FM/CFS/ME RESOURCES - Drug Database - Serzone

 

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Drug Database - Serzone Serzone 100 mg. tablet

Generic Name: nefazodone (nef-AY-zoe-done)

Brand Names: Serzone®

Classification: Antidepressant

Issue Date: 1992

This medication is no longer availble in the U.S.

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.

WARNING

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- 300,000 patient-years of SERZONE treatment. The total patient-years is a summation of each patients 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. (See WARNINGS.)

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 (see PRECAUTIONS: Information for Patients). 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injury such as increased serum AST or serum ALT levels ≥ 3 times the upper limit of NORMAL, while on SERZONE should be withdrawn from the drug.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.

Suicidality in Children and Adolescents

Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of SERZONE or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be 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. (See WARNINGS and PRECAUTIONS: Pediatric Use.)

Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of nine antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials.

  • Before Using This Medicine
  • How To Use This Medicine
  • Precautions While on this Medicine
  • Side Effects
  • Overdosage
  • Drug Interactions
  • Divider
    Before Using This Medicine

    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.

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    How To Use This Medicine

    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.

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    Precautions While on this Medicine

    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.

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    Overdosage

    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

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    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.

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    Drug Interactions

    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.

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