What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
Brisdelle (Paroxetine)
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Product Details
Description
Brisdelle (paroxetine) is a drug used to treat moderate to severe hot flashes in women with menopause.
Fact Table
Formula
C19H20FNO3
License
US FDA, US DailyMed
Bioavailability
about 50%
Legal status
Rx-Only
Chemical Name
Paroxetine
Elimination half-life
21 hours
Dosage (Strength)
7.5mg
Pregnancy
not recommended
Brands
Brisdelle
Protein binding
93–95%
PubChem CID
43815
MedlinePlus
a698032
ChEBI
7936
ATC code
N06AB05
DrugBank
DB00715
KEGG
D02362
Routes of administration
By mouth
Directions
Brisdelle is available in 7.5 mg capsules.
The recommended dose is 7.5 mg by mouth once daily at bedtime.
Ingredients
The active ingredient in Brisdelle is paroxetine.
Contraindications
Do not take Brisdelle with monoamine oxidase inhibitors or within 14 days of using a monoamine oxidase inhibitor.
Do not take Brisdelle with thioridazine.
Do not take Brisdelle with pimozide.
Do not take Brisdelle if you are allergic to paroxetine or any other ingredient in Brisdelle.
Do not take Brisdelle if you are pregnant.
Cautions
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
See full prescribing information for complete boxed warning.
- Potential for increased risk of suicidal thinking and behavior
- Monitor for worsening and emergence of suicidal thoughts and behaviors
- Before you start taking Brisdelle, tell your doctor:
- About any allergies you have
- About any medications you take, including prescription, over-the-counter, vitamins, and herbal supplements
- About any medical conditions you have
- If you are pregnant or plan to become pregnant
- If you are currently breastfeeding or plan to breastfeed
- Brisdelle can increase the risk of suicidal thinking and behavior. Tell your doctor right away if you experience suicidal thoughts, ideations, or behavioral changes.
- Brisdelle may increase your risk for serotonin syndrome. Seek medical care right away if you experience agitation, restlessness, trouble sleeping, confusion, fast heart rate, high blood pressure, dilated pupils, loss of muscle coordination, muscle twitching or rigidity, excessive sweating, diarrhea, headache, shivering, or goosebumps.
- Brisdelle can reduce the effects of Tamoxifen.
- Your risk for bleeding increases when taking Brisdelle and non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, or other drugs that increase the risk of bleeding. Watch for signs of bleeding such as nosebleeds, bleeding from your gums, or the presence of blood in your stools.
- Tell your doctor if you have vision problems such as glaucoma.
- Tell your doctor if you have seizures or a condition that can cause seizures.
- Brisdelle can cause low sodium levels in the blood. Seek medical care right away if you experience confusion, nausea, vomiting, energy loss, drowsiness, mood changes, restlessness, muscle weakness, muscle spasms or cramps, or seizures.
- Brisdelle can increase your risk for bone fractures.
- Brisdelle can cause mania or hypomania.
- Brisdelle can cause feelings of restlessness.
- Brisdelle can cause problems with sex.
- Do not drive or operate machinery until you know how Brisdelle affects you.
Side Effects
The most common side effects associated with Brisdelle include headache, fatigue, nausea, and vomiting. Contact your doctor right away if you develop side effects that worsen or won't go away.
References:
- Brisdelle Prescribing Information. Roswell, GA: Sebela Pharmaceuticals, Inc.; 2021.
- Serotonin syndrome. Mayo Clinic. January 22, 2022. Accessed February 4, 2022.
- Hyponatremia. Mayo Clinic. May 23, 2020. Accessed February 4, 2022.
Frequently Asked Questions about Brisdelle (Paroxetine)
What is Brisdelle used for?
Brisdelle is specifically approved to treat moderate to severe hot flashes and other vasomotor symptoms (VMS) associated with menopause. It's not intended for any other conditions, including depression or anxiety.
How does it work?
Brisdelle belongs to a class of medications called SSRIs (selective serotonin reuptake inhibitors). It affects the levels of serotonin in the brain, which helps regulate mood and temperature control, potentially easing hot flashes.
What dosage is typically prescribed?
The recommended dosage for VMS is 7.5mg once daily, usually taken at bedtime. Your doctor may adjust the dose based on your individual needs and response.
Does it have any side effects?
Common side effects can include nausea, fatigue, headache, dry mouth, and difficulty sleeping. More serious side effects are rare but possible, so tell your doctor about any concerning symptoms.
Who shouldn't take Brisdelle?
It's contraindicated for people with allergies to paroxetine, taking certain medications (like MAOIs), pregnant or breastfeeding women, and those with certain medical conditions like uncontrolled epilepsy or severe liver or kidney disease.
Can I take it with other medications?
Drug interactions are possible, so inform your doctor about all medications and supplements you take before starting Brisdelle.
How long does it take to work?
You may experience some improvement within a week, but it can take 4-6 weeks to see the full effects. Consistent use is crucial for optimal benefit.
Is it addictive?
Brisdelle is not considered addictive, but stopping it abruptly can cause withdrawal symptoms like dizziness, irritability, and sleep disturbances.Gradually tapering off under your doctor's guidance is recommended.
Are there any lifestyle changes I can make to manage hot flashes alongside Brisdelle?
Staying cool, managing stress, avoiding triggers like spicy food and alcohol, and practicing relaxation techniques can complement Brisdelle's effects.
What are the differences between Brisdelle and Paxil?
Both contain paroxetine, but Brisdelle uses a lower dose specifically for VMS, while Paxil is prescribed for various mental health conditions at higher doses.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 13596
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