Levomilnacipran extended-release capsules

Generic Name: levomilnacipran (LEE-voe-mil-NA-si-pran)
Brand Name: Fetzima

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 levomilnacipran extended-release capsules outweigh the risks.

Families and caregivers must closely watch patients who take levomilnacipran extended-release capsules. 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.

Levomilnacipran extended-release capsules is not approved for use in children.


Levomilnacipran extended-release capsules is used for:

Treatment of major depression disorder (MDD).

Levomilnacipran extended-release capsules 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 levomilnacipran extended-release capsules if:

  • you are allergic to any ingredient in levomilnacipran extended-release capsules or to milnacipran
  • you have uncontrolled narrow-angle glaucoma or end-stage kidney disease
  • you are taking linezolid or you have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days
  • you are taking tryptophan, a selective serotonin reuptake inhibitor (SSRI) (eg, fluoxetine), or another SNRI (eg, duloxetine)

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

Slideshow: Depression, the Risk of Suicide, and Treatment Options

Before using levomilnacipran extended-release capsules:

Some medical conditions may interact with levomilnacipran extended-release capsules. 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), recent heart attack, high blood pressure, bleeding problems, kidney problems, urinary blockage or trouble urinating, enlarged prostate, or increased eye pressure (eg, glaucoma)
  • if you are dehydrated, have low blood sodium levels, or drink alcohol
  • if you are taking a medicine that contains methylene blue

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

  • 5-HT1 receptor agonists (eg, sumatriptan), buspirone, fentanyl, linezolid, lithium, MAOIs (eg, phenelzine), sibutramine, SNRIs (eg, venlafaxine), SSRIs (eg, fluoxetine, fluvoxamine), St. John's wort, tramadol, 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
  • Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood sodium levels may be increased
  • Anticoagulants (eg, warfarin), aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDS) (eg, ibuprofen) because the risk of bleeding may be increased by levomilnacipran extended-release capsules

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

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

  • Levomilnacipran extended-release capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get levomilnacipran extended-release capsules refilled.
  • Take levomilnacipran extended-release capsules by mouth with or without food.
  • Swallow levomilnacipran extended-release capsules whole. Do not break, crush, cut, or chew before swallowing.
  • Take levomilnacipran extended-release capsules on a regular schedule to get the most benefit from it. Taking levomilnacipran extended-release capsules at the same time each day will help you remember to take it.
  • Continue to take levomilnacipran extended-release capsules even if you feel well. Do not miss any doses.
  • Do not suddenly stop taking levomilnacipran extended-release capsules without checking with your doctor. Side effects may occur. They may include mental or mood changes, numbness or tingling of the skin, dizziness, confusion, headache, nausea, nightmare, ringing in the ears, seizures, trouble sleeping, unusual tiredness, or vomiting. You will be closely monitored when you start levomilnacipran extended-release capsules and whenever a change in dose is made.
  • If you miss a dose of levomilnacipran extended-release capsules, 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 levomilnacipran extended-release capsules.

Important safety information:

  • Levomilnacipran extended-release capsules may cause drowsiness or may affect your ability to make decisions, think clearly, or react quickly. 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 levomilnacipran extended-release capsules.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using levomilnacipran extended-release capsules; 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 levomilnacipran extended-release capsules may be at increased risk for suicidal thoughts or actions. Adults may also be affected. The risk may be greater in patients who have had suicidal thoughts or actions in the past. The risk may also be greater in patients who have had bipolar (manic-depressive) illness, or if their family members have had it. Watch patients who take levomilnacipran extended-release capsules 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 levomilnacipran extended-release capsules. Your risk may be greater if you take levomilnacipran extended-release capsules with certain other medicines (eg, SSRIs, "triptans"). 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.
  • If your doctor tells you to stop taking levomilnacipran extended-release capsules, you will need to wait for at least 7 days before beginning to take certain other medicines (eg, MAOIs). Ask your doctor when you should start to take your new medicines after you have stopped taking levomilnacipran extended-release capsules.
  • Lab tests, including blood pressure and heart rate may be performed while you use levomilnacipran extended-release capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use levomilnacipran extended-release capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood sodium levels.
  • Levomilnacipran extended-release capsules should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Levomilnacipran extended-release capsules 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 levomilnacipran extended-release capsules while you are pregnant. It is not know if levomilnacipran extended-release capsules is found in breast milk. If you are or will be breast-feeding while you use levomilnacipran extended-release capsules, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of levomilnacipran extended-release capsules:

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:

Constipation; decreased sexual desire or ability; increased sweating; nausea; vomiting.

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); bloody or black, tarry stools; confusion; decreased concentration; decreased coordination; excessive sweating; fainting; fast or irregular heartbeat; fever; hallucinations; memory problems; new or worsening mental, mood, or behavior changes (eg, agitation, anxiety, depression, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, inability to sit still); seizures; severe or persistent headache or dizziness; severe or persistent nausea, vomiting, or diarrhea; suicidal thoughts or attempts; tremor; trouble sleeping; trouble urinating; unusual bruising or bleeding; unusual weakness; vomit that looks like coffee grounds.

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 levomilnacipran extended-release capsules:

Store levomilnacipran extended-release capsules 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 levomilnacipran extended-release capsules out of the reach of children and away from pets.

General information:

  • If you have any questions about levomilnacipran extended-release capsules, please talk with your doctor, pharmacist, or other health care provider.
  • Levomilnacipran extended-release capsules 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 levomilnacipran extended-release capsules 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 levomilnacipran extended-release capsules. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to levomilnacipran extended-release capsules. 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 levomilnacipran extended-release capsules.

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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