Trazodone extended-release tablets

Pronunciation

Generic Name: trazodone (TRAZ-oh-done)
Brand Name: Oleptro

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 trazodone extended-release tablets outweigh the risks.

Family and caregivers must closely watch patients who take trazodone extended-release tablets. 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.

Trazodone extended-release tablets is not approved for use in children. Talk with the doctor.


Trazodone extended-release tablets is used for:

Treating depression. It may also be used for other conditions as determined by your doctor.

Trazodone extended-release tablets is an antidepressant. It is thought to increase the activity of one of the brain chemicals (serotonin), which helps elevate mood.

Do NOT use trazodone extended-release tablets if:

  • you are allergic to any ingredient in trazodone extended-release tablets or nefazodone
  • you are taking sodium oxybate (GHB)
  • you are taking or have taken linezolid or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

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Before using trazodone extended-release tablets:

Some medical conditions may interact with trazodone extended-release tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • 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, alcohol or substance abuse, or a certain type of irregular heartbeat (QT prolongation)
  • if you have liver problems, kidney problems, low blood sodium levels, low blood potassium levels, low blood magnesium levels, heart problems, low blood pressure, or have had a heart attack
  • if you have sickle cell anemia, multiple myeloma, a deformed penis (eg, angulation, cavernosal fibrosis, Peyronie disease), or leukemia
  • if you are scheduled to have surgery, if you are dehydrated, or if you drink alcohol
  • if you are taking a medicine that contains methylene blue
  • if you take any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat

Some MEDICINES MAY INTERACT with trazodone extended-release tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Anticoagulants (eg, warfarin), aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of bleeding may be increased
  • Antipsychotics (eg, olanzapine, haloperidol), buspirone, fentanyl, linezolid, lithium, MAOIs, (eg, phenelzine), methylene blue, phenothiazines (eg, thioridazine), selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), serotonin-norepinephrine reuptake inhibitors (SNRIs) (eg, duloxetine, venlafaxine), St. John's wort, tramadol, tricyclic antidepressants (eg, amitriptyline), "triptans" (eg, sumatriptan), or tryptophan because severe side effects, such as a reaction that may include fever, rigid muscles, blood pressure changes, mental changes, confusion, irritability, agitation, delirium, or coma, may occur
  • Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood sodium levels may be increased
  • Azole antifungals (eg, itraconazole, ketoconazole), delavirdine, HIV protease inhibitors (eg, indinavir, ritonavir), or perampanel because they may increase the risk of trazodone extended-release tablets's side effects
  • Carbamazepine because it may decrease trazodone extended-release tablets's effectiveness
  • Amiodarone, barbiturates (eg, phenobarbital), digoxin, hydantoins (eg, phenytoin), nefazodone, sodium oxybate (GHB ), or medicine for high blood pressure because the risk of their side effects may be increased by trazodone extended-release tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if trazodone extended-release tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use trazodone extended-release tablets:

Use trazodone extended-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Trazodone extended-release tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get trazodone extended-release tablets refilled.
  • Take trazodone extended-release tablets by mouth on an empty stomach at least 1 hour before or 2 hours after eating.
  • Take trazodone extended-release tablets at bedtime unless your doctor tells you otherwise.
  • Swallow trazodone extended-release tablets whole. Do not crush or chew before swallowing. If your doctor tells you to break trazodone extended-release tablets in half, be sure to break the tablet along the score line.
  • Trazodone extended-release tablets works best if it is taken at the same time each day.
  • Continue to take trazodone extended-release tablets even if you feel well. Do not miss any doses.
  • Do not suddenly stop taking trazodone extended-release tablets. You may experience side effects, such as anxiety, agitation, or trouble sleeping. If you need to stop trazodone extended-release tablets or add a new medicine, your doctor will gradually lower your dose.
  • If you miss a dose of trazodone extended-release tablets, 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.

Ask your health care provider any questions you may have about how to use trazodone extended-release tablets.

Important safety information:

  • Trazodone extended-release tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use trazodone extended-release tablets 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 trazodone extended-release tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Trazodone extended-release tablets may cause dizziness, light-headedness, 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.
  • Tell your doctor or dentist that you take trazodone extended-release tablets before you receive any medical or dental care, emergency care, or surgery.
  • Children, teenagers, and young adults who take trazodone extended-release tablets may be at increased risk of suicidal thoughts or actions. Watch all patients who take trazodone extended-release tablets 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 trazodone extended-release tablets. 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 trazodone extended-release tablets. Your risk may be greater if you take trazodone extended-release tablets 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.
  • Trazodone extended-release tablets may rarely cause a prolonged, painful erection. 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 trazodone extended-release tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood sodium levels.
  • Trazodone extended-release tablets should not be used in CHILDREN or TEENAGERS; safety and effectiveness have not been confirmed. Children and teenagers may also be more sensitive to its effects, especially the increased risk of suicidal thoughts or actions.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using trazodone extended-release tablets while you are pregnant. Trazodone extended-release tablets is found in breast milk. If you are or will be breast-feeding while you use trazodone extended-release tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of trazodone extended-release tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; constipation; decreased sexual desire or ability; dizziness; drowsiness; dry mouth; headache; light-headedness when sitting up or standing; nausea; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; chest pain; decreased coordination; fainting; fast or irregular heartbeat; hallucinations; new or worsening agitation, anxiety, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, trouble sleeping, or inability to sit still; prolonged, painful erection; seizures; severe or persistent dizziness; shortness of breath; 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; vomit that looks like coffee grounds; worsening depression.

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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include irregular heartbeat; prolonged, painful erection; seizures; severe drowsiness; slow or shallow breathing; vomiting.

Proper storage of trazodone extended-release tablets:

Store trazodone extended-release tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C) in a tight, light-resistant container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep trazodone extended-release tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about trazodone extended-release tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Trazodone extended-release tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take trazodone extended-release tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about trazodone extended-release tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to trazodone extended-release tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using trazodone extended-release tablets.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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