- What is paroxetine (Brisdelle), and how does it work (mechanism of action)?
- What brand names are available for paroxetine (Brisdelle)?
- Is paroxetine (Brisdelle) available as a generic drug?
- Do I need a prescription for paroxetine (Brisdelle)?
- What are the uses for paroxetine (Brisdelle)?
- What are the side effects of paroxetine (Brisdelle)?
- What is the dosage for paroxetine (Brisdelle)?
- Which drugs or supplements interact with paroxetine (Brisdelle)?
- Is paroxetine (Brisdelle) safe to take if I'm pregnant or breastfeeding?
- What else should I know about paroxetine (Brisdelle)?
What is paroxetine (Brisdelle), and how does it work (mechanism of action)?
- 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 are the uses for paroxetine (Brisdelle)?
What are the side effects of paroxetine (Brisdelle)?
The most common side effects of Brisdelle are:
Other side effects include:
- Dry mouth
Possible serious side effects include:
- Increased risk for suicidal thoughts or actions
- Bone fracture
- Low salt (sodium) levels in the blood (hyponatremia)
- Visual problems
- Toxic epidermal necrolysis
- Abnormal bleeding
- Manic episodes
Numerous other side effects may also occur infrequently.
Quick GuideMenopause & Perimenopause: Symptoms, Signs
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).
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).
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Women's Health Resources
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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Dealing With Menopause SymptomsMenopause can cause night sweats, hot flashes, mood swings, and relationship challenges. Learn how to manage these symptoms here.
Alternative Treatments for Hot FlashesHot flashes are experienced by many women, especially at night. However, not all women undergoing menopause experience hot flashes. What causes hot flashes? A hot flash is a feeling of warmth that spreads over the body. Treatment for hot flashes include hormone replacement therapy and alternative prescription medications such as:
- SSRIs (Effexor, Paxil, Prozac),
- clonidine (Catapres),
- megestrol (Megace),
- and gabapentin (Neurontin).
Female Sexual ProblemsSexual dysfunction in women is common, from female sexual arousal disorder to other sexual problems. Causes of female sexual disorders include stress, anxiety, and medications.
Hot flashes (or flushing) is the most common symptom experienced by a woman prior to and during the early stages of menopause, and often is described as the feeling of warmth that spreads over the body, often starting at the head accompanied by sweating. In the Study of Women Across America the Nation (SWAN) women had hot flashes that lasted on average 7 1/2 years. Symptoms of hot flashes include:
- Excessive sweating
Diagnosis is made by taking a patient history and, at times, blood tests. Treatment options include hormone therapy, bioidentical hormone therapy, and medications. There are non-FDA approved natural home remedies such as:
- Black cohosh
- Evening primrose oil
- Wild yam
- Dong quai
Hot flashes also can be caused by other conditions. Scientific studies to prove the safety and effectiveness of these products in relieving hot flashes have not been adequately performed. Consult your health-care professional before taking any herbal supplement.
Male MenopauseMale menopause refers to the decline in testosterone production in men. As men age, they often experience many of the same symptoms that women experience in menopause. Testosterone replacement therapy may relieve some of these symptoms.
MenopauseMenopause is the time in a woman's life when menstrual periods permanently stop, also called the "change of life." Menopause symptoms include hot flashes, night sweats, irregular vaginal bleeding, vaginal dryness, painful intercourse, urinary incontinence, weight gain, and emotional symptoms such as mood swings. Treatment of menopausal symptoms varies, and should be discussed with your physician.
Menopause QuizThe Menopause Quiz challenges your knowledge about the time in a woman’s life when menstruation ceases. Menopause can bring many physical, mental and sexual challenges to maturing women, but they don’t have to be limiting. Take the Menopause Quiz to learn the causes, symptoms and treatments of what’s known as "the change of life."
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Night sweats are severe hot flashes that occur at night and result in a drenching sweat. The causes of night sweats in most people are not serious, like menopause in women, sleep apnea, medications, alcohol withdrawal, and thyroid problems. However, more serious diseases like cancer and HIV also can cause night sweats. Your doctor will treat your night sweats depending upon the cause.
You may experience other signs and symptoms that are associated with night sweats, which depend upon the cause, but may include, shaking, and chills with a fever caused by an infection like the flu or pneumonia; unexplained weight loss due to lymphoma; women in perimenopause or menopause may also have vaginal dryness, mood swings, and hot flashes during the day; and low blood sugar in people with diabetes.
Other causes of night sweats include medications like NSAIDs (aspirin, acetaminophen, ibuprofen (Motrin, Advil), and naproxen (Aleve, Naprosyn), antidepressants, sildenafil (Viagra), and abuse of prescription or illegal drugs and drug withdrawal; hormone disorders like pheochromocytoma and carcinoid syndrome; idiopathic hyperhidrosis; infections like endocarditis, AIDs, and abscesses; alcoholism and alcohol withdrawal; drug abuse, addiction, and withdrawal; and stroke.
A doctor or other health care professional can treat your night sweats after the cause has been diagnosed.
PerimenopausePerimenopause is the time in a woman's life when she is approaching menopause. During this time a woman starts to develop symptoms of declining estrogen levels that may include mood swings, painful sex, night sweats, hot flashes, and weight gain. Every adult woman eventually will experience perimenopause.
Premature Menopause (Medical Procedural Causes)Premature menopause is when menopause occurs in a woman before the age of 40. Causes of premature menopause include premature ovarian failure, treatments for cancer and other conditions, surgical removal of the ovaries, or chronic diseases of the pituitary or thyroid gland, or psychiatric disorders. Treatment is directed at menopausal symptoms.
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