Paroxetine (Brisdelle) for Hot Flashes: Dosage & Side Effects

What is paroxetine (Brisdelle)? What is paroxetine used for?

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?

Do I need a prescription for paroxetine (Brisdelle)?

Yes

What are the uses for paroxetine (Brisdelle)?

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.

What are the side effects of paroxetine (Brisdelle)?

The most common side effects of Brisdelle are:

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.

What is the dosage for paroxetine (Brisdelle)?

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

Which drugs or supplements interact with paroxetine (Brisdelle)?

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).

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Is paroxetine (Brisdelle) safe to take if I’m pregnant or breastfeeding?

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 else should I know about paroxetine (Brisdelle)?

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).