Dextromethorphan; Bupropion Extended-Release Tablets

What is this medication?

DEXTROMETHORPHAN; BUPROPION (dex troe meth OR fan; byoo PROE pee on) treats depression. It works by balancing substances in your brain that help regulate mood. It is a combination of dextromethorphan and an NDRI.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): AUVELITY

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• An eating disorder, such as anorexia or bulimia
• Bipolar disorder or schizophrenia
• Brain or spine tumor
• Diabetes treated with medications
• Frequently drink alcohol
• Glaucoma
• Heart disease, previous heart attack, or irregular heart beat
• Head injury
• High blood pressure
• History of substance use disorder
• Kidney disease
• Liver disease
• Low blood sugar
• Low levels of sodium in the blood
• Seizures
• Stroke
• Suicidal thoughts, plans or attempt by you or a family member
• Weight loss
• An unusual or allergic reaction to bupropion, dextromethorphan, other medications, foods, dyes, or preservatives
• Pregnant or trying to become pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush, or chew this medication. Swallow the tablets whole. You can take this medication with or without food. If it upsets your stomach, take it with food. Take your medication at regular intervals. Do not take it more often than directed. Do not stop taking this medication except on your care team's advice. Stopping this medication too quickly may cause serious side effects or worsen your condition.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

Do not take this medication with any of the following:

• Linezolid
• MAOIs like Azilect, Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Methylene blue (injected into a vein)
• Other medications that contain bupropion like Wellbutrin or Zyban or that contain dextromethorphan like Robitussin or Delsym

This medication may also interact with the following:

• Alcohol
• Certain medications for anxiety or sleep
• Certain medications for blood pressure like metoprolol, propranolol
• Certain medications for depression or psychotic disturbances
• Certain medications for HIV or AIDS like efavirenz, lopinavir, nelfinavir, ritonavir
• Certain medications for irregular heart beat like propafenone, flecainide
• Certain medications for Parkinson's disease like amantadine, levodopa
• Certain medications for seizures like carbamazepine, phenytoin, phenobarbital
• Cimetidine
• Clopidogrel
• Cyclophosphamide
• Digoxin
• Furazolidone
• Isoniazid
• Nicotine
• Orphenadrine
• Procarbazine
• Steroid medications like prednisone or cortisone
• Stimulant medications for attention disorders, weight loss, or to stay awake
• Tamoxifen
• Theophylline
• Thiotepa
• Ticlopidine
• Tramadol
• Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not get better or if they get worse. Because it may take several weeks to see the full effects of this medication, it is important to continue your treatment as prescribed.

Watch for new or worsening thoughts of suicide or depression. This includes sudden changes in mood, behaviors, or thoughts. These changes can happen at any time but are more common in the beginning of treatment or after a change in dose. Call your care team right away if you experience these thoughts or worsening depression.

Manic episodes may happen in patients with bipolar disorder who take this medication. Watch for changes in feelings or behaviors such as feeling anxious, nervous, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or trouble sleeping. These symptoms can happen at anytime but are more common in the beginning of treatment or after a change in dose. Call your care team right away if you notice any of these symptoms.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

Avoid drinks that contain alcohol while taking this medication. Drinking large amounts of alcohol, using sleeping or anxiety medications, or quickly stopping the use of these agents while taking this medication may increase your risk for a seizure.

Do not drive or use heavy machinery until you know how this medication affects you. This medication can impair your ability to perform these tasks.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your care team if the problem does not go away or is severe.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Increase in blood pressure
• Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Seizures
• Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Change in sex drive or performance
• Diarrhea
• Dizziness
• Drowsiness
• Dry mouth
• Excessive sweating
• Headache

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original container until you are ready to take it. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.

If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.