Vilazodone

Medications such as vilazodone 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; frenzied abnormal excitement; or any other changes in your usual thoughts, mood, or behavior. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to do so.

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.htmto obtain the Medication Guide.

Talk to your doctor about the risks of taking vilazodone.

Vilazodone is used to treat depression. Vilazodone is in a class of medications called serotonin modulators. It works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.

Vilazodone comes as a tablet to take by mouth. Take with food once a day. Take vilazodone at around the same time every day.

Take vilazodone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of vilazodone and gradually increase your dose, not more than once every 7 days.

Vilazodone controls depression but does not cure it. It may take several weeks before you feel the full benefit of vilazodone. Continue to take vilazodone even if you feel well. Do not stop taking vilazodone without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking vilazodone, you may experience withdrawal symptoms such as dizziness; nausea; headache; confusion; irritability; agitation; difficulty falling asleep or staying asleep; anxiety; extreme tiredness; seizures; pain, burning, or tingling in the hands or feet; frenzied or abnormally excited mood; or sweating. Tell your doctor if you experience any of these symptoms while you are decreasing your dose of vilazodone or soon after you stop taking vilazodone.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking vilazodone,

• 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) inhibitor, such as isocarboxazid, linezolid, methylene blue, phenelzine, selegiline or tranylcypromine. If you stop taking vilazodone, your doctor will tell you that you should wait at least 14 days before you start to take an MAO inhibitor.
• some medications should not be taken with vilazodone. Other medications may cause dosing changes or extra monitoring when taken with vilazodone. Make sure you have discussed any medications you are currently taking or plan to take before starting vilazodone with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking vilazodone, please get the advice of your doctor or pharmacist).
• the following nonprescription or herbal products may interact with vilazodone: St. John's wort; tryptophan; aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil^®, Motrin^®) and naproxen (Aleve^®). Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking vilazodone. Do not start any of these medications while taking vilazodone 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 bleeding problems, or seizures.
• tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breast-feeding. If you become pregnant while taking vilazodone, call your doctor.
• you should know that vilazodone may make you drowsy and affect your judgment and thinking. Do not drive a car or operate machinery until you know how this medication affects you.
• ask your doctor about the safe use of alcoholic beverages while you are taking vilazodone. Alcohol can make the side effects from vilazodone worse.
• you should know that vilazodone 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.

Unless your doctor tells you otherwise, continue your normal diet.

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.

Vilazodone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea, vomiting, diarrhea
• difficulty falling asleep or staying asleep
• 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

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, call your doctor immediately:

• rash, hives
• seizures
• fever, sweating, confusion, fast or irregular heartbeat, and severe muscle stiffness or twitching, agitation, hallucinations, loss of coordination, nausea, vomiting, or diarrhea, coma (loss of consciousness)
• unusual bleeding or bruising
• headache; unsteadiness; problems with thinking, concentration, or memory

Vilazodone 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).

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 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.org

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.

Symptoms of overdose may include the following:

• fever, sweating, confusion, fast or irregular heartbeat, and severe muscle stiffness or twitching, agitation, hallucinations, loss of coordination, nausea, vomiting, or diarrhea
• lack of energy
• restlessness

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.

• Viibryd^®