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Pexeva
Generic Name: Paroxetine Mesylate
Drug Category: SSRI
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 1 year.
| Approved Uses |
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Indicated in adults for the treatment of: • Major Depressive Disorder (MDD) • Obsessive-Compulsive Disorder (OCD) • Panic Disorder (PD) • Generalized Anxiety Disorder (GAD) Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. 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. It should be noted that PEXEVA (paroxetine mesylate) is not approved for use in treating bipolar depression. Prior to initiating treatment with PEXEVA or other antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania. In patients with bipolar disorder, treating a depressive episode with PEXEVA or another antidepressant may precipitate a mixed/manic episode. The recommended initial dose is 10 mg/day for elderly patients, patients with severe renal impairment and patients with severe hepatic impairment. Dosage should not exceed 40 mg/day. Adverse reactions may occur upon discontinuation of PEXEVA. Gradually reduce the dosage rather than stopping PEXEVA abruptly whenever possible. The pupillary dilation that occurs following use of many antidepressant drugs including PEXEVA trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. Hyponatremia may occur as a result of treatment with SSRIs and SNRIs, including PEXEVA. Epidemiological studies on bone fracture risk following exposure to some antidepressants, including SSRIs, have reported an association between antidepressant treatment and fractures. The use of paroxetine or other SSRIs has been associated with the development of akathisia, which is characterized by an inner sense of restlessness and psychomotor agitation such as an inability to sit or stand still usually associated with subjective distress. PEXEVA should be prescribed with caution in patients with a seizure disorder. Discontinue PEXEVA in any patient who develops seizures. Use of SSRIs, including PEXEVA, may cause symptoms of sexual dysfunction. In male patients, SSRI use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. . In female patients, SSRI use may result in decreased libido and delayed or absent orgasm. PEXEVA is contraindicated:
The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including PEXEVA, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). When tamoxifen is used for the treatment or prevention of breast cancer, prescribers should consider using an alternative antidepressant with little or no CYP2D6 inhibition. The concomitant use of PEXEVA with a CYP2D6 substrate may increase the exposure of the CYP2D6 substrate. SSRIs and SNRIs, including PEXEVA (paroxetine mesylate), may increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti inflammatory drugs, warfarin, and other anticoagulants may add to this risk. Paroxetine, the active ingredient in PEXEVA is also the active ingredient of Paxil. Thus, these two agents should not be co-administered. Concomitant use of paroxetine with tryptophan is not recommended. The concomitant use of PEXEVA with another drug that is highly bound to plasma protein may increase free concentrations of PEXEVA or other tightly-bound drugs in plasma. Although paroxetine has not been shown to increase the impairment of mental and motor skills caused by alcohol, patients should be advised to avoid alcohol while taking PEXEVA (paroxetine mesylate). Some clinical studies have shown that SSRIs (including paroxetine) may affect sperm quality during SSRI treatment, which may affect fertility in some men. Epidemiological studies have shown that infants exposed to paroxetine in the first trimester of pregnancy have an increased risk of congenital malformations, particularly cardiovascular malformations. If a patient becomes pregnant while taking paroxetine, she should be advised of the potential harm to the fetus. 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. |
| Off-label Uses |
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• Use in patients under the age of 18. GoToSource • Bipolar disorder depression. GoToSource • Compulsive gambling. GoToSource • Diabetic neuropathy. GoToSource • Sleep terrors. GoToSource • Eating disorders. GoToSource • Fibromyalgia. GoToSource • Menopausal vasomotor symptoms. GoToSource • Post-traumatic stress disorder. GoToSource • Hypochondria. GoToSource • Premature ejaculation and neurocardiogenic syncope. GoToSource • Somatic type delusional disorder. GoToSource • Dizziness. GoToSource • Use with antipsychotics for negative symptoms of chronic schizophrenia. GoToSource • Improve motor performance in patients with multiple system atrophy. GoToSource • Chronic primary insomnia. GoToSource • Irritable bowel syndrome refractory to high fiber diet. GoToSource • Hot flashes in men with prostate cancer undergoing androgen deprivation therapy. GoToSource • Post-stroke patients. GoToSource |
| Adverse Events |
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⚠️ Patients with CYP2D6 gene variation may have pharmacotherapy failure or increased side effects. Suicidal thinking and behavior (suicidality) in children, adolescents and young adults. GoToSource Spontaneous abortion. GoToSource Exacerbation of nervous tics in patients with tourette syndrome. GoToSource Birth defects. GoToSource Liver injury. GoToSource Severe sleepiness and excess sleep duration. GoToSource Idiopathic thrombocytopenic purpura (bleeding disorder). GoToSource Hypereosinophilia (blood disorder). GoToSource Granuloma annulare (skin disease). GoToSource Increased risk of falls. GoToSource Hyponatremia (decreased serum sodium levels). GoToSource Discontinuation syndrome. GoToSource Serotonin syndrome or neuroleptic malignant syndrome reactions. GoToSource Abnormal sperm DNA fragmentation. GoToSource Angle-closure glaucoma. GoToSource Induction of mania. GoToSource Seizures. GoToSource Akathisia. GoToSource Fractures. GoToSource Sexual dysfunction. GoToSource |
| Litigation |
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Lawsuits for birth defects and suicidal thinking and behavior. |
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