Serzone

Serzone is a prescription medication used to treat depression. Serzone belongs to a group of drugs called serotonin modulators. These work by increasing serotonin in the brain that maintains mental balance. 

This medication comes in an oral (by mouth) tablet form and is usually taken 2 times a day, with or without food. 

Common side effects of Serzone include nausea and constipation.

Serzone can also cause dizziness and blurred vision. Do not drive or operate heavy machinery until you know how Serzone affects you.

Serzone is a prescription medication used to treat depression. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Serzone. See the "Serzone Precautions" section.

Common side effects of Serzone include the following:

• nausea
• constipation
• dry mouth
• dizziness
• weakness
• lightheadedness
• blurred vision and/or abnormal vision
• confusion
• weakness
• sleepiness

This is not a complete list of Serzone side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Many medicines can interact with nefazodone. Talk to your doctor if you take one of the following medicines:

• antifungal medicine (ketoconazole, itraconazole, fluconazole)
• warfarin (coumadin)
• antidepressants
• MAO inhibitors such as such as Nardil or Parnate
• digoxin
• phenytoin
• Tegretol (carbamazepine)
• HIV medicines
• Halcion (triazolam)

These are not all the possible drug interactions with Serzone. Ask your doctor or pharmacist for more information

Do not take Serzone if you

• are allergic to Serzone or the related medicine Desyrel (trazodone).
• are taking Orap (pimozide) used to treat Tourette’s syndrome or Tegretol (carbamazepine) used to control seizures.
• currently have liver problems or have had liver injury while using Serzone
• are taking or have taken within the last 14 days one of the medicines for depression known as monoamine oxidase inhibitors (MAOIs), such as Nardil or Parnate.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods.

In the case of Serzone, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Serzone, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

Be sure to tell your doctor if you:

• have ever had liver problems
• are taking any other medicine, vitamin supplement, or herbal remedy, including those sold without a prescription (over-the-counter)
• have heart problems or have had a heart attack or stroke
• have had manic episodes (extreme agitation or excitability)
• have ever attempted suicide
• have had convulsions (seizures)
• are pregnant or breast-feeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Serzone falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

It is not known if Serzone crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Serzone.

Take Serzone exactly as prescribed.

Serzone comes in tablet form and is taken twice a day, with or without food.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose of Serzone (nefazodone) for the treatment of depression is starting at 100mg twice daily to a maintenance dose of 150mg to 300mg twice daily.

If you take too much Serzone, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Serzone at room temperature.
• Keep this and all medicines out of the reach of children.

Suicidality and Antidepressant Drugs

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Serzone or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Serzone is not approved for use in pediatric patients.

Warning- Liver Failure

Cases of life-threatening hepatic failure have been reported in patients treated with Serzone. The reported rate in the United States is about 1 case of liver failure resulting in death or transplant per 250,000 to 300,000 patient-years of Serzone treatment. The total patient-years is a summation of each patient’s duration of exposure expressed in years. For example, 1 patient-year is equal to 2 patients each treated for 6 months, 3 patients each treated for 4 months, etc.

Ordinarily, treatment with Serzone should not be initiated in individuals with active liver disease or with elevated baseline serum transaminases. There is no evidence that pre-existing liver disease increases the likelihood of developing liver failure, however, baseline abnormalities can complicate patient monitoring.

Patients should be advised to be alert for signs and symptoms of liver dysfunction (jaundice, anorexia, gastrointestinal complaints, malaise, etc.) and to report them to their doctor immediately if they occur.

Serzone should be discontinued if clinical signs or symptoms suggest liver failure. Patients who develop evidence of hepatocellular injury such as increased serum AST or serum ALT levels ≥ 3 times the upper limit of NORMAL, while on nefazodone hydrochloride tablets should be withdrawn from the drug. These patients should be presumed to be at increased risk for liver injury if Serzone is reintroduced. Accordingly, such patients should not be considered for re-treatment.