines, risperidone, and Type 1C antiarrhythmics (eg, propafenone, flecainide, and encainide), or that inhibit this enzyme (eg, quinidine), should be approached with caution.
However, due to the risk of serious ventricular arrhythmias and sudden death potentially associated with elevated plasma levels of thioridazine, paroxetine, and thioridazine should not be coadministered (see
and
).
Tamoxifen is a pro-drug requiring metabolic activation by CYP2D6. Inhibition of CYP2D6 by paroxetine may lead to reduced plasma concentrations of an active metabolite (endoxifen) and hence reduced efficacy of tamoxifen (see
).
At steady state, when the CYP2D6 pathway is essentially saturated, paroxetine clearance is governed by alternative P450 isozymes, which, unlike CYP2D6, show no evidence of saturation (see
).
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Carcinogenesis, Mutagenesis, Impairment of Fertility
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A reduced pregnancy rate was found in reproduction studies in rats at a dose of paroxetine of 15 mg/kg/day, which is 2.9 times the MRHD for MDD and GAD or 2.4 times the MRHD for OCD on a mg/m2 basis. Irreversible lesions occurred in the reproductive tract of male rats after dosing in toxicity studies for 2 to 52 weeks. These lesions consisted of vacuolation of epididymal tubular epithelium at 50 mg/kg/day and atrophic changes in the seminiferous tubules of the testes with arrested spermatogenesis at 25 mg/kg/day (9.8 and 4.9 times the MRHD for MDD and GAD; 8.2 and 4.1 times the MRHD for OCD and PD on a mg/m2 basis).
Pregnancy
Pregnancy Category D (see
and
).
Labor and Delivery
The effect of paroxetine on labor and delivery in humans is unknown.
Nursing Mothers
Like many other drugs, paroxetine is secreted in human milk, and caution should be exercised when PEXEVA® (paroxetine mesylate) is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in the pediatric population have not been established (see
and
). Three placebo-controlled trials in 752 pediatric patients with MDD have been conducted with paroxetine, and the data were not sufficient to support a claim for use in pediatric patients. Anyone considering the use of paroxetine mesylate in a child or adolescent must balance the potential risks with the clinical need. Decreased appetite and weight loss have been observed in association with the use of SSRIs. Consequently, regular monitoring of weight and growth should be performed in children and adolescents treated with an SSRI such as PEXEVA®.
In placebo-controlled clinical trials conducted with pediatric patients, the following adverse events were reported in at least 2% of pediatric patients treated with paroxetine and occurred at a rate at least twice that for pediatric patients receiving placebo: emotional lability (including self-harm, suicidal thoughts, attempted suicide, crying, and mood fluctuations), hostility, decreased appetite, tremor, sweating, hyperkinesia, and agitation.
Events reported upon discontinuation of treatment with paroxetine in the pediatric clinical trials that included a taper phase regimen, which occurred in at least 2% of patients who received paroxetine and which occurred at a rate at least twice that of placebo, were: emotional lability (including suicidal ideation, suicide attempt, mood changes, and tearfulness), nervousness, dizziness, nausea, and abdominal pain (see
).
Geriatric Use
SSRIs and SNRIs, including PEXEVA® (paroxetine mesylate), have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event (See
).
In worldwide premarketing paroxetine clinical trials, 17% of paroxetine-treated patients (approximately 700) were 65 years of age or older. Pharmacokinetic studies revealed a decreased clearance in the elderly, and a lower starting dose is recommended; there were, however, no overall differences in the adverse event profile between elderly and younger patients, and effectiveness was similar in younger and older patients (see
and
).
What are the side effects of PEXEVA?
Associated with Discontinuation of Treatment
Twenty percent (1199/6145) of patients treated with paroxetine in worldwide clinical trials in MDD and 11.8% (64/542), 9.4% (44/469), and 10.7% (79/735) of patients treated with paroxetine in worldwide trials in OCD, PD, and GAD, respectively, discontinued treatment due to an adverse event. The most common events (≥1%) associated with discontinuation and considered to be drug related (ie, those events associated with dropout at a rate approximately twice or greater for paroxetine compared to placebo) included the following:
| Where numbers are not provided the incidence of the adverse events in patients treated with paroxetine was not >1% or was not greater than or equal to two times the incidence of placebo. | ||||||||
| 1 | ||||||||
| MDD | OCD | PD | GAD | |||||
| Paroxetine | Placebo | Paroxetine | Placebo | Paroxetine | Placebo | Paroxetine | Placebo | |
| CNS | ||||||||
| Somnolence | 2.3% | 0.7% | - | - | 1.9% | 0.3% | 2.0% | 0.2% |
| Insomnia | - | - | 1.7% | 0% | 1.3% | 0.3% | - | - |
| Agitation | 1.1% | 0.5% | - | - | - | - | - | - |
| Tremor | 1.1% | 0.3% | - | |||||
| Dizziness | - | - | 1.5% | 0% | - | - | 1.0% | 0.2% |
| Gastrointestinal | ||||||||
| Constipation | - | - | 1.1% | 0% | - | - | - | - |
| Nausea | 3.2% | 1.1% | 1.9% | 0% | 3.2% | 1.2% | 2.0% | 0.2% |
| Diarrhea | 1.0% | 0.3% | - | - | - | - | - | - |
| Dry mouth | 1.0% | 0.3% | - | - | - | - | - | - |
| Vomiting | 1.0% | 0.3% | - | - | - | - | - | - |
| Other | ||||||||
| Asthenia | 1.6% | 0.4% | 1.9% | 0.4% | - | - | 1.8% | 0.2% |
| Abnormal Ejaculation | 1.6% | 0% | 2.1% | 0% | - | - | 2.5% | 0.5% |
| Sweating | 1.0% | 0.3% | - | - | - | - | 1.1% | 0.2% |
| Impotence | - | - | 1.5% | 0% | - | - | - | - |
Commonly Observed Adverse Events
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The most commonly observed adverse events associated with the use of paroxetine (incidence of 5% or greater and incidence for paroxetine at least twice that for placebo, derived from below) were: asthenia, sweating, nausea, decreased appetite, somnolence, dizziness, insomnia, tremor, nervousness, ejaculatory disturbance, and other male genital disorders.
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The most commonly observed adverse events associated with the use of paroxetine (incidence of 5% or greater and incidence for paroxetine at least twice that of placebo, derived from Table 3 below) were: nausea, dry mouth, decreased appetite, constipation, dizziness, somnolence, tremor, sweating, impotence, and abnormal ejaculation.
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The most commonly observed adverse events associated with the use of paroxetine (incidence of 5% or greater and incidence for paroxetine at least twice that for placebo, derived from below) were: asthenia, sweating, decreased appetite, libido decreased, tremor, abnormal ejaculation, female genital disorders, and impotence.
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The most commonly observed adverse events associated with the use of paroxetine (incidence of 5% or greater and incidence for paroxetine at least twice that for placebo, derived from ) were: asthenia, infection, constipation, decreased appetite, dry mouth, nausea, libido decreased, somnolence, tremor, sweating, and abnormal ejaculation.
Incidence in Controlled Clinical Trials
The prescriber should be aware that the figures in the tables following cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence rate in the populations studied.
Major Depressive Disorder
Table 2
| 1 | |||
| 2 | |||
| 3 | |||
| 4 | |||
| 5 | |||
| 6 | |||
| 7 | Treatment-Emergent Adverse Experience Incidence in Placebo-Controlled Clinical Trials for MDD | 1 | |
| Body System | Preferred Term | ||
| Body as a Whole | Headache | 18% | 17% |
| Asthenia | 15% | 6% | |
| Cardiovascular | Palpitation | 3% | 1% |
| Vasodilation | 3% | 1% | |
| Dermatologic | Sweating | 11% | 2% |
| Rash | 2% | 1% | |
| Gastrointestinal | Nausea | 26% | 9% |
| Dry Mouth | 18% | 12% | |
| Constipation | 14% | 9% | |
| Diarrhea | 12% | 8% | |
| Decreased Appetite | 6% | 2% | |
| Flatulence | 4% | 2% | |
| Oropharynx Disorder | 2% | 0% | |
| Dyspepsia | 2% | 1% | |
| Musculoskeletal | Myopathy | 2% | 1% |
| Myalgia | 2% | 1% | |
| Myasthenia | 1% | 0% | |
| Nervous System | Somnolence | 23% | 9% |
| Dizziness | 13% | 6% | |
| Insomnia | 13% | 6% | |
| Tremor | 8% | 2% | |
| Nervousness | 5% | 3% | |
| Anxiety | 5% | 3% | |
| Paresthesia | 4% | 2% | |
| Libido Decreased | 3% | 0% | |
| Drugged Feeling | 2% | 1% | |
| Confusion | 1% | 0% | |
| Respiration | Yawn | 4% | 0% |
| Special Senses | Blurred Vision | 4% | 1% |
| Taste Perversion | 2% | 0% | |
| Urogenital System | Ejaculatory Disturbance | 13% | 0% |
| Other Male Genital Disorders | 10% | 0% | |
| Urinary Frequency | 3% | 1% | |
| Urination Disorder | 3% | 0% | |
| Female Genital Disorders | 2% | 0% |
Obsessive Compulsive Disorder and Panic Disorder
Table 3
| 1 | |||||
| 2 | Treatment-Emergent Adverse Experience Incidence in Placebo-Controlled Clinical Trials for Obsessive Compulsive Disorder and Panic Disorder | 1 | |||
| Body System | Preferred Term | ||||
| Body as a Whole | Asthenia | 22% | 14% | 14% | 5% |
| Abdominal Pain | - | - | 4% | 3% | |
| Chest Pain | 3% | 2% | - | - | |
| Back Pain | - | - | 3% | 2% | |
| Chills | 2% | 1% | 2% | 1% | |
| Cardiovascular | Vasodilation | 4% | 1% | - | - |
| Palpitation | 2% | 0% | - | - | |
| Dermatologic | Sweating | 9% | 3% | 14% | 6% |
| Rash | 3% | 2% | - | - | |
| Gastrointestinal | Nausea | 23% | 10% | 23% | 17% |
| Dry Mouth | 18% | 9% | 18% | 11% | |
| Constipation | 16% | 6% | 8% | 5% | |
| Diarrhea | 10% | 10% | 12% | 7% | |
| Decreased Appetite | 9% | 3% | 7% | 3% | |
| Increased Appetite | 4% | 3% | 2% | 1% | |
| Nervous System | Insomnia | 24% | 13% | 18% | 10% |
| Somnolence | 24% | 7% | 19% | 11% | |
| Dizziness | 12% | 6% | 14% | 10% | |
| Tremor | 11% | 1% | 9% | 1% | |
| Nervousness | 9% | 8% | - | - | |
| Libido Decreased | 7% | 4% | 9% | 1% | |
| Agitation | - | - | 5% | 4% | |
| Anxiety | - | - | 5% | 4% | |
| Abnormal Dreams | 4% | 1% | - | - | |
| Concentration Impaired | 3% | 2% | - | - | |
| Depersonalization | 3% | 0% | - | - | |
| Myoclonus | 3% | 0% | 3% | 2% | |
| Amnesia | 2% | 1% | - | - | |
| Respiratory System | Rhinitis | - | - | 3% | 0% |
| Special Senses | Abnormal Vision | 4% | 2% | - | - |
| Taste Perversion | 2% | 0% | - | - | |
| Urogenital System | Abnormal Ejaculation | 23% | 1% | 21% | 1% |
| Female Genital Disorder | 3% | 0% | 9% | 1% | |
| Impotence | 8% | 1% | 5% | 0% | |
| Urinary Frequency | 3% | 1% | 2% | 0% | |
| Urination Impaired | 3% | 0% | - | - | |
| Urinary Tract Infection | 2% | 1% | 2% | 1% |
Generalized Anxiety Disorder
Table 4
| 1 | |||
| 2 | Treatment-Emergent Adverse Experience Incidence in Placebo-Controlled Clinical Trials for Generalized Anxiety Disorder | 1 | |
| Body System | Preferred Term | ||
| Body as a Whole | Asthenia | 14% | 6% |
| Headache | 17% | 14% | |
| Infection | 6% | 3% | |
| Cardiovascular | Vasodilation | 3% | 1% |
| Dermatologic | Sweating | 6% | 2% |
| Gastrointestinal | Nausea | 20% | 5% |
| Dry Mouth | 11% | 5% | |
| Constipation | 10% | 2% | |
| Diarrhea | 9% | 7% | |
| Decreased Appetite | 5% | 1% | |
| Vomiting | 3% | 2% | |
| Nervous System | Insomnia | 11% | 8% |
| Somnolence | 15% | 5% | |
| Dizziness | 6% | 5% | |
| Tremor | 5% | 1% | |
| Nervousness | 4% | 3% | |
| Libido Decreased | 9% | 2% | |
| Respiratory System | Respiratory Disorder | 7% | 5% |
| Sinusitis | 4% | 3% | |
| Yawn | 4% | - | |
| Special Senses | Abnormal Vision | 2% | 1% |
| Urogenital System | Abnormal Ejaculation | 25% | 2% |
| Female Genital Disorder | 4% | 1% | |
| Impotence | 4% | 3% |
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In a fixed-dose study comparing placebo and paroxetine 20, 40, and 60 mg in the treatment of OCD, there was no clear relationship between adverse events and the dose of paroxetine to which patients were assigned. No new adverse events were observed in the paroxetine 60 mg dose group compared to any of the other treatment groups.
In a fixed-dose study comparing placebo and paroxetine 10, 20, and 40 mg in the treatment of PD, there was no clear relationship between adverse events and the dose of paroxetine to which patients were assigned, except for asthenia, dry mouth, anxiety, libido decreased, tremor, and abnormal ejaculation. In flexible-dose studies, no new adverse events were observed in patients receiving 60 mg of paroxetine compared to any of the other treatment groups.
In a fixed-dose study comparing placebo and 20 and 40 mg of paroxetine in the treatment of GAD, for most of the adverse events, there was no clear relationship between adverse events and the dose of paroxetine to which patients were assigned, except for the following adverse events: asthenia, constipation, and abnormal ejaculation.
In flexible dose studies, no new adverse events were observed in patients receiving paroxetine 60 mg compared to any of the other treatment groups.
| *Rule for including adverse events in table: incidence at least 5% for one of paroxetine groups and ≥ twice the placebo incidence for at least one paroxetine group. | Treatment-Emergent Adverse Experience Incidence in a Dose-Comparison Trial in the Treatment of MDD* | ||||
| Placebo | Paroxetine | ||||
| 10 mg n=102 | 20 mg n=104 | 30 mg n=101 | 40 mg n=102 | ||
| Body as a Whole | |||||
| Asthenia | 0.0% | 2.9% | 10.6% | 13.9% | 12.7% |
| Dermatology | |||||
| Sweating | 2.0% | 1.0% | 6.7% | 8.9% | 11.8% |
| Gastrointestinal | |||||
| Constipation | 5.9% | 4.9% | 7.7% | 9.9% | 12.7% |
| Decreased Appetite | 2.0% | 2.0% | 5.8% | 4.0% | 4.9% |
| Diarrhea | 7.8% | 9.8% | 19.2% | 7.9% | 14.7% |
| Dry Mouth | 2.0% | 10.8% | 18.3% | 15.8% | 20.6% |
| Nausea | 13.7% | 14.7% | 26.9% | 34.7% | 36.3% |
| Nervous System | |||||
| Anxiety | 0.0% | 2.0% | 5.8% | 5.9% | 5.9% |
| Dizziness | 3.9% | 6.9% | 6.7% | 8.9% | 12.7% |
| Nervousness | 0.0% | 5.9% | 5.8% | 4.0% | 2.9% |
| Paresthesia | 0.0% | 2.9% | 1.0% | 5.0% | 5.9% |
| Somnolence | 7.8% | 12.7% | 18.3% | 20.8% | 21.6% |
| Tremor | 0.0% | 0.0% | 7.7% | 7.9% | 14.7% |
| Special Senses | |||||
| Blurred Vision | 2.0% | 2.9% | 2.9% | 2.0% | 7.8% |
| Urogenital System | |||||
| Abnormal Ejaculation | 0.0% | 5.8% | 6.5% | 10.6% | 13.0% |
| Impotence | 0.0% | 1.9% | 4.3% | 6.4% | 1.9% |
| Male Genital Disorders | 0.0% | 3.8 | 8.7% | 6.4% | 3.7% |
Array
Array
Reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance, and satisfaction are difficult to obtain, however, in part because patients and physicians may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in product labeling are likely to underestimate their actual incidence.
In placebo-controlled clinical trials involving more than 3200 patients the ranges for the reported incidence of sexual side effects in males and females with MDD, OCD, PD, social anxiety disorder, GAD, and post traumatic stress disorder (PTSD) are displayed in .
There are no adequate and well-controlled studies examining sexual dysfunction with paroxetine treatment.
Paroxetine treatment has been associated with several cases of priapism. In those cases with a known outcome, patients recovered without sequelae.
While it is difficult to know the precise risk of sexual dysfunction associated with the use of SSRIs, physicians should routinely inquire about such possible side effects.
| Incidence of Sexual Adverse Events in Controlled Clinical Trials | ||
| Paroxetine | Placebo | |
| n (males) | 1446 | 1042 |
| Decreased Libido | 6% - 15% | 0% - 5% |
| Ejaculatory Disturbance | 13% - 28% | 0% - 2% |
| Impotence | 2% - 9% | 0% - 3% |
| n (females) | 1822 | 1340 |
| Decreased Libido | 0% - 9% | 0% - 2% |
| Orgasmic Disturbance | 2% - 9% | 0% - 1% |
Array
Array
Array
Array
Other Events Observed During the Premarketing Evaluation of Paroxetine
During its premarketing assessment in MDD, multiple doses of paroxetine were administered to 6145 patients in phase 2 and 3 studies. The conditions and duration of exposure to paroxetine varied greatly and included (in overlapping categories) open and double-blind studies, uncontrolled and controlled studies, inpatient and outpatient studies, and fixed-dose and titration studies. During premarketing clinical trials in OCD, PD, and GAD, 542, 469, and 735 patients, respectively, received multiple doses of paroxetine. Untoward events associated with this exposure were recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of untoward events into a smaller number of standardized event categories.
In the tabulations that follow, reported adverse events were classified using a standard COSTART-based Dictionary terminology. The frequencies presented, therefore, represent the proportion of the 9089 patients exposed to multiple doses of paroxetine who experienced an event of the type cited on at least one occasion while receiving paroxetine. All reported events are included except those already listed in to , those reported in terms so general as to be uninformative, and those events where a drug cause was remote.
It is important to emphasize that although the events reported occurred during treatment with paroxetine, they were not necessarily caused by it.
Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring on one or more occasions in at least 1/100 patients (only those not already listed in the tabulated results from placebo-controlled trials appear in this listing); infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in fewer than 1/1000 patients. Events of major clinical importance are also described in the PRECAUTIONS section.
Array
Postmarketing Reports
Voluntary reports of adverse events in patients taking paroxetine that have been received since market introduction and not listed above that may have no causal relationship with the drug include acute pancreatitis, elevated liver function tests (the most severe cases were deaths due to liver necrosis, and grossly elevated transaminases associated with severe liver dysfunction), Guillain-Barré syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, priapism, syndrome of inappropriate ADH secretion, symptoms suggestive of prolactinemia and galactorrhea; extrapyramidal symptoms which have included akathisia, bradykinesia, cogwheel rigidity, dystonia, hypertonia, oculogyric crisis which has been associated with concomitant use of pimozide, tremor and trismus; status epilepticus, acute renal failure, pulmonary hypertension, allergic alveolitis, anaphylaxis, eclampsia, laryngismus, optic neuritis, porphyria, restless legs syndrome (RLS), ventricular fibrillation, ventricular tachycardia (including torsade de pointes), thrombocytopenia, hemolytic anemia, events related to impaired hematopoiesis (including aplastic anemia, pancytopenia, bone marrow aplasia, and agranulocytosis), and vasculitic syndromes (such as Henoch-Schönlein purpura), and premature births in pregnant women.
There has been a case report of an elevated phenytoin level after 4 weeks of paroxetine and phenytoin coadministration. There has been a case report of severe hypotension when paroxetine was added to chronic metoprolol treatment.
What should I look out for while using PEXEVA?
The use of MAOIs intended to treat psychiatric disorders with PEXEVA® or within 14 days of stopping treatment with PEXEVA® is contraindicated because of an increased risk of serotonin syndrome. The use of PEXEVA® within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see
and
).
Starting PEXEVA® in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see
and
).
Concomitant use in patients taking thioridazine is contraindicated (see
and
).
Concomitant use in patients taking pimozide is contraindicated (see
).
PEXEVA® (paroxetine mesylate) tablets are contraindicated in patients with a hypersensitivity to paroxetine or any of the inactive ingredients in PEXEVA® (paroxetine mesylate) tablets.
What might happen if I take too much PEXEVA?
How should I store and handle PEXEVA?
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Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The efficacy of paroxetine in the treatment of MDD, OCD, panic disorder (PD), and generalized anxiety disorder (GAD) is presumed to be linked to potentiation of serotonergic activity in the central nervous system resulting from inhibition of neuronal reuptake of serotonin (5-hydroxy-tryptamine, 5-HT). Studies at clinically relevant doses in humans have demonstrated that paroxetine blocks the uptake of serotonin into human platelets.
studies in animals also suggest that paroxetine is a potent and highly selective inhibitor of neuronal serotonin reuptake and has only very weak effects on norepinephrine and dopamine neuronal reuptake.
radioligand binding studies indicate that paroxetine has little affinity for muscarinic alpha1-, alpha2-, beta-adrenergic-, dopamine (D2)-, 5-HT1-, 5-HT2-, and histamine (H1)-receptors; antagonism of muscarinic, histaminergic, and alpha1-adrenergic receptors has been associated with various anticholinergic, sedative, and cardiovascular effects for other psychotropic drugs.
Because the relative potencies of paroxetine's major metabolites are at most 1/50 of the parent compound, they are essentially inactive.
Non-Clinical Toxicology
The use of MAOIs intended to treat psychiatric disorders with PEXEVA® or within 14 days of stopping treatment with PEXEVA® is contraindicated because of an increased risk of serotonin syndrome. The use of PEXEVA® within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see and ).Starting PEXEVA® in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see and ).
Concomitant use in patients taking thioridazine is contraindicated (see and ).
Concomitant use in patients taking pimozide is contraindicated (see ).
PEXEVA® (paroxetine mesylate) tablets are contraindicated in patients with a hypersensitivity to paroxetine or any of the inactive ingredients in PEXEVA® (paroxetine mesylate) tablets.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).