Vilazodone 10mg Tablets
WARNING: Drugs like this one have raised the chance of suicidal thoughts or actions in children and young adults. The risk may be greater in people who have had these thoughts or actions in the past. All people who take this drug need to be watched closely. Call the doctor right away if signs like depression, nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.This drug is not approved for use in children. Talk with the doctor. @ COMMON USES: It is used to treat depression.
Drug Class
Antidepressant
Pharmacologic Class
Serotonin Partial Agonist/Reuptake Inhibitor (SPARI)
Pregnancy Category
Not available
FDA Approved
Jan 2011
DEA Schedule
Not Controlled
Overview
What is this medicine?
Vilazodone is a medication used to treat depression. It works by affecting certain chemicals in the brain, primarily serotonin, to help improve mood and feelings of well-being. It's important to take this medication exactly as prescribed, and always with food.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. It's recommended to take this medication with food.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better. This will help ensure that you receive the full benefits of the treatment.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature in a dry location, avoiding the bathroom. Keep all medications in a secure place, out of the reach of children and pets.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless specifically instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to inquire about drug take-back programs in your area, which can provide a safe and responsible way to dispose of unwanted medications.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. It's recommended to take this medication with food.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better. This will help ensure that you receive the full benefits of the treatment.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature in a dry location, avoiding the bathroom. Keep all medications in a secure place, out of the reach of children and pets.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless specifically instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to inquire about drug take-back programs in your area, which can provide a safe and responsible way to dispose of unwanted medications.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take vilazodone with food (a meal or substantial snack) to ensure proper absorption and effectiveness. Taking it without food can significantly reduce how much medication your body absorbs.
- Do not stop taking vilazodone suddenly without talking to your doctor, as this can cause withdrawal symptoms.
- Avoid alcohol while taking vilazodone, as it can worsen side effects like drowsiness or dizziness.
- Be cautious when driving or operating machinery until you know how vilazodone affects you, as it may cause dizziness or drowsiness.
- Inform your doctor about all other medications, supplements, and herbal products you are taking, especially St. John's Wort, as interactions can occur.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 10 mg once daily for 7 days. Maintenance: 20 mg once daily. May increase to 40 mg once daily if needed. Must be taken with food.
Dose Range:
10 - 40 mg
Condition-Specific Dosing:
Major Depressive Disorder (MDD):
Initial: 10 mg once daily for 7 days. Maintenance: 20 mg once daily. May increase to 40 mg once daily if needed. Must be taken with food.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed.
Moderate:
No dose adjustment needed.
Severe:
Not studied, use with caution.
Dialysis:
Not studied, use with caution.
Hepatic Impairment:
Mild:
No dose adjustment needed.
Moderate:
No dose adjustment needed.
Severe:
Not studied, use with caution.
Pharmacology
Mechanism of Action
Vilazodone is a selective serotonin reuptake inhibitor (SSRI) and a 5-HT1A receptor partial agonist. It is believed that the antidepressant effects are mediated by its enhancement of serotonergic activity in the central nervous system through these combined actions.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 10% (fasted); approximately 72% (with food)
Tmax:
4-5 hours (with food)
FoodEffect:
Food significantly increases bioavailability and Cmax. Must be taken with food.
Distribution:
Vd:
Not available
ProteinBinding:
>99%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 25 hours
Clearance:
Not available
ExcretionRoute:
Feces (60%), Urine (36%)
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Typically 1-2 weeks for initial therapeutic effects, full effect may take 4-6 weeks.
PeakEffect:
4-6 weeks
DurationOfAction:
Due to long half-life, once daily dosing provides sustained effect.
Safety & Warnings
BLACK BOX WARNING
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of vilazodone or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Vilazodone is not approved for use in pediatric patients.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels, including:
+ Headache
+ Difficulty focusing
+ Memory problems
+ Confusion
+ Weakness
+ Seizures
+ Changes in balance
Signs of bleeding, such as:
+ Vomiting or coughing up blood
+ Vomit that resembles coffee grounds
+ Blood in the urine
+ Black, red, or tarry stools
+ Bleeding from the gums
+ Abnormal vaginal bleeding
+ Unexplained bruises or bruises that enlarge
+ Uncontrollable bleeding
Seizures
Sex-related problems, including:
+ Decreased interest in sex
+ Difficulty having an orgasm
+ Ejaculation problems
+ Trouble getting or maintaining an erection
Serotonin syndrome, a potentially life-threatening condition, which may be more likely to occur if you are taking certain other medications. Seek immediate medical attention if you experience:
+ Agitation
+ Changes in balance
+ Confusion
+ Hallucinations
+ Fever
+ Rapid or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea
+ Upset stomach
+ Vomiting
+ Severe headache
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or persist:
Trouble sleeping
Diarrhea
Stomach pain
Upset stomach
Vomiting
Dry mouth
Dizziness
Headache
* Feeling sleepy
This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels, including:
+ Headache
+ Difficulty focusing
+ Memory problems
+ Confusion
+ Weakness
+ Seizures
+ Changes in balance
Signs of bleeding, such as:
+ Vomiting or coughing up blood
+ Vomit that resembles coffee grounds
+ Blood in the urine
+ Black, red, or tarry stools
+ Bleeding from the gums
+ Abnormal vaginal bleeding
+ Unexplained bruises or bruises that enlarge
+ Uncontrollable bleeding
Seizures
Sex-related problems, including:
+ Decreased interest in sex
+ Difficulty having an orgasm
+ Ejaculation problems
+ Trouble getting or maintaining an erection
Serotonin syndrome, a potentially life-threatening condition, which may be more likely to occur if you are taking certain other medications. Seek immediate medical attention if you experience:
+ Agitation
+ Changes in balance
+ Confusion
+ Hallucinations
+ Fever
+ Rapid or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea
+ Upset stomach
+ Vomiting
+ Severe headache
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or persist:
Trouble sleeping
Diarrhea
Stomach pain
Upset stomach
Vomiting
Dry mouth
Dizziness
Headache
* Feeling sleepy
This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- New or worsening depression, anxiety, or panic attacks
- Thoughts about self-harm or suicide
- Extreme restlessness or agitation
- Unusual changes in behavior or mood (e.g., irritability, aggression, impulsivity, mania)
- Symptoms of serotonin syndrome: fast heartbeat, sweating, muscle stiffness or spasms, fever, confusion, severe nausea/vomiting/diarrhea, hallucinations, unsteadiness
- Unusual bleeding or bruising
- Seizures
- Severe allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
If you have been diagnosed with glaucoma.
* If you are currently taking or have recently taken certain medications, including:
+ Linezolid
+ Methylene blue
+ Specific drugs for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, within the last 14 days. Taking these medications with this drug may lead to very high blood pressure.
Please note that this is not an exhaustive list of all potential interactions. It is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure your safety while taking this medication.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
If you have been diagnosed with glaucoma.
* If you are currently taking or have recently taken certain medications, including:
+ Linezolid
+ Methylene blue
+ Specific drugs for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, within the last 14 days. Taking these medications with this drug may lead to very high blood pressure.
Please note that this is not an exhaustive list of all potential interactions. It is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure your safety while taking this medication.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you. Additionally, avoid consuming alcohol while taking this medication.
Before using marijuana, other forms of cannabis, or prescription or over-the-counter (OTC) drugs that may cause drowsiness, consult with your doctor. It may take several weeks to experience the full effects of this medication.
Do not abruptly stop taking this drug without first consulting your doctor, as this may increase your risk of side effects. If you need to discontinue this medication, your doctor will instruct you on how to gradually stop taking it.
This medication may increase the risk of bleeding, which can be life-threatening in some cases. Discuss this risk with your doctor. Certain individuals may have a higher risk of developing eye problems while taking this drug. Your doctor may recommend an eye exam to assess your risk. If you experience eye pain, changes in vision, or swelling and redness in or around the eye, contact your doctor immediately.
Low blood sodium levels (hyponatremia) can occur with this medication, and in severe cases, this can be fatal. Discuss this risk with your doctor. If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the benefits and risks of taking this medication during pregnancy and breastfeeding. Taking this drug during the third trimester of pregnancy may increase the risk of bleeding after delivery and may cause health problems in the newborn. If you are breastfeeding, discuss any potential risks to your baby with your doctor.
Before using marijuana, other forms of cannabis, or prescription or over-the-counter (OTC) drugs that may cause drowsiness, consult with your doctor. It may take several weeks to experience the full effects of this medication.
Do not abruptly stop taking this drug without first consulting your doctor, as this may increase your risk of side effects. If you need to discontinue this medication, your doctor will instruct you on how to gradually stop taking it.
This medication may increase the risk of bleeding, which can be life-threatening in some cases. Discuss this risk with your doctor. Certain individuals may have a higher risk of developing eye problems while taking this drug. Your doctor may recommend an eye exam to assess your risk. If you experience eye pain, changes in vision, or swelling and redness in or around the eye, contact your doctor immediately.
Low blood sodium levels (hyponatremia) can occur with this medication, and in severe cases, this can be fatal. Discuss this risk with your doctor. If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the benefits and risks of taking this medication during pregnancy and breastfeeding. Taking this drug during the third trimester of pregnancy may increase the risk of bleeding after delivery and may cause health problems in the newborn. If you are breastfeeding, discuss any potential risks to your baby with your doctor.
Overdose Information
Overdose Symptoms:
- Serotonin syndrome (agitation, confusion, rapid heart rate, sweating, muscle rigidity, tremors, seizures)
- Drowsiness
- Nausea
- Vomiting
- Diarrhea
- Dizziness
- Hypotension
- Hallucinations
- Bradycardia
- QTc prolongation
What to Do:
Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic. There is no specific antidote.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of discontinuing MAOIs or starting MAOIs within 14 days of discontinuing vilazodone.
Major Interactions
- Serotonergic drugs (e.g., other SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, St. John's Wort) - increased risk of serotonin syndrome.
- Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir) - may significantly increase vilazodone exposure; reduce vilazodone dose by half.
- Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital) - may significantly decrease vilazodone exposure; consider increasing vilazodone dose.
Monitoring
Baseline Monitoring
Psychiatric evaluation (diagnosis, symptom severity)
Rationale: To establish baseline and confirm diagnosis of MDD.
Timing: Prior to initiation of therapy.
Assessment for suicidal ideation/behavior
Rationale: Antidepressants carry a black box warning for increased risk of suicidality in young adults.
Timing: Prior to initiation and throughout therapy.
Routine Monitoring
Efficacy (symptom improvement)
Frequency: Weekly for first few weeks, then monthly or as clinically indicated.
Target: Reduction in depressive symptoms (e.g., HAM-D, MADRS scores).
Action Threshold: Lack of improvement after adequate trial (4-6 weeks) may warrant dose adjustment or change in therapy.
Side effects (e.g., nausea, diarrhea, insomnia, sexual dysfunction)
Frequency: Regularly, especially during dose titration and initial weeks.
Target: Tolerable side effect profile.
Action Threshold: Intolerable side effects may require dose reduction or discontinuation.
Suicidal ideation/behavior
Frequency: Regularly, especially in children, adolescents, and young adults, and during dose changes.
Target: Absence of new or worsening suicidal thoughts/behaviors.
Action Threshold: Any emergence or worsening requires immediate clinical assessment and intervention.
Weight
Frequency: Periodically
Target: Stable weight or clinically acceptable changes.
Action Threshold: Significant weight gain or loss may require intervention.
Blood pressure
Frequency: Periodically
Target: Within normal limits.
Action Threshold: Significant changes may require intervention.
Symptom Monitoring
- Worsening depression
- Suicidal thoughts or behavior
- Unusual changes in behavior (e.g., agitation, irritability, anxiety, panic attacks, insomnia, impulsivity, aggression, mania/hypomania)
- Symptoms of serotonin syndrome (e.g., agitation, hallucinations, delirium, coma, tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia, tremor, rigidity, myoclonus, hyperreflexia, incoordination, GI symptoms)
- Abnormal bleeding or bruising
- Hyponatremia (headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, seizures, falls)
- Gastrointestinal upset (nausea, diarrhea)
Special Patient Groups
Pregnancy
Limited data on vilazodone use in pregnant women. Studies in animals have shown adverse effects. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to SSRIs/SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of major congenital malformations, though data are limited and inconsistent for SSRIs in general.
Second Trimester:
Not well studied specifically for vilazodone.
Third Trimester:
Risk of persistent pulmonary hypertension of the newborn (PPHN) and neonatal withdrawal syndrome (e.g., respiratory distress, feeding difficulties, irritability, tremor, hypotonia).
Lactation
Vilazodone is excreted into breast milk. The amount is low, but potential for adverse effects on the infant exists. Monitor breastfed infants for sedation, poor feeding, and poor weight gain. Use with caution, or consider alternatives.
Infant Risk:
Low to moderate risk. Monitor for sedation, irritability, poor feeding, and weight gain.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients for Major Depressive Disorder. Antidepressants increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Use with caution due to potential for age-related decreases in renal or hepatic function and increased risk of hyponatremia and falls.
Clinical Information
Clinical Pearls
- Vilazodone MUST be taken with food (a meal or substantial snack) to ensure adequate absorption. Taking it on an empty stomach can lead to significantly reduced drug levels and decreased efficacy.
- Titration is essential: Start with 10 mg for 7 days before increasing to 20 mg, and then potentially 40 mg. This helps minimize gastrointestinal side effects.
- Common side effects include diarrhea, nausea, insomnia, and vomiting, especially during the initial titration phase.
- As with other antidepressants, monitor for signs of serotonin syndrome, especially when co-administered with other serotonergic agents.
- Discontinuation syndrome can occur if vilazodone is stopped abruptly. Tapering the dose gradually is recommended when discontinuing therapy.
Alternative Therapies
- Selective Serotonin Reuptake Inhibitors (SSRIs) e.g., fluoxetine, sertraline, escitalopram
- Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) e.g., venlafaxine, duloxetine
- Atypical antidepressants e.g., bupropion, mirtazapine
- Tricyclic Antidepressants (TCAs) e.g., amitriptyline, nortriptyline
- Monoamine Oxidase Inhibitors (MAOIs) e.g., phenelzine, tranylcypromine (reserved for refractory cases)
Cost & Coverage
Average Cost:
$100 - $200 per 30 tablets (generic 10mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, don't hesitate to consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, don't hesitate to consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.