Medications such as levomilnacipran may increase the risk of suicidal thoughts and actions. This increase was found in children, teenagers, and young adults (less than 24 years of age). The risk may be more likely with the first few months of treatment and when the dose is increased.
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 if you are unable to seek treatment on your own.
Your doctor or pharmacist will give you the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm to obtain the Medication Guide.Talk to your doctor about the risks of taking levomilnacipran.
Why is this medicine prescribed?
Levomilnacipran is used to treat depression. Levomilnacipran is in a class of medications called selective serotonin and norepinephrine reuptake inhibitors (SNRIs). It works by increasing the amount of serotonin and norepinephrine, natural substances in the brain that helps maintain mental balance.
Are there other uses for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
How should this medicine be used?
Levomilnacipran comes as an extended-release (long-acting) capsule to take by mouth. Take once daily with or without food. Take levomilnacipran at around the same time every day.
Take levomilnacipran exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the capsules whole; do not open, chew, or crush them.
Your doctor may start you on a low dose of levomilnacipran and gradually increase your dose, not more than once every 2 days.
Levomilnacipran controls depression but does not cure it. It may take several weeks or longer before you feel the full benefit of levomilnacipran. Continue to take levomilnacipran even if you feel well. Do not stop taking levomilnacipran without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking levomilnacipran, you may experience withdrawal symptoms such as mood changes, agitation, irritability, dizziness, ringing in the ears, shock-like sensations, anxiety, confusion, tiredness, difficulty falling asleep or staying asleep, numbness or tingling in the arms, legs, hands, or feet, headache, increased sweating, seizures, or nausea. Tell your doctor if you experience any of these symptoms when your dose of levomilnacipran is decreased.
What special precautions should I follow?
Before taking levomilnacipran,
- tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
- tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: monoamine oxidase (MAO) inhibitors including isocarboxazid, phenelzine, selegiline, tranylcypromine linezolid or methylene blue Your doctor will probably tell you not to take levomilnacipran. If you stop taking levomilnacipran, you should wait at least one week before you start to take an MAO inhibitor.
- some medications should not be taken with levomilnacipran. Other medications may cause dosing changes or extra monitoring when taken with levomilnacipran. Make sure you have discussed any medications you are currently taking or plan to take before starting levomilnacipran with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking levomilnacipran, please get the advice of your doctor or pharmacist.
- the following nonprescription or herbal products may interact with levomilnacipran: St. John's wort; tryptophan; aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil®, Motrin®), and naproxen (Aleve®, Naprosyn®). Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking levomilnacipran. Do not start any of these medications while taking levomilnacipran without discussing with your healthcare provider.
- tell your doctor if you drink or have ever drunk large amounts of alcohol or use or have ever used street drugs or have ever overused prescription medications. Also tell your doctor if you have or have ever had high blood pressure, a stroke, urinary retention or problems urinating, bleeding problems, low salt (sodium) levels in your blood, glaucoma (increased pressure in the eye that may cause loss of sight), seizures, or kidney or heart disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking levomilnacipran, call your doctor.
- you should know that levomilnacipran may make you drowsy and may affect your judgment, thinking, and movements. Do not drive a car or operate machinery until you know how this medication affects you.
- you should know that levomilnacipran may cause angle-closure glaucoma (a condition where the fluid is suddenly blocked and unable to flow out of the eye causing a quick, severe increase in eye pressure which may lead to a loss of vision). Talk to your doctor about having an eye examination before you start taking this medication. If you have nausea, eye pain, changes in vision, such as seeing colored rings around lights, and swelling or redness in or around the eye, call your doctor or get emergency medical treatment right away.
- talk to your doctor about the safe use of alcoholic beverages during your treatment withlevomilnacipran. Alcohol can make the side effects of levomilnacipran worse.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget to take 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.
What should I do in case of overdose?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help . If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
What side effects can this medicine cause?
Levomilnacipran may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- nausea, vomiting
- constipation
- excessive sweating
- sexual problems in males; decreased sex drive, inability to get or keep an erection, or delayed or absent ejaculation
- sexual problems in females; decreased sex drive, or delayed orgasm or unable to have an orgasm
- fast heartbeat
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:
- rash; itching; hives; difficulty breathing or swallowing; swelling of the face, throat, tongue, lips, eyes
- headache; unsteadiness; problems with thinking, concentration, or memory
- agitation, fever, sweating, confusion, fast or irregular heartbeat, severe muscle stiffness or twitching, agitation, hallucinations, loss of coordination, nausea, vomiting, or diarrhea
- seizures
- chest pain, shortness of breath, dizziness, fainting
- coma (loss of consciousness for a period of time)
- abnormal bleeding or bruising
- difficulty urinating or unable to urinate
- rapid, pounding, or irregular heartbeat
Levomilnacipran 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 ( https://www.fda.gov/Safety/MedWatch ) or by phone ( 1-800-332-1088).What should I know about storage and disposal of this medication?
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 light, excess heat and moisture (not in the bathroom).
Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information. Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.orgWhat other information should I know?
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.