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Brisdelle (paroxetine)

Indications

• Brisdelle tablets are indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause, such as hot flashes and night sweats.
• It provides relief from these symptoms and improves the quality of life in menopausal women.

Dosage and Administration

• Take Brisdelle tablets exactly as prescribed by your doctor, usually once daily in the evening, with or without food.
• Swallow the tablet whole with a full glass of water.
• Follow the prescribed dosage regimen carefully to achieve optimal results.
• Continue taking Brisdelle regularly, even if you start feeling better, unless instructed otherwise by your healthcare provider.
• Do not exceed the recommended dose of Brisdelle or take it more frequently than prescribed.
• Do not crush, chew, or break the tablet.
• Avoid suddenly discontinuing Brisdelle without consulting your doctor, as it may lead to withdrawal symptoms such as dizziness, nausea, headache, or irritability.

Mechanism of Action

Brisdelle contains Paroxetine, which belongs to a class of medications known as selective serotonin reuptake inhibitors (SSRIs). It works by increasing the levels of serotonin, a neurotransmitter in the brain, which helps to regulate mood and alleviate vasomotor symptoms associated with menopause.

Contraindications

• Do not use Brisdelle if you are allergic to Paroxetine or any other ingredients in the tablets.
• Avoid taking it if you are currently taking or have recently taken (within 14 days) monoamine oxidase inhibitors (MAOIs), as concurrent use may lead to serious drug interactions.
• Consult your doctor before using Brisdelle if you have a history of bipolar disorder, seizures, or liver or kidney impairment.

Side Effects

Common Side Effects:

• Nausea or vomiting
• Headache
• Drowsiness or fatigue
• Dry mouth
• Changes in appetite or weight

Serious Side Effects:

• Suicidal thoughts or behavior (especially in young adults)
• Serotonin syndrome (agitation, hallucinations, fever, sweating, shivering, fast heart rate)
• Bleeding or bruising easily
• Seizures
• Changes in vision or eye pain

Precautions

• Inform your doctor about any existing medical conditions, especially if you have a history of psychiatric disorders or suicidal thoughts.
• Be cautious when driving or operating machinery until you know how Brisdelle affects you, as it may cause dizziness or drowsiness.
• Monitor for signs of worsening depression or suicidal ideation, especially at the beginning of treatment or when doses are adjusted.
• If you become pregnant while taking Brisdelle, inform your healthcare provider immediately and discuss the risks and benefits of continuing the medication.

Storage Instructions

• Store Brisdelle tablets at room temperature (20°C to 25°C) in a dry place, away from moisture and heat.
• Keep the tablets in their original packaging until they are ready to use.
• Keep Brisdelle out of reach of children and pets.
• Do not use Brisdelle if the tablets appear discolored, damaged, or show signs of deterioration.

References

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204516s003lbl.pdf