Description

Indications 

Brisdelle is a prescription medication for treating moderate to severe vasomotor symptoms (VMS) associated with menopause. 

While Brisdelle is categorized as a selective serotonin reuptake inhibitor (SSRI), it is not indicated for treating psychiatric disorders, and its mechanism for treating VMS remains unknown. 

Uses and Dosage 

Before taking Brisdelle and with each prescription refill, thoroughly review its medication guide and patient information leaflet. Talk to your doctor or pharmacist if you have any questions or concerns. 

Typically, Brisdelle is taken once daily at bedtime as prescribed by the doctor, without regard to food intake.  

For optimal efficacy, take Brisdelle around the same time(s) each day and avoid changing the dosage or frequency of administration without first consulting with your physician. 

Continue taking this medication as prescribed, even if you feel better. Do not stop intake without consulting with a doctor, as some conditions may worsen due to abrupt discontinuation. Your physician may gradually reduce your dosage. 

Side Effects 

Listed below are the side effects associated with the use of Brisdelle. If any of them persist or worsen, notify your doctor promptly. 

Common Side Effects 

• Vision changes 
• Weakness, drowsiness, dizziness, and tiredness 
• Sweating, anxiety, and shaking 
• Sleep problems (insomnia) 
• Loss of appetite, nausea, vomiting, diarrhea, and constipation 
• Dry mouth and yawning 
• Infection 
• Headache 
• Decreased sex drive, impotence, abnormal ejaculation, or difficulty having an orgasm 

Serious Side Effects 

• Racing thoughts, decreased need for sleep, unusual risk-taking behavior, feelings of extreme happiness or sadness, or being more talkative than usual 
• Blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights 
• Unusual bone pain or tenderness, swelling, or bruising 
• Changes in weight or appetite 
• Easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), or coughing up blood 
• Indication of a severe nervous system reaction: 
  • Very stiff (rigid) muscles 
  • High fever 
  • Sweating 
  • Confusion 
  • Fast or uneven heartbeats 
  • Tremors 
  • Fainting 
• Signs of low levels of sodium in the body: 
  • Headache 
  • Confusion 
  • Slurred speech 
  • Severe weakness 
  • Loss of coordination 
  • Feeling unsteady 

Call your doctor right away if you experience any of the above-mentioned severe symptoms. 

Notify your doctor of any newly occurring or intensifying symptoms, including: 

• Mood or behavioral changes 
• Anxiety 
• Panic attacks 
• Sleep disturbances 
• Impulsivity 
• Irritability 
• Agitation 
• Hostility 
• Aggression 
• Restlessness 
• Hyperactivity (mental or physical) 
• Suicidal ideation 

Allergic Reactions 

In rare cases, Brisdelle may cause a severe allergic reaction. Get emergency medical care if you experience any of the following symptoms of a severe allergic reaction: 

• Hives 
• Breathing difficulties 
• Swelling of the face or throat 

Severe skin reactions may also occur. Seek immediate medical attention if you experience the following: 

• Fever 
• Sore throat 
• Burning eyes 
• Skin pain 
• A red or purple rash with blistering and peeling 

This list does not contain all the potential side effects of Brisdelle. If you experience other effects not listed above, inform your doctor promptly. 

Cautions 

Before taking Brisdelle, inform your doctor and pharmacist if you have any known hypersensitivities, especially to paroxetine, other medicines, or any ingredients present in Brisdelle tablets. 

To ensure Brisdelle is safe for you, disclose to your physician your medical background, specifically regarding any history of: 

• Bipolar/manic-depressive disorder (personal or family history) 
• Suicide attempts (personal or family history) 
• Liver problems 
• Kidney problems 
• Low sodium in the blood 
• Seizures 
• Intestinal ulcers/bleeding (peptic ulcer disease) or bleeding problems 
• Glaucoma (angle-closure type) (personal or family history) 

Some products may interact with Brisdelle, including: 

• Thioridazine 
• Medicines that can cause bleeding/bruising, including: 
  • Antiplatelet drugs (e.g., clopidogrel) 
  • NSAIDs (e.g., ibuprofen) 
  • Blood thinners (e.g., warfarin or dabigatran)  

To prevent such drug interactions that can impact the efficacy of Brisdelle or lead to unfavorable reactions, inform your doctor and pharmacist of all medications you are presently taking, including prescription and non-prescription drugs, dietary supplements, and herbal products. 

Taking aspirin with Brisdelle may increase the risk of bleeding. However, if your doctor has prescribed low-dose aspirin (usually 81-162 milligrams a day) for preventing heart attack or stroke, you should continue taking it unless otherwise advised. 

Co-administrating certain drugs with Brisdelle can increase the risk of serotonin syndrome/toxicity. These drugs include MDMA/ecstasy, St. John’s wort, and certain antidepressants such as SSRIs (citalopram/fluoxetine) and SNRIs (duloxetine/venlafaxine), as well as tryptophan and others. The risk of serotonin syndrome/toxicity may be more likely when starting or increasing the dose of these drugs. 

Before taking any medication, read the labels carefully, as they may contain ingredients that cause drowsiness. If you’re unsure about the safety of a particular product, consult with your pharmacist. 

Make sure to inform your doctor and pharmacist if you are taking other products that may cause drowsiness, including: 

• Alcohol 
• Marijuana (cannabis) 
• Antihistamines (e.g., cetirizine, diphenhydramine) 
• Drugs for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem) 
• Muscle relaxants 
• Opioid pain relievers (e.g., codeine) 

Brisdelle should not be used within 14 days before or after taking MAO inhibitors such as: 

• Isocarboxazid 
• Linezolid 
• Methylene blue injection 
• Phenelzine 
• Rasagiline 
• Selegiline 
• Tranylcypromine 

Brisdelle may impair cognitive function and induce drowsiness. Avoid driving or operating machinery until the medication’s effects are known. 

Brisdelle is not recommended for pregnant women because it can cause fetal harm, and menopausal VMS does not occur during pregnancy. If a patient becomes pregnant while taking this drug or is used during pregnancy, the potential hazard to the fetus should be communicated to the patient. 

Consult with a physician before breastfeeding, as paroxetine can be transferred into breast milk.