Serzone is an antidepressant medication. It affects chemicals in the brain that may become unbalanced and cause depression. Serzone is used to relieve symptoms of depression such as:

• feelings of sadness
• worthlessness
• guilt
• loss of interest in daily activities
• changes in appetite
• tiredness
• sleeping too much
• insomnia
• thoughts of death or suicide

While you are taking Serzone you may need to be monitored for worsening symptoms of depression and/or suicidal thoughts at the start of therapy or when doses are changed. This concern about the increased risk of suicidal thoughts or behaviors may be greater if you are 18 years of age or younger and are taking Serzone. In patients younger than 18 years, the period of risk may extend beyond start of therapy or when doses are changed. Your doctor may want you to monitor for the following symptoms:

• anxiety
• panic attacks
• difficulty sleeping
• irritability
• hostility
• impulsivity
• severe restlessness
• mania (mental and/ or physical hyperactivity)

These symptoms may be associated with the development of worsening symptoms of depression and/or suicidal thoughts or actions. Contact your healthcare provider if you develop any new or worsening mental health symptoms during treatment with Serzone. Do not stop taking Serzone.

Do not take Serzone if you have taken a monoamine oxidase inhibitor (MAOI) in the last 14 days, or if you are taking:

• isocarboxazid (Marplan®)
• phenelzine (Nardil®)
• tranylcypromine (Parnate®)
• cisapride (Propulsid®)
• pimozide (Orap®)
• triazolam (Halcion®)
• carbamazepine (Tegretol®, TegretolXR®, Epitol®, Carbatrol®)

In rare cases, treatment with Serzone has been associated with serious liver problems, sometimes resulting in liver transplant or death. Contact your doctor IMMEDIATELY if you experience:

• yellowing of the skin or eyes
• unusually dark urine
• loss of appetite that lasts several days or longer
• severe nausea
• stomach pain

These may be early signs of liver problems.

Use caution when driving, operating machinery, or performing other hazardous activities. Serzone may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Dizziness may be more likely to occur when you rise from a sitting or lying position. Rise slowly to prevent dizziness and a possible fall.

Avoid alcohol during treatment with Serzone. Alcohol may increase drowsiness and dizziness while taking Serzone.

Take Serzone exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain the instructions to you.

Take each dose with a full glass of water. It is important to take Serzone regularly to get the most benefit. Do not stop taking Serzone without first talking to your doctor. It may be several weeks before you begin to feel better, and you may require continuous treatment for quite some time.

Your doctor may want you to have blood tests or other medical evaluations during treatment with Serzone to monitor progress and side effects.

While you are taking Serzone you may need to be monitored for worsening symptoms of depression and/or suicidal thoughts at the start of therapy or when doses are changed. This concern about the increased risk of suicidal thoughts or behaviors may be greater if you are 18 years of age or younger and are taking Serzone. In patients younger than 18 years, the period of risk may extend beyond start of therapy or when doses are changed. Your doctor may want you to monitor for the following symptoms:

• anxiety
• panic attacks
• difficulty sleeping
• irritability
• hostility
• impulsivity
• severe restlessness
• mania (mental and/ or physical hyperactivity)

These symptoms may be associated with the development of worsening symptoms of depression and/or suicidal thoughts or actions. Contact your healthcare provider if you develop any new or worsening mental health symptoms during treatment with Serzone. Do not stop taking Serzone.

In RARE cases, treatment with Serzone has been associated with serious liver problems, sometimes resulting in liver transplant or death. Contact your doctor IMMEDIATELY if you experience:

• yellowing of the skin or eyes
• unusually dark urine
• loss of appetite that lasts several days or longer
• severe nausea
• stomach pain

These may be early signs of liver problems.

Do not take Serzone if you are taking any of the following drugs:

• isocarboxazid (Marplan®)
• phenelzine (Nardil®)
• tranylcypromine (Parnate®)
• cisapride (Propulsid®)
• pimozide (Orap®)
• triazolam (Halcion®)
• carbamazepine (Tegretol®, TegretolXR®, Epitol®, Carbatrol®)

These drugs can cause very serious interactions with Serzone that could lead to seizures, heart damage, and even death. Before taking this medication, tell your doctor if you have:

• heart disease
• high or low blood pressure
• irregular heartbeats
• seizures
• manic episodes (extreme agitation or excitability)
• kidney disease
• liver disease

You may not be able to take Serzone, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

It is not known whether Serzone will harm an unborn baby. Do not take Serzone without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether Serzone passes into breast milk. Do not take Serzone without first talking to your doctor if you are breast-feeding.

If you are over 60 years of age, you may be more likely to experience side effects from Serzone.

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a Serzone overdose include:

• drowsiness
• nausea
• vomiting
• seizures

Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction:

• hives
• difficulty breathing
• swelling of your face, lips, tongue, or throat

If you experience any of the following uncommon but serious side effects, stop taking Serzone and seek emergency medical attention or contact your doctor immediately:

• fainting
• prolonged, painful, or inappropriate erections

Other, less serious side effects may be more likely to occur. Continue to take Serzone and talk to your doctor when it is convenient if you experience:

• dizziness
• lightheadedness
• drowsiness
• upset stomach
• insomnia
• dry mouth
• constipation
• blurred or abnormal vision

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Do not take Serzone if you are taking any of the following drugs:

• isocarboxazid (Marplan®)
• phenelzine (Nardil®)
• tranylcypromine (Parnate®)
• cisapride (Propulsid®)
• pimozide (Orap®)
• triazolam (Halcion)
• carbamazepine (Tegretol®, TegretolXR®, Epitol®, Carbatrol®)

These drugs can have very serious interactions with Serzone that could lead to seizures, heart damage, and even death.

Many other drugs may interact with Serzone. Talk to your doctor before taking any other medications during treatment with Serzone, especially any of the following:

• haloperidol (Haldol®)
• alprazolam (Xanax®)
• lorazepam (Ativan®)
• cyclosporine (Neoral®, Sandimmune®)
• tacrolimus (Prograf®)
• digoxin (Lanoxin®, Lanoxicaps®)
• phenytoin (Dilantin®)
• warfarin (Coumadin®)
• atorvastatin (Lipitor®)
• lovastatin (Mevacor®)
• simvastatin (Zocor®)

You may require a dosage adjustment or special monitoring during treatment if you are taking any of these medicines.

Drugs other than those listed here may also interact with Serzone. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.