Vilazodone 20mg 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 Reuptake Inhibitor and 5-HT1A Receptor Partial Agonist
Pregnancy Category
Category C
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 natural substances in the brain, particularly serotonin, to help improve mood and feelings of well-being. It's important to take this medication exactly as prescribed, especially with food, to ensure it works properly.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with food as directed. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling well.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
Missing 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 use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with food as directed. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling well.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
Missing 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 every day at approximately the same time.
- Do not stop taking vilazodone suddenly without talking to your doctor, as this can cause withdrawal symptoms.
- Avoid alcohol while taking this medication, as it can worsen side effects.
- Be aware that it may take several weeks to feel the full benefits of the medication.
- Report any new or worsening symptoms, especially changes in mood, behavior, or thoughts of self-harm, to your doctor immediately.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 10 mg once daily for 7 days, then 20 mg once daily for 7 days, then 40 mg once daily. Must be taken with food.
Dose Range:
20 - 40 mg
Condition-Specific Dosing:
Major Depressive Disorder (MDD):
Initial: 10 mg once daily for 7 days, then 20 mg once daily for 7 days, then 40 mg once daily. 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 an antidepressant that acts as a selective serotonin reuptake inhibitor (SSRI) and a partial agonist at serotonin 5-HT1A receptors. This dual mechanism is thought to contribute to its antidepressant effects.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 10% (fasted), significantly increased with food (2.5-fold increase in AUC and Cmax).
Tmax:
4-5 hours
FoodEffect:
Must be taken with food to ensure adequate absorption and bioavailability. Taking without food significantly reduces exposure.
Distribution:
Vd:
Approximately 2500 L
ProteinBinding:
>96%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 25 hours
Clearance:
Not available
ExcretionRoute:
Feces (60%), Urine (40%)
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Typically 1-2 weeks for initial antidepressant effects, full effect may take 4-6 weeks.
PeakEffect:
4-6 weeks for full therapeutic effect.
DurationOfAction:
Due to its half-life, effects persist for approximately 24 hours, allowing once-daily dosing.
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. Vilazodone is not approved for use in pediatric patients. Closely monitor all antidepressant-treated patients for clinical worsening, suicidality, or unusual changes in behavior, especially during the initial few months of treatment or when the dose is changed.
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 medical attention immediately:
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. Symptoms include:
+ Agitation
+ Changes in balance
+ Confusion
+ Hallucinations
+ Fever
+ Fast or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea
+ Upset stomach or vomiting
+ Severe headache
Other Possible Side Effects
Most people experience few or no side effects while taking this medication. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:
Trouble sleeping
Diarrhea
Stomach pain
Upset stomach or vomiting
Dry mouth
Dizziness or headache
* Feeling sleepy
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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 medical attention immediately:
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. Symptoms include:
+ Agitation
+ Changes in balance
+ Confusion
+ Hallucinations
+ Fever
+ Fast or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea
+ Upset stomach or vomiting
+ Severe headache
Other Possible Side Effects
Most people experience few or no side effects while taking this medication. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:
Trouble sleeping
Diarrhea
Stomach pain
Upset stomach or vomiting
Dry mouth
Dizziness or headache
* Feeling sleepy
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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:
- Worsening depression or anxiety
- Thoughts of suicide or self-harm
- New or severe agitation, restlessness, panic attacks, or irritability
- Difficulty sleeping (insomnia)
- Aggressive or violent behavior
- Acting on dangerous impulses
- An extreme increase in activity and talking (mania)
- Unusual changes in behavior or mood
- Symptoms of serotonin syndrome (e.g., confusion, hallucinations, rapid heart rate, fever, sweating, muscle stiffness, tremors, severe nausea, vomiting, diarrhea)
- Unusual bleeding or bruising
- Seizures
- Severe skin rash or allergic reaction
- Low sodium levels (headache, confusion, weakness, unsteadiness)
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 or methylene blue.
+ Certain antidepressants or Parkinson's disease medications within the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of very high blood pressure.
Other health problems or medications that may interact with this drug, as this is not an exhaustive list.
To ensure your safety, it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting 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 or methylene blue.
+ Certain antidepressants or Parkinson's disease medications within the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of very high blood pressure.
Other health problems or medications that may interact with this drug, as this is not an exhaustive list.
To ensure your safety, it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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.
Prior to using marijuana, other forms of cannabis, or prescription and over-the-counter (OTC) drugs that may impair your actions, consult with your doctor. Be aware that 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 to minimize potential risks.
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 your risk of bleeding after delivery and may lead to health problems in the newborn. Your doctor will help you weigh the benefits and risks to you and your baby.
Prior to using marijuana, other forms of cannabis, or prescription and over-the-counter (OTC) drugs that may impair your actions, consult with your doctor. Be aware that 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 to minimize potential risks.
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 your risk of bleeding after delivery and may lead to health problems in the newborn. Your doctor will help you weigh the benefits and risks to you and your baby.
Overdose Information
Overdose Symptoms:
- Serotonin syndrome (agitation, confusion, hallucinations, rapid heart rate, fever, sweating, muscle rigidity, tremors, nausea, vomiting, diarrhea)
- Sedation
- Lethargy
- Restlessness
- Tachycardia
- Hypertension
- Dizziness
- Dry mouth
- Insomnia
- Decreased appetite
What to Do:
Seek immediate medical attention or call 911. For poison control, call 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 stopping MAOI or starting MAOI after vilazodone.
Major Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir) - may increase vilazodone exposure; reduce vilazodone dose by half.
- Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) - may decrease vilazodone exposure; consider increasing vilazodone dose.
- Serotonergic drugs (e.g., SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, St. John's Wort) - increased risk of serotonin syndrome.
Moderate Interactions
- Drugs that prolong QT interval - theoretical risk, monitor ECG if co-administered with other QT-prolonging agents.
- Warfarin - potential for altered anticoagulation, monitor INR.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Mental Status Examination
Rationale: To establish baseline symptoms of depression, suicidality, and other psychiatric conditions.
Timing: Prior to initiation of therapy.
Electrolytes (Sodium)
Rationale: To establish baseline for hyponatremia risk, especially in elderly or those on diuretics.
Timing: Prior to initiation, if clinically indicated.
Routine Monitoring
Mental Status Examination (including suicidality)
Frequency: Weekly for the first 4 weeks, then every 2 weeks for the next 4 weeks, then periodically as clinically indicated.
Target: Improvement in depressive symptoms, absence of suicidal ideation/behavior.
Action Threshold: Worsening depression, emergence of suicidal thoughts/behaviors, or unusual changes in behavior warrant immediate re-evaluation and potential dose adjustment or discontinuation.
Signs/Symptoms of Serotonin Syndrome
Frequency: Routinely, especially when initiating therapy or increasing dose, or when co-administering with other serotonergic drugs.
Target: Absence of symptoms (agitation, hallucinations, tachycardia, fever, hyperreflexia, incoordination, nausea, vomiting, diarrhea).
Action Threshold: Presence of symptoms requires immediate medical attention and discontinuation of serotonergic agents.
Electrolytes (Sodium)
Frequency: Periodically, especially in elderly, volume-depleted patients, or those on diuretics.
Target: Normal serum sodium levels.
Action Threshold: Hyponatremia (Na < 135 mEq/L) requires investigation and potential discontinuation.
Symptom Monitoring
- Worsening depression
- Suicidal thoughts or behavior
- Unusual changes in behavior (e.g., agitation, irritability, anxiety, panic attacks, insomnia, impulsivity, akathisia, hypomania, mania)
- Symptoms of serotonin syndrome (e.g., agitation, confusion, hallucinations, rapid heart rate, fever, sweating, muscle rigidity, tremors, nausea, vomiting, diarrhea)
- Gastrointestinal upset (nausea, diarrhea)
- Insomnia
- Dizziness
- Sexual dysfunction
Special Patient Groups
Pregnancy
Category C. 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. These complications can arise immediately upon delivery.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally considered low risk for major malformations compared to other trimesters.
Second Trimester:
Not available
Third Trimester:
Risk of neonatal complications (e.g., respiratory distress, feeding difficulties, jitteriness, persistent pulmonary hypertension of the newborn (PPHN)).
Lactation
It is unknown if vilazodone is excreted in human milk. Due to the potential for serious adverse reactions in a breastfed infant, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Risk is unknown; potential for adverse effects on the infant. Monitor for sedation, poor feeding, and weight gain.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Vilazodone carries a Black Box Warning regarding increased risk of suicidal thoughts and behavior in children, adolescents, and young adults treated with antidepressants.
Geriatric Use
No dose adjustment is specifically recommended based on age. However, elderly patients may be at increased risk for hyponatremia and should be monitored. Use with caution due to potential for increased sensitivity to adverse effects.
Clinical Information
Clinical Pearls
- Always instruct patients to take vilazodone with food to maximize absorption and efficacy. Taking it without food can significantly reduce its effectiveness.
- Titrate the dose slowly to minimize gastrointestinal side effects (nausea, diarrhea), which are common during initiation.
- Educate patients and caregivers about the Black Box Warning for suicidality, especially during the initial weeks of treatment or dose changes.
- Vilazodone's dual mechanism (SSRI + 5-HT1A partial agonist) may offer a different profile compared to traditional SSRIs for some patients.
- Monitor for symptoms of serotonin syndrome, particularly when co-administered with other serotonergic agents.
- Avoid abrupt discontinuation to prevent withdrawal symptoms; taper dose gradually under medical supervision.
Alternative Therapies
- Other SSRIs (e.g., escitalopram, sertraline, fluoxetine)
- SNRIs (e.g., venlafaxine, duloxetine)
- Atypical antidepressants (e.g., bupropion, mirtazapine)
- Tricyclic antidepressants (TCAs)
- MAOIs (less common due to interaction profile)
- Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT)
Cost & Coverage
Average Cost:
$300 - $500 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for generic), Tier 3 or Tier 4 (for brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult 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.