Venlafaxine extended-release tablets

Pronunciation

Generic Name: venlafaxine (VEN-la-FAX-een)
Brand Name: Effexor XR

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 venlafaxine extended-release tablets outweigh the risks.

Families and caregivers must closely watch patients who take venlafaxine 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.

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


Venlafaxine extended-release tablets is used for:

Treating depression, generalized or social anxiety disorder, or panic disorder. It may also be used for other conditions as determined by your doctor.

Venlafaxine extended-release tablets is a serotonin-norepinephrine reuptake inhibitor (SNRI). It works by restoring the balance of certain natural substances in the brain (serotonin and norepinephrine), which helps to improve certain mood problems.

Do NOT use venlafaxine extended-release tablets if:

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

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

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Before using venlafaxine extended-release tablets:

Some medical conditions may interact with venlafaxine 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, suicidal thoughts or attempts, or alcohol or substance abuse
  • if you have a history of seizures, heart problems (eg, heart failure, irregular heartbeat), abnormal electrocardiograms (ECGs), a recent heart attack, high blood pressure, high cholesterol, an overactive thyroid, liver problems, lung problems, kidney problems, stomach or bowel bleeding, blood or bleeding problems, diabetes, increased eye pressure or glaucoma, nervous system problems, or metabolism problems
  • if you are dehydrated, have low blood sodium levels, or drink alcohol
  • if you will be having electroconvulsive therapy (ECT)
  • if you are taking a medicine that contains methylene blue

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

  • Bupropion, buspirone, certain diet medicines (eg, phentermine, fenfluramine, lorcaserin), fentanyl, linezolid, lithium, MAOIs (eg, phenelzine, selegiline), meperidine, metoclopramide, nefazodone, rasagiline, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), serotonin 5-HT1 receptor agonists (eg, sumatriptan), sibutramine, SNRIs (eg, duloxetine), St. John's wort, tramadol, trazodone, tricyclic antidepressants (eg, amitriptyline), 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, and coma, may occur
  • Anticoagulants (eg, warfarin), aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of bleeding, including stomach bleeding, may be increased
  • Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood sodium levels may be increased
  • Azole antifungals (eg, ketoconazole), cimetidine, or terbinafine because they may increase the risk of venlafaxine extended-release tablets's side effects
  • Cyproheptadine because it may decrease venlafaxine extended-release tablets's effectiveness
  • Aripiprazole, clozapine, haloperidol, phenothiazines (eg, chlorpromazine, thioridazine), or risperidone because the risk of their side effects may be increased by venlafaxine extended-release tablets
  • Metoprolol because its effectiveness may be decreased by venlafaxine extended-release tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if venlafaxine 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 venlafaxine extended-release tablets:

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

  • Venlafaxine extended-release tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get venlafaxine extended-release tablets refilled.
  • Take venlafaxine extended-release tablets by mouth with food.
  • Take venlafaxine extended-release tablets with a full glass of water (8 oz [240 mL]).
  • Swallow venlafaxine extended-release tablets whole. Do not break, crush, chew, or place in water before swallowing.
  • Venlafaxine extended-release tablets works best if it is taken at the same time each day.
  • Continue to take venlafaxine extended-release tablets even if you feel well. Do not miss any doses.
  • Do not suddenly stop taking venlafaxine extended-release tablets without checking with your doctor. You may have an increased risk of side effects (eg, mental or mood changes, numbness or tingling of the skin, dizziness, confusion, headache, increased sweating, diarrhea, nausea, vomiting, trouble sleeping, or unusual tiredness). If you need to stop venlafaxine extended-release tablets, your doctor may need to gradually lower your dose.
  • If you miss a dose of venlafaxine 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 venlafaxine extended-release tablets.

Important safety information:

  • Venlafaxine 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 venlafaxine extended-release tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol while you are taking venlafaxine extended-release tablets.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using venlafaxine extended-release tablets without checking with your doctor; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Several weeks may pass before your symptoms improve. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • Children, teenagers, and young adults who take venlafaxine extended-release tablets may be at increased risk for suicidal thoughts or actions. Watch all patients who take venlafaxine 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.
  • Serotonin syndrome is a possibly fatal syndrome that can be caused by venlafaxine extended-release tablets. Your risk may be greater if you take venlafaxine extended-release tablets with certain other medicines (eg, "triptans," MAOIs, SSRIs). Symptoms may include agitation; coma; confusion; excessive sweating; fever; fast or irregular heartbeat; hallucinations; nausea, vomiting, or diarrhea; and tremor. Contact your doctor at once if you have any of these symptoms.
  • Tell your doctor or dentist that you take venlafaxine extended-release tablets before you receive any medical or dental care, emergency care, or surgery.
  • If your doctor tells you to stop taking venlafaxine extended-release tablets, you will need to wait for a period of time before beginning to take certain other medicines (eg, MAOIs, nefazodone, thioridazine). Ask your doctor when you should start to take your new medicines after you have stopped taking venlafaxine extended-release tablets.
  • Certain antidepressants, including venlafaxine extended-release tablets, may increase the risk of bleeding. Sometimes bleeding can be life-threatening. Discuss any questions or concern with your doctor.
  • Some people may be at risk for eye problems from venlafaxine extended-release tablets. Your doctor may want you to have an eye exam to see if you are at risk for these eye problems. Call your doctor right away if you have eye pain, vision changes, or swelling or redness in or around the eye.
  • Venlafaxine extended-release tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking venlafaxine extended-release tablets.
  • Lab tests, including blood pressure and blood cholesterol levels, may be performed while you use venlafaxine extended-release tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use venlafaxine extended-release tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood sodium levels.
  • Caution is advised when using venlafaxine extended-release tablets in CHILDREN; they may be more sensitive to its effects, especially increased risk of suicidal thoughts or actions.
  • Venlafaxine extended-release tablets should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • Venlafaxine extended-release tablets may cause weight changes and growth changes. CHILDREN and teenagers may need regular weight and growth checks while they take venlafaxine extended-release tablets.
  • PREGNANCY and BREAST-FEEDING: Venlafaxine extended-release tablets may cause harm to the fetus if it is used during the last 3 months of pregnancy. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using venlafaxine extended-release tablets while you are pregnant. Venlafaxine extended-release tablets is found in breast milk. Do not breast-feed while taking venlafaxine extended-release tablets.

Possible side effects of venlafaxine 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:

Abnormal dreams; constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; increased sweating; loss of appetite; nausea; nervousness; tiredness; trouble sleeping; vomiting; weakness; weight loss; yawning.

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 or discomfort; confusion; decreased coordination; decreased sexual desire or ability; decreased urination; fainting; fast or irregular heartbeat; fever, chills, or persistent cough or sore throat; hallucinations; memory problems; new or worsening mental, mood, or behavior changes (eg, aggressiveness, agitation, anxiety, depression, hostility, impulsiveness, inability to sit still, irritability, panic attacks, or restlessness); persistent trouble sleeping; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe stomach pain; severe or persistent headache or dizziness; shortness of breath; significant weight loss; suicidal thoughts or attempts; tremor; trouble concentrating; unsteadiness; unusual bruising or bleeding; unusual weakness.

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.

Proper storage of venlafaxine extended-release tablets:

Store venlafaxine extended-release tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep venlafaxine extended-release tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about venlafaxine extended-release tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Venlafaxine 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 venlafaxine 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 venlafaxine 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 venlafaxine 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 health care provider for complete information about the risks and benefits of using venlafaxine extended-release tablets.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
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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