paroxetine (Brisdelle)

• Brisdelle (paroxetine) is a prescription medicine used to treat moderate to severe hot flashes associated with menopause. Brisdelle is a non-hormonal treatment for this condition. Paroxetine, the medicine in Brisdelle, is a selective serotonin reuptake inhibitor (SSRI). Brisdelle contains a low dose of paroxetine that is especially formulated to treat hot flashes associated with menopause. Higher doses of paroxetine have been used as an antidepressant for many years. How low doses of paroxetine help to treat hot flashes associated with menopause is not known. Brisdelle should not be used to treat depression or any other mood disorders.
• The FDA approved Brisdelle in June 2013.

What brand names are available for paroxetine (Brisdelle)?

Brisdelle

Is paroxetine (Brisdelle) available as a generic drug?

No

Do I need a prescription for paroxetine (Brisdelle)?

Yes

• Brisdelle is a prescription medicine used for the treatment of moderate to severe hot flashes associated with menopause.
• Brisdelle should not be used to treat depression or other mood disorders. The drug is not indicated for pediatric use.

The most common side effects of Brisdelle are:

• Headache
• Tiredness
• Nausea
• Vomiting

Other side effects include:

• Restlessness
• Constipation
• Dry mouth
• Diarrhea
• Tremor

Possible serious side effects include:

• Increased risk for suicidal thoughts or actions
• Bone fracture
• Seizure
• Low salt (sodium) levels in the blood (hyponatremia)
• Visual problems
• Toxic epidermal necrolysis
• Abnormal bleeding
• Manic episodes
• Glaucoma
• Restlessness

Numerous other side effects may also occur infrequently.

• The recommended dosage of Brisdelle is 7.5 mg by mouth once daily at bedtime.
• Brisdelle can be taken with or without food.

• Brisdelle should not be used with or within 14 days of taking a monoamine oxidase inhibitor (MAOI) due to the risk of serotonin syndrome, a rare, but potentially life-threatening condition caused by abnormally high levels of the chemical serotonin in the body. Similarly, due to a high risk of serotonin syndrome, Brisdelle should not be combined with linezolid (Zyvox) or intravenous methylene blue (Urolene Blue).
• Other medications that also increase the risk of serotonin syndrome and should be used cautiously with Brisdelle include triptans (a type of antimigraine medication), lithium (Lithobid, Eskalith), tramadol (Ultram), St. John's Wort, dextromethorphan (an over-the-counter common cold/cough medicine), and various classes of commonly used antidepressants including selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), and tricyclic antidepressants (TCAs).
• Brisdelle should not be used with thioridazine (Mellaril) or pimozide (Orap). Thioridazine and pimozide are known to prolong the QT interval (a heart rhythm disorder). Because Brisdelle increases the concentration of these drugs in the blood, coadministration increases the risk of death.
• Serotonin plays an important role in forming blood clots. SSRI's, including Brisdelle may increase the risk of bleeding, especially if taken with the blood thinner warfarin (Coumadin, Jantoven), aspirin, or non-steroidal anti-inflammatory drugs (NSAIDS) such as ibuprofen (Motrin), naproxen (Naprosyn), and indomethacin (Indocin).
• Paroxetine, the medicine in Brisdelle, is a strong inhibitor of the CYP2D6 enzymes. Taking Brisdelle with other drugs that are metabolized by this pathway may increase the risk for side effects. Therefore, Brisdelle should be used cautiously with nortriptyline (Pamelor), amitriptyline (Elavil), imipramine (Tofranil), desipramine (Norpramin), fluoxetine (Prozac), risperidone (Risperdal), flecainide (Tambocor), and others.
• In addition to being a strong CYP2D6 inhibitor, paroxetine is also a CYP2D6 substrate and is itself metabolized via this pathway. Consequently, administration with drugs that alter the activity of these enzymes may affect the concentration of Brisdelle in the body. Strong CYP2D6 inducers may decrease the blood levels of paroxetine, resulting in poor treatment outcomes. Examples of strong CYP2D6 inducers include rifampin (Rimactane), carbamazepine (Tegretol), and phenytoin (Dilantin).

• Brisdelle is classified as FDA pregnancy risk category X and should not be used during pregnancy because menopausal vasomotor symptoms do not occur during pregnancy, and Brisdelle can cause harm to the unborn baby.
• Paroxetine is excreted in human milk. Due to the potential risk of causing harm to the nursing infant, Brisdelle should only be using by a nursing mother if clearly needed.

What preparations of paroxetine (Brisdelle) are available?

Oral capsules: 7.5 mg

How should I keep paroxetine (Brisdelle) stored?

Tablets should be stored at room temperature between 15 C to 30 C (59 F to 86 F).