Bupropion Hydrochloride (bue-PROE-pee-on hye-droe-KLOR-ide), Dextromethorphan Hydrobromide (dex-troe-meth-OR-fan hye-droe-BROE-mide)

Treats depression.

Brand Name(s):

Auvelity

When This Medicine Should Not Be Used:

How to Use This Medicine:

Long Acting Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the extended-release tablet whole. Do not crush, break, or chew it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you have used an MAO inhibitor within the past 14 days. Do not take an MAOI for at least 14 days after you stop this medicine.
• Tell your doctor if you take barbiturates, benzodiazepines, or antiseizure medicines, or if you recently stopped taking them.
• Some medicines can affect how dextromethorphan/bupropion works. Tell your doctor if you are using any of the following:
  • Amantadine, carbamazepine, clopidogrel, digoxin, levodopa
  • Medicine to treat depression (including SSRIs, TCAs)
• Do not drink alcohol while you are using this medicine. Talk with your doctor before suddenly stopping drinking alcohol.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Do not breastfeed during treatment and for 5 days after the last dose.
• Tell your doctor if you have kidney disease, liver disease, diabetes, glaucoma, heart disease, brain tumors, low blood sugar, mental problems (including bipolar disorder, suicide, or depression), high blood pressure, or a history of stroke or falls. Tell your doctor if you have a history of drug addiction or if you drink alcohol.
• For some children, teenagers, and young adults, this medicine may increase mental or emotional problems. This may lead to thoughts of suicide and violence. Talk with your doctor right away if you have any thoughts or behavior changes that concern you. Tell your doctor if you or anyone in your family has a history of bipolar disorder or suicide attempts.
• This medicine may cause the following problems:
  • Increased risk of seizures
  • Hypertension (high blood pressure)
  • Changes in mood or behavior
  • Serotonin syndrome (may be life-threatening when used with certain other medicines)
• This medicine may make you dizzy. Do not drive or do anything that could be dangerous until you know how this medicine affects you.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, restlessness, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, seeing or hearing things that are not there
• Blurred vision, severe headache, slow or fast heartbeat, lightheadedness, or dizziness
• Problems with sex
• Seizures
• Unusual behavior, thoughts of hurting yourself or others, trouble sleeping

If you notice these less serious side effects, talk with your doctor:

• Dry mouth

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088