Nefazodone
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Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with SERZONE and should counsel them in its appropriate use. A patient Medication Guide About Using Antidepressants in Children and Teenagers is available for SERZONE. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.
Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking SERZONE.
Clinical Worsening and Suicide Risk
Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, agressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to observe for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.
SERZONE®
Read this information completely before using SERZONE. Read the information each time you get more medicine. There may be new information. This leaflet provides a summary about SERZONE and does not include everything there is to know about your medicine.This information is not meant to take the place of talking with your doctor.
Before taking this medication, be sure to check the tablets in the bottle to make sure they match one of the following descriptions:
• 50 mg tablets are six-sided, light pink tablets imprinted with "BMS" and "50" on one face of the tablet;
• 100 mg tablets are six-sided, white tablets imprinted with "BMS" and "100" on one face of the tablet;
• 150 mg tablets are six-sided, peach-colored tablets imprinted with "BMS" and "150" on one face of the tablet;
• 200 mg tablets are six-sided, light yellow tablets imprinted with "BMS" and "200" on one face of the tablet; and
• 250 mg tablets are six-sided, white tablets imprinted with "BMS" and "250" on one face of the tablet.
What is the most important information that I should know about SERZONE?
Rarely,people who take SERZONE can develop serious liver problems. If you get any of the following symptoms while taking SERZONE, call your doctor right away because you may be developing a liver problem:
• Yellowing of the skin or whites of eyes (jaundice)
• Unusually dark urine
• Loss of appetite that lasts several days or longer
• Nausea
• Abdominal (lower stomach) pain
People who currently have liver problems should not take SERZONE (nefazodone hydrochloride).
What is SERZONE?
SERZONE (pronounced sir-ZONE) is a medicine used to treat depression.SERZONE is thought to treat depression by correcting an imbalance in the amounts of certain natural chemicals, such as serotonin and norepinephrine, which are in your brain.
Who should not take SERZONE?
Do not take SERZONE if you
• are allergic to SERZONE or the related medicine Desyrel® (trazodone).
• are taking Seldane® (terfenadine),an antihistamine; Hismanal® (astemizole),an antihistamine; Propulsid® (cisapride),used for heartburn; Halcion® (triazolam),used for insomnia; Orap® (pimozide),used to treat Tourette's syndrome; or Tegretol® (carbamazepine), used to control seizures.
• currently have liver problems.
• 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®.
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.
How should I take SERZONE?
• Take SERZONE at the same time every day exactly as prescribed by your doctor.You may take SERZONE with or without food.
• It may take a while for you to feel that SERZONE is working. You may not feel the full effect for several weeks.Once you feel better,it is important to keep taking SERZONE as directed by your doctor.
• If you miss a dose of SERZONE, skip that dose and continue with your regular schedule. Never take 2 doses at the same time.
• If you think that you have taken more SERZONE than prescribed, contact your doctor, local poison control center, or emergency room right away.
What should I avoid while taking SERZONE?
• Do not drive or operate possibly dangerous machinery (such as an automobile, power mower, or power tool) or participate in any hazardous activity that requires full mental alertness until you know how SERZONE affects you.
• Before taking SERZONE, tell your doctor about any medicines you are taking, including vitamin supplements, herbal remedies, and any non-prescription (over-the-counter) medicines. Some of these medicines may affect how SERZONE works and should not be used in combination without talking to your doctor.
• Do not drink alcoholic beverages while taking SERZONE.
• Tell your doctor if you are pregnant, planning to become pregnant, or become pregnant while taking SERZONE. It is not known whether SERZONE can harm your unborn baby.
• Talk with your doctor before taking SERZONE if you are breast-feeding. It is not known whether SERZONE can pass through your breast milk to the baby.
What are the possible side effects of SERZONE?
The most common side effects of SERZONE are sleepiness, dry mouth, nausea, dizziness, constipation, weakness, lightheadedness, problems with vision, and confusion.
Call your doctor right away if you have any of the following side effects:
• Yellowing of the skin or whites of eyes (jaundice)
• Unusually dark urine
• Loss of appetite that lasts several days or longer
• Severe nausea
• Abdominal (lower stomach) pain
• Rash or hives
• Seizure (convulsion)
• Fainting
• Erection that lasts too long
Tell your doctor right away about any side effects that you have or discomfort that you experience. Do not change your dose or stop taking SERZONE (nefazodone hydrochloride) without talking with your doctor first.
What else should I know about SERZONE?
Patients with depression may experience worsening of their symptoms, which may include thinking about or planning suicide, whether or not they are taking medicine for their depression. There has been a concern that medicines to treat depression may contribute to this worsening of depression and/or new thoughts or plans about suicide in some patients, especially children and teenagers.
Patients and their families should be encouraged to be aware of the development of symptoms such as anxiety, agitation, panic attacks, difficulty sleeping, irritability, hostility, impulsiveness, restlessness, difficulty concentrating, worsening of depression, or thoughts of suicide, especially early on while taking medicine to treat depression. If patients have any of these symptoms they should contact their doctor, especially if the symptoms are severe, began suddenly, or were not seen before they began taking SERZONE.
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Your doctor has prescribed SERZONE for you and you alone. Do not give SERZONE to other people, even if they have the same condition. It may harm them.
This leaflet provides a summary of the most important information about SERZONE. If you would like more information, talk with your doctor or pharmacist.You can ask for information about SERZONE that is written for healthcare professionals. You can also get more information by visiting www.serzone.com.
SERZONE® is a registered trademark of Bristol-Myers Squibb Company.Other brand names listed are trademarks of their respective owners and are not trademarks of Bristol-Myers Squibb Company.
Medication Guide
About Using Antidepressants in Children and Teenagers
What is the most important information I should know if my child is being prescribed an antidepressant?
Parents or guardians need to think about 4 important things when their child is prescribed an antidepressant:
- There is a risk of suicidal thoughts or actions
- How to try to prevent suicidal thoughts or actions in your child
- You should watch for certain signs if your child is taking an antidepressant
- There are benefits and risks when using antidepressants
1. There is a Risk of Suicidal Thoughts or Actions
Children and teenagers sometimes think about suicide, and many report trying to kill themselves.
Antidepressants increase suicidal thoughts and actions in some children and teenagers. But suicidal thoughts and actions can also be caused by depression, a serious medical condition that is commonly treated with antidepressants. Thinking about killing yourself or trying to kill yourself is called suicidality or being suicidal.
A large study combined the results of 24 different studies of children and teenagers with depression or other illnesses. In these studies, patients took either a placebo (sugar pill) or an antidepressant for 1 to 4 months. No one committed suicide in these studies, but some patients became suicidal. On sugar pills, 2 out of every 100 became suicidal. On the antidepressants, 4 out of every 100 patients became suicidal.
For some children and teenagers, the risks of suicidal actions may be especially high. These include patients with
- Bipolar illness (sometimes called manic-depressive illness)
- A family history of bipolar illness
- A personal or family history of attempting suicide
If any of these are present, make sure you tell your healthcare provider before your child takes an antidepressant.
2. How to Try to Prevent Suicidal Thoughts and Actions
To try to prevent suicidal thoughts and actions in your child, pay close attention to changes in her or his moods or actions, especially if the changes occur suddenly. Other important people in your child's life can help by paying attention as well (e.g., your child, brothers and sisters, teachers, and other important people). The changes to look out for are listed in Section 3, on what to watch for.
Whenever an antidepressant is started or its dose is changed, pay close attention to your child.
After starting an antidepressant, your child should generally see his or her healthcare provider:
- Once a week for the first 4 weeks
- Every 2 weeks for the next 4 weeks
- After taking the antidepressant for 12 weeks
- After 12 weeks, follow your healthcare provider's advice about how often to come back
- More often if problems or questions arise
You should call your child's healthcare provider between visits if needed.
3. You Should Watch for Certain Signs If Your Child is Taking an Antidepressant
Contact your child's healthcare provider right away if your child exhibits any of the following signs for the first time, or if they seem worse, or worry you, your child, or your child's teacher:
- Thoughts about suicide or dying
- Attempts to commit suicide
- New or worse depression
- New or worse anxiety
- Feeling very agitated or restless
- Panic attacks
- Difficulty sleeping (insomnia)
- New or worse irritability
- Acting aggressive, being angry, or violent
- Acting on dangerous impulses
- An extreme increase in activity and talking
- Other unusual changes in behavior or mood
Never let your child stop taking an antidepressant without first talking to his or her healthcare provider. Stopping an antidepressant suddenly can cause other symptoms.
4. There are Benefits and Risks When Using Antidepressants
Antidepressants are used to treat depression and other illnesses. Depression and other illnesses can lead to suicide. In some children and teenagers, treatment with an antidepressant increases suicidal thinking or actions. It is important to discuss all the risks of treating depression and also the risks of not treating it. You and your child should discuss all treatment choices with your healthcare provider, not just the use of antidepressants.
Other side effects can occur with antidepressants.
Of all the antidepressants, only fluoxetine (Prozac®) has been FDA approved to treat pediatric depression.
For obsessive compulsive disorder in children and teenagers, FDA has approved only fluoxetine (Prozac®)*, sertraline (Zoloft®)*, fluvoxamine, and clomipramine (Anafranil®)*.
Your healthcare provider may suggest other antidepressants based on the past experience of your child or other family members.
Is this all I need to know if my child is being prescribed an antidepressant?
No. This is a warning about the risk for suicidality. Other side effects can occur with antidepressants. Be sure to ask your healthcare provider to explain all the side effects of the particular drug he or she is prescribing. Also ask about drugs to avoid when taking an antidepressant. Ask your healthcare provider or pharmacist where to find more information.
*The following are registered trademarks of their respective manufacturers: Prozac®/Eli Lilly and Company; Zoloft®/Pfizer Pharmaceuticals; Anafranil®/Mallinckrodt Inc.
This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.
Revised January 2005
Based on package insert dated 01/05
