Generic Name: paroxetine (pa-ROX-e-teen)
Brand Name: Brisdelle
Antidepressants (eg, selective serotonin reuptake inhibitors [SSRIs]) may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Because Brisdelle is an SSRI, talk with the patient's doctor to be sure that the benefits of using Brisdelle outweigh the risks.
Families and caregivers must closely watch patients who take Brisdelle. It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor.
Brisdelle is used for:
Treating moderate to severe hot flashes associated with menopause. It may also be used for other conditions as determined by your doctor.
Brisdelle is an SSRI. The way it works to treat hot flashes is not known.
Do NOT use Brisdelle if:
- you are allergic to any ingredient in Brisdelle
- you are pregnant
- you are taking or have taken linezolid, a monoamine oxidase inhibitor (MAOI) (eg, phenelzine, selegiline), or St. John's wort within the last 14 days
- you are taking a fenfluramine derivative (eg, dexfenfluramine), nefazodone, pimozide, a serotonin-norepinephrine reuptake inhibitor (SNRI) (eg, venlafaxine), another SSRI (eg, fluoxetine), sibutramine, thioridazine, or tryptophan
Contact your doctor or health care provider right away if any of these apply to you.
Before using Brisdelle:
Some medical conditions may interact with Brisdelle. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you or a family member has a history of bipolar disorder (manic-depression), other mental or mood problems, suicidal thoughts or attempts, or alcohol or substance abuse
- if you have a history of seizures, stroke, heart problems, high blood pressure, liver problems, kidney problems, bleeding problems, bone problems (eg, osteoporosis), or narrow-angle glaucoma or increased pressure in the eye
- if you are dehydrated, have low blood sodium levels, low blood volume, or drink alcohol
- if you will be having electroconvulsive therapy (ECT)
- if you are taking a medicine that contains methylene blue
Some MEDICINES MAY INTERACT with Brisdelle. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Abiraterone, anorexiants (eg, phentermine), buspirone, cimetidine, fenfluramine derivatives (eg, dexfenfluramine), fentanyl, linezolid, lithium, lorcaserin, MAOIs (eg, phenelzine), meperidine, metoclopramide, nefazodone, selegiline, serotonin 5-HT1 receptor agonists (eg, sumatriptan), sibutramine, SNRIs (eg, venlafaxine), another SSRI (eg, fluoxetine), St. John's wort, tramadol, trazodone, or tryptophan because severe side effects, such as a reaction that may include fever, rigid muscles, blood pressure changes, mental changes, confusion, irritability, agitation, delirium, or coma, may occur
- Anticoagulants (eg, warfarin), aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of bleeding, including stomach bleeding, may be increased
- Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood sodium levels may be increased
- Antiarrhythmics (eg, flecainide, propafenone, quinidine) or phenothiazines (eg, chlorpromazine, thioridazine) because severe heart problems, including irregular heartbeat, may occur
- Cyproheptadine, HIV protease inhibitors (eg, ritonavir), phenobarbital, or phenytoin because they may decrease Brisdelle's effectiveness
- Aripiprazole, atomoxetine, clozapine, fluoxetine, iloperidone, pimozide, risperidone, tetrabenazine, theophylline, or tricyclic antidepressants (eg, amitriptyline) because the risk of their side effects may be increased by Brisdelle
- Digoxin or tamoxifen because their effectiveness may be decreased by Brisdelle
This may not be a complete list of all interactions that may occur. Ask your health care provider if Brisdelle may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Brisdelle:
Use Brisdelle as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Brisdelle comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Brisdelle refilled.
- Take Brisdelle by mouth with or without food.
- Take Brisdelle at bedtime unless your doctor has told you otherwise.
- Continue to take Brisdelle even if you feel well. Do not miss any doses.
- Do not suddenly stop taking Brisdelle without checking with your doctor.
- If you miss a dose of Brisdelle, take it as soon as possible. If it almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Brisdelle.
Important safety information:
- Brisdelle may cause you to not be able to make decisions, think clearly, or react quickly. Do not drive or perform other possibly unsafe tasks until you know how you react to Brisdelle.
- Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Brisdelle; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Do not drink alcohol while you are taking Brisdelle.
- Antidepressants (eg, SSRIs) increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. Because Brisdelle is an SSRI, closely watch all patients who take Brisdelle. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
- If your doctor tells you to stop taking Brisdelle, you will need to wait for several weeks before beginning to take certain other medicines (eg, MAOIs, nefazodone). Ask your doctor when you should start to take your new medicines after you have stopped taking Brisdelle.
- Serotonin syndrome is a possibly fatal syndrome that can be caused by Brisdelle. Your risk may be greater if you take Brisdelle with certain other medicines (eg, triptans, MAOIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.
- Low blood sodium levels may occur from treatment with Brisdelle. In severe cases, this can be deadly. Call your doctor right away if you have confusion, decreased coordination, fainting, hallucinations, headache, memory problems, mental or mood changes, seizures, sluggishness, trouble concentrating, or weakness.
- Women who take Brisdelle may have a higher risk of bone fractures. Call your doctor right away if you have unusual bone pain or unexplained swelling, tenderness, or bruising.
- Other brands of medicine that contain the same ingredient (paroxetine) are available. These other brands may be used to treat depression or other mental problems. Do not take Brisdelle if you are taking any other medicine that contains paroxetine. Discuss any questions or concerns with your doctor.
- Use Brisdelle with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood sodium levels.
- Brisdelle should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not use Brisdelle if you are pregnant. It may cause harm to the fetus. If you think you may be pregnant, contact your doctor right away. Brisdelle is found in breast milk. Do not breast-feed while taking Brisdelle.
Possible side effects of Brisdelle:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Headache; nausea; tiredness; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; new or worsening mental, mood, or behavior changes (eg, agitation, panic attacks, aggressiveness, depression, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, inability to sit still); red, swollen, blistered, or peeling skin; seizures; stomach pain; suicidal thoughts or attempts; vision changes; vomit that looks like coffee grounds.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Brisdelle:
Store Brisdelle at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Brisdelle out of the reach of children and away from pets.
- If you have any questions about Brisdelle, please talk with your doctor, pharmacist, or other health care provider.
- Brisdelle is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Brisdelle or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Brisdelle. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Brisdelle. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Brisdelle.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.