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Brintellix (Generic Vortioxetine)

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WARNING

A tiny number of kids, teenagers, and young adults (up to 24 years old) who took mood-elevating antidepressants like vortioxetine in clinical research developed 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. Discuss these dangers and whether your child needs to take an antidepressant with your child’s doctor. Children under the age of 18 have not been examined in relation to vortioxetine.

Even if you are an adult above the age of 24, you should be aware that taking vortioxetine or other antidepressants may cause your mental health to change in unexpected ways. Suicidal thoughts may come to mind, especially at the start of treatment and whenever your dose is changed. Any of the following symptoms should prompt you, your family, or your carer to call your doctor immediately away: Depression that is either new or getting worse, thoughts of self-harm or suicide, plans or attempts to do so, excessive worry, agitation, panic attacks, trouble falling or staying asleep, aggressive behaviour, irritability, acting without thinking, extreme 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 taking vortioxetine, your doctor will want to visit 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 vortioxetine therapy, your doctor or pharmacist will provide you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the FDA website.

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?

Adult depression is treated with vortioxetine. Vortioxetine belongs to the group of drugs known as serotonin modulators. Serotonin, a naturally occurring chemical in the brain that aids in maintaining mental balance, is the primary mechanism by which it functions.

How should this medicine be used?

Tablets for oral use of vortioxetine are available. It is typically taken once day, with or without food. Vortioxetine should be taken every day at about the same time. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Take vortioxetine as prescribed by your doctor. Never take it in larger or less amounts or more frequently than directed by your doctor.

Depending on how well you respond to treatment and whether you suffer any adverse effects, your doctor may change the dosage of vortioxetine you’re taking. When receiving vortioxetine medication, be sure to discuss your feelings with your doctor.

Before you experience the full benefits of vortioxetine, it could take 2 to 4 weeks or longer. Even if you are feeling fine, keep taking vortioxetine. Without consulting your doctor, do not discontinue taking vortioxetine. Your dose will likely be gradually reduced by your doctor. You might experience withdrawal symptoms if you abruptly stop taking vortioxetine, including headache, mood swings, irritability, agitation, nausea, dizziness, burning, numbness, or tingling in the hands or feet, anxiety, confusion, sweating, shaking, frenzied or abnormally excited mood, ringing in the ears, exhaustion, and trouble falling or staying asleep. and convulsions. If you have any of these symptoms while lowering your vortioxetine dosage or right away after stopping vortioxetine, let your doctor know right away.

Other uses for this medicine

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 vortioxetine,

  • If you have an allergy to vortioxetine, any other medications, or any of the ingredients in vortioxetine tablets, let your doctor and pharmacist know right away. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • Inform your doctor if you are taking monoamine oxidase (MAO) inhibitors, such as tranylcypromine (Parnate), isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), and selegiline (Emsam, Zelapar), or if you have recently stopped taking them. Your physician might advise against taking vortioxetine. You should wait at least 21 days after stopping vortioxetine before starting an MAO inhibitor.
  • Inform your physician and pharmacist of all additional prescription and non-prescription drugs, vitamins, and dietary supplements you are currently taking or intend to take. Any of the following should be mentioned: amphetamines such as amphetamine (in Mydayis and Adderall), dextroamphetamine (in Adderall and Dexedrine), and methamphetamine (in Desoxyn); anticoagulants (also known as “blood thinners”) such warfarin (Coumadin, Jantoven); Antidepressants (also known as “mood lifters”) like amitriptyline, amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline,buspirone; carbamazepine (Carbatrol, Equetro, Tegretol, among others); clopidogrel (Plavix); diuretics (‘water pills’); fentanyl (Actiq, Duragesic, Fentora, Subsys); aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn); heparin, lithium (Lithobid), drugs for mental illness, migraine drugs including rizatriptan (Maxalt), sumatriptan (Imitrex), and zolmitriptan (Zomig), as well as drugs for migraines like almotriptan, eletriptan (Relpax), frovatriptan (Frova), and naratriptan (Amerge); rifampin (Rifadin, Rimactane); phenytoin (Dilantin, Phenytek); quinidine (in Nuedexta); various selective serotonin-reuptake inhibitors include citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Paxil, Pexeva), tramadol, desvenlafaxine (Pristiq), venlafaxine (Effexor), and duloxetine (Cymbalta) are examples of serotonin and norepinephrine reuptake inhibitors (Conzip, Qdola, Ulltram, in Ultracet). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • 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 have low sodium levels in your blood, use a lot of alcohol now or in the past, suffer from seizures, glaucoma (increased eye pressure that can result in blindness), or experience bleeding issues.
  • If you are breastfeeding a child or intend to become pregnant, let your doctor know. Call your doctor if you conceive while taking vortioxetine. If vortioxetine is taken in the latter few months of pregnancy, it may have negative effects on babies after birth.
  • Inform your doctor or dentist that you are taking vortioxetine if you are having any type of surgery, including dental surgery, or a test that requires the use of dyes.
  • You should be aware that vortioxetine may impair your decision-making, thinking, and behaviour. Prior to understanding how this drug affects you, avoid using machinery or driving a car.
  • Inquire with your doctor if drinking alcohol is okay for you to do so while taking vortioxetine.
  • It’s important to be aware that vortioxetine 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). Ask your doctor if you should get your eyes checked before beginning this medicine. Call your doctor or get emergency medical attention right away if you are experiencing nausea, eye pain, changes in your vision, such as seeing coloured rings around lights, or swelling or redness in or around your 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?

There may be side effects from vortioxetine. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Nausea
  • Vomiting
  • Diarrhea
  • Constipation
  • Gas
  • Mouth ache
  • Dizziness
  • Strange dreams
  • 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

Some adverse effects can be very harmful. Call your doctor right away if you have any of the following symptoms or any of those detailed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections:

  • Rash
  • Hives
  • Itching
  • Enlargement of the throat, lips, tongue, eyes, or face
  • Hoarseness
  • Breathing or swallowing challenges
  • Significant bruising or bleeding
  • Fever, sweating, confusion, anxiety, hallucinations, lack of coordination, severe muscle stiffness or twitching, nausea, vomiting, or diarrhoea
  • Nosebleed
  • Headache
  • Having trouble concentrating
  • Memory issues
  • Confusion
  • Weakness
  • Unsteadiness
  • Hallucinations
  • Fainting
  • Seizures
  • Coma (loss of consciousness for a period of time)

Other negative effects of vortioxetine are possible. 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 tightly closed in the original container and out of the reach of children. Store it away from excessive heat and moisture at room temperature (not in the bathroom).

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.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

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:

  • Nausea
  • Dizziness
  • Diarrhea
  • Abdominal pain
  • Itching
  • Sleepiness
  • Flushing
  • Anxiety, confusion, hallucinations, fever, sweating, shivering, extremely rigid or twitching muscles, loss of coordination, nausea, vomiting, or diarrhoea
  • Seizures

What other information should I know?

Keep all of your doctor’s appointments.

Inform your doctor and the lab staff that you are taking vortioxetine 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

  • Trintellix®
  • Brintellix®
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