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Brisdelle (Generic Paroxetine)

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WARNING

In clinical investigations, a tiny proportion of youngsters, teenagers, and young adults (aged up to 24) who took mood-elevating antidepressants like paroxetine had suicidal thoughts (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental diseases may have a higher risk of committing suicide than those who do not take these medications. When depression in adolescents and teenagers is not addressed, there are hazards as well. If you have questions about these dangers or whether your kid needs to take an antidepressant, speak with their doctor. Paroxetine is typically not recommended for use in people under the age of 18, however in some circumstances, a doctor may determine that it is the best treatment option for a child’s condition.

You should be aware that even if you are an adult older than 24 years old and using paroxetine or another antidepressant to treat depression or another mental disorder, your mental health may change in unanticipated ways. In addition, if you have never experienced depression or another mental disease and you are a woman taking a modest dose of paroxetine to treat hot flashes, you can see changes in your mental health. Particularly at the start of your treatment and if your dose is changed, you may experience suicidal thoughts. If you experience any of the following symptoms, you, your family, or your carer should contact your doctor right away: new or worsening depression; thoughts of self-harm or suicide; plans or attempts to do so; extreme worry; agitation; panic attacks; difficulty falling or staying asleep; aggressive behaviour; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Make sure your family or carer is aware of any symptoms that could be significant so they can contact the doctor on your behalf if you are unable to call for help.

While you are on paroxetine, your doctor may want to see you frequently, especially at the start of your treatment. Be sure to show up for all of your doctor’s appointment times.

When you start paroxetine therapy, your doctor or pharmacist will provide you the medication guide (patient information sheet) from the manufacturer. If you have any questions, carefully read the material and contact your doctor or pharmacist. The FDA website (http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273) also has the medication guide available.

No of your age, you, your parent, or your carer should discuss the advantages and disadvantages of treating your disease with an antidepressant or with alternative treatments with your doctor before starting an antidepressant. The dangers and advantages of not treating your ailment should also be discussed. You should be aware that your chance of committing suicide is significantly increased if you suffer from depression or any mental disorder. This risk is increased if you or a family member currently has, or previously had, bipolar disorder (depression followed by periods of extreme excitement) or mania (frenzied, abnormally excited mood), or if you have ever considered or tried suicide. Discuss your ailment, symptoms, and personal and family medical history with your doctor. What kind of treatment is best for you will be decided by both you and your doctor.

Why is this medication prescribed?

Paroxetine is used to treat depression, panic disorder (sudden, unexpected attacks of great fear and worry about these attacks), and social anxiety disorder with pills, suspension (liquid), and extended-release (long-acting) tablets (extreme fear of interacting with others or performing in front of others that interferes with normal life). Additionally, paroxetine tablets and suspension are used to treat posttraumatic stress disorder, generalised anxiety disorder (GAD), and obsessive-compulsive disorder (PCD), which are all characterised by persistent, unwanted thoughts and the desire to repeatedly carry out certain behaviours (disturbing psychological symptoms that develop after a frightening experience). Premenstrual dysphoric disorder is also treated with paroxetine extended-release pills (PMDD, physical and psychological symptoms that occur before the onset of the menstrual period each month). Women going through menopause can use paroxetine capsules (Brisdelle) to alleviate hot flashes (sudden feelings of warmth, particularly in the face, neck, and chest) (stage of life when menstrual periods become less frequent and stop and women may experience other symptoms and body changes). Paroxetine belongs to the group of drugs known as selective serotonin-reuptake inhibitors (SSRIs). Serotonin, a naturally occurring chemical in the brain that aids in maintaining mental equilibrium, is increased in order to treat depression and other mental diseases. At this moment, not enough data are available to determine how paroxetine combats hot flashes.

How should this medicine be used?

The oral dosage forms of paroxetine include tablets, liquid suspensions, controlled-release (long-acting) tablets, and capsules. Usually used once daily in the morning or evening, with or without meals, the tablets, suspension, and controlled-release tablets are taken orally. The pills are typically taken once day, with or without food, at bedtime. To avoid stomach problems, you may wish to take paroxetine with meal. Take paroxetine every day at roughly the same time. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Follow the paroxetine directions precisely. Never take it in larger or less amounts or more frequently than directed by your doctor.

Before each usage, give the beverage a good shake to evenly distribute the medication.

Do not chew or crush the standard or extended-release pills; instead, swallow them whole.

Your doctor may start you on a low dose of paroxetine and gradually increase it up to once a week if you’re taking paroxetine tablets, suspension, or controlled-release tablets.

The amount of paroxetine in paroxetine capsules is less than what is required to cure depression and other mental illnesses. For the treatment of a mental condition, avoid taking paroxetine pills. Consult your doctor about treatment options if you believe you suffer from depression or another mental disorder.

Paroxetine might help you manage your symptoms, but it won’t make you better. Before you experience paroxetine’s full benefits, it could take a few weeks or longer. Even if you feel good, keep taking paroxetine. Never stop taking paroxetine without consulting your doctor first. Your dosage may progressively be reduced by your doctor. You might experience withdrawal symptoms if you abruptly stop taking paroxetine tablets, suspension, or controlled-release tablets, including depression, mood swings, frenzied or abnormally excited mood, irritability, anxiety, confusion, dizziness, headache, fatigue, numbness or tingling in the arms, legs, hands, or feet, strange dreams, trouble falling or staying asleep, nausea, or sweating. If you encounter any of these side effects after your paroxetine dosage is reduced, let your doctor know.

Other uses for this medicine

Paroxetine is also occasionally used to treat certain male sexual issues, chronic migraines, and tingling, discomfort, or numbness in the hands and feet brought on by diabetes. In addition to other drugs, paroxetine is used to treat bipolar illness (mood that changes from depressed to abnormally excited). Discuss the potential dangers of using this medication for your illness with your doctor.

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking paroxetine,

  • If you have any allergies, including to paroxetine, any other medications, or any of the substances in paroxetine tablets, controlled-release tablets, capsules, or suspension, inform your doctor and pharmacist right away. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • If you have recently ceased taking any monoamine oxidase (MAO) inhibitors, such as isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Emsam, Zelapar), or tranylcypromine (Parnate), or if you are on thioridazine or pimozide, let your doctor know (Orap). Most likely, your doctor will advise against using paroxetine. You should wait at least two weeks after stopping paxil before starting an MAO inhibitor.
  • Inform your physician and pharmacist of all prescription, over-the-counter, and vitamin products you are now taking or intend to use. Be certain to bring up any of the following: Antihistamines, aspirin, and other nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), and trimipramine; anticoagulants (also known as “blood thinners”) such as warfarin (Coumadin, Jantoven), and heparin; antidepressants (also known as “mood elevators”) such as amitriptyline; atomoxetine (Straterra), buspirone (Buspar), chlorpromazine (Thorazine), cimetidine (Tagamet), clopidogrel (Plavix), dextromethorphan (present in many cough medicines; in Nuedexta), digoxin (Lanoxin), dipyridamole (Persantine), diuretics (‘water pills’), fentanyl (Actiq, Fentora, Lazanda, others); medications for mental illness and nausea, medications for migraine headaches such as almotriptan, eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), sumatriptan (Imitrex), and zolmitriptan (Zomig), medications for seizures such as phenobarbital and phenytoin (Dilantin), medications for mental illness and nausea; metoprolol (Lopressor, Toprol XL); other selective serotonin-reuptake inhibitors like citalopram (Celexa), fluoxetine (Prozac), fluvoxamine (Luvox), and sertraline (Zoloft); propranolol (Inderal); risperidone (Risperdal); ritonavir (Norvir); serotonin-norepinephrine reuptake inhibitors (SNRI) medications such as desvenlafaxine (Khedezla, Pristiq), theophylline (Theobid, Theo-Dur), tramadol (Conzip, Qdolo, Ultram, in Ultracet), tamoxifen (Soltamox), and trazodone. Your doctor might need to adjust your medication doses or keep a close eye out for any negative side effects. Paroxetine may also interact with many other drugs, so be sure to let your doctor know about all the drugs you’re taking, even if they don’t appear on this list.
  • You should be aware that there are paroxetine medications available under many brand names that are intended to treat various ailments. Take no more than one paroxetine-containing product at a time.
  • In particular, mention St. John’s wort and tryptophan to your doctor along with any other nutritional supplements you may be taking.
  • Inform your doctor if you use or have previously used illegal substances, abused prescription drugs, experienced a recent heart attack, or have low sodium levels in your blood. Tell your doctor if you suffer from liver, kidney, or heart illness, have ever had seizures, have bleeding from your stomach or oesophagus (the tube connecting your mouth and stomach), or have any other medical conditions.
  • Inform your doctor if you are nursing a baby, pregnant, or planning a pregnancy. While taking paroxetine, call your doctor right away if you find out you’re pregnant. If used early in pregnancy, paroxetine may result in cardiac malformations in the foetus, and if taken later in pregnancy, paroxetine may result in issues with babies after birth.
  • If you are 65 years of age or older, discuss the advantages and disadvantages of taking paroxetine with your doctor. Paroxetine is typically not recommended for usage in older adults since it is less reliable and less efficient than alternative drugs that can be used to treat the same condition.
  • Inform the surgeon or dentist if you are having surgery, including dental surgery, that you are taking paroxetine.
  • You should be aware that paroxetine may cause you to feel sleepy, impair your judgement, and alter your thoughts. Prior to understanding how this drug affects you, avoid using machinery or driving a car.
  • Consult your doctor about whether drinking alcohol is safe while taking paroxetine.
  • You ought to be aware that paroxetine may result in angle-closure glaucoma (a condition where the fluid is suddenly blocked and unable to flow out of the eye causing a quick, severe increase in eye pressure which may lead to a loss of vision). Before beginning this medicine, discuss having your eyes checked with your doctor. Call your doctor or get emergency medical attention as soon as possible if you have nausea, eye pain, vision changes such as seeing coloured rings around lights, or swelling or redness in or around the eyes.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

If you miss a dosage, take it as soon as you recall. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Side effects from paroxetine are possible. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Headache
  • Dizziness
  • Weakness
  • Difficulty concentrating
  • Nervousness
  • Forgetfulness
  • Confusion
  • Nausea
  • Sleepiness
  • Nausea
  • Vomiting
  • Diarrhea
  • Constipation
  • Gas
  • Abdominal pain
  • Heartburn
  • Alterations in food taster abilities
  • Reduction in appetite
  • Weight loss or gain
  • Changes in sex drive or ability
  • Gain or loss of weight
  • Male sexual dysfunction includes reduced sex desire, difficulty getting or maintaining an erection, and delayed or
  • Nonexistent ejaculation
  • Issues with sex; lack of orgasm, delayed orgasm, or diminished sex drive in women
  • Mouth ache
  • Sweating
  • Yawning
  • Everywhere in the body, including the back, muscles, bones, and joints
  • Edoema or sensitivity in the joints

Some adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you experience any of the following symptoms or those noted in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections:

  • Seeing or hearing things or voices that are not there (hallucinating)
  • Fainting
  • Irregular, hammering, or quick heartbeat
  • Chest ache
  • Having trouble breathing
  • Seizures
  • Hallucinations, lack of coordination, severe muscle stiffness or twitching, fever, sweating, confusion, and nausea, vomiting, or diarrhoea
  • Unusual bruising or bleeding
  • Little red patches under the skin
  • Skin scorching or peeling
  • Infection-related symptoms such as a sore throat, fever, chills, and cough
  • Body part shaking that is uncontrollable
  • Shaky gait that could lead to falling
  • Tingling or numbness in your arms, legs, feet, or hands
  • Hours-long erection that is agonising
  • Sudden headache, dizziness, nausea, cramps, bloating, edoema, tightness in the hands and feet, and confusion
  • Itching
  • Edoema of the hands, feet, ankles, lower legs, cheeks, neck, tongue, lips, and eyes
  • Hoarseness
  • Stool that is dark and tarry
  • Bench with a reddish tint
  • Vomit that is bloody and resembles coffee grounds
  • Osteoporosis or fracture
  • One area of your body is sore, swollen, or bruised

Children who take paroxetine may experience decreased appetite and weight loss. The physician for your child will keep a close eye on their development. If you are worried about your child’s weight gain or growth while taking this medicine, talk to your child’s doctor. Discuss the dangers of administering paroxetine to your child with their doctor.

Other negative effects of paroxetine may occur. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication out of the reach of children and tightly closed in the original container. Keep it at normal temperature, away from sources of extreme heat and moisture (not in the bathroom).

All medications should be kept out of the sight and reach of children, as many of the containers (such as weekly pill containers and those for eye drops, lotions, patches, and inhalers) are not child-resistant and are simple for small children to open. Always lock safety caps and put the medication in a secure spot right away, up high and out of young children’s sight and reach, to prevent poisoning. http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose signs could include the following:

  • Drowsiness
  • Coma
  • Seizures
  • Fever, perspiration, dizziness, rapid or erratic heartbeat, and significant muscle rigidity or twitching
  • Diarrhoea, vomiting, and nausea
  • Aggressive conduct
  • Dark-colored or brown urine
  • Frenetic, unusually eager state of mind

What other information should I know?

Keep all of your doctor’s appointments.

Inform your doctor and the lab staff that you are taking paroxetine prior to any laboratory test (particularly one that uses methylene blue).

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Brisdelle®
  • Paxil®
  • Paxil® CR
  • Pexeva®
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