Vilazodone

Vilazodone is used to treat depression. Vilazodone is in a class of medications called selective serotonin reuptake inhibitors (SSRIs) and is also a 5HT1A receptor partial agonist. It works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.

Vilazodone and other antidepressant medicines may cause serious side effects.

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if there is an emergency:

1. Suicidal thoughts or actions:
   • Vilazodone and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.
   • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
   • Watch for these changes and call your healthcare provider right away if you notice:
     • New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
     • Pay particular attention to such changes when vilazodone is started or when the dose is changed.
     
     Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms. 
     Call your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:
     • attempts to commit suicide
     • acting on dangerous impulses
     • acting aggressive or violent
     • thoughts about suicide or dying
     • new or worse depression
     • new or worse anxiety or panic attacks
     • feeling agitated, restless, angry or irritable
     • trouble sleeping
     • an increase in activity or talking more than what is normal for you (mania)
     • other unusual changes in behavior or mood
2. Serotonin Syndrome or Neuroleptic Malignant Syndrome-like reactions:
   • agitation, hallucinations, coma or other changes in mental status
   • coordination problems or muscle twitching (overactive reflexes)
   • fast heartbeat, high or low blood pressure
   • sweating or fever
   • nausea, vomiting, or diarrhea
   • muscle stiffness or tightness
3. Abnormal bleeding: Vilazodone and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin, Jantoven), a non-steroidal anti-inflammatory drug (NSAID), or aspirin.
4. Seizures or convulsions.
5. Manic episodes:
   • greatly increased energy
   • severe trouble sleeping
   • racing thoughts
   • reckless behavior
   • unusually grand ideas
   • excessive happiness or irritability
   • talking more or faster than usual
6. Low salt (sodium) levels in the blood. 
   Elderly people may be at greater risk for this. Symptoms may include:
   • headache
   • weakness or feeling unsteady
   • confusion, problems concentrating or thinking or memory problems

Do not stop vilazodone without first talking to your healthcare provider. Stopping vilazodone suddenly may cause serious symptoms including:

• anxiety, irritability, high or low mood, feeling restless or sleepy
• headache, sweating, nausea, dizziness
• electric shock-like sensations, tremor, confusion

Do not take vilazodone if you:

• Take an monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI.
  People who take vilazodone close in time to taking an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:
  • Do not take an MAOI within 14 days of stopping vilazodone.
  • Do not start vilazodone if you stopped taking an MAOI in the last 14 days.
  • high fever
  • uncontrolled muscle spasms
  • stiff muscles
  • rapid changes in heart rate or blood pressure
  • confusion
  • loss of consciousness (pass out)

• Vilazodone can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how vilazodone affects you.
• You should avoid drinking alcohol while taking vilazodone. 

You should not use vilazodone if you are being treated with methylene blue injection.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Vilazodone is not approved for use in children.

You should not use vilazodone if you are being treated with methylene blue injection.

Do not use vilazodone if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

After you stop taking vilazodone, you must wait at least 14 days before you start taking an MAOI.

Some medicines can interact with vilazodone and cause a serious condition called serotonin syndrome. Be sure your doctor knows about all other medicines you use. Ask your doctor before making any changes in how or when you take your medications.

To make sure vilazodone is safe for you, tell your doctor if you have:

• liver or kidney disease;

• a bleeding or blood clotting disorder;

• narrow-angle glaucoma;

• seizures or epilepsy;

• bipolar disorder (manic depression);

• a history of drug abuse or suicidal thoughts; or

• if you drink alcohol.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Taking an SSRI antidepressant during pregnancy may cause serious lung problems or other complications in the baby. However, you may have a relapse of depression if you stop taking your antidepressant. Tell your doctor right away if you become pregnant. Do not start or stop taking this medicine during pregnancy without your doctor's advice.

It is not known whether vilazodone passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to anyone under 18 years old without medical advice. Vilazodone is not approved for use in children.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Vilazodone works best if you take it with food.

It may take several weeks or months before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve, or if they get worse.

Do not stop using vilazodone suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using vilazodone.

Store at room temperature away from moisture and heat.

• It is used to treat low mood (depression).

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with food.
• To gain the most benefit, do not miss doses.
• Keep taking vilazodone as you have been told by your doctor or other health care provider, even if you feel well.
• It may take several weeks to see the full effects.
• Do not stop taking this medicine all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop vilazodone, you will want to slowly stop it as ordered by your doctor.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low sodium levels like headache, trouble focusing, memory problems, feeling confused, weakness, seizures, or change in balance.
• Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
• Change in how you act.
• If you are planning to harm yourself or the want to harm yourself gets worse.
• Very nervous and excitable.
• Seizures.
• A very bad and sometimes deadly health problem called serotonin syndrome may happen. The risk may be greater if you take this medicine with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.

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Refer to adult dosing.

Antidepressants increased the risk of suicidal thoughts and behavior in patients 24 years and younger in short-term studies. Monitor closely for clinical worsening and for emergence of suicidal thoughts and behaviors. The safety and efficacy of vilazodone have not been established in pediatric patients.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience insomnia, nausea, vomiting, diarrhea, dry mouth, fatigue, dizziness, headache, or abdominal pain. Have patient report immediately to prescriber signs of depression (suicidal ideation, anxiety, emotional instability, or confusion), signs of low sodium (headache, difficulty focusing, memory impairment, confusion, weakness, seizures, or change in balance), signs of bleeding (vomiting blood or vomit that looks like coffee grounds; coughing up blood; hematuria; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any severe or persistent bleeding), agitation, irritability, seizures, panic attacks, mood changes, behavioral changes, vision changes, eye pain, eye irritation, or signs of serotonin syndrome (dizziness, severe headache, agitation, hallucinations, tachycardia, abnormal heartbeat, flushing, tremors, sweating a lot, change in balance, severe nausea, or severe diarrhea) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.