Nefazodone (patient information)

IMPORTANT WARNING:
A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') such as nefazodone during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant. Children younger than 18 years of age should not normally take nefazodone, but in some cases, a doctor may decide that nefazodone is the best medication to treat a child's condition.

You should know that your mental health may change in unexpected ways when you take nefazodone or other antidepressants even if you are an adult over age 24. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor when you are unable to seek treatment on your own.

Your healthcare provider will want to see you often while you are taking nefazodone, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.

The doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with nefazodone. Read the information carefully and ask your doctor or pharmacist if you have any questions. You also can obtain the Medication Guide from the FDA website: http://www.fda.gov/cder/drug/antidepressants/antidepressants_MG_2007.pdf.

No matter what your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood) or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.

Why is this medication prescribed
Nefazodone is used to treat depression. Nefazodone is in a class of medications called antidepressants. It works by increasing the amounts of certain natural substances in the brain that are needed to maintain mental balance.

How should this medicine be used
Nefazodone comes as a tablet to take by mouth. It is usually taken two times a day and may be taken with or without food. Take nefazodone at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take nefazodone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

It may take a few weeks or longer for you to feel the full benefit of nefazodone. Continue to take nefazodone even if you feel well. Do not stop taking nefazodone without talking to your doctor. Your doctor will probably want to decrease your dose gradually.

Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow
Before taking nefazodone


 * tell your doctor and pharmacist if you are allergic to nefazodone or any other medications.
 * tell your doctor if you are taking alprazolam (Xanax), astemizole (Hismanal) (not available in the United States), cisapride (Propulsid) (not available in the United States), pimozide (Orap), or terfenadine (Seldane),(not available in the United States) if you are taking or have taken a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar) or tranylcypromine (Parnate), or if you have taken an MAO inhibitor in the past two weeks. Your doctor will probably tell you not to take nefazodone.
 * tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin); antihistamines; buspirone (Buspar); carbamazepine (Tegretol); cimetidine (Tagamet); cyclosporine (Neoral, Sandimmune); digoxin (Lanoxin); haloperidol (Haldol); levodopa (Sinemet, Larodopa); medication for high blood pressure, seizures, Parkinson's disease, asthma, colds, or allergies; methylphenidate (Ritalin); muscle relaxants; propranolol (Inderal); sedatives; sleeping pills; tacrolimus (Prograf); thyroid medications; tranquilizers; and triazolam (Halcion). If you have recently stopped taking fluoxetine (Prozac, Sarafem), you may have to wait several weeks before beginning to take nefazodone. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
 * tell your doctor if you have or have ever had difficulty urinating; seizures; or kidney, liver, or heart disease.
 * tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking nefazodone, call your doctor.
 * if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking nefazodone.
 * you should know that this medication may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
 * remember that alcohol can add to the drowsiness caused by this medication. Avoid drinking alcohol while taking nefazodone.

What should I do if I forget a dose
Take the missed dose as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Mild side effects
''Nefazodone may cause side effects. Call your doctor if any of these symptoms are severe or do not go away:''


 * nausea
 * drowsiness
 * weakness or tiredness
 * nightmares
 * dry mouth
 * skin more sensitive to sunlight than usual
 * changes in appetite or weight
 * constipation
 * difficulty urinating
 * frequent urination
 * blurred vision
 * changes in sex drive or ability
 * excessive sweating

Severe side effects
''Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNINGS section, call your doctor immediately:''


 * jaw, neck, and back muscle spasms
 * slow or difficult speech
 * shuffling walk
 * uncontrollable shaking of a part of the body
 * fever
 * difficulty breathing or swallowing
 * rash
 * irregular heartbeat
 * seizures
 * painful erections of the penis lasting more than 4 hours

''Nefazodone may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.''

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to nefazodone.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.