Bupropion and dextromethorphan is used in adults to treat major depressive disorder.

Bupropion and dextromethorphan may also be used for purposes not listed in this medication guide.

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Bupropion and dextromethorphan is usually taken once a day. Your doctor may change your dose after the third day. Do not take more than 2 tablets in 24 hours.

You may take bupropion and dextromethorphan with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

Your blood pressure will need to be checked often.

Do not stop using bupropion and dextromethorphan suddenly. Ask your doctor before stopping the medicine.

This medicine may cause false results on a drug-screening urine test. Tell the laboratory staff that you use bupropion and dextromethorphan.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Major Depressive Disorder:

Initial dose: 1 tablet orally once a day in the morning for 3 days
Maintenance dose: 1 tablet orally twice a day

Comments:
-Maintenance doses should be administered at least 8 hours apart.
-The maintenance dose should not be exceeded.

Use: For the treatment of major depressive disorder

You should not use bupropion and dextromethorphan if you are allergic to it, or if you have:

• a seizure disorder;

• an eating disorder such as anorexia or bulimia; or

• if you have suddenly stopped using alcohol, seizure medication, or a sedative (such as Xanax, Valium, Fiorinal, Klonopin, and others).

Do not use bupropion and dextromethorphan if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine. Wait at least 14 days after stopping an MAO inhibitor before you take bupropion and dextromethorphan.

Tell your doctor if you have ever had:

• low blood sodium;

• a stroke;

• a head injury, seizures, or brain or spinal cord tumor;

• glaucoma;

• heart disease, high blood pressure, or a heart attack;

• diabetes;

• kidney or liver disease;

• depression, bipolar disorder, or other mental illness;

• if you have a history of falls; or

• if you have alcoholism or drug addiction.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of bupropion and dextromethorphan on the baby.

Bupropion and dextromethorphan may harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breastfeed while using bupropion and dextromethorphan, and for at least 5 days after your last dose.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take more than one dose at a time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid drinking alcohol.

Avoid driving or hazardous activity until you know how bupropion and dextromethorphan will affect you. Your reactions could be impaired.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

Bupropion and dextromethorphan may cause serious side effects. Call your doctor at once if you have:

• seizures;

• changes in your vision, eye pain or redness;

• paranoia (feeling that people are against you), hallucinations (see or hear things that are not there), delusions (belief that you are someone else), or feeling confused; OR

• serotonin syndrome--agitation, hallucinations, fever, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, diarrhea.

Common side effects of bupropion and dextromethorphan may include:

• dizziness;

• headache;

• diarrhea;

• drowsiness;

• dry mouth;

• excessive sweating; or

• sexual problems.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• other medicines containing bupropion or dextromethorphan;

• medicine to treat anxiety, mood disorders, or mental illness;

• theophylline;

• steroids;

• insulin or oral diabetes medicine;

• medicines to control appetite;

• medicines to help you stop smoking; or

• street drugs.

Other drugs may affect bupropion and dextromethorphan, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.