Aplenzin

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Treatment & Uses
Treating Overdose
Safety Information
Before Using

Generic Name: bupropion hydrobromide
Date of Approval: April 23, 2008
Company: Biovail Corporation

Treatment for: Depression

FDA Approves Aplenzin

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The United States Food and Drug Administration (FDA) has approved Aplenzin (formerly known as BVF-033), a once-daily formulation of bupropion hydrobromide for the treatment of depression in adults.

Aplenzin is an alcohol-resistant formulation of a new bupropion salt and has been approved in 174mg, 348mg, and 522mg extended-release tablets. The 522mg dosage strength provides patients requiring the maximum allowable dose of bupropion the only single tablet, once-daily option.

What is Aplenzin?

Aplenzin is an antidepressant medication used for the treatment of depression in adults.

What is the most important information I should know about Aplenzin?

You should not take Aplenzin (bupropion hydrobromide) if you have epilepsy or a seizure disorder, an eating disorder such as anorexia or bulimia, if you are using a second form of bupropion, or if you have suddenly stopped using alcohol or sedatives. Do not take Aplenzin if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl), or tranylcypromine (Parnate) in the last 14 days.

You may have thoughts about suicide when you first start taking an antidepressant such as Aplenzin, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Avoid using bupropion to treat more than one condition at a time. If you take Aplenzin for depression, do not also take Zyban to quit smoking. Too much of this medicine can increase your risk of a seizure.

Avoid drinking alcohol while taking Aplenzin. Alcohol may increase your risk of a seizure while you are taking Aplenzin. If you drink alcohol regularly, talk with your doctor before changing the amount you drink. Bupropion can cause seizures in people who drink a lot of alcohol and then suddenly quit drinking when they start using the medication.

What should I discuss with my healthcare provider before taking Aplenzin?

Do not take Aplenzin if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl), or tranylcypromine (Parnate) in the last 14 days. You should not take Aplenzin if you have:

epilepsy or a seizure disorder;
an eating disorder such as anorexia or bulimia;
if you are using a second form of bupropion; or
if you have suddenly stopped using alcohol or sedatives (such as Valium).

Bupropion may cause seizures, especially in people with certain medical conditions or when using certain drugs. Tell your doctor about all of your medical conditions and the drugs you use.

Before taking Aplenzin, tell your doctor if you have:

heart disease or high blood pressure;
head injury, brain or spinal cord tumor;
kidney disease;
liver disease (especially cirrhosis);
bipolar disorder (manic depression);
diabetes for which you use insulin or take oral medication;
if you currently use steroids, theophylline (Theo-Dur, Slo-Bid, Bronkodyl Theolair, Respbid), or medicine to treat depression or mental illness; or
if you recently used alcohol, sedatives (such as Valium), narcotic pain medicines, diet pills, or street drugs such as "speed" or cocaine.

If you have any of these conditions, you may not be able to use Aplenzin, or you may need a dosage adjustment or special tests during treatment.

You may have thoughts about suicide when you first start taking an antidepressant such as Aplenzin, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose of Aplenzin is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of Aplenzin treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Aplenzin passes into breast milk and could be harmful to a nursing baby. Do not take Aplenzin without telling your doctor if you are breast-feeding a baby. Do not give Aplenzin to anyone younger than 18 years old without the advice of a doctor.

How should I take Aplenzin?

Take Aplenzin exactly as it was prescribed for you. Do not take it in larger doses or for longer than recommended by your doctor. Follow the directions on your prescription label.

Aplenzin can be taken with or without food.

Do not crush, chew, or break the Aplenzin tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

Do not stop taking Aplenzin without first talking to your doctor. You may have unpleasant side effects if you stop taking this medication suddenly.

Store Aplenzin at room temperature away from moisture and heat.

What happens if I miss a dose of Aplenzin?

Take the missed dose of Aplenzin as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra Aplenzin to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much Aplenzin. Overdose symptoms may include seizures, muscle stiffness, hallucinations, fainting, fast or uneven heartbeat, shallow breathing, heart failure, or coma.

What should I avoid while taking Aplenzin?

Aplenzin can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

For more information, please visit www.biovail.com.