Trazodone (patient information)

IMPORTANT WARNING:
Studies have shown that children and teenagers who take antidepressants ('mood elevators') such as trazodone may be more likely to think about harming or killing themselves or to plan or try to do so than children who do not take antidepressants. Children younger than 18 years of age should not normally take trazodone.

If your child's doctor has prescribed trazodone for your child, you should watch his or her behavior very carefully, especially at the beginning of treatment and any time his or her dose is increased or decreased. Your child may develop serious symptoms very suddenly, so it is important to pay attention to his or her behavior every day. Call your child's doctor right away if he or she experiences any of these symptoms: new or worsening depression; thinking about harming or killing him- or herself or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; irritability; aggressive behavior; acting without thinking; severe restlessness; frenzied abnormal excitement, or any other sudden or unusual changes in behavior.

Your child's doctor will want to see your child often while he or she is taking trazodone, especially at the beginning of his or her treatment.Your child's doctor may also want to speak with you or your child by telephone from time to time. Be sure that your child keeps all appointments for office visits or telephone conversations with his or her doctor.

Your child's doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when your child begins treatment with trazodone. Read the information carefully and ask your child's 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/MG_template.pdf.

Talk to your child's doctor about the risks of giving trazodone to your child.

Why is this medication prescribed
Trazodone is used to treat depression. Trazodone is in a class of medications called serotonin modulators. It works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.

How should this medicine be used
Trazodone comes as a tablet to take by mouth. It is usually taken with a meal or light snack two or more times a day. To help you remember to take trazodone, take it 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 trazodone exactly as directed. Do not take more or less of it, take it more often, or take it for a longer time than prescribed by your doctor.

Your doctor may start you on a low dose of trazodone and gradually increase your dose, not more than once every 3 to 4 days. Your doctor may decrease your dose once your condition is controlled.

Trazodone controls depression, but does not cure it. It may take 2 weeks or longer before you feel the full benefit of trazodone. Continue to take trazodone even if you feel well. Do not stop taking trazodone without talking to your doctor. Your doctor will probably decrease your dose gradually.

Other uses for this medicine
Trazodone is also sometimes used to treat schizophrenia (long lasting, disabling mental illness in which the patient loses touch with reality); anxiety (excessive worry); alcohol abuse; and abnormal, uncontrollable movements that may be experienced as side effects of other medications. Talk to your doctor about the possible risks of using this medication for your condition.

What special precautions should I follow
Before taking trazodone


 * tell your doctor and pharmacist if you are allergic to trazodone or any other medications.
 * tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin); antidepressants, especially selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine (Prozac, Sarafem) and fluvoxamine (Luvox); antifungal medications such as fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); cimetidine (Tagamet); clarithromycin (Biaxin, Prevpac); cyclosporine (Neoral, Sandimmune); danazol (Danocrine); delaviridine (Rescriptor); dexamethasone (Decadron); digoxin (Digitek, Lanoxin, Lanoxicaps); diltiazem (Cardizem, Dilacor, Tiazac); erythromycin (E.E.S., E-Mycin, Erythrocin); HIV protease inhibitors such as indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Fortovase, Invirase); isoniazid (INH, Nydrazid); medications for allergies, cough or colds; medications for anxiety, high blood pressure, irregular heartbeat, mental illness or pain; medication for seizures such as carbamazepine (Tegretol), ethosuximide (Zarontin), phenobarbital (Luminal, Solfoton), and phenytoin (Dilantin); metronidazole (Flagyl); muscle relaxants; nefazodone; oral contraceptives (birth control pills); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane); sedatives; sleeping pills; tranquilizers; troleandomycin (TAO); verapamil (Calan, Isoptin, Verelan); or zafirlukast (Accolate). Also, tell your doctor or pharmacist if you are taking the following medications, called MAO inhibitors, or if you have stopped taking them within the past two weeks: isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Carbex), or tranylcypromine (Parnate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
 * tell your doctor what herbal products you are taking, especially St. John's wort.
 * tell your doctor if you or anyone in your family has or has ever had depression, bipolar disorder (mood that changes from depressed to abnormally excited), or mania (frenzied, abnormally excited mood), or if you or anyone in your family has thought about or attempted suicide. Also tell your doctor if you are being treated with electroshock therapy and if you have or have ever had cancer; a heart attack, irregular heart beat; high blood pressure; human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDs); low white blood cell count; or heart disease.
 * tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking trazodone, call your doctor.
 * if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking trazodone.
 * you should know that trazodone may make you drowsy and affect your judgment. Do not drive a car or operate machinery until *you know how this medication affects you. If drowsiness is a problem, ask your doctor about taking part of your dose at bedtime.
 * ask your doctor about the safe use of alcoholic beverages while you are taking trazodone. Alcohol can make the side effects from trazodone worse.
 * you should know that your mental health may change in unexpected ways, especially at the beginning of your treatment and any time that your dose is increased or decreased. These changes may occur at any time if you have depression or another mental illness, whether or not you are taking trazodone or any other medication. 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.
 * you should know that trazodone may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

What special dietary instructions should I follow
Talk to your doctor about drinking grapefruit juice while taking this medicine.

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 the 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.

Minor Side Effects
''Trazodone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:''


 * headache or heaviness in head
 * upset stomach
 * vomiting
 * bad taste in mouth
 * stomach pain
 * diarrhea
 * constipation
 * changes in appetite or weight
 * weakness or tiredness
 * nervousness
 * decreased ability to concentrate or remember things
 * confusion
 * difficulty falling asleep or staying asleep
 * nightmares
 * muscle pain
 * dry mouth
 * sweating
 * blurred vision
 * tired, red, or itchy eyes
 * runny nose
 * congestion
 * ringing in ears

Severe Side Effects
''Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them or those listed in the IMPORTANT WARNING section, call your doctor immediately:''


 * chest pain
 * fast, pounding, or irregular heart beat
 * shortness of breath
 * fever, sore throat, chills, or other signs of infection
 * hives
 * skin rash
 * itching
 * difficulty breathing or swallowing
 * swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
 * hoarseness
 * decreased coordination
 * shaking hands that you cannot control
 * numbness, burning, or tingling in the arms, legs, hands, or feet
 * dizziness or lightheadedness
 * fainting
 * thoughts of hurting yourself

Trazodone may cause painful, long lasting erections in males. In some cases emergency and/or surgical treatment has been required and, in some of these cases, permanent damage has occurred. Talk to your doctor about the risk of taking trazodone.

Trazodone may cause other side effects. Call your doctor if you have any unusual problems while 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.

Symptoms of overdose may include:


 * vomiting
 * drowsiness
 * changes in heart beat
 * seizures
 * difficulty breathing
 * painful erection that does not go away

What other information should I know
Keep all appointments with your doctor.

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

Brand names

 * Desyrel®