Brisdelle

Brisdelle is a prescription medication used to treat moderate to severe vasomotor symptoms, such as hot flashes, associated with menopause (VMS). Brisdelle belongs to a group of drugs called selective serotonin-reuptake inhibitors (SSRIs). The way Brisdelle treats hot flashes associated with menopause is not known.

This medication comes in capsule form. It is usually taken once daily, at bedtime.

Common side effects of Brisdelle include headache, fatigue, nausea, and vomiting.

Brisdelle can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. Do not drive or operate heavy machinery until you know how Brisdelle affects you.

Brisdelle is a prescription medicine used to treat moderate to severe vasomotor symptoms, such as hot flashes, associated with menopause (VMS).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Noven Therapeutics, Llc

Common side effects include:

• nausea
• vomiting
• headache
• weakness
• feeling tired or sleepy
• insomnia (having trouble falling or staying asleep)

Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Brisdelle. For more information, ask your healthcare provider or pharmacist. Brisdelle may cause serious side effects, see "Drug Precautions".

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Emsam, Eldepryl, Zelapar) and tranylcypromine (Parnate)
• Mellaril (thioridazine)
• Orap (pimozide)
• triptans used to treat migraine headache
• other antidepressants (SSRIs, SNRIs, tricyclics, or lithium) or antipsychotics
• drugs that affect serotonin, such as lithium, tramadol, tryptophan, St. John’s wort
• certain drugs used to treat irregular heart beats
• certain drugs used to treat schizophrenia
• certain drugs used to treat HIV infection
• certain drugs that affect the blood, such as warfarin, aspirin, and ibuprofen
• certain drugs used to treat epilepsy
• atomoxetine
• cimetidine
• fentanyl
• metoprolol
• certain medicines used to treat seizures (like phenobarbital and phenytoin)
• procyclidine
• tamoxifen

Ask your healthcare provider if you are not sure if you are taking any of these medications.

Brisdelle and other antidepressant medicines may cause serious side effects, including:

1. Suicidal thoughts or actions:

• Brisdelle and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.
• Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
• Watch for these changes and call your healthcare provider right away if you notice:
  • New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
  • Pay particular attention to such changes when Brisdelle is started or when the dose is changed.

Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:

• attempts to commit suicide
• acting on dangerous impulses
• acting aggressive or violent
• thoughts about suicide or dying
• new or worse depression
• new or worse anxiety or panic attacks
• feeling agitated, restless, angry, or irritable
• trouble sleeping
• an increase in activity or talking more than what is normal for you
• other unusual changes in behavior or mood

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Brisdelle may be associated with these serious side effects:

2. Serotonin Syndrome or Neuroleptic Malignant Syndrome-like reactions. This condition can be life-threatening and may include:

• agitation, hallucinations, coma, or other changes in mental status
• coordination problems or muscle twitching (overactive reflexes)
• racing heartbeat, high or low blood pressure
• sweating or fever
• nausea, vomiting, or diarrhea
• muscle rigidity

3. Reduced effectiveness of tamoxifen. Tamoxifen (a medicine used to treat breast cancer) may not work as well if it is taken while you take Brisdelle. If you are taking tamoxifen, tell your healthcare provider before starting Brisdelle.

4. Abnormal bleeding. Brisdelle may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin or non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen, naproxen, or aspirin.

5. Visual problems.

• Eye pain
• Changes in vision
• Swelling or redness in or around the eye

Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

6. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this condition. Symptoms may include:

• headache
• weakness or feeling unsteady
• confusion, problems concentrating or thinking or memory problems.

7. Bone Fractures. Women who take Brisdelle may have a higher risk of bone fractures. Contact your healthcare provider if you have pain in a bone.

8. Manic episodes:

• greatly increased energy
• severe trouble sleeping
• racing thoughts
• reckless behavior
• unusually grand ideas
• excessive happiness or irritability
• talking more or faster than usual.

9. Seizures or convulsions.

10. Restlessness. Women who take Brisdelle may feel an inner restlessness, agitation (nervousness), or be unable to sit still or stand still especially when they start taking Brisdelle. Call your healthcare provider if this happens to you.

11. Driving. Brisdelle may affect your ability to make decisions, think clearly, or react quickly. Do not drive, operate heavy machinery, or do other potentially dangerous activities until you know how Brisdelle affects you.

Do not stop Brisdelle without first talking to your healthcare provider. Stopping Brisdelle too quickly may cause serious symptoms including:

• anxiety, irritability, high or low mood, feeling restless, or changes in sleep habits
• headache, sweating, nausea, dizziness
• electric shock-like sensations, shaking, confusion

Do not take Brisdelle if you:

• are allergic to Brisdelle or any of the ingredients in Brisdelle.
• take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
• Do not take an MAOI within 2 weeks of stopping Brisdelle unless directed to do so by your physician.
• Do not start Brisdelle if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.
• People who take Brisdelle close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:
  • high fever
  • uncontrolled muscle spasms
  • stiff muscles
  • rapid changes in heart rate or blood pressure
  • confusion
  • loss of consciousness (pass out)
• take Mellaril (thioridazine). Do not take Mellaril together with Brisdelle because this can cause serious heart rhythm problems or sudden death.
• take the antipsychotic medicine pimozide (Orap) because this can cause serious heart problems.

If you take Brisdelle, you should not take any other medicines that contain paroxetine, including Paxil, Paxil CR and Pexeva.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Brisdelle there are no specific foods that you must exclude from your diet when receiving Brisdelle.

Before starting Brisdelle, tell your healthcare provider if you:

• are pregnant or breastfeeding
• have liver problems
• have kidney problems
• have heart problems
• have or had seizures or convulsions
• have bipolar disorder or mania
• have low sodium levels in your blood
• have a history of a stroke
• have high blood pressure
• have or had bleeding problems
• have glaucoma (high pressure in the eye)

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. Brisdelle is approved to treat the symptoms of menopause. 

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Brisdelle falls into category X. Brisdelle should not be used in pregnant women because symptoms associated with menopause (VMS) do not occur during pregnancy and Brisdelle can cause fetal harm. This medication should not be used by pregnant women.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Brisdelle has been detected in human breast milk. Because of the possibility for side effects in nursing infants from Brisdelle, a choice should be made whether to stop nursing or to stop using Brisdelle. You should discuss the importance of Brisdelle to your health before any decision to stop or continue using Brisdelle.

• Brisdelle comes in capsule form to take by mouth.
• Brisdelle is taken once daily, at bedtime.
• You may want to take Brisdelle with food to prevent stomach upset. Take Brisdelle at around the same time every day.
• Follow the directions on your prescription label carefully.
• Take Brisdelle exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
• Brisdelle does not prevent or treat osteoporosis or dryness, itching or burning in and around the vagina.
• Talk to your healthcare provider if you do not think that your hot flashes are getting better while taking Brisdelle.
• If you miss a dose of Brisdelle, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Brisdelle at the same time.

Do not stop taking Brisdelle without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking Brisdelle, you may experience withdrawal symptoms such as depression; mood changes; frenzied or abnormally excited mood; irritability; anxiety; confusion; dizziness; headache; tiredness; numbness or tingling in the arms, legs, hands, or feet; unusual dreams; difficulty falling asleep or staying asleep; nausea; or sweating. Tell your doctor if you experience any of these symptoms when your dose of Brisdelle is decreased.

Take Brisdelle exactly as prescribed. Follow the directions on your prescription label carefully.

The recommended dosage of Brisdelle is 7.5 mg once daily, at bedtime.

If you take too much Brisdelle, call your healthcare provider or poison control center right away or get emergency treatment.

• Store Brisdelle capsules dry and at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Brisdelle away from light.
• Keep bottle of Brisdelle closed tightly.
• Keep Brisdelle and all medicines out of the reach of children.

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

Antidepressants, including selective serotonin reuptake inhibitors (SSRIs), have been shown to increase the risk of suicidal thoughts and behavior in pediatric and young adult patients when used to treat major depressive disorder and other psychiatric disorders. Because BRISDELLE is an SSRI, monitor patients closely for worsening and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber