Auvelity 45 mg-105 mg tablet, extended release

Generic name:
Dextromethorphan/bupropion extended release - oral

Pronunciation
(DEX-troe-meth-OR-fan/bue-PROE-pee-on)

Brand name(s)
Auvelity

Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. It is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition.

Tell the doctor right away if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.

This combination medication is used to treat depression. Dextromethorphan/bupropion works by helping to restore the balance of certain natural substances (dopamine, norepinephrine) in the brain.

Read the Medication Guide provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually starting with once daily in the morning for 3 days, then increasing to twice daily. If you are taking this medication twice daily, take your doses at least 8 hours apart. The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Swallow the tablets whole. Do not crush, split, or chew the tablets. Doing so can release all of the drug at once, increasing the risk of side effects.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.

Tell your doctor if your condition does not get better or if it gets worse.

See also Warning section.

Dry mouth, sore throat, dizziness, nausea, vomiting, ringing in the ears, headache, decreased appetite, weight loss, constipation, trouble sleeping, increased sweating, or sexual function problems may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including:

• fast/pounding/irregular heartbeat
• mental/mood changes (such as anxiety, agitation, confusion, unusual behavior/thinking, memory loss)

Stop taking this medication and get medical help right away if any of these very serious side effects occur:

• seizure
• eye pain/swelling/redness
• vision changes (such as seeing rainbows around lights at night, blurred vision)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking this medication, tell your doctor or pharmacist if you are allergic to dextromethorphan or bupropion; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• diabetes
• heart problems (such as previous heart attack)
• high blood pressure
• glaucoma
• kidney problems
• liver disease
• substance use disorder (such as overuse of or addiction to drugs/alcohol)
• seizures or conditions that increase your risk of seizures (including brain/head injury, brain tumor, eating disorders such as bulimia/anorexia nervosa)
• stroke

This medication should not be used if you are suddenly stopping regular use of sedatives (including benzodiazepines such as lorazepam), drugs used to treat seizures, or alcohol. Doing so may increase your risk of seizures.

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Alcohol can also increase your risk of seizures.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially dizziness. Dizziness can increase the risk of falling.

During pregnancy, this medication should be used only when clearly needed. Since untreated mental/mood problems (such as depression) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, talk to your doctor right away about the benefits and risks of using this medication during pregnancy.

It is unknown if dextromethorphan passes into breast milk. Bupropion passes into breast milk and may have undesirable effects on a nursing infant. Breastfeeding is not recommended while using this medication and for 5 days after the last dose. Consult your doctor before breastfeeding.

See also Precautions section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• pimozide
• thioridazine

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before and after treatment with this medication. Ask your doctor when to start or stop taking this medication.

This medication contains dextromethorphan and bupropion. Do not take any other medications that contain dextromethorphan or bupropion while taking this medication unless otherwise directed by your doctor.

This medication may interfere with certain lab/medical tests (such as brain scan for Parkinson's disease, urine screening for amphetamines), possibly causing false results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: seizures, severe confusion, hallucinations, rapid heart rate, loss of consciousness.

Do not share this medication with others.

Lab and/or medical tests (such as blood pressure, kidney/liver function) may be done while you are taking this medication. Keep all medical and lab appointments.

If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.