Desyrel Tablets

GENERIC NAME: TRAZODONE (TRAZ-oh-done)

COMMON USES: This medicine is a modified cyclic antidepressant used to treat depression. It may also be used for relief of an anxiety disorder (e.g., sleeplessness, tension), chronic pain or to treat other conditions as determined by your doctor.

HOW TO USE THIS MEDICINE: Follow the directions for taking this medicine provided by your doctor. This medicine comes with a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully each time you refill this medicine. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. Take this medicine shortly after a meal or light snack. It may take 1 to 4 weeks for this medicine to work. Do not stop taking this medicine without checking with your doctor. STORE THIS MEDICINE at room temperature, between 68 and 77 degrees F (20 and 25 degrees C) in a tight, light-resistant container. Store away from heat, moisture, and light. Protect from temperatures above 104 degrees F (40 degrees C). Do not store in the bathroom. KEEP THIS MEDICINE out of reach of children and pets. IF YOU MISS A DOSE of this medicine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

CAUTIONS: DO NOT USE THIS MEDICINE if you are allergic to any ingredient in this medicine or to nefazodone. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. THIS MEDICINE MAY CAUSE DROWSINESS, DIZZINESS, OR BLURRED VISION. These effects may be worse if you take it with alcohol or certain medicines. Use this medicine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. CHECK WITH YOUR DOCTOR before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using this medicine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness. THIS MEDICINE MAY CAUSE DIZZINESS, LIGHTHEADEDNESS, OR FAINTING; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects. CHILDREN, TEENAGERS, AND YOUNG ADULTS who take this medicine may be at increased risk for suicidal thoughts or actions. Watch all patients who take this medicine closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur. NEUROLEPTIC MALIGNANT SYNDROME (NMS) is a possibly fatal syndrome that can be caused by this medicine. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms. SEROTONIN SYNDROME is a possibly fatal syndrome that can be caused by this medicine. Your risk may be greater if you take this medicine with certain other medicines (eg, "triptans", MAOIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms. TELL YOUR DOCTOR OR DENTIST that you take this medicine before you receive any medical or dental care, emergency care, or surgery. THIS MEDICINE MAY RARELY CAUSE a prolonged, painful erection (priapism). This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens. Use this medicine with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood sodium levels. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using this medicine while you are pregnant. This medicine is found in breast milk. If you are or will be breast-feeding while you use this medicine, check with your doctor. Discuss any possible risks to your baby.

POSSIBLE SIDE EFFECTS: SIDE EFFECTS that may occur while taking this medicine include: blurred vision; constipation; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry mouth; headache; lightheadedness when sitting up or standing; muscle aches or pains; nausea; nervousness; stomach pain; stuffy nose; tiredness. If they continue or are bothersome, check with your doctor. SEEK MEDICAL ATTENTION RIGHT AWAY if any of these SEVERE side effects occur: black, tarry, or bloody stools; bloody or dark urine; chest pain; decreased coordination; fainting; fever, chills, or sore throat; hallucinations; irregular heartbeat; new or worsening agitation, anxiety, depression, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, trouble sleeping, or inability to sit still; prolonged, inappropriate, or painful erections; seizures; severe or persistent dizziness or tiredness; shortness of breath; speech problems; suicidal thoughts or actions; swelling of the hands, ankles, or feet; symptoms of low blood sodium levels (eg, confusion, persistent headache, trouble concentrating, memory problems, weakness, unsteadiness, sluggishness, personality changes); tremor; unusual bruising or bleeding; unusual weight changes; vomit that looks like coffee grounds; yellowing of the eyes or skin. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

BEFORE USING THIS MEDICINE: WARNING: Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using this medicine outweigh the risks. Families and caregivers must closely watch patients who take this medicine. It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor. SOME MEDICINES MAY INTERACT with this medicine. DO NOT TAKE THIS MEDICINE IF you are taking sodium oxybate (GHB), tryptophan, a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), or if you have taken an MAOI within the past 14 days. TELL YOUR HEALTH CARE PROVIDER if you are taking any other medicines, especially any of the following: anticoagulants (eg, warfarin), aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), antipsychotics (eg, olanzapine, haloperidol), phenothiazines (eg, thioridazine), selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), serotonin-norepinephrine reuptake inhibitors (SNRIs) (eg, duloxetine, venlafaxine), "triptans" (eg, sumatriptan), diuretics (eg, furosemide, hydrochlorothiazide), azole antifungals (eg, itraconazole, ketoconazole), delavirdine, HIV protease inhibitors (eg, indinavir, ritonavir), carbamazepine, amiodarone, barbiturates (eg, phenobarbital), buspirone, digoxin, hydantoins (eg, phenytoin), nefazodone, or medicine for high blood pressure. This may not be a complete list of all interactions that may occur. Ask your health care provider if this medicine may interact with other medicines you take. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including irregular heartbeat (eg, long QT syndrome) or other heart problems, low blood pressure, liver problems, kidney problems, blood electrolyte problems (eg, low blood sodium, potassium, or magnesium levels), sickle cell anemia, multiple myeloma, leukemia, dehydration, a deformed penis (eg, angulation, cavernosal fibrosis, Peyronie disease), allergies, pregnancy, or breast-feeding. Tell your doctor if you or a family member has a history of bipolar disorder (manic-depression), other mental or mood problems (eg, depression), suicidal thoughts or attempts, or alcohol or substance abuse. Tell your doctor if you drink alcohol, are scheduled to have surgery, or if you have a history of a heart attack. This medicine should not be used in CHILDREN or TEENAGERS; safety and effectiveness in children and teenagers have not been confirmed. Children and teenagers may also be more sensitive to its effects, especially the increased risk of suicidal thoughts or actions. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.

OVERDOSE: IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately. Symptoms may include loss of consciousness; low blood pressure; prolonged, painful erection; seizures; slow, fast, or irregular heartbeat; slowed or shallow breathing; unusual drowsiness or dizziness; vomiting; weakness.

ADDITIONAL INFORMATION: DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.

The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions, or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse.