Viibryd 40mg Tablets

Manufacturer ACTAVIS Active Ingredient Vilazodone(vil AZ oh done) Pronunciation vil AZ oh done
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
Category C
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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?

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.
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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 this medication with food as directed. Continue taking the medication as prescribed by your doctor or healthcare provider, even if you start feeling well.

Storing and Disposing of Your Medication

Store this medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a safe place, 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 medications, 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.
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Lifestyle & Tips

  • Always take vilazodone with food. Taking it without food can significantly reduce its absorption and effectiveness.
  • 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 cautious when driving or operating machinery until you know how this medication 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, triptans, or other antidepressants, to avoid serious interactions like serotonin syndrome.
  • Report any new or worsening symptoms, especially changes in mood, behavior, or suicidal thoughts, to your doctor immediately.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 20 mg once daily, titrated from 10 mg
Dose Range: 10 - 40 mg

Condition-Specific Dosing:

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

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established (Safety and efficacy not established in pediatric patients for MDD)
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment needed
Moderate: No dosage adjustment needed
Severe: No dosage adjustment needed
Dialysis: No specific recommendations; vilazodone is highly protein-bound and unlikely to be removed by dialysis.

Hepatic Impairment:

Mild: No dosage adjustment needed
Moderate: Maximum recommended dose is 20 mg once daily
Severe: Maximum recommended dose is 20 mg once daily

Pharmacology

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Mechanism of Action

Vilazodone is an antidepressant that acts as a selective serotonin reuptake inhibitor (SSRI) and a 5-HT1A receptor partial agonist. The combination of these two activities is thought to contribute to its antidepressant effects.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 10% (fasted), 72% (with food)
Tmax: 4-5 hours
FoodEffect: Absorption is significantly increased (approximately 72% bioavailability) when taken with food. Must be taken with food.

Distribution:

Vd: 2571 L
ProteinBinding: Approximately 96-99%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 25 hours
Clearance: Not available
ExcretionRoute: Feces (60%), Urine (36%)
Unchanged: Not available
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Pharmacodynamics

OnsetOfAction: Typically 1-2 weeks for initial therapeutic effects, full effect may take 4-6 weeks.
PeakEffect: 4-6 weeks for maximal antidepressant effect.
DurationOfAction: Due to its half-life, effects persist for approximately 24 hours, allowing once-daily dosing.
Confidence: Medium

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. Viibryd is not approved for use in pediatric patients.
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Side Effects

Urgent Side Effects: Seek Medical Help Immediately

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 right away:

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
+ Trouble focusing
+ Memory problems
+ Feeling confused
+ 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 medical help immediately 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
+ Upset stomach
+ Vomiting
+ Severe headache

Other Possible Side Effects

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

Trouble sleeping
Diarrhea
Stomach pain
Upset stomach
Vomiting
Dry mouth
Dizziness
Headache
* Feeling sleepy

Reporting 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:

  • Signs of Serotonin Syndrome: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness or twitching, loss of coordination, nausea, vomiting, diarrhea.
  • New or worsening depression, anxiety, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, restlessness, or suicidal thoughts/behavior.
  • Symptoms of an allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
  • Unusual bleeding or bruising.
  • Seizures.
  • Symptoms of hyponatremia (low sodium): headache, confusion, weakness, unsteadiness, memory problems, severe drowsiness, seizures.
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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 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 medications for Parkinson's disease within the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of very high blood pressure.

Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to discuss all of your:

Prescription and over-the-counter (OTC) medications.
Natural products.
Vitamins.
* Health problems.

with your doctor and pharmacist. They will help determine whether it is safe for you to take this medication in combination with your other medications and health conditions. Never start, stop, or adjust the dosage 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.

Prior to using marijuana, other cannabis products, or prescription and over-the-counter (OTC) medications 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 medication 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.

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 be more prone to eye problems while taking this medication. Your doctor may recommend an eye exam to assess your risk. Immediately contact your doctor if you experience eye pain, changes in vision, or swelling and redness in or around the eye.

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, planning to become pregnant, or may be pregnant, inform your doctor. You will need to discuss the benefits and risks of taking this medication during pregnancy, as it may increase the risk of bleeding after delivery and cause health problems in the newborn, particularly if taken during the third trimester.

If you are breastfeeding, inform your doctor to discuss any potential risks to your baby.
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Overdose Information

Overdose Symptoms:

  • Serotonin syndrome symptoms (see above)
  • Sedation
  • Lethargy
  • Restlessness
  • Agitation
  • Tachycardia
  • Hypertension
  • Nausea
  • Vomiting
  • Diarrhea
  • Dizziness
  • Mydriasis
  • Tremor
  • Seizures
  • Coma

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

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Major Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (e.g., phenelzine, selegiline, linezolid, methylene blue) - risk of serotonin syndrome.
  • Pimozide (risk of QT prolongation, though not a direct interaction with vilazodone, generally avoided with drugs affecting serotonin).
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Moderate Interactions

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir) - may increase vilazodone exposure; consider dose reduction.
  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) - may decrease vilazodone exposure; consider dose increase.
  • Strong CYP2C19 inhibitors (e.g., omeprazole, fluoxetine) - may increase vilazodone exposure; consider dose reduction.
  • Serotonergic drugs (e.g., other SSRIs, SNRIs, triptans, fentanyl, lithium, tramadol, St. John's Wort, buspirone) - increased risk of serotonin syndrome.
  • Drugs that impair metabolism of serotonin (e.g., dextromethorphan, meperidine) - increased risk of serotonin syndrome.
  • Anticoagulants/Antiplatelets (e.g., warfarin, aspirin, NSAIDs) - increased risk of bleeding due to SSRI effect on platelet aggregation.

Monitoring

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Baseline Monitoring

Diagnosis of MDD

Rationale: Confirm appropriate indication for treatment.

Timing: Prior to initiation

Suicidal ideation/behavior assessment

Rationale: Antidepressants can increase risk of suicidal thoughts and behavior in young adults.

Timing: Prior to initiation

History of mania/hypomania

Rationale: To assess risk of mood switching in bipolar disorder.

Timing: Prior to initiation

Renal and Hepatic function tests

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

Timing: Prior to initiation

Electrolytes (Sodium)

Rationale: To assess baseline for hyponatremia risk, especially in elderly.

Timing: Prior to initiation

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Routine Monitoring

Clinical response to treatment (e.g., HAM-D, PHQ-9 scores)

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

Target: Reduction in symptom severity

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

Emergence of suicidal ideation or unusual changes in behavior

Frequency: Especially during initial treatment and dose changes, then regularly

Target: Absence of new or worsening suicidal thoughts/behaviors

Action Threshold: Immediate clinical evaluation and intervention if observed.

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

Frequency: Regularly, especially during titration

Target: Tolerable side effect profile

Action Threshold: Significant or intolerable side effects may require dose adjustment or discontinuation.

Signs/symptoms of Serotonin Syndrome (e.g., agitation, hallucinations, tachycardia, fever, hyperreflexia)

Frequency: Regularly, especially when co-administered with other serotonergic drugs

Target: Absence of symptoms

Action Threshold: Immediate discontinuation of vilazodone and supportive care if suspected.

Blood pressure and heart rate

Frequency: Periodically

Target: Within normal limits

Action Threshold: Significant changes may warrant investigation.

Weight

Frequency: Periodically

Target: Stable or within healthy range

Action Threshold: Significant weight changes may require intervention.

Serum Sodium

Frequency: Periodically, especially in elderly or those on diuretics

Target: 135-145 mEq/L

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

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Symptom Monitoring

  • Worsening depression
  • Suicidal thoughts or attempts
  • Unusual changes in behavior (e.g., agitation, irritability, anxiety, panic attacks, insomnia, aggression, impulsivity, akathisia, hypomania, mania)
  • Symptoms of Serotonin Syndrome (e.g., mental status changes, autonomic instability, neuromuscular abnormalities, gastrointestinal symptoms)
  • Abnormal bleeding or bruising
  • Seizures
  • Hyponatremia symptoms (e.g., headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, falls, severe and more acute symptoms include hallucinations, syncope, seizure, coma, respiratory arrest)

Special Patient Groups

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Pregnancy

Use during pregnancy should only be considered 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 not associated with major congenital malformations.
Second Trimester: Limited data.
Third Trimester: Risk of persistent pulmonary hypertension of the newborn (PPHN) and neonatal withdrawal/toxicity syndrome (e.g., respiratory distress, feeding difficulties, irritability, tremor, hypotonia, constant crying).
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Lactation

Vilazodone is excreted into breast milk. The decision to breastfeed should consider the developmental and health benefits of breastfeeding, the mother’s clinical need for vilazodone, and any potential adverse effects on the breastfed infant from vilazodone or from the underlying maternal condition.

Infant Risk: L3 (Moderate risk - monitor infant for sedation, poor feeding, and weight gain).
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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.

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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. Elderly patients may be at increased risk for hyponatremia and falls. Use with caution and monitor closely.

Clinical Information

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Clinical Pearls

  • Vilazodone MUST be taken with food. Taking it without food significantly reduces its absorption and effectiveness, leading to treatment failure.
  • Titration is crucial: Start with 10 mg for 7 days, then increase to 20 mg. If needed, increase to 40 mg after another 7 days. This helps minimize gastrointestinal side effects.
  • Common side effects include nausea, diarrhea, insomnia, and vomiting, especially during the initial titration phase. Taking with a substantial meal can help mitigate GI upset.
  • As with other serotonergic antidepressants, monitor for serotonin syndrome, especially when co-administered with other serotonergic agents.
  • Vilazodone has a low risk of weight gain and sexual dysfunction compared to some other antidepressants, which can be a benefit for some patients.
  • Discontinuation syndrome can occur if stopped abruptly; taper dose gradually under medical supervision.
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Alternative Therapies

  • SSRIs (e.g., escitalopram, sertraline, fluoxetine)
  • SNRIs (e.g., venlafaxine, duloxetine)
  • Atypical antidepressants (e.g., bupropion, mirtazapine)
  • Other SPARI (e.g., vortioxetine)
  • Tricyclic Antidepressants (TCAs)
  • Monoamine Oxidase Inhibitors (MAOIs)
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Cost & Coverage

Average Cost: $300 - $500 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (preferred or non-preferred brand/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 your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, we encourage you to discuss them 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 seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.