Viibryd 20mg Tablets

Manufacturer ACTAVIS Active Ingredient Vilazodone(vil AZ oh done) Pronunciation VYE-brid (for Viibryd); vil-AZ-oh-done (for vilazodone)
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.
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Drug Class
Antidepressant
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Pharmacologic Class
Serotonin Partial Agonist/Reuptake Inhibitor (SPARI)
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Pregnancy Category
Not available
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FDA Approved
Jan 2011
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Viibryd is a medication used to treat depression. It works by affecting certain natural substances in the brain, primarily serotonin, to help improve mood. It's important to take this medication exactly as prescribed, especially with food, to ensure it works properly.
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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 to feel better.

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 dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Always take Viibryd with food. Taking it without food can significantly reduce how much medication your body absorbs, making it less effective.
  • Do not stop taking Viibryd suddenly without talking to your doctor, as this can cause withdrawal symptoms.
  • Avoid alcohol while taking Viibryd, as it can worsen side effects like dizziness or drowsiness.
  • Be cautious when driving or operating machinery until you know how Viibryd 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.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 10 mg orally once daily for 7 days, then increase to 20 mg orally once daily. Must be taken with food.
Dose Range: 10 - 40 mg

Condition-Specific Dosing:

Major Depressive Disorder (MDD): Initial: 10 mg orally once daily for 7 days, then increase to 20 mg orally once daily. May increase to 40 mg orally once daily if needed and tolerated. Must be taken with food.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No dose adjustment necessary.
Moderate: No dose adjustment necessary.
Severe: Use with caution; no specific dose recommendations available. Consider maximum dose of 20 mg/day.
Dialysis: Not studied; use with caution.

Hepatic Impairment:

Mild: No dose adjustment necessary.
Moderate: No dose adjustment necessary.
Severe: Maximum recommended dose is 20 mg orally once daily. Use with caution.

Pharmacology

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Mechanism of Action

Vilazodone is a selective serotonin reuptake inhibitor (SSRI) and a partial agonist at serotonin 5-HT1A receptors. It is believed that the combination of these two activities contributes to its antidepressant effects.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 10% (fasted), approximately 72% (with food)
Tmax: 4-5 hours
FoodEffect: Food significantly increases the absorption of vilazodone (AUC and Cmax increase by approximately 160% and 70%, respectively, when taken with food compared to fasted state). Must be taken with food.

Distribution:

Vd: Approximately 2500 L
ProteinBinding: >96%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 10 hours
Clearance: Not available
ExcretionRoute: Feces (61%), urine (35%)
Unchanged: <1% (in urine)
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Pharmacodynamics

OnsetOfAction: Typically 1-2 weeks for initial antidepressant effects, full effect may take 4-6 weeks.
PeakEffect: Not precisely defined for clinical effect; relates to steady-state plasma concentrations achieved after 4-5 days of dosing.
DurationOfAction: Maintained with once-daily dosing due to half-life.

Safety & Warnings

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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 Viibryd 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.
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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 or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels, including:
+ Headache
+ Trouble focusing or memory problems
+ Feeling confused or weak
+ Seizures or 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 get bigger
+ Uncontrollable bleeding
Seizures
Sex 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 that may occur, especially if you take certain other medications. Call your doctor right away if you experience:
+ Agitation
+ Changes in balance
+ Confusion
+ Hallucinations
+ Fever
+ Fast or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea, stomach upset, or vomiting
+ Severe headache

Other Possible Side Effects

Most people do not experience severe side effects, and some may have only minor side effects. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

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.
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Seek Immediate Medical Attention If You Experience:

  • Worsening depression or new suicidal thoughts/behaviors, especially in the first few weeks of treatment or after a dose change.
  • Symptoms of serotonin syndrome: agitation, hallucinations, confusion, fast heart rate, fever, sweating, shivering, muscle stiffness or twitching, loss of coordination, nausea, vomiting, diarrhea.
  • Symptoms of hyponatremia (low sodium): headache, confusion, weakness, unsteadiness, memory problems, seizures.
  • Unusual bleeding or bruising.
  • Symptoms of a manic episode: greatly increased energy, severe trouble sleeping, racing thoughts, reckless behavior, unusually grand ideas, excessive happiness or irritability.
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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 symptoms 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 medications, including prescription and over-the-counter drugs, natural products, and vitamins, as this is not an exhaustive list of potential interactions.

To ensure your safety, it is crucial to discuss all your medications and health conditions with your doctor and pharmacist. They will help determine if 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.
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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 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 of taking this medication while breastfeeding.
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Overdose Information

Overdose Symptoms:

  • Serotonin syndrome (as described above)
  • Nausea
  • Vomiting
  • Diarrhea
  • Lethargy
  • Restlessness
  • Hallucinations
  • Disorientation
  • Tachycardia
  • Hypertension
  • Hypotension
  • Syncope
  • Seizures
  • Coma

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic. There is no specific antidote.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (e.g., phenelzine, tranylcypromine, selegiline, linezolid, methylene blue) - risk of serotonin syndrome. Allow at least 14 days between discontinuing an MAOI and starting vilazodone, and 14 days between discontinuing vilazodone and starting an MAOI.
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Major Interactions

  • Strong CYP3A4 Inhibitors (e.g., ketoconazole, clarithromycin, ritonavir): Reduce vilazodone dose by half (e.g., from 40 mg to 20 mg, or from 20 mg to 10 mg).
  • Strong CYP3A4 Inducers (e.g., rifampin, carbamazepine, phenytoin): Increase vilazodone dose (e.g., from 20 mg to 40 mg).
  • Other Serotonergic Drugs (e.g., SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan, St. John's Wort): Increased risk of serotonin syndrome.
  • Drugs that impair platelet aggregation (e.g., NSAIDs, aspirin, warfarin): Increased risk of bleeding.
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Moderate Interactions

  • Moderate CYP3A4 Inhibitors (e.g., erythromycin, diltiazem, verapamil): Monitor for increased vilazodone effects.
  • Moderate CYP3A4 Inducers (e.g., efavirenz, bosentan): Monitor for decreased vilazodone efficacy.
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Minor Interactions

  • Not specifically defined for minor interactions; generally, monitor for additive CNS effects with other CNS depressants.

Monitoring

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Baseline Monitoring

Depression severity (e.g., PHQ-9, HAM-D)

Rationale: To establish baseline and monitor treatment efficacy.

Timing: Prior to initiation

Suicidal ideation/behavior

Rationale: Antidepressants carry a Black Box Warning for increased risk of suicidality in young adults.

Timing: Prior to initiation

Electrolytes (especially sodium)

Rationale: To assess baseline for risk of hyponatremia, particularly in elderly or those on diuretics.

Timing: Prior to initiation (consider in at-risk patients)

Liver and renal function tests

Rationale: To guide dosing adjustments in patients with severe impairment.

Timing: Prior to initiation (if clinically indicated)

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Routine Monitoring

Depression severity and clinical response

Frequency: Weekly for first 4-6 weeks, then monthly or as clinically indicated.

Target: Reduction in symptom scores, improved mood and functioning.

Action Threshold: Lack of improvement or worsening symptoms may require dose adjustment or alternative therapy.

Emergence or worsening of suicidal thoughts/behaviors

Frequency: Especially during initial treatment and dose changes.

Target: Absence of suicidal ideation/behavior.

Action Threshold: Immediate clinical assessment and intervention if observed.

Side effects (e.g., nausea, diarrhea, insomnia, sexual dysfunction)

Frequency: Regularly, especially during titration and initial weeks.

Target: Tolerable side effect profile.

Action Threshold: Severe or intolerable side effects may require dose reduction or discontinuation.

Serum sodium levels

Frequency: Periodically, especially in elderly, volume-depleted, or those on diuretics.

Target: 135-145 mEq/L

Action Threshold: <135 mEq/L (hyponatremia) requires investigation and management.

Blood pressure and heart rate

Frequency: Periodically, as some antidepressants can affect cardiovascular parameters.

Target: Within normal limits for patient.

Action Threshold: Significant changes may require intervention.

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Symptom Monitoring

  • Worsening depression
  • Suicidal thoughts or attempts
  • Unusual changes in behavior or mood (e.g., agitation, irritability, anxiety, panic attacks, insomnia, aggression, impulsivity, akathisia, hypomania, mania)
  • Serotonin syndrome symptoms (e.g., agitation, hallucinations, delirium, coma, tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia, tremor, rigidity, myoclonus, hyperreflexia, incoordination, GI symptoms)
  • Hyponatremia symptoms (e.g., headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, hallucinations, syncope, seizures, coma)
  • Abnormal bleeding or bruising
  • Gastrointestinal upset (nausea, diarrhea, vomiting)
  • Insomnia or somnolence
  • Sexual dysfunction

Special Patient Groups

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Pregnancy

Vilazodone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. 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; potential for increased risk of some congenital malformations with SSRIs, but data for vilazodone specifically is limited.
Second Trimester: Potential for persistent pulmonary hypertension of the newborn (PPHN) if exposed late in pregnancy (though data for vilazodone is limited, this is a class effect for SSRIs).
Third Trimester: Risk of neonatal withdrawal syndrome (e.g., respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, constant crying).
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Lactation

Vilazodone is present in human milk. The effects on the breastfed infant and on milk production are unknown. 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: L3 (Moderately Safe) - Monitor breastfed infants for adverse effects such as sedation, irritability, poor feeding, and poor weight gain. Consider alternative agents with more established safety data if possible.
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Pediatric Use

Safety and effectiveness in pediatric patients (under 18 years of age) have not been established. Antidepressants, including vilazodone, increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults.

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Geriatric Use

No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients may be at increased risk for hyponatremia (low sodium levels) when treated with vilazodone. A lower starting dose (10 mg) may be considered for some elderly patients.

Clinical Information

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Clinical Pearls

  • Vilazodone MUST be taken with food. Taking it without food significantly reduces its absorption and effectiveness.
  • The initial 10 mg dose for 7 days is a titration step to improve tolerability; patients should then increase to 20 mg daily.
  • Like other antidepressants, vilazodone should not be stopped abruptly due to the risk of discontinuation syndrome (e.g., dizziness, sensory disturbances, agitation, anxiety, nausea, sweating, tremor, confusion). Tapering is recommended.
  • Monitor for symptoms of serotonin syndrome, especially when co-administered with other serotonergic agents.
  • Be aware of the Black Box Warning regarding increased risk of suicidality in children, adolescents, and young adults.
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Alternative Therapies

  • Other Selective Serotonin Reuptake Inhibitors (SSRIs) (e.g., fluoxetine, sertraline, escitalopram, citalopram, paroxetine)
  • Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) (e.g., venlafaxine, duloxetine, desvenlafaxine)
  • Atypical Antidepressants (e.g., bupropion, mirtazapine, vortioxetine)
  • Tricyclic Antidepressants (TCAs)
  • Monoamine Oxidase Inhibitors (MAOIs)
  • Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT)
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Cost & Coverage

Average Cost: $300 - $500 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (Brand), Tier 1 (Generic)
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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 you receive a refill of this medication. 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 seeking help, be prepared to provide details about the overdose, including the substance taken, the amount, and the time it occurred.