PRODUCTS AVAILABLE IN THE UNITED STATES
Please visit our product websites to view complete prescribing information, including a BOXED warning for Lotronex® (alosetron HCl) 0.5 & 1 MG TABLETS. The product information provided is intended only for residents of the United States.
To report an adverse event or a product complaint, please visit this page.
See new NDC number below.
IMPORTANT SAFETY INFORMATION
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants, including selective serotonin reuptake inhibitors (SSRIs), have been shown to increase the risk of suicidal thoughts and behavior in pediatric and young adult patients when used to treat major depressive disorder and other psychiatric disorders. Because BRISDELLE is an SSRI, monitor patients closely for worsening and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber.
BRISDELLE® (paroxetine) is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.
BRISDELLE is not indicated for the treatment of any psychiatric condition. BRISDELLE contains a lower dose of paroxetine than that used for psychiatric conditions. The safety and efficacy of this lower dose of paroxetine in BRISDELLE have not been established for any psychiatric condition. Patients who require paroxetine for treatment of a psychiatric condition should discontinue BRISDELLE and initiate a paroxetine-containing medication that is indicated for such use.
- Concurrent use with monoamine oxidase inhibitors (MAOIs) or use within 14 days of MAOI use because of an increased risk of serotonin syndrome.
- Starting BRISDELLE in a patient who is being treated with linezolid or intravenous methylene blue because of an increased risk of serotonin syndrome.
- Concomitant use with thioridazine or pimozide due to their increased plasma concentrations and because of the potential of QTc prolongation.
- Hypersensitivity to any ingredient in BRISDELLE.
- Pregnancy because BRISDELLE may cause fetal harm.
WARNINGS AND PRECAUTIONS:
- Suicidality: All patients being treated with BRISDELLE should be observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of treatment.
- Serotonin Syndrome: Serotonin syndrome, which is potentially life-threatening, has been reported with concomitant use of serotonergic drugs, and with drugs that impair metabolism of serotonin (in particular, MAOIs). Monitor patients for the emergence of serotonin syndrome. Discontinue BRISDELLE and any concomitant serotonergic agents and initiate supportive treatment.
- Tamoxifen: Efficacy of tamoxifen may be reduced when administered concomitantly with BRISDELLE.
- Abnormal Bleeding: SSRIs, including BRISDELLE, may increase the risk of bleeding events. Caution patients about the risk of bleeding associated with the concomitant use of BRISDELLE and non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, or other drugs that affect coagulation.
- Angle Closure Glaucoma: Angle-closure glaucoma has occurred in patients treated with antidepressants with untreated anatomically narrow angles
- Hyponatremia: may occur as a result of treatment with SSRIs, including BRISDELLE. Elderly patients may be at greater risk, and in many cases it can occur in association with syndrome of inappropriate antidiuretic hormone secretion (SIADH). Consider discontinuation of BRISDELLE in patients with symptomatic hyponatremia and institute appropriate medical intervention.
- Bone fracture: Epidemiological studies have reported an association between SSRI treatment and fractures.
- Activation of Mania/Hypomania: Screen for bipolar disorder and monitor for mania/ hypomania.
- Seizures: Use cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold. Evaluate and consider discontinuation in any patients who develop seizures.
- Akathisia: Can occur, most likely in the first few weeks of treatment. Discontinue treatment with BRISDELLE if akathisia occurs.
- Cognitive and Motor Impairment: May cause impairment; patients should not operate machinery or motor vehicles until certain that BRISDELLE does not affect them adversely.
- Sexual Dysfunction: May cause symptoms of sexual dysfunction, including decreased libido and delayed or absent orgasm.
The most common adverse reactions (≥ 2%) reported in clinical trials were: headache, fatigue, and nausea and vomiting. Of these, nausea occurred primarily within the first 4 weeks of treatment and fatigue occurred primarily within the first week of treatment and decreased in frequency with continued therapy.
To report SUSPECTED ADVERSE REACTIONS, contact Sebela Pharmaceuticals at 888-271-4621 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Paroxetine is a strong CYP2D6 inhibitor. Co-administration of BRISDELLE can alter concentrations of other drugs that are metabolized by CYP2D6. Use caution if coadministering BRISDELLE with other drugs that are metabolized by CYP2D6.
These are not all the possible side effects of BRISDELLE. Please read the Full Prescribing Information including Boxed WARNING and patient Medication Guide.
The NDC # for Brisdelle changed to 54766-907-53 in November 2017. Please call 678-736-5206 if you have challenges getting Brisdelle at your retail pharmacy.