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Auvelity (Generic Dextromethorphan and Bupropion)

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WARNING

This drug contains bupropion, which is the same active component as various antidepressants (Aplenzin, Forfivo, Wellbutrin). A tiny number of kids, teenagers, and young adults (up to 24 years old) who took mood-elevating antidepressants like bupropion in clinical research developed suicide 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. Bupropion and dextromethorphan together are not recommended for usage in children under the age of 18.

Even if you are an adult over the age of 24, you should be aware that taking dextromethorphan and bupropion together may cause unanticipated changes in your mental health. 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: intense worry; new or deepening despair; considering injuring or killing yourself; intending to do so; agitation, anxiety, or panic attacks; trouble falling or staying asleep; aggressive, angry, or violent behaviour; irritability; acting without thinking; extreme restlessness; the impression that others are against you; hallucinations (hearing voices or seeing things that are not there); confusion; frenzied abnormal excitement; or any other abrupt or unusual changes in behaviour. In case you are unable to call for help on your own, make sure your family or caretaker is aware of any symptoms that could be serious.

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. The best course of therapy for you will be decided by you and your doctor.

When you are taking dextromethorphan and bupropion together, your doctor will 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 therapy with the combination of dextromethorphan and bupropion as well as each time you renew your prescription, 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 manufacturer’s website or the Food and Drug Administration (FDA) website.

Why is this medication prescribed?

Bupropion and dextromethorphan are used to treat depression. The drug dextromethorphan belongs to the group of drugs known as NMDA receptor antagonists. It is unknown how depression is treated by this medication in the brain. The drug bupropion belongs to the group of drugs known as antidepressants. It functions by boosting specific types of brain activity.

How should this medicine be used?

A pill containing dextromethorphan and bupropion is available for oral use with or without food. In the beginning, it is typically taken once day for three days. It is often taken twice day after 3 days (at least 8 hours apart). Take bupropion and dextromethorphan daily at around the same time(s). Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Take bupropion and dextromethorphan exactly as prescribed. Never take it in larger or less amounts or more frequently than directed by your doctor.

Do not chew, break, or crush the tablets; instead, swallow them whole.

Bupropion and dextromethorphan help manage depression but do not treat it. Without first seeing your doctor, do not discontinue taking bupropion with dextromethorphan. You may experience severe side effects, including mood swings, agitation, irritability, dizziness, ringing in the ears, shock-like sensations, anxiety, confusion, fatigue, difficulty falling asleep or staying asleep, numbness or tingling in the arms, legs, hands, or feet, headache, increased sweating, seizures, or nausea, if you abruptly stop taking dextromethorphan and bupropion.

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 dextromethorphan and bupropion,

  • If you have any allergies, including to dextromethorphan, bupropion, other drugs, or any of the substances in dextromethorphan and bupropion tablets, let your doctor and pharmacist know right once. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • Inform your physician if you are currently using an MAO inhibitor, such as isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), rasagiline (Azilect), selegiline (Emsam, Zelapar), or tranylcypromine (Parnate), or if you have just discontinued taking one. Most likely, your doctor will advise against taking bupropion and dextromethorphan together. Your doctor would advise you to wait at least 14 days before starting an MAO inhibitor if you stop taking the combination of dextromethorphan and bupropion.
  • Never take more than one bupropion- or dextromethorphan-containing medicine (Aplenzin, Forfivo, Wellbutrin) or cough-and-cold remedy (Nuedexta) at a time. Dextromethorphan or bupropion overdose could result in serious adverse effects.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • Inform your physician if you suffer from or have ever suffered from bulimia, anorexia nervosa, or seizures (an eating disorder). Tell your doctor if you consume a lot of alcohol but anticipate quitting abruptly, or if you take sedatives but anticipate quitting abruptly. You won’t want to take bupropion plus dextromethorphan, according to your doctor.
  • A heart attack, stroke, head injury, tumour in the brain or spine, high blood pressure, low sodium levels in the blood, issues with low blood sugar, diabetes, glaucoma (a condition where increased pressure in the eyes can cause gradual loss of vision), or other eye problems; problems walking or falling down; or liver, kidney, or other organ problems should all be disclosed to your doctor.
  • If you are pregnant or plan to become pregnant, let your doctor know. Call your doctor if you become pregnant while taking bupropion with dextromethorphan.
  • Inform your doctor if you are nursing a baby. While using bupropion and dextromethorphan, as well as for five days after your final dose, you shouldn’t breastfeed.
  • Dextromethorphan with bupropion may cause you to feel sleepy or lightheaded, so be aware of this. Prior to understanding how this drug affects you, avoid using machinery or driving a car.
  • Discuss with your doctor whether you should consume alcohol while taking dextromethorphan and bupropion. Dextromethorphan and bupropion side effects can both be exacerbated by alcohol.
  • You should be aware that bupropion might make your blood pressure go up. Before beginning treatment and periodically while you are on dextromethorphan and bupropion, especially if you also use nicotine replacement therapy, your doctor may check your blood pressure.
  • Dextromethorphan with bupropion may cause angle-closure glaucoma, so you should be aware of this (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 with your doctor getting an eye check to see whether you are at risk for this condition. Call your doctor or get emergency medical attention right away if you experience eye pain, changes in your vision, or swelling or redness in or around your eye.

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?

Ignore the missed dose and carry on with my normal dosing routine. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Bupropion with dextromethorphan may have negative side effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Drowsiness
  • Tiredness
  • Dizziness
  • Nervousness
  • Restlessness
  • Headache
  • Nausea
  • Diarrhea
  • Constipation
  • Mouth ache
  • Excessive perspiration
  • Reduced appetite
  • Abdominal pain
  • Joints hurt
  • Tingling or numbness in the hands, feet, legs, arms, or hands
  • Having trouble falling or staying asleep
  • 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 or seek emergency medical attention if you encounter any of the symptoms mentioned above or those in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections:

  • Seizures
  • Severe muscle stiffness or twitching, loss of coordination, fever, sweating, shivering, anxiety, sweating excessively, nausea, vomiting, or diarrhoea
  • Coma (loss of consciousness for a period of time) (loss of consciousness for a period of time)
  • Edoema of the hands, feet, ankles, lower legs, cheeks, neck, tongue, lips, and eyes
  • Hives, fever, chest pain, shortness of breath, muscular or joint pain, rash, itching, or chest pain.

Bupropion and dextromethorphan may also have other adverse effects. 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).

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

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 symptoms could include:

  • Nausea
  • Vomiting
  • Drowsiness
  • Unresponsiveness
  • Alterations to vision
  • Seizures
  • Hallucinating (seeing objects or hearing sounds and voices that do not exist)
  • Coma (short duration of not being conscious)
  • Hammering or fast heartbeat
  • Inability to coordinate

What other information should I know?

Keep all of your doctor’s appointments.

Inform the lab staff and your doctor that you are taking bupropion and dextromethorphan prior to any laboratory test.

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

  • Auvelity®
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